Retail Sales of Scheduled Listed Chemical Products; Self-Certification of Regulated Sellers of Scheduled Listed Chemical Products, 56008-56027 [06-8194]
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Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Rules and Regulations
The basis of approval is discussed in the
freedom of information summary.
In addition, FDA is amending
§ 558.311 to remove redundant text in
an entry for combination use of singleingredient lasalocid and
chlortetracycline in cattle feed which
was published in error in the Federal
Register of April 27, 2006 (71 FR
24816). This correction is being made to
improve the accuracy of the regulations.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
The agency has determined under 21
CFR 25.33(a)(6) that this action is of a
type that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 558 is amended as follows:
I
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
I
Authority: 21 U.S.C. 360b, 371.
§ 558.311
[Amended]
2. In § 558.311, in paragraph (b)(8),
after the number ‘‘15’’ add the words
‘‘and 20’’; and in paragraph (e)(1)(xxvii)
in the ‘‘Indications for use’’ column,
remove ‘‘control of control of’’ and in its
place add ‘‘control of’’.
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I
Dated: September 15, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 06–8261 Filed 9–25–06; 8:45 am]
BILLING CODE 4160–01–S
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1300, 1309, 1310, 1314
[Docket No. DEA–291I]
RIN 1117–AB05
Retail Sales of Scheduled Listed
Chemical Products; Self-Certification
of Regulated Sellers of Scheduled
Listed Chemical Products
Drug Enforcement
Administration (DEA), Justice.
ACTION: Interim final rule with request
for comment.
AGENCY:
In March 2006, the President
signed the Combat Methamphetamine
Epidemic Act of 2005, which establishes
new requirements for retail sales of
over-the-counter (nonprescription)
products containing the List I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine. The three
chemicals can be used to manufacture
methamphetamine illegally. DEA is
promulgating this rule to incorporate
the statutory provisions and make its
regulations consistent with the new
requirements. This action establishes
daily and 30-day limits on the sales of
scheduled listed chemical products to
individuals and requires recordkeeping
on most sales.
DATES: Effective Dates: September 21,
2006, except that §§ 1314.20, 1314.25,
and 1314.30 (with the exception of
§ 1314.30(a)(2)) are effective September
30, 2006. Section 1314.30(a)(2) is
effective November 27, 2006.
Comment Date: Written comments
must be postmarked on or before
November 27, 2006.
ADDRESSES: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–291I’’ on all written and
electronic correspondence. Written
comments being sent via regular mail
should be sent to the Deputy
Administrator, Drug Enforcement
Administration, Washington, DC 20537,
Attention: DEA Federal Register
Representative/ODL. Written comments
sent via express mail should be sent to
DEA Headquarters, Attention: DEA
Federal Register Representative/ODL,
2401 Jefferson-Davis Highway,
Alexandria, VA 22301. Comments may
be directly sent to DEA electronically by
sending an electronic message to
dea.diversion.policy@usdoj.gov.
Comments may also be sent
electronically through https://
www.regulations.gov using the
electronic comment form provided on
that site. An electronic copy of this
SUMMARY:
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document is also available at the https://
www.regulations.gov Web site. DEA will
accept attachments to electronic
comments in Microsoft word,
WordPerfect, Adobe PDF, or Excel file
formats only. DEA will not accept any
file format other than those specifically
listed here.
FOR FURTHER INFORMATION CONTACT:
Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion
Control, Drug Enforcement
Administration, Washington, DC 20537;
telephone: (202) 307–7297.
SUPPLEMENTARY INFORMATION:
DEA’s Legal Authority
DEA implements the Comprehensive
Drug Abuse Prevention and Control Act
of 1970, often referred to as the
Controlled Substances Act (CSA) and
the Controlled Substances Import and
Export Act (21 U.S.C. 801–971), as
amended. DEA publishes the
implementing regulations for these
statutes in Title 21 of the Code of
Federal Regulations (CFR), Parts 1300 to
1399. These regulations are designed to
ensure that there is a sufficient supply
of controlled substances for legitimate
medical, scientific, research, and
industrial purposes and to deter the
diversion of controlled substances to
illegal purposes. The CSA mandates that
DEA establish a closed system of control
for manufacturing, distributing, and
dispensing controlled substances. Any
person who manufactures, distributes,
dispenses, imports, exports, or conducts
research or chemical analysis with
controlled substances must register with
DEA (unless exempt) and comply with
the applicable requirements for the
activity. The CSA as amended also
requires DEA to regulate the
manufacture and distribution of
chemicals that may be used to
manufacture controlled substances
illegally. Listed chemicals that are
classified as List I chemicals are
important to the manufacture of
controlled substances. Those classified
as List II chemicals may be used to
manufacture controlled substances.
On March 9, 2006, the President
signed the Combat Methamphetamine
Epidemic Act of 2005 (CMEA), which is
Title VII of the USA PATRIOT
Improvement and Reauthorization Act
of 2005 (Pub. L. 109–177). DEA is
promulgating this rule as an interim
final rule rather than a proposed rule
because the changes being made codify
statutory provisions, some of which are
already in effect. Parts of the statute are
self-implementing; certain changes
related to retail sales became effective
upon signature (March 9, 2006), others
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became effective on April 8, 2006, and
still others will become effective
September 30, 2006. An agency may
find good cause to exempt a rule from
certain provisions of the Administrative
Procedure Act (APA) (5 U.S.C. 553),
including notice of proposed
rulemaking and the opportunity for
public comment, if it is determined to
be unnecessary, impracticable, or
contrary to the public interest. Many of
the requirements of the Combat
Methamphetamine Epidemic Act of
2005 included in this rulemaking were
set out in such detail as to be selfimplementing. Therefore the changes in
this rulemaking provide conforming
amendments to make the language of
the regulations consistent with that of
the law. DEA is accepting comments on
other aspects of this rulemaking,
particularly those not specifically
mandated by the Combat
Methamphetamine Epidemic Act of
2005.
Combat Methamphetamine Epidemic
Act of 2005
The Combat Methamphetamine
Epidemic Act of 2005 (CMEA) amends
the CSA to change the regulations for
selling nonprescription products that
contain ephedrine, pseudoephedrine,
and phenylpropanolamine, their salts,
optical isomers, and salts of optical
isomers. CMEA creates a new category
of products called ‘‘scheduled listed
chemical products.’’ Ephedrine,
pseudoephedrine, and
phenylpropanolamine are List I
chemicals because they are used in, and
important to, the illegal manufacture of
methamphetamine. Products containing
these List I chemicals also have
legitimate medical uses. Ephedrine is
used in some products for treating
asthma. Pseudoephedrine, a
decongestant, is a common ingredient in
cold and allergy medications. In
November 2000, the Food and Drug
Administration (FDA) issued a public
health advisory concerning
phenylpropanolamine and requested
that all drug companies discontinue
marketing products containing
phenylpropanolamine due to risk of
hemorrhagic stroke. In response, many
companies voluntarily reformulated
their products to exclude
phenylpropanolamine. Subsequently,
on December 22, 2005, FDA published
a Notice of Proposed Rulemaking (70 FR
75988) proposing to categorize all overthe-counter nasal decongestants and
weight control drug products containing
phenylpropanolamine preparations as
Category II, nonmonograph, i.e., not
generally recognized as being safe for
human consumption. Most products
containing phenylpropanolamine
intended for humans have been
withdrawn from the market, but
phenylpropanolamine is still sold by
prescription for veterinary uses.
Under previous CSA amendments
(the Comprehensive Methamphetamine
Control Act of 1996 (MCA) and the
Methamphetamine Anti-Proliferation
Act of 2000 (MAPA)), Congress limited
the quantity of products containing
ephedrine, pseudoephedrine, and
phenylpropanolamine that could be
sold as nonprescription drugs at retail
(which were, along with certain liquid
products, defined as ‘‘ordinary over-thecounter pseudoephedrine or
phenylpropanolamine products’’)
without recordkeeping, but generally
exempted products sold in blister packs
sold by ‘‘retail distributors’’. The MCA
established thresholds for these drug
products, including a threshold of 24
grams of combination ephedrine
products; single-entity ephedrine
products had been regulated by the
Domestic Chemical Diversion Control
Act of 1993 (Pub. L. 103–200). MAPA
reduced existing thresholds for
pseudoephedrine and
phenylpropanolamine to 9 grams per
transaction, with each package
containing not more than 3 grams of
pseudoephedrine base or
phenylpropanolamine base, but retained
the so-called ‘‘blister pack’’ exemption.
Because most retail outlets did not want
to create and maintain records of sales
or register as a retail distributor, the
threshold for recordkeeping functioned
for practical purposes similarly to a
sales limit. Much of the product was
also sold in blister packs.
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Congress determined that the existing
limits were not sufficient to prevent
people from buying these products and
using them to illegally manufacture
methamphetamine. In the Combat
Methamphetamine Epidemic Act of
2005, Congress adopted provisions that
do the following:
• Limit the quantity of each of the
chemicals that may be sold to an
individual in a day to 3.6 grams of the
chemical, without regard to the number
of transactions.
• For nonliquids, limit packaging to
blister packs containing no more than 2
dosage units per blister. Where blister
packs are not technically feasible, the
product must be packaged in unit dose
packets or pouches.
• Require regulated sellers to place
the products behind the counter or in
locked cabinets.
• Require regulated sellers to check
the identity of purchasers and maintain
a log of each sale that includes the
purchaser’s name and address, signature
of the purchaser, product sold, quantity
sold, date, and time.
• Require regulated sellers to
maintain the logbook for at least two
years.
• Require regulated sellers to train
employees in the requirements of the
law and certify to DEA that the training
has occurred.
• For mobile retail vendors and mail
order sales, require sellers to limit sales
to an individual in a 30-day period to
7.5 grams.
• For individuals, limit purchases in
a 30-day period to 9 grams, of which not
more than 7.5 grams may be imported
by means of a common or contract
carrier or the U.S. Postal Service.
The numbers of dosage units and
milliliters (mL) that may be purchased
under the sales limits are shown in
Table 1 below. As noted previously, the
FDA issued a voluntary recall on
phenylpropanolamine products as being
unsafe for humans so no
phenylpropanolamine over-the-counter
(OTC) product should be available for
human consumption. Veterinary use is
by prescription only.
TABLE 1.—NUMBER OF TABLETS/MILLILITERS THAT EQUAL RETAIL TRANSACTION LIMITS (AS BASE) FOR SCHEDULED
LISTED CHEMICAL PRODUCTS
Transaction limits
Scheduled listed chemical product
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3.6 gm
7.5 gm
9.0 gm
Tablets
Ephedrine:
25 mg Ephedrine HCl ...................................................................................................................................
25 mg Ephedrine Sulfate ..............................................................................................................................
Pseudoephedrine (as HCl):
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175
186
366
389
439
466
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Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Rules and Regulations
TABLE 1.—NUMBER OF TABLETS/MILLILITERS THAT EQUAL RETAIL TRANSACTION LIMITS (AS BASE) FOR SCHEDULED
LISTED CHEMICAL PRODUCTS—Continued
Transaction limits
Scheduled listed chemical product
3.6 gm
30 mg Pseudoephedrine HCl .......................................................................................................................
60 mg Pseudoephedrine HCl .......................................................................................................................
120 mg Pseudoephedrine HCl .....................................................................................................................
Pseudoephedrine (as Sulfate):
30 mg Pseudoephedrine Sulfate ..................................................................................................................
60 mg Pseudoephedrine Sulfate ..................................................................................................................
120 mg Pseudoephedrine Sulfate ................................................................................................................
240 mg Pseudoephedrine Sulfate ................................................................................................................
7.5 gm
9.0 gm
146
73
36
305
152
76
366
183
91
155
77
38
19
324
162
81
40
389
194
97
48
Number of mL
Ephedrine:
6.25 mg/5 ml Ephedrine HCl ........................................................................................................................
Pseudoephedrine (as HCl):
15 mg/1.6 mL Pseudoephedrine HCl ...........................................................................................................
7.5 mg/5 mL Pseudoephedrine HCl .............................................................................................................
15 mg/5 mL Pseudoephedrine HCl ..............................................................................................................
15 mg/2.5 mL Pseudoephedrine HCl ...........................................................................................................
30 mg/5 mL Pseudoephedrine HCl ..............................................................................................................
30 mg/2.5 mL Pseudoephedrine HCl ...........................................................................................................
60 mg/5 mL Pseudoephedrine HCl ..............................................................................................................
Provisions of CMEA
Overview. Before CMEA, requirements
for sales of products containing
ephedrine, pseudoephedrine, and
phenylpropanolamine, which were then
called regulated drug products or drug
products regulated pursuant to 21 CFR
1300.02(b)(28)(i)(D), distinguished
between in-person sales to a purchaser
(retail distribution) and mail order sales,
which covered any sale where the
product is shipped using the Postal
Service or any common or private
carrier. Mail order sellers had to file
monthly reports with DEA if they sold
a purchaser drug products containing
more than a threshold quantity (9 grams
for pseudoephedrine and
phenylpropanolamine (maximum per
package of 3 grams), 24 grams for
ephedrine combination products),
regardless of how the products were
packaged. Retailers conducting face-toface transactions had to maintain
records for sales above the same
thresholds except that, as noted above,
sales of products in blister packs
generally were not covered. The status
of such sales was discussed in detail in
an interpretive rule (69 FR 2862,
3,515
7,323
8,788
468
2,929
1,464
732
732
366
366
976
6,103
3,051
1,525
1,525
762
762
1,171
7,323
3,661
1,830
1,830
915
915
January 14, 2004; corrected at 69 FR
3198, January 22, 2004). Either type of
seller had to register with DEA if they
sold the products to individuals in
amounts above the threshold quantity.
Only two persons are registered as retail
distributors.
The CMEA provisions on retail sales
create differing requirements for the
various types of retail sales. As
discussed further below, Table 2
summarizes the applicability of the
CMEA provisions as well as existing
DEA provisions to the different types of
sellers.
TABLE 2.—SUMMARY OF REQUIREMENTS BY TYPE OF SELLER
Regulated sellers
(store)
Daily sales limit .....................................................................................................
30-day sales limit ..................................................................................................
Blister packs .........................................................................................................
Storage .................................................................................................................
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Logbook ................................................................................................................
Customer ID ..........................................................................................................
Train employees ...................................................................................................
Self-Certify ............................................................................................................
Notice of misrepresentation ..................................................................................
Monthly reports .....................................................................................................
Theft and loss reports ...........................................................................................
CMEA defines nonprescription drug
products containing ephedrine,
pseudoephedrine, or
phenylpropanolamine as ‘‘scheduled
listed chemical products.’’ Direct, inperson sales to a customer, whether at
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Mobile retail
vendors
3.6 gm/chemical ....
...............................
Yes ........................
Behind the counter
Locked cabinet.
Yes ........................
Examine photo ID
Yes ........................
Yes ........................
Yes ........................
No ..........................
Yes ........................
3.6 gm/chemical ....
7.5 gm ...................
Yes ........................
Locked cabinet ......
3.6 gm/chemical.
7.5 gm.
Yes.
NA.
Yes ........................
Examine photo ID
Yes ........................
Yes ........................
Yes ........................
No ..........................
Yes ........................
NA.
Verify ID.
NA.
NA.
NA.
Yes.
Yes.
a permanent store or movable site (e.g.,
kiosk, flea market), are subject to new
requirements for training of employees
who take part in the sale of scheduled
listed chemical products and
certification to DEA that the employees
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Mail order sellers
have been trained. These sellers, called
‘‘regulated sellers’’ in CMEA, must also
check photo identifications of
purchasers and maintain specific
records of each sale of scheduled listed
chemical products. Under CMEA, the
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only sales exempt from recordkeeping
are sales of single packages of
pseudoephedrine where the package
contains not more than 60 milligrams.
DEA will issue future guidance to
further clarify remaining questions
about how regulated entities may meet
this regulation’s training requirements.
The recordkeeping and reporting
requirements for mail order sales
basically remain the same as under the
previous regulations, except that a
waiver in the prior law that covered non
face-to-face distributions by retail
distributors has been eliminated for
scheduled listed chemical products. As
a result, retail stores that deliver these
products to customers by mail or
delivery services will need to comply
with the provisions for mail order sales
reporting for these transactions. Mail
order sellers must file monthly reports
with DEA. CMEA adds the requirement
that these sellers verify the purchaser’s
identity prior to shipping.
As noted above, CMEA changes the
limits on retail sales. Daily sales are
now limited to a maximum of 3.6 grams
of each chemical in scheduled listed
chemical products. Mobile retail
vendors and mail order vendors must
also limit sales to an individual
purchaser to 7.5 grams of each chemical
in scheduled listed chemical products
in any 30-day period. CMEA limits
purchases by an individual purchaser to
9 grams of each chemical in scheduled
listed chemical products in any 30-day
period, not more than 7.5 grams of
which may be imported by means of a
private or commercial carrier or the U.S.
Postal Service. Any imports of
scheduled listed chemical products
subject to the 7.5 gram purchase limit
under CMEA must also otherwise
comply with all other applicable
Federal and State laws regarding their
importation, including the Federal,
Food, Drug, and Cosmetic Act. This
provision is not included in this rule,
but will be addressed in other
rulemakings DEA is promulgating to
implement the various provisions of the
Combat Methamphetamine Epidemic
Act of 2005. Finally, CMEA exempts all
retail sellers and mail order distributors
selling the products at retail from
registration. The following sections
discuss each of the statutory provisions
in more detail.
Definitions. CMEA revises the
definition of ‘‘regulated transaction,’’
adds several new definitions, and
removes the definition of ‘‘ordinary
over-the-counter pseudoephedrine or
phenylpropanolamine product.’’ CMEA
adds a definition of ‘‘scheduled listed
chemical product,’’ which means any
nonprescription product that contains
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ephedrine, pseudoephedrine, or
phenylpropanolamine and is marketed
lawfully under the Federal Food, Drug,
and Cosmetic Act. References to
ephedrine, pseudoephedrine, or
phenylpropanolamine include their
salts, optical isomers, and salts of
optical isomers. CMEA exempts
scheduled listed chemical products sold
at retail by a regulated seller or by
persons that sell the product for
personal use and ship the product by
mail or private or common carriers (mail
order sellers) from the definition of
regulated transaction. It also removes
other references to the sale of these
chemicals in drug products from the
definition of regulated transactions.
DEA notes that further clarification
regarding regulated transactions will be
addressed in a separate rulemaking.
These changes remove retail sellers and
mail order sellers from the registration
system; in practice, retail and mail order
sellers have not registered because they
limited sales to below threshold
quantities and to products sold in blister
packs. At present, only two persons are
registered as retail distributors.
CMEA adds definitions of ‘‘regulated
seller,’’ to mean a retail distributor
(including a pharmacy and mobile retail
vendors), and ‘‘at retail,’’ to mean sale
or purchase for personal use. It also
revises the definition of ‘‘retail
distributor’’ to remove the sentence
referring to below threshold quantities.
This change subjects all sales, except for
sales of single packages containing not
more than 60 milligrams of
pseudoephedrine, to recordkeeping
requirements.
Sales limits. Effective April 8, 2006,
CMEA limits sales to an individual to
3.6 grams per day of each chemical in
scheduled listed chemical products
regardless of the number of purchases.
Mobile retail vendors and mail order
sellers may not sell an individual more
than 7.5 grams of each chemical in
scheduled listed chemical products in a
30-day period. A seller who violates
these provisions is subject to civil
penalties and possible criminal
penalties.
Purchase limits. CMEA imposes a 9
gram purchase limit in a 30-day period
on individuals. Not more than 7.5 grams
of the 9 grams may be imported by
means of common/contract carrier or
the U.S. Postal Service. Any imports of
scheduled listed chemical products
subject to the 7.5 gram purchase limit
under CMEA must also otherwise
comply with all other applicable
Federal and State laws regarding their
importation, including the Federal,
Food, Drug, and Cosmetic Act. This
provision is not included in this rule,
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but will be addressed in other
rulemakings DEA is promulgating to
implement the various provisions of the
Combat Methamphetamine Epidemic
Act of 2005. In other rulemakings based
on new CMEA provisions, imports,
other than this 30-day individual limit,
are limited to DEA registrants that have
been issued a quota to import. (These
rulemakings will be separately
published in the Federal Register.) A
purchaser who violates these limits is
subject to criminal penalties.
Thirty-day limit. CMEA creates a 30day sales limit. DEA interprets this to
mean a rolling calendar where the sales
limit is based on sales to the purchaser
in the previous 30 days. DEA interprets
the per day limit to refer to midnight to
midnight, not a rolling 24-hour clock.
Blister packs. Effective April 8, 2006,
nonliquid forms of scheduled listed
chemical products (including gel
capsules) must be sold only in blister
packs, with no more than two dosage
units per blister unless blister packs are
technically infeasible. In that case, the
dosage units must be in unit dose
packets or pouches.
Product placement: Behind counter or
locked cabinet. CMEA requires that on
and after September 30, 2006, scheduled
listed chemical products must be stored
behind the counter or, if in an area
where the public has access, in a locked
cabinet. Although DEA is not including
cabinet specifications in the rule, a
locked cabinet should be substantial
enough that it cannot be easily picked
up and removed. In a store setting, the
cabinet should be similar to those used
to store items, such as cigarettes, that
can be accessed only by sales staff.
Logbooks. CMEA requires retail
sellers to maintain logbooks on and after
September 30, 2006. If a retailer
maintains the logbook on paper, DEA is
requiring that the logbook be bound, as
is currently the case for records of sales
of Schedule V controlled substances
that are sold without a prescription.
Bound blank logbooks and ledger books
meeting DEA’s regulatory requirements
are readily available on the commercial
market. If the logbook is maintained
electronically, the records must be
readily retrievable by the seller and any
DEA or other authorized law
enforcement official. Logs must be kept
for two years from the date the entry
was made. The logs must include the
information entered by the purchaser
(name, address, signature, date, and
time of sale) and the quantity and form
of the product sold.
Where the record is entered
electronically, the computer system may
enter the date and time automatically.
An electronic signature system, such as
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the ones many stores use for credit card
purchases, may be employed to capture
the signature for electronic logs. The
information that the seller must enter
may be accomplished through a pointof-sales system and bar code reader.
DEA is aware that in some cases, such
as pharmacy counters where the
computer is behind the pharmacy
counter, it may be difficult for the
purchaser to enter the information
electronically. DEA is seeking
comments on whether systems currently
used to capture signatures for credit or
debit card purchases can be
reprogrammed to allow customers to
enter name and address, as well as the
signature. DEA also recognizes that
some purchasers will find it difficult or
impossible to enter the information
themselves. In these cases, the seller
should ask for the name and address
and enter it, rather than simply copy it
off the photo ID. Regardless of how the
information is entered, however, there
must be a mechanism to allow the
customer to sign the logbook.
Verification of photo ID. CMEA
requires on and after September 30,
2006, that an individual must present an
identification card that includes a
photograph and is issued by a State or
the Federal government or a document
considered acceptable under 8 CFR
274a.2(b)(1)(v)(A) and (B). Those
documents currently include the
following:
• United States passport (unexpired
or expired).
• Alien Registration Receipt Card or
Permanent Resident Card, Form I–551.
• An unexpired foreign passport that
contains a temporary I–551 stamp.
• An unexpired Employment
Authorization Document issued by the
Immigration And Naturalization Service
which contains a photograph, Form I–
766; Form I–688, Form I–688A, or Form
I–688B.
• In the case of a nonimmigrant alien
authorized to work for a specific
employer incident to status, an
unexpired foreign passport with an
Arrival-Departure Record, Form I–94,
bearing the same name as the passport
and containing an endorsement of the
alien’s nonimmigrant status, so long as
the period of endorsement has not yet
expired and the proposed employment
is not in conflict with any restrictions or
limitations identified on the Form I–94.
For individuals 16 years of age or
older:
• A driver’s license or identification
card containing a photograph, issued by
a State or an outlying possession of the
United States. If the driver’s license or
identification card does not contain a
photograph, identifying information
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shall be included such as: Name, date of
birth, sex, height, color of eyes, and
address.
• School identification card with a
photograph.
• Voter’s registration card.
• U.S. military card or draft record.
• Identification card issued by
Federal, State, or local government
agencies or entities. If the identification
card does not contain a photograph,
identifying information shall be
included such as: Name, date of birth,
sex, height, color of eyes, and address.
• Military dependent’s identification
card.
• Native American tribal documents.
• United States Coast Guard
Merchant Mariner Card.
• Driver’s license issued by a
Canadian government authority.
For individuals under age 18 who are
unable to produce a document from the
list above of acceptable documents for
persons age 16 years and older:
• School record or report card.
• Clinic doctor or hospital record.
• Daycare or nursery school record.
The list of acceptable forms of
identification, as cited in CMEA, may
change (‘‘in effect on or after the date of
enactment’’). DEA has no discretion to
alter the list.
Notice on misrepresentations. CMEA
requires that on and after September 30,
2006, the logbooks include a notice to
purchasers that entering false statements
or misrepresentations may subject the
purchaser to criminal penalties under
section 1001 of title 18 of the U.S. Code.
DEA is requiring the inclusion of the
following language in all logbooks:
Warning: Section 1001 of Title 18, United
States Code, states that whoever, with respect
to the logbook, knowingly and willfully
falsifies, conceals, or covers up by any trick,
scheme, or device a material fact, or makes
any materially false, fictitious, or fraudulent
statement or representation, or makes or uses
any false writing or document knowing the
same to contain any materially false,
fictitious, or fraudulent statement or entry,
shall be fined not more than $250,000 if an
individual or $500,000 if an organization,
imprisoned not more than five years, or both.
With both a bound logbook and
electronic log, inclusion of this notice
may present difficulties. If the purchaser
is not able to enter the information
electronically in a store, providing the
notice electronically will not meet the
requirements. If not feasible in these
situations, one alternative is that the
seller prominently display the notice
where the purchaser will see it when
entering or providing the information.
Verification of identity for mail order
sales. The Controlled Substances Act
(21 U.S.C. § 830(b)(3)) requires that each
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regulated person, as defined in the Act,
who engages in a transaction that
involves ephedrine, pseudoephedrine,
or phenylpropanolamine (including
drug products containing these
chemicals) and uses or attempts to use
the Postal Service or any private or
commercial carrier shall, on a monthly
basis, submit a report of each
transaction conducted during the
previous month to DEA. Data contained
in the report includes, but is not limited
to: Name of purchaser; quantity and
form of ephedrine, pseudoephedrine, or
phenylpropanolamine purchased; and
the address to which such ephedrine,
pseudoephedrine, or
phenylpropanolamine was sent. DEA
has specified further information
regarding mail order reports by
regulation (21 CFR 1310.05).
CMEA requires that effective April 8,
2006, the mail order seller confirm the
identity of the purchaser prior to
shipping the product. CMEA requires
DEA to establish procedures for this
identity verification by regulation. To
parallel the identification requirements
for regulated sellers, and to provide
reasonable assurance that the person
purchasing the product is who they
claim to be, DEA is requiring that mail
order sellers verify the identity of the
purchaser by obtaining a copy of an
identification card that includes a
photograph and is issued by a State or
the Federal government or a document
considered acceptable under 8 CFR
274a.2(b)(1)(v)(A) and (B). Such a copy
may be obtained through use of the
Postal Service, facsimile transmission of
a photocopy, or the scanning and
transmission of the identification card,
among other examples. The mail order
seller must determine that the name and
address on the identification card
correspond to the name and address
provided to the mail order seller as part
of the sales transaction. If the
information cannot be confirmed, the
seller may not ship the items.
Selling at retail. CMEA requires that
on and after September 30, 2006, a
regulated seller must not sell scheduled
listed chemical products unless it has
self-certified to DEA, through DEA’s
Web site. The self-certification requires
the regulated seller to confirm the
following:
• Its employees who will be engaged
in the sale of scheduled listed chemical
products have undergone training
regarding provisions of CMEA.
• Records of the training are
maintained.
• Sales to individuals do not exceed
3.6 grams of ephedrine,
pseudoephedrine, or
phenylpropanolamine per day. (Mobile
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retail vendors must also confirm that
sales to an individual in a 30-day period
do not exceed 7.5 grams.)
• Nonliquid forms are packaged as
required.
• Scheduled listed chemical products
are stored behind the counter or in a
locked cabinet.
• A written or electronic logbook
containing the required information on
sales of these products is properly
maintained.
• The logbook information will be
disclosed only to Federal, State, or local
law enforcement and only to ensure
compliance with Title 21 of the United
States Code or to facilitate a product
recall.
The seller must train its employees and
self-certify before either the seller or
individual employees may sell
scheduled listed chemical products. The
self-certification is subject to the
provisions of 18 U.S.C. 1001. A
regulated seller who knowingly or
willfully self-certifies to facts that are
not true is subject to fines and
imprisonment.
Training. DEA has developed training
that it has made available on its Web
site (https://
www.deadiversion.usdoj.gov).
Employers must use the content of this
training in the training of their
employees who sell scheduled listed
chemical products. An employer may
include additional content to DEA’s, but
DEA’s content must be included in the
training. For example, a regulated seller
may elect to incorporate DEA’s content
into initial training for new employees.
Training records. On and after
September 30, 2006, each employee of
a regulated seller who is responsible for
delivering scheduled listed chemical
products to purchasers or who deals
directly with purchasers by obtaining
payment for the scheduled listed
chemical products must undergo
training and must sign an
acknowledgement of training received
prior to selling scheduled listed
chemical products. This record must be
kept in the employee’s personnel file.
Self-certification. On and after
September 30, 2006, the regulated seller
must self-certify to DEA as described
above. DEA has established a Web page
that will allow regulated sellers to
complete the self-certification on-line
and submit it to DEA electronically. A
self-certification certificate will be
generated by DEA upon receipt of the
application. The regulated seller will
print this self-certification certificate, or
if the regulated seller is unable to print
it, DEA will print and mail the
certificate to the self-certifier. The
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regulated sellers will be classified into
three categories: Chain stores that are
currently controlled substance
registrants, chain stores that are not
registrants, and individual outlets.
Chain stores wishing to file selfcertifications for more than 10 locations
will have to print or copy the form
electronically and submit the
information to DEA by mail. DEA will
work with these persons to facilitate this
process. Persons interested in this selfcertification option should contact DEA
for assistance. For current DEA
registrants, the system will pre-populate
the form with basic information.
Because CMEA specifically states that
a separate self-certification is required
for each separate location at which
scheduled listed chemical products are
sold, mobile retail vendors must selfcertify for each location at which sales
transactions occur. This selfcertification for locations is required
even if the same person or persons sell
at each of the different locations.
DEA requests comments on who
should be authorized to sign the selfcertification for the regulated seller. The
person should be in a position to know
that all employees who require training
have been trained and that the retail
outlet is complying with all other
requirements and should be authorized
to sign documents for the regulated
seller.
Time for self-certification. CMEA
requires that regulated sellers selfcertify by September 30, 2006. Although
CMEA appears to link self-certification
to training of each individual who will
deliver the products to customers, the
high rate of employee turnover in the
retail sector could require frequent
submissions of self-certifications if the
regulated seller needed to recertify each
time a new employee is trained. DEA,
therefore, will require regulated sellers
to self-certify by September 30, 2006.
When regulated sellers file the initial
self-certification, DEA will assign them
to groups. Each group will have an
expiration date that will be the last day
of a month from 12 to 23 months after
the initial filing. After the second selfcertification, regulated sellers will be
required to self-certify annually. It is the
responsibility of the regulated seller to
ensure that all employees have been
trained prior to self-certifying each time.
It is also the responsibility of the
regulated seller to ensure that they selfcertify before the self-certification
lapses. DEA requests comments on
annual self-certifications versus
certifications whenever new employees
are trained or quarterly self-certification.
Fee for self-certification. In a separate
Notice of Proposed Rulemaking, DEA is
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proposing that regulated sellers who are
not DEA registrants pay a fee for selfcertification. While DEA is not making
this fee effective with this Interim Rule,
DEA is providing background
discussion and rationale for this
decision here so that all persons will be
aware of this issue.
Section 886a of the CSA defines the
Diversion Control Program as ‘‘the
controlled substance and chemical
diversion control activities of the Drug
Enforcement Administration,’’ which
are further defined as the ‘‘activities
related to the registration and control of
the manufacture, distribution and
dispensing, importation and exportation
of controlled substances and listed
chemicals.’’ The CSA also states that
reimbursements from the Diversion
Control Fee Account ‘‘* * * shall be
made without distinguishing between
expenses related to controlled
substances activities and expenses
related to chemical activities.’’ [Pub. L.
108–447 Consolidated Appropriations
Act of 2005].
In addition, Section 111(b)(3) of the
Departments of Commerce, Justice, and
State, the Judiciary, and Related
Agencies Appropriations Act of 1993
(Pub. L. 102–395), codified at 21 U.S.C.
886a(3), requires that ‘‘fees charged by
the Drug Enforcement Administration
under its diversion control program
shall be set at a level that ensures the
recovery of the full costs of operating
the various aspects of that program.’’
CMEA implements new requirements
governing the sale of scheduled listed
chemical products, defined as
nonprescription drug products
containing ephedrine, pseudoephedrine,
or phenylpropanolamine. CMEA
requires self-certification for all
regulated sellers of scheduled listed
chemical products. CMEA also exempts
retail distributors from registration
requirements under the CSA; however,
in practice, retail distributors have not
previously registered with DEA because
they limited their sales to below
threshold quantities and to products
sold in blister packs.
DEA considers the self-certification
requirements of the CMEA to fall within
the legal definition of control as
governed by Section 886a of the CSA
(see above). Accordingly, these activities
fall under the general operation of the
Diversion Control Program and are
subject to the requirements of the
Appropriations Act of 1993 that
mandates that fees charged shall be set
at a level that ensures the recovery of
the full costs of operating the various
aspects of the Diversion Control
Program. The self-certification
requirements of CMEA fall under these
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‘‘various aspects.’’ Therefore, in its
Notice of Proposed Rulemaking, DEA
will propose to charge a fee for each
self-certification to comply with these
statutory requirements.
DEA is proposing, in its separate
Notice of Proposed Rulemaking, that the
fee for self-certification will cover all
associated costs, including the initial
one-time costs of setting up the selfcertification program, Web site, and
programmatic infrastructure, as well as
ongoing costs associated with the
provision of self-certifications, call
center support, maintenance of the selfcertification system, printing costs for
certificates that regulated sellers cannot
print, financial management, and other
related costs. DEA must establish a
program to train its employees to
provide information regarding, and
accept, self-certifications and must
establish the infrastructure necessary for
the program. Required systems include
creation of history, renewal cycles,
investigative tools, business validation
rules, and development and
maintenance of the self-certification
Web site.
In its Notice of Proposed Rulemaking,
DEA is proposing that when regulated
sellers submit a self-certification online
via the DEA self-certification Web site
that they pay a fee by credit card at the
time of self-certification. DEA calculated
this fee based on estimated set-up costs
in Fiscal Year 2006 ($117,198) and
Fiscal Year 2007 operating costs
($1,624,443) totaling $1,741,641, as
shown below in Table 3. The initial
systems development and set-up costs
will not be repeated in subsequent
years. The operational and maintenance
costs for Fiscal Year 2008 are estimated
to be $1,099,782. Total annual costs
associated with operating the selfcertification process include staff costs,
operational and administrative costs,
Web hosting, monitoring and
maintenance costs (including hardware
and software maintenance), and annual
inflation adjustments. Therefore, DEA
will propose in its separate Notice of
Proposed Rulemaking, that the 89,000
persons DEA estimates will self-certify
with the Administration would pay a
self-certification fee of $32 for the Fiscal
Year 2006 through Fiscal Year 2008
period.
To calculate the fee, DEA divided the
total costs for Fiscal Years 2006 through
2008 by the anticipated population of
affected regulated sellers of 89,000. DEA
estimates 89,000 current retail vendors
of scheduled listed chemical products.
All costs are shown in the table below
for Fiscal Years 2006 through 2008. The
self-certification costs reflect the cost
per each self-certification per each
facility as required by CMEA.
TABLE 3.—SELF-CERTIFICATION COSTS AND FEE CALCULATION
Project detail
2006 *
2007
2008
Total cost
Planning 1 .................................................................................................................
Design, Development, Deployment 2 .......................................................................
Call center, Finance, Mail room, Printing 3 ..............................................................
Maintenance 4 ..........................................................................................................
Enhancements 5 .......................................................................................................
$3,029
43,512
59,253
11,405
......................
$36,343
703,863
711,034
173,203
90,861
$37,002
71,662
723,916
176,341
90,861
$76,373
819,037
1,494,203
360,949
Total ..................................................................................................................
117,198
1,624,443
1,099,782
2,841,423
Population ................................................................................................................
Cost per certification ................................................................................................
......................
......................
89,000
......................
89,000
......................
......................
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1 Planning is the costs to the government to plan the development, design, and implementation of the self-certification online system. This item
is the costs of three percent of the time used by five government employees to supervise and manage software development.
2 Design, development and deployment of the online self-certification system represents the cost to pay contract programmers, web designers,
system administrators and database administrators to design, develop, and deploy the new application. These costs include testing and quality
assurance of the new software and establishment of new security controls. The self-certification system will be designed with business validation
rules and provide investigative tools to ensure compliance with the new legislation.
3 Call Center, finance, mail room and printing represent the following costs.
• DEA currently operates a registration Call Center. Based on current Call Center customer service representative costs, this item includes the
cost of the additional time required to respond to inquiries regarding the CMEA self-certification program. DEA provides call center assistance to
approximately 400,000 persons annually. DEA estimates that CMEA will increase that population by 89,000 persons, a 23% increase.
• DEA currently operates a registration Finance Center. Based on current Finance Center employee costs, this item includes the cost of the
additional time required to process fees collected from CMEA self-certifications.
• DEA currently operates a registration Mail Room. Based on current Mail Room clerical costs, this item includes cost of employee time for
handling and mailing out of CMEA self-certification certificates if the self-certifier is unable to print the certificate.
• DEA currently operates a Printing and Mailing Facility. Based on current Printing Costs, this item includes paper, toner, envelope, and postage costs to mail out the CMEA self-certification certificates.
4 Maintenance. This item includes all employee salaries, hardware maintenance, and software license costs associated with the daily operation
of the self-certification system.
5 Enhancements. This item is the enhancement of the system to add the ability to maintain a history of changes to records and to allow for
yearly renewal of records.
* 2006 is for 1 month of operations.
To minimize administrative and
collection burdens, it is DEA’s policy to
round to the nearest dollar when
calculating fees. The annual selfcertification fee will be clearly defined
on the self-certification Web site.
However, in setting this fee DEA notes
that it is based on assumptions about
the total number of regulated sellers
who will be required to self-certify.
Should the total number of regulated
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sellers be significantly more or less than
89,000, DEA may adjust the selfcertification fee as appropriate through
future rulemakings. In any case, DEA
will not exceed its operating budget as
authorized by Congress.
In implementing this fee, DEA also
notes that many of the affected regulated
sellers are already registered with DEA
to dispense controlled substances and
therefore already pay a registration/
reregistration fee to DEA. While these
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existing registrants are required by the
CMEA to self-certify with DEA if selling
scheduled listed chemical products, in
its Notice of Proposed Rulemaking, DEA
is proposing that the self-certification
fee be waived upon submission of an
active DEA registration number.
Other DEA activities associated with
self-certification and compliance with
CMEA include enforcement and judicial
proceedings. CMEA gives DEA the
authority to prohibit a regulated seller
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from selling scheduled listed chemical
products for certain violations of CMEA.
If DEA issues an order to a regulated
seller prohibiting that regulated seller
from selling scheduled listed chemical
products, the regulated seller is entitled
to an administrative hearing if the seller
files a timely request for a hearing. The
costs of these enforcement activities and
the subsequent proceedings must be
supported through fees pursuant to the
above described statutory requirements.
DEA notes that these costs are not
recovered in these fee calculations as
DEA is uncertain of their utilization.
However, once DEA is able to determine
the frequency of use of these tools, and
their associated costs, these costs will be
recovered through fees associated with
self-certification as established in future
rulemakings.
Relationship to State Laws
Many States have enacted laws and/
or regulations that impose conditions on
the sale of scheduled listed chemical
products.
• Eight states have enacted and six
others have proposed legislation that
makes these products Schedule V
controlled substances. Among other
requirements, Schedule V substances
may be sold only by a pharmacist to
individuals who are at least 18. A
logbook of the sales must be maintained.
• Sixteen states have passed laws
limiting sales to a pharmacist or
pharmacy technicians or requiring that
the products be stored behind the
counter.
• Twenty-seven states require a photo
ID for such purchases.
• Twenty-six states require a signed
logbook.
• Twenty-seven states impose single
transaction limits.
• Nineteen states have monthly or
weekly limits.
• Twenty-seven states have
exemptions for prescription drugs and
various forms of over-the-counter (OTC)
drugs (liquids, pediatric forms, etc.).
• One state requires a prescription to
purchase these products.
As the list indicates, the State laws
vary considerably. Some parts of a State
law may be less stringent than the
CMEA requirements; other parts may be
more stringent. CMEA does not preempt
those requirements under State laws/
regulations that are more stringent than
the CMEA requirements. Simply put, all
persons subject to CMEA must comply
with the CMEA and the laws in the
State(s) in which they sell scheduled
listed chemical products at retail. Where
the CMEA is less stringent than a State
law (e.g., the State limits sales to
licensed pharmacists or pharmacy
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technicians where CMEA does not), the
State requirements continue to be in
force. If there are State requirements
that are less stringent than the CMEA
provisions (e.g., higher daily limits,
exemptions of some products), CMEA
supersedes the provisions. DEA
emphasizes that if State requirements
for records cover the information CMEA
mandates, the record created to meet the
State law is sufficient to meet DEA’s
regulation.
Regarding quantity sold, units may be
specified in terms of the weight of the
product or in terms of the number of
packages sold. Logbook systems that
display the quantity of the product sold
by UPC code are sufficient to meet
DEA’s requirements. These options do
not exclude other methods of displaying
the quantity sold.
DEA is accepting public comment on
the interaction between state and federal
logbook requirements. In addition, DEA
is accepting public comment on the
broader interplay and potential overlap
between state regulations and CMEA
requirements, and whether compliance
with state regulations, if comparable to
or more stringent than an associated
CMEA requirement, should constitute
compliance with such Federal
requirement.
Discussion of the Rule
To make the rule easier to follow for
regulated sellers and mail order/Internet
sellers, DEA is creating a new part 1314
that will include all requirements
related to the sale of scheduled listed
chemical products to end users.
Regulations for the retail sale of these
products that currently exist in part
1310 will either be moved, if still
applicable, or removed. The new
statutory definitions of ‘‘scheduled
listed chemical product,’’ ‘‘regulated
seller,’’ ‘‘mobile retail vendor,’’ and ‘‘at
retail’’ are being added to part 1300
(Definitions). The definition of ‘‘retail
distributor’’ is also being revised. Most
of the new provisions in this Interim
Final Rule are drawn from section 711
of the USA PATRIOT Improvement and
Reauthorization Act of 2005.
Part 1314 is divided into four
subparts. Subpart A contains
requirements that apply to any retail
sale. Subpart B applies to sales by
regulated sellers (i.e., sales for personal
use, both in number of sales and volume
of sales, either directly to walk-in
customers or in face-to-face
transactions, by stores or mobile retail
vendors). Subpart C applies to retail
sales that are shipped by mail or
common or private carriers, regardless
of how those sales are ordered. Subpart
D contains the procedural requirements
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for issuing and responding to an order
to show cause why the regulated seller
or distributor should not be prohibited
from selling scheduled listed chemical
products.
Sections 1314.01 and 1314.02 simply
state the scope and applicability of the
part. Section 1314.03 defines ‘‘mail
order sales’’ using the language from
§ 1310.03(c) and further clarifies that
mail order includes any retail sale for
personal use where the product is
shipped by U.S. mail or by private or
common carriers whether the order is
received by mail, phone, fax, the
Internet, or any method other than a
face-to-face transaction.
Section 1314.05 incorporates the
statutory requirement for blister packs
for nonliquids unless such packaging is
not technically feasible.
Section 1314.10 states the regulations
do not preempt State laws unless there
is a positive conflict between the laws
and the regulations such that the two
cannot consistently stand together. This
language is drawn from 21 U.S.C. 903.
Section 1314.15 copies the
requirements for reporting losses,
including thefts, that currently exist in
§ 1310.06. DEA emphasizes that thefts
must be reported as well as unusual or
excessive losses or disappearances.
In subpart B, § 1314.20 includes the
statutory requirements limiting sales,
the daily limit of 3.6 grams and the 30day mobile retail vendor limit of 7.5
grams. The 30-day limit of 9 grams
applies to purchasers who are not
addressed by this regulation. As noted
previously, this provision is not
included in this rule, but will be
addressed in other rulemakings DEA is
promulgating to implement the various
provisions of the Combat
Methamphetamine Epidemic Act of
2005.
Section 1314.25 incorporates CMEA’s
provisions for storing the products
behind the counter or in a locked
cabinet. Mobile retail vendors are
required to store the product in a locked
cabinet.
Section 1314.30 covers recordkeeping
(logbook) requirements from CMEA as
well as requirements currently in
§ 1310.04. In addition to CMEA’s
requirements, DEA has copied the
existing requirements from part 1310
relative to where the records must be
kept (at the place of business or at a
central location if DEA has been
notified). DEA is including in this
section language stating that if a
regulated seller is already maintaining
records of these sales under State law,
those records may be used to meet this
requirement if they include the
information specified in CMEA.
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The part 1310 requirements
incorporated into the amended
regulations do not include the provision
that a regulated seller with multiple
locations must have a system to detect
a person purchasing from multiple
locations owned or operated by the
regulated seller. CMEA in section 711(f)
provides for a civil penalty for a person
who sells at retail a scheduled listed
chemical product in violation of the
daily 3.6 gram sales limit, ‘‘knowing at
the time of the transaction involved
(independent of consulting the logbook
* * *) that the transaction is a
violation.’’ While the availability of civil
penalties is not necessarily co-extensive
with the chemical control requirements
of the new law, DEA is not mandating,
by this rule, that regulated sellers, other
than mail order and mobile retail
vendors, track multiple sales to
individuals on a single day within the
same retail outlet or across outlets of the
same company. CMEA explicitly
requires mail order outlets and mobile
retail vendors to limit sales to an
individual to 7.5 grams in a 30-day
period; it imposes no similar
requirement on other retail sellers to
limit 30-day sales to individuals. The
30-day limit of 9 grams is imposed on
the purchaser, not the seller.
Section 1314.35 incorporates the
statutory requirements for training of
sales personnel. DEA has developed
training material, which it has made
available on its Web site (https://
www.deadiversion.usdoj.gov).
Section 1314.40 covers CMEA’s
requirements on self-certification. As
discussed above, DEA is setting an
annual period for renewal of the
certification.
DEA has developed a web site that
will allow many regulated sellers to
complete and submit the selfcertification form on line and print out
a self-certification certificate for their
records. The information required will
include the name and address of the
location and a point of contact. The
regulated sellers will be classified into
three categories: Chain stores that are
currently controlled substance
registrants, chain stores that are not
registrants, and individual outlets.
Chain stores wishing to file selfcertifications for more than 10 locations
will have to print or copy the form
electronically and submit the
information to DEA by mail. DEA will
work with these persons to facilitate this
process. Persons interested in this selfcertification option should contact DEA
for assistance. For current DEA
registrants, the system will pre-populate
the form with basic information.
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Section 1314.45 incorporates the
privacy protection provisions of CMEA.
These provisions define who may access
the sales records and the use to which
the data may be put. They also provide
a good faith protection to regulated
sellers that release the data to law
enforcement authorities.
Section 1314.50 includes CMEA’s
provision that states that a seller may
take reasonable measures to guard
against employing people who may
present a risk of diversion. The
measures may include asking about
convictions of any crimes involving
controlled substances or scheduled
listed chemical products.
In subpart C, § 1314.100 incorporates
the daily and 30-day sales limits for
mail order sales. Section 1314.105
provides the above described
requirements for verifying identity of
the purchaser prior to shipment of the
product. Section 1314.110 covers
reports on mail order sales and is copied
from § 1310.06. Finally, § 1314.115
copies language from § 1310.05(f) on
distributions not subject to reporting
(sample packages, sales to long-term
care facilities, prescription drugs).
CMEA added to 21 U.S.C. 842 a
provision that authorizes DEA to
prohibit a regulated seller or a mail
order seller from selling scheduled
listed chemical products if the seller is
found to be knowingly or recklessly in
violation of the provisions controlling
retail sales. To take this step, DEA must
issue an order to show cause, as it does
to suspend or revoke registrations. DEA
is including in subpart D in §§ 1314.150
and 1314.155 provisions on the process
of issuing and responding to an order to
show cause. These sections are taken
from part 1309 and are the same as DEA
uses to issue and reach a conclusion on
orders to show cause under other DEA
programs. If DEA issues an order to
show cause, the regulated seller or mail
order distributor must respond to the
order to show cause within 30 days of
service of the order to show cause. The
regulated seller or mail order seller may
request a hearing. The seller may
continue to sell scheduled listed
chemical products until DEA issues a
final order. If DEA finds that a regulated
seller or mail order distributor poses an
imminent danger to public health or
safety, DEA may suspend the seller’s
right to sell scheduled listed chemical
products pending a final decision on the
order to show cause.
Other Changes
As noted above, CMEA’s new
definitions will be added to § 1300.02.
In addition, the definition of ‘‘regulated
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transaction’’ is revised as mandated by
section 712 of CMEA.
In § 1309.71, paragraph (a)(2), which
requires certain ephedrine products to
be stored behind the counter, is being
removed because the new CMEA
requirements supersede it. CMEA
imposes the same restrictions on all
scheduled listed chemical products
unless they are stored in a locked
cabinet in areas where the public has
access.
In § 1310.04, paragraph (f)(1)(ii) is
revised to indicate that the thresholds
presented in the previous paragraph and
in paragraph (g) for ephedrine,
pseudoephedrine, and
phenylpropanolamine apply only to
non-retail distribution, import, and
export and references part 1314 for
retail sales. The table of thresholds for
retail distribution has been removed.
In § 1310.05, paragraph (f)(2) is
revised to remove retail sales of
scheduled listed chemical products.
Sections 1310.14 and 1310.15 are
being removed because the CSA no
longer treats certain ephedrine products
differently from other scheduled listed
chemical products. These sections are
being replaced by new § 1310.16, which
states that a manufacturer may apply to
have a scheduled listed chemical
product exempted from the
requirements if DEA determines that the
product cannot be used in the illicit
manufacture of methamphetamine. DEA
is adopting the application process that
currently applies to ephedrine products
that include other medically significant
ingredients (§ 1310.14).
Regulatory Certifications
Administrative Procedure Act (5 U.S.C.
553)
The Administrative Procedure Act
(APA) generally requires that agencies,
prior to issuing a new rule, publish a
Notice of Proposed Rulemaking in the
Federal Register. The APA also
provides, however, that agencies may be
excepted from this requirement when
‘‘the agency for good cause finds (and
incorporates the finding and a brief
statement of reasons therefore in the
rules issued) that notice and public
procedure thereon are impracticable,
unnecessary, or contrary to the public
interest.’’ 5 U.S.C. 553(b)(B).
With publication of this interim rule,
DEA is invoking this ‘‘good cause’’
exception to the APA’s notice
requirement based on the combination
of several extraordinary factors. CMEA
requires that on and after September 30,
2006, regulated sellers selling scheduled
listed chemical products at retail shall
self-certify with DEA in order to
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continue to sell these products. CMEA
imposes sales limits, purchase limits,
product placement requirements, mail
order customer identification
requirements, and other requirements,
some of which must be specified by
regulation, all with an effective date of
September 30, 2006. Based on the
effective date of this law, it is
impracticable for DEA to comply with
the APA’s notice and comment
requirements due to the limited time
involved. Were DEA not to publish this
Interim Rule with Request for Comment,
regulated sellers selling scheduled listed
chemical products at retail would not be
able to self-certify by the date specified
in the law. Were this not to occur, these
regulated sellers would be forced to stop
selling scheduled listed chemical
products, or violate the law by doing so.
Mail order distributors would also have
difficulty, as DEA is required by
regulation to establish procedures for
these persons to identify their customers
prior to shipping product. Without these
regulations, mail order distributors
would not be able to sell scheduled
listed chemical products. Therefore,
DEA also finds that it is contrary to the
public interest not to issue these
regulations as an Interim Rule, thereby
allowing regulated sellers and mail
order distributors to fully comply with
the requirements of CMEA. While the
CMEA was signed into law in March of
2006, most of the law must be in effect
by September 30, 2006. The broad scope
of the new law, as well as the expedited
effective dates, is a clear reflection of
Congress’s concern about the nation’s
growing methamphetamine epidemic
and its desire to act quickly to prevent
further illicit use of these chemicals.
In light of these factors, DEA finds
that ‘‘good cause’’ exists to issue this
interim rule without engaging in
traditional notice and comment
rulemaking. In so doing, DEA recognizes
that exceptions to the APA’s notice and
comment procedures are to be
‘‘narrowly construed and only
reluctantly countenanced.’’ Am. Fed’n
of Gov’t Employees v. Block, 655 F2d
1153, 1156 (D.C.Cir. 1981) (quoting New
Jersey Dep’t of Envtl. Prot. v. EPA, 626
F.2d 1038, 1045 (D.C.Cir. 1980)). Based
on the totality of the circumstances
associated with the CMEA, however,
DEA finds that invocation of the ‘‘good
cause’’ exception is justified.
As noted throughout this document,
DEA is seeking comments on details of
implementation, particularly related to
self-certification, where it has
discretion.
Under section 553(d) of the APA, DEA
must generally provide a 30-day delayed
effective date for final rules. DEA may
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dispense with the 30-day delayed
effective date requirement ‘‘for good
cause found and published with the
rule.’’ Since it would be unnecessary to
provide a delayed effective date for a
change to the law that has already taken
effect DEA has dispensed with the 30day delayed effective date requirement.
The sales limits and blister pack
provisions became effective on April 8,
2006. The requirements for logbooks,
training, and self-certification become
effective September 30, 2006.
Regulatory Flexibility Act
The Deputy Administrator hereby
certifies that this rulemaking has been
drafted in accordance with the
Regulatory Flexibility Act (5 U.S.C.
605(b)). The Regulatory Flexibility Act
(RFA) applies to rules that are subject to
notice and comment. Because this rule
is simply codifying statutory provisions,
DEA has determined, as explained
above, that public notice and comment
are not necessary. Consequently, the
RFA does not apply. Where DEA has
discretion in the way in which
provisions of CMEA are implemented,
however, DEA is seeking public
comment and has sought, through the
development of training materials and
Web sites for self-certification, to reduce
the cost to small entities.
Although the RFA does not apply to
this final rule, DEA has reviewed the
potential impacts. The rule will affect a
substantial number of small entities, but
DEA does not believe that it will have
a significant economic impact on small
entities. As shown in the next section,
OTC medications as a whole represent
less than two percent of sales except for
drug stores and mail order houses. Even
the highest estimate of the value of
scheduled listed chemical products
represents less than 10 percent of the
OTC market. Consequently, the loss of
sales, if that occurs, will reduce sales at
most by a fraction of one percent, not a
significant economic impact. DEA
expects that regulated sellers will
decide whether their sale of the
products is great enough to justify the
cost of compliance or whether they can
retain sufficient sales revenues by
shifting to non-regulated substitutes.
The smallest stores, which DEA expects
to be convenience stores, may limit their
sales of the products to individual
transactions involving packages
containing not more than 60 milligrams
of pseudoephedrine, which would allow
them to avoid the recordkeeping
requirements. In this case, their total
cost of compliance could be about $50
for training and self-certification. DEA is
specifically seeking public comments
regarding the cost of this regulation to
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small entities, using a pre-statutory
baseline of comparison (i.e., the state of
the market prior to the Combat
Methamphetamine Epidemic Act of
2005).
Although not directly the subject of
this rule, manufacturers and distributors
will be affected by a reduction in sales
of these products. The manufacturers of
scheduled listed chemical products are
also the manufacturers of the substitutes
being marketed and the distributors
handle both product lines; DEA has not
been able to identify any manufacturer
of these products that does not also
market substitute products. DEA expects
that the primary impact will be limited
to reduction in sales that occurs because
diversion is curbed. If the sales
restrictions and quotas reduce the
United States’ demand for these
chemical products, the world
production of the chemicals is likely to
drop, which will make less available to
be diverted to superlabs operated by
drug cartels. DEA seeks comments on
impacts on manufacturers and
distributors.
Executive Order 12866
The Deputy Administrator further
certifies that this rulemaking has been
drafted in accordance with the
principles in Executive Order 12866
§ 1(b). It has been determined that this
is ‘‘a significant regulatory action.’’
Therefore, this action has been reviewed
by the Office of Management and
Budget. As discussed above, this action
is codifying statutory provisions and
involves no agency discretion. However,
DEA has reviewed the potential benefits
and costs following OMB Circular A–4.
The CMEA requirements impose the
following costs on regulated sellers:
• Training of employees who sell
scheduled listed chemical product sales
(0.5 hours).
• Time to file the self-certification
(0.5 hours).
• Costs for logbooks ($47.55) or
creating an electronic record system.
• Additional time per sale to verify
purchaser IDs and enter information
into the logbook (1 to 2 minutes).
• Storage space behind the counter or
in locked cabinets ($200-$600).
DEA is seeking comments regarding
all of the above assumptions and
estimates.
The requirements may also affect the
sales at regulated sellers. If a seller
decides to avoid the requirements by
eliminating the product line or selling
only the available substitutes, some
customers may seek the products from
sellers that continue to carry them.
Regulated sellers, manufacturers, and
distributors will also see some reduction
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in sales as a result of diversion from
regulated sellers becoming more
difficult.
Although DEA has estimated the unit
cost of training, certification, logbooks,
logbook entries, and storage space, DEA
cannot estimate the total cost of the rule
because the following critical items are
unknown:
• The value of the existing market in
these products and the number of
transactions that this market represents.
• The number of stores that currently
sell these products.
• The number and type of stores that
will continue to sell the products, the
number that will elect to sell only the
substitutes, and the number that will
limit sales of the products to individual
transactions involving not more than
one 60-milligram or two 30-milligram
pseudoephedrine dosage units, which
would not require recordkeeping, the
most expensive part of compliance.
• The number of customers who will
seek out these products rather than
purchase substitutes available on open
shelves.
• The number of stores that will elect
to use bound logbooks versus using
electronic systems.
• The number of existing electronic
signature capture systems that are
capable of accepting or linking to name
and address records.
• The percentage of existing sales
(and theft of the product) that is being
diverted to illicit use.
DEA is seeking comments and data from
the industry that would help address
these items and provide an estimate of
the impact. DEA recognizes that the
answers to some of these issues will
evolve over time as regulated sellers and
manufacturers adjust to consumer
choices. For example, regulated sellers
may see little impact beyond the initial
costs of training and self-certification if
most consumers elect to purchase the
substitute products that are already
available under the same brand names
as scheduled listed chemical products,
either because the consumers are
unaware of the product change, because
the substitutes meet the consumers’
needs, or because they are unwilling to
spend extra time to buy scheduled listed
chemical products.
Regulated Sellers. The 2002 Economic
Census data on product line sales
indicate that about 92,000 retailers sell
OTC medications. These include
pharmacies, grocery stores, discount
stores, warehouse clubs and superstores,
convenience stores, variety stores, and
mail order stores. In addition, up to
40,000 gas stations with convenience
stores may sell OTC drug products. The
number of retailers in each sector, the
number with pharmacies, the number
that sell nonprescription OTC drugs,
and the percentage of their sales
represented by OTC drugs are shown in
Table 4 below. DEA solicits comments
on the number of these entities that sell
these products.
TABLE 4.—SECTORS SELLING SCHEDULED LISTED CHEMICAL PRODUCTS
Total
number
NAICS
Number w
pharmacy
Number w OTC
44511 Grocery stores ......................................................................
44611 Pharmacy and drug stores ...................................................
452112 Discount department stores ................................................
45291 Warehouse clubs and superstores .......................................
66,150
40,234
5,650
2,912
19,721
39,121
4,887
2,553
26,029
36,493
2,079
2,758
Subtotal .....................................................................................
114,946
66,282
29,212
93,691
28,456
15,910
370
0
577
453
12,399
** 40,068
11,840
250
Total ..........................................................................................
167,269
1,400
OTC as
percent of
total sales *
67,359
44512 Convenience stores ..............................................................
44711 Gas stations with convenience stores ..................................
45299 All other general merchandise stores *** ..............................
4541 Electronic shopping and mail order houses ...........................
Percent
without
pharmacy
70.2
2.8
13.5
12.3
1.30
5.70
1.80
1.20
98.7
100
98
97.2
1.60
** 1.10
1.20
13
24,489–64,557
those firms that handle the product line.
** Drugs, health aids, beauty aids including cosmetics.
*** Includes variety stores.
rmajette on PROD1PC67 with RULES1
* For
Even if all gas stations with
convenience stores sold OTC drugs,
there would be fewer of these
establishments than exist in the main
sectors selling OTC drugs. Most gas
stations and convenience stores do not
have pharmacies; OTC products
represent a very small percentage of
sales for them.
DEA cannot determine what
percentage of those selling OTC drugs
sell scheduled listed chemical products,
although it is likely that outlets that
have pharmacies sell these products.
Because 16 States representing 27
percent of the U.S. population already
limit sales of these products to
pharmacies, DEA estimates that the
number of potentially regulated entities
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is between 89,000 and 118,000.1 This
estimate does not specifically include
mobile retail vendors, but DEA does not
believe that they constitute a large
segment of retail sellers. The actual
number could be lower; many of the
stores, particularly convenience stores,
do not carry a full range of OTC drug
products, and some may not sell this
category of drugs. DEA seeks comment
on this issue. Conversely, large mail
order distributors may handle large
quantities of scheduled listed chemical
products. DEA also seeks comment on
1 The 27 percent is a conservation estimate; the
16 states represents 28 percent of the convenience
stores in the country and 35 percent of the gas
stations with convenience stores.
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the number, size, and sales of mail order
entities.
Substitutes. As discussed above,
many States have imposed sales
restrictions on scheduled listed
chemical products prior to CMEA. In
reaction to those restrictions and to
concern about diversion of their
products, manufacturers have
reformulated many product lines to
alternative decongestants that cannot be
used to make methamphetamine. These
substitutes are being sold under the
same product names and in boxes that
look the same as those used for
scheduled listed chemical products.
One major manufacturer expected to
have converted half of its decongestant
product line to substitutes by January
2006. Two of the largest drug store
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chains do not list scheduled listed
chemical products on their online
stores, but offer more than 60 cold
medications containing other
ingredients.
At present, there is little information
on how consumers will react to sales
restrictions. On April 7, 2004,
Oklahoma made pseudoephedrine
products Schedule V controlled
substances, but exempted gel caps and
liquids. According to IRI InfoScan, in
the 52 weeks after implementation, sales
of all pseudoephedrine products fell
16.2 percent and sales of the substitutes
rose by 24 percent. Sales of exempted
gel caps rose 109.3 percent and liquids
14.5 percent, but tablets fell 35.5
percent. Overall, sales in the cold and
allergy group in Oklahoma fell 3.9
percent. Illinois, which imposed less
stringent rules, saw little change in
purchases, according to IRI InfoScan.
The Slone Epidemiology Center at
Boston University took a broader look at
drug purchases in 2004 and found that
between 2003 and 2004, the number of
adults reporting use of pseudoephedrine
fell from 7 percent to 4.8 percent. This
decline occurred prior to State
restrictions and to the availability of
many substitute products, but after
limits on purchases were set by Federal
law and by many large chain stores.
If national patterns reflect Oklahoma’s
experience, a 3.9 percent drop in cold/
allergy medicine sales would imply a
$117,000,000 loss in sales. However, if
they reflect national trends reported by
the Slone Epidemiology Center, a 2.2
percent drop in cold/allergy medicine
sales would imply a $33,000,000 loss in
sales. Since market effects will occur
within the context of increased
marketing and distribution of
substitutes, the direct effects on
revenues could be lower than either
estimate.
It is not clear how consumers and
retailers will react to a nationwide limit
on all scheduled listed chemical
product sales because the availability of
substitute products may increase. If
consumers continue to ask for
scheduled listed chemical products,
retailers will incur costs to store them
behind the counter or in locked cabinets
and to record every transaction. The
purchaser will take extra time and
possibly delay other customers who
have to wait while the transaction is
completed. DEA notes that in stores
with pharmacies, the recordkeeping
requirements established by this rule
may direct a higher proportion of
transactions to the pharmacy versus the
standard checkout line. DEA is seeking
public comment on the effect of these
recordkeeping and product placement
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requirements on pharmacy wait times
and any staffing costs these
requirements generate. Alternatively, if
few consumers seek the products, many
retailers may decide not to carry them.
This decision would eliminate their
costs, but could impose a cost on the
consumer who has to go to multiple
stores or travel greater distances to find
the product. Regulated sellers who
continue to sell the products will have
to decide how to log the sales, which
will impose costs. DEA is seeking
comment on the cost of logging sales,
whether this log be paper or electronic.
Part of each seller’s calculation will be
whether the value of the sales is
sufficient to offset the costs. As
discussed above, OTC medications as a
whole represent between one and two
percent of the sales of sellers except for
pharmacies and mail order sellers;
scheduled listed chemical products
probably represent less than 10 percent
of those sales. For many smaller stores
a small decline in sales, if that occurs,
may be less costly than compliance.
DEA has estimated that small
convenience stores sell between $20 and
$40 a month of these products for
legitimate purposes (69 FR 8691,
February 25, 2004).
Size of the market; data issues. DEA
has been unable to determine the size of
the market for scheduled listed
chemical products. The Food and Drug
Administration reported that IMS
Health data estimated the market is
about $500 million; FDA further
reported that IRI estimated the market
was $1.5 billion. The IRI Oklahoma data
implied that pseudoephedrine
represented about 75 percent of the cold
medication market, but the value other
sources provide for the cold medication
market in 2005 is about $4 billion.
IRI indicated that national sales for
the category had dropped by 0.5 percent
between May 2004 and May 2005. A
Kline & Company study indicated that
sales in the cold medication category
rose 12 percent in 2005. Part of the
problem is that different groups appear
to define the market segment differently,
including a different mix of products.
DEA seeks information on the actual
value of the market for scheduled listed
chemical products and the number of
transactions. Even with the total value
of the market, DEA would need to
understand the value of the average
transactions. The products are available
in a wide variety of strengths and
number of dosage units; the sales limits
allow purchases of multiple packages of
most products. DEA also seeks
comments on the effect of the
restrictions on product prices. At
present, the substitutes are selling for
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56019
prices that are equivalent to those for
scheduled listed chemical products
(based on maximum daily dosage units).
The additional costs of handling
scheduled listed chemical products
could, however, increase their prices if
sellers pass on the costs to consumers.
Diversion. The limits and restrictions
that CMEA imposes are intended to
reduce the diversion of scheduled listed
chemical products. Manufacturers and
regulated sellers will see some
reduction in sales as a result of retail
purchases for diversion declining. DEA
has no reliable information on the
percentage of the market in these
products that was diverted. DEA expects
that as it implements other CMEA
requirements it will have a better
understanding of the size of the
diversion market. Nonetheless, because
sales of these products represent less
than one percent of most retailer’s total
sales, the loss of sales for diversion is
unlikely to impose a substantial cost on
retailers selling to legitimate purchasers.
Implementation Costs. For most
regulated sellers that continue to carry
scheduled listed chemical products, the
largest cost will be the added time to
collect and record logbook information
regarding the purchaser at each
transaction. DEA estimates that it will
take one to two minutes for the seller
and purchaser to enter into the logbook
the information required by CMEA—
name and address of purchaser, name
and quantity of product sold, date and
time of transaction, and purchaser’s
signature—and seeks comment on this
estimate.
Assuming market changes may reflect
the Oklahoma experience to a degree, a
16 percent drop in sales of regulated
products would change the number of
transactions that would require
recordkeeping to 56,490,000. Assuming
the recordkeeping requirements add 2
minutes to each transaction, they would
impose an annual cost between
$73,000,000 and $80,000,000 in terms of
time burden. These estimates assume,
for the low end, the average hourly wage
of retail sales clerks ($11.86 with fringe
benefits) plus public time ($27/hour);
for the high end, it assumes the average
hourly wage of a pharmacy technician
($15.26 with fringe benefits) plus public
time ($27/hour).
Assuming market changes reflect data
reported by The Slone Epidemiology
Center, a 2.2 percent drop in sales of
regulated products would change the
number of transactions that would
require recordkeeping by 2,193,000.
Using the same assumptions regarding
increased transaction times, this would
imply an annual cost in terms of time
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burden between $85,000,000 and
$93,000,000.
Another cost will be the costs of
recordkeeping systems. CMEA allows
either a logbook or an electronic record.
DEA is seeking comments on whether
regulated sellers will be able to use
electronic signature capture systems to
collect names and addresses as well as
signatures, the cost of adapting systems
to perform this function, and likelihood
that sellers will do this versus using a
bound logbook. DEA is seeking
information from regulated sellers on
whether they plan to limit sales to
pharmacy or special counters or
whether they will handle sales at
regular checkout lines. Finally, DEA is
seeking comments on how much
behind-the-counter space regulated
sellers will need to devote to these
products, the cost of doing so, and the
extent to which costs may be passed on
to the consumer.
Blister Packs. For reasons of product
safety and the previous blister-pack
exemption, almost all scheduled listed
chemical products are already sold in
blister packs. DEA seeks comments on
whether this requirement imposes a
burden on any manufacturers.
Benefits. Congress passed CMEA to
make it more difficult for individuals to
purchase scheduled listed chemical
products and use them to make
methamphetamine. The retail
restrictions are part of a series of steps
that Congress adopted to address the
sources of methamphetamine abuse;
other steps include import and
production quotas and tracking of
international transactions.
Methamphetamine remains the
primary drug produced in illicit
laboratories within the United States.
Data from the El Paso Intelligence
Center’s (EPIC) Clandestine Laboratory
Database indicates that more than
17,170 methamphetamine laboratory
incidents in calendar year 2004 and
12,139 incidents in calendar year 2005
(as reported to EPIC through June 29,
2006). According to EPIC, from January
2000 through June 2006, there were
7,125 laboratories reportedly using
ephedrine and 44,380 reportedly using
pseudoephedrine as precursor material
for methamphetamine production.
Additionally EPIC reports the seizure of
51 amphetamine laboratories (using
phenylpropanolamine) during the same
period. The vast majority of these
laboratories used pharmaceutical
products containing pseudoephedrine,
ephedrine, and phenylpropanolamine as
the source of precursor material.
According to the Substance Abuse
and Mental Health Services
Administration (SAMHSA), Drug Abuse
Warning Network (DAWN), in 2004, the
latest year for which data are available,
amphetamine and methamphetamine
was mentioned in almost 103,000
emergency department (ED) visits;
methamphetamine accounted for 73,400
of these visits. These numbers represent
a rapid increase in recent years.
SAMHSA reported that drug abuserelated ED visits involving
amphetamine/methamphetamine rose
from 25,200 in 1995 to 38,960 in 2002
and 42,500 in 2003. If the cost of the
visit is $500, which is probably low in
many areas, the total cost would have
been $50 million. The DAWN mortality
data for 33 metropolitan areas in 2003,
the most recent year available, report
amphetamine or methamphetamine was
involved in 524 deaths and was the only
drug present in 93 of those deaths. A
University of Arkansas Study on the
economic impact of methamphetamine
use in Benton County, Arkansas,
estimated that the average
methamphetamine user cost his or her
employer $47,500 a year, with 50
percent of cost due to increased
absenteeism and 32 percent due to lost
productivity.
The surge in methamphetamine abuse
and the manufacture of the drug in
clandestine laboratories has caused
serious law enforcement and
environmental problems, particularly in
rural communities. Rural areas are
frequently the site of clandestine
laboratories because the manufacturing
process produces distinctive odors and
can be identified if there are close
neighbors. Besides causing crime as
people steal ingredients to make
methamphetamine and steal to support
their addiction, the clandestine
laboratories often leave serious
pollution behind. A laboratory can
produce 6 to 10 pounds of hazardous
waste for every pound of
methamphetamine produced. Table 5
shows the hazardous waste cleanup
costs incurred by States and DEA by
Fiscal Year (October 1 through
September 30) for several previous fiscal
years.
TABLE 5.—STATE AND FEDERAL CLANDESTINE LABORATORY CLEANUP COSTS
Fiscal year
DEA cost
1998 .............................................................................................................................................
1999 .............................................................................................................................................
2000 .............................................................................................................................................
2001 .............................................................................................................................................
2002 .............................................................................................................................................
2003 .............................................................................................................................................
2004 .............................................................................................................................................
2005 .............................................................................................................................................
2006* ............................................................................................................................................
$4,030,000
3,020,000
4,120,000
2,800,000
2,190,000
1,150,000
810,000
650,000
470,000
State/local
meth cost
$1,420,000
8,420,000
11,800,000
19,240,000
21,490,000
15,040,000
17,680,000
17,020,000
12,180,000
Total cost
$5,450,000
11,440,000
15,920,000
22,040,000
23,680,000
16,190,000
18,490,000
17,670,000
12,650,000
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* Data for fiscal year 2006 is through the third quarter (June 30, 2006).
The Federal and State cleanups are
generally limited to removing chemicals
that could be reused; they do not
address water and soil pollution that
remain. Owners of the property are
responsible for completing the cleanup
of contaminated water and soil, but if
the owner cannot pay the cost, local
governments bear the burden or the
contamination remains.
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The effectiveness of the control of
retail sales can be seen in the decline in
clandestine laboratory incidents in
States such as Oklahoma. In 2003,
before Oklahoma implemented retail
sales controls, there were 1,068
clandestine laboratory incidents in the
State. In 2005, the first full year of the
sales controls, there were only 217
incidents. The CMEA provisions on
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retail sales will continue the trend of
reducing the number of clandestine
laboratories. This trend will reduce the
cost to State and local governments as
well as the hazard to law enforcement
officers and others from exposure to the
hazardous chemicals left behind.
Conclusion. Because of the many
unknowns, DEA is unable to determine
with any certainty whether the CMEA
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requirements will impose an annual
cost on the economy of $100 million or
more, the standard for an economically
significant rule under Executive Order
12866. If the value of the existing
market is on the low end of the range
($500 million), the additional costs,
including transaction costs, would be
considerably lower than $100 million
even if there is no reduction in sales. If
the value of the market is $1.5 billion
and there is no reduction in sales, the
cost could exceed $100 million. DEA
considers it likely that product
switching and reduced sales will result
in annual costs below $100 million, but
until the statutory requirements are
implemented and both retailers and
consumers respond, DEA cannot
estimate total costs with any certainty.
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Public Comment
To assist DEA in finalizing its
Regulatory Impact Analysis, DEA is
seeking public comment on the
following questions:
• What is the size of the market for
products regulated under this rule?
What proportion of the cold and allergy
product market are pseudoephedrinebased products?
• Using a pre-CMEA baseline, will
this regulation have any effect on the
prices of regulated products? If so, what
is the magnitude of the change?
• How many retailers may choose not
to carry the regulated products rather
than incur the regulatory costs? What is
their annual sales volume with regard to
regulated products? What is the cost
associated with that effect?
• If stores choose not to carry the
regulated products, what are consumers’
travel costs associated with the
decreased quantity of stores selling the
product?
• Placing products behind the
counter may increase competition for
space behind the counter. Will it
increase the cost of storage space behind
the counter? What is the cost imposed
on the consumption of other goods?
What, if any, effect will this have on the
prices of other goods?
• Among stores that opt to direct
regulated transactions to their
pharmacies, will this additional traffic
have an effect on pharmacy wait times?
Will the increase in pharmacy
transactions require additional staffing?
• What equipment is required for
retailers who wish to handle regulated
sales at the regular checkout line? What
is its cost?
• What are wait times for regulated
transactions when two or more
consumers arrive to purchase regulated
products?
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Jkt 208001
• What is the cost to manufacturers,
given expected demand reductions for
regulated products?
• To what extent, and under what
circumstances, can substitutes for the
regulated products reduce the expected
cost of this regulation?
• What are the results of any recent
studies on the effective doses of
substitute products and their safety at
different levels?
• To what extent are training and
recordkeeping costs fixed versus
variable?
Paperwork Reduction Act of 1995
CMEA mandates a number of new
information collections and
recordkeeping requirements. Regulated
sellers are required to train any
employee who will be involved in
selling scheduled listed chemical
products and to document the training.
Regulated sellers must also self-certify
to DEA that all affected employees have
been trained and that the seller is in
compliance with all CMEA provisions.
Finally, CMEA mandates that each sale
at retail be documented in a written or
electronic logbook and that the logbooks
be retained for two years.
The Department of Justice, Drug
Enforcement Administration, has
submitted the following information
collection request to the Office of
Management and Budget for review and
clearance in accordance with review
procedures of the Paperwork Reduction
Act of 1995. The information collection
is published to obtain comments from
the public and affected agencies.
All comments and suggestions, or
questions regarding additional
information, to include obtaining a copy
of the information collection instrument
with instructions, should be directed to
Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion
Control, Drug Enforcement
Administration, Washington, DC 20537.
Written comments and suggestions
from the public and affected agencies
concerning the collection of information
are encouraged. Your comments on the
information collection-related aspects of
this rule should address one or more of
the following four points:
(1) Evaluate whether the collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden of the
collection of information, including the
validity of the methodology and
assumptions used;
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56021
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
Overview of This Information Collection
(1) Type of Information Collection:
New collection.
(2) Title of the Form/Collection: Selfcertification, Training and Logbooks for
Regulated Sellers of Scheduled Listed
Chemical Products.
(3) Agency form number, if any, and
the applicable component of the
Department of Justice sponsoring the
collection: Form Number: DEA Form
597, Office of Diversion Control, Drug
Enforcement Administration, U.S.
Department of Justice.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract:
Primary: Business or other for-profit.
Other: None.
Abstract: CMEA mandates that retail
sellers of scheduled listed chemical
products maintain a written or
electronic logbook of sales, retain a
record of employee training, and
complete a self-certification form
verifying the training and compliance
with CMEA provisions regarding retail
sales of scheduled listed chemical
products.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: 89,000, 25.9 hours.
As discussed in the previous section,
DEA estimates that the number of
potential regulated sellers could range
from 89,000 to 118,000. That number
would include a substantial number of
convenience stores, most of which may
not find the burden of self-certification,
storage, recordkeeping, and training
worth the sales of items that represent
a very small percentage of their overall
sales. Thus, DEA expects that the
number of regulated sellers that will
seek to self-certify will be no higher
than 89,000. Consequently, DEA has
used the lower estimate for the
information collection. The average
annual burden hour per respondent is
25.9 hours, most of which is the
additional time needed to record the
statutorily mandated information on
each sales transaction.
(6) An estimate of the total public
burden (in hours) associated with the
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Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Rules and Regulations
collection: 4,548,500 hours. The
estimate includes both the burden hours
for regulated sellers and the time
customers would take to provide
information during the transaction.
Regulated sellers will need to
maintain a record of employee training,
self-certify, and maintain a logbook of
transactions. DEA estimates that each
regulated seller will spend 0.5 hours
collecting the information and
completing the online self-certification
form. Completing a roster of employees
trained is estimated to take 3 minutes
per employee, assuming that the
recordkeeping takes one tenth of the
time spent on training. Finally, DEA
estimates that having the customer enter
information and sign the log while the
sales person checks the photo ID will
take two minutes per transaction. DEA
assumes recordkeeping requirements
will not lengthen checkout lines, and
will not influence the transaction times
of other customers. Further, this
estimate does not account for scenarios
in which two or more customers arrive
to purchase scheduled listed chemical
products. DEA assumes that all
pharmacists and pharmacy technicians
will be trained (about 300,000) plus
100,000 other sales clerks. DEA used an
estimate of 133 million transactions to
develop total burden hours for
transactions, assuming that the total
value of the market is the midpoint of
the estimates ($1 billion) and that the
average value of a transaction is $8.
(Product prices range from $4 to $14 per
package depending on the number of
dosage units and strength.) The number
of transactions was reduced to 67.25
million to account for the states that
already have requirements for logbooks;
this rule imposes no additional burden
for the transactions on either purchasers
or sellers in those states. Based on
Bureau of Census state population
numbers for 2005, these states represent
49 percent of the United States
population. Table 6 presents the burden
hour calculations.
TABLE 6.—ESTIMATE OF TOTAL BURDEN HOURS
Number of
activities
Total burden
hours
Activity
Unit burden hour
Training record .............................................................
Self-certification ............................................................
Transaction record ........................................................
Customer time ..............................................................
0.05 hour (3 minutes) ...................................................
0.5 hour (30 minutes) ...................................................
0.033 hour (2 minutes) .................................................
0.033 hour (2 minutes) .................................................
400,000
89,000
67,250,000
67,250,000
20,000
44,500
2,242,000
2,242,000
Total .......................................................................
.......................................................................................
........................
4,548,500
If additional information is required
contact: Lynn Bryant, Department
Clearance Officer, Information
Management and Security Staff, Justice
Management Division, Department of
Justice, Patrick Henry Building, Suite
1600, 601 D Street NW., Washington,
DC 20530.
Executive Order 12988
This regulation meets the applicable
standards set forth in sections 3(a) and
3(b)(2) of Executive Order 12988 Civil
Justice Reform.
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Executive Order 13132
This rulemaking does not impose
enforcement responsibilities on any
State; nor does it diminish the power of
any State to enforce its own laws. The
rule does preempt State laws that are
less stringent than the statutory
requirements. These requirements,
however, are mandated under CMEA
and DEA has no authority to alter them
or change the preemption. Accordingly,
this rulemaking does not have
federalism implications warranting the
application of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rule will not result in the
expenditure by State, local, and tribal
governments, in the aggregate, or by the
private sector, of $118,000,000 or more
in any one year, and will not
significantly or uniquely affect small
governments. Therefore, no actions were
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14:57 Sep 25, 2006
Jkt 208001
deemed necessary under the provisions
of the Unfunded Mandates Reform Act
of 1995.
Congressional Review Act
This rule is a major rule as defined by
section 804 of the Small Business
Regulatory Enforcement Fairness Act of
1996 (Congressional Review Act). This
rule may result in an annual effect on
the economy of $100,000,000 or more; it
will not cause a major increase in costs
or prices; or significant adverse effects
on competition, employment,
investment, productivity, innovation, or
on the ability of United States-based
companies to compete with foreignbased companies in domestic and
export markets. Depending heavily on
the assumptions used, the economic
impact of this rule could be
substantially higher or lower than
$100,000,000.
CMEA requires that on and after
September 30, 2006, regulated sellers
selling scheduled listed chemical
products at retail shall self-certify with
DEA in order to continue to sell these
products. CMEA imposes sales limits,
purchase limits, product placement
requirements, mail order customer
identification requirements, and other
requirements, some of which must be
specified by regulation, all with an
effective date of September 30, 2006.
Based on the effective date of this law,
it is impracticable for DEA to comply
with the requirements of CRA section
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801 pertaining to delayed effective dates
of major rules due to the limited time
involved. Were DEA not to publish this
Interim Rule with Request for Comment,
regulated sellers selling scheduled listed
chemical products at retail would not be
able to self-certify by the date specified
in the law. Were this not to occur, these
regulated sellers would be forced to stop
selling scheduled listed chemical
products, or violate the law by doing so.
Mail order distributors would also have
difficulty, as DEA is required by
regulation to establish procedures for
these persons to identify their customers
prior to shipping product. Without these
regulations, mail order distributors
would not be able to sell scheduled
listed chemical products. Therefore,
DEA also finds that it is contrary to the
public interest not to issue these
regulations as an Interim Rule, thereby
allowing regulated sellers and mail
order distributors to fully comply with
the requirements of CMEA. While the
CMEA was signed into law in March of
2006, most of the law must be in effect
by September 30, 2006. The broad scope
of the new law, as well as the expedited
effective dates, is a clear reflection of
Congress’s concern about the nation’s
growing methamphetamine epidemic
and its desire to act quickly to prevent
further illicit use of these chemicals. In
light of these factors, DEA finds that
‘‘good cause’’ exists to make this Interim
Rule with Request for Comment
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Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Rules and Regulations
effective September 21, 2006, except
that §§ 1314.20, 1314.25, and 1314.30
(with the exception of § 1314.30(a)(2))
are effective September 30, 2006.
Section 1314.30(a)(2) is effective
November 27, 2006.
List of Subjects
21 CFR Part 1300
Chemicals, Drug traffic control.
21 CFR Part 1309
Administrative practice and
procedure, Drug traffic control, Exports,
Imports, Security measures.
21 CFR Part 1310
Drug traffic control, Exports, Imports,
Reporting and recordkeeping
requirements.
21 CFR Part 1314
Drug traffic control, Reporting and
recordkeeping requirements.
For the reasons set out above, 21 CFR
Chapter II is amended as follows:
I
PART 1300—DEFINITIONS
1. The authority citation for part 1300
continues to read as follows:
I
Authority: 21 U.S.C. 802, 871(b), 951,
958(f).
2. Section 1300.02 is amended by
revising paragraphs (b)(28) and (29),
removing paragraph (b)(31),
redesignating paragraphs (b)(32) through
(b)(34) as (b)(31) through (b)(33), and
adding new paragraphs (b)(34) through
(b)(37) to read as follows:
I
§ 1300.02 Definitions related to listed
chemicals.
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*
*
*
*
*
(b) * * *
(28) The term regulated transaction
means:
(i) A distribution, receipt, sale,
importation, or exportation of a listed
chemical, or an international transaction
involving shipment of a listed chemical,
or if the Administrator establishes a
threshold amount for a specific listed
chemical, a threshold amount as
determined by the Administrator, which
includes a cumulative threshold amount
for multiple transactions, of a listed
chemical, except that such term does
not include:
(A) A domestic lawful distribution in
the usual course of business between
agents or employees of a single
regulated person; in this context, agents
or employees means individuals under
the direct management and control of
the regulated person;
(B) A delivery of a listed chemical to
or by a common or contract carrier for
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14:57 Sep 25, 2006
Jkt 208001
carriage in the lawful and usual course
of the business of the common or
contract carrier, or to or by a
warehouseman for storage in the lawful
and usual course of the business of the
warehouseman, except that if the
carriage or storage is in connection with
the distribution, importation, or
exportation of a listed chemical to a
third person, this paragraph does not
relieve a distributor, importer, or
exporter from compliance with parts
1309, 1310, and 1313 of this chapter;
(C) Any category of transaction or any
category of transaction for a specific
listed chemical or chemicals specified
by regulation of the Administrator as
excluded from this definition as
unnecessary for enforcement of the Act;
(D) Any transaction in a listed
chemical that is contained in a drug
other than a scheduled listed chemical
product that may be marketed or
distributed lawfully in the United States
under the Federal Food, Drug, and
Cosmetic Act, subject to paragraph
(b)(28)(i)(E) of this section, unless—
(1) The Administrator has determined
pursuant to the criteria in § 1310.10 of
this chapter that the drug or group of
drugs is being diverted to obtain the
listed chemical for use in the illicit
production of a controlled substance;
and
(2) The quantity of the listed chemical
contained in the drug included in the
transaction or multiple transactions
equals or exceeds the threshold
established for that chemical;
(E) Any transaction in a scheduled
listed chemical product that is a sale at
retail by a regulated seller or a
distributor required to submit reports
under § 1310.03(c) of this chapter; or
(F) Any transaction in a chemical
mixture designated in §§ 1310.12 and
1310.13 of this chapter that the
Administrator has exempted from
regulation.
(ii) A distribution, importation, or
exportation of a tableting machine or
encapsulating machine except that such
term does not include a domestic lawful
distribution in the usual course of
business between agents and employees
of a single regulated person; in this
context, agents or employees means
individuals under the direct
management and control of the
regulated person.
(29) The term retail distributor means
a grocery store, general merchandise
store, drug store, or other entity or
person whose activities as a distributor
relating to drug products containing
pseudoephedrine or
phenylpropanolamine are limited
almost exclusively to sales for personal
use, both in number of sales and volume
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56023
of sales, either directly to walk-in
customers or in face-to-face transactions
by direct sales. Also for the purposes of
this paragraph, a grocery store is an
entity within Standard Industrial
Classification (SIC) code 5411, a general
merchandise store is an entity within
SIC codes 5300 through 5399 and 5499,
and a drug store is an entity within SIC
code 5912.
*
*
*
*
*
(34)(i) The term scheduled listed
chemical product means a product that
contains ephedrine, pseudoephedrine,
or phenylpropanolamine and may be
marketed or distributed lawfully in the
United States under the Federal, Food,
Drug, and Cosmetic Act as a
nonprescription drug. Ephedrine,
pseudoephedrine, and
phenylpropanolamine include their
salts, optical isomers, and salts of
optical isomers.
(ii) Scheduled listed chemical product
does not include any product that is a
controlled substance under part 1308 of
this chapter. In the absence of such
scheduling by the Attorney General, a
chemical specified in paragraph
(b)(34)(i) of this section may not be
considered to be a controlled substance.
(35) The term regulated seller means
a retail distributor (including a
pharmacy or a mobile retail vendor),
except that the term does not include an
employee or agent of the distributor.
(36) The term mobile retail vendor
means a person or entity that makes
sales at retail from a stand that is
intended to be temporary or is capable
of being moved from one location to
another, whether the stand is located
within or on the premises of a fixed
facility (such as a kiosk at a shopping
center or an airport) or whether the
stand is located on unimproved real
estate (such as a lot or field leased for
retail purposes).
(37) The term at retail, with respect to
the sale or purchase of a scheduled
listed chemical product, means a sale or
purchase for personal use, respectively.
PART 1309—REGISTRATION OF
MANUFACTURERS, DISTRIBUTORS,
IMPORTERS, AND EXPORTERS OF
LIST I CHEMICALS
3. The authority citation for part 1309
continues to read as follows:
I
Authority: 21 U.S.C. 802, 821, 822, 823,
824, 830, 871(b), 875, 877, 958.
4. Section 1309.71(a) is revised to read
as follows:
I
§ 1309.71
General security requirements.
(a) All applicants and registrants must
provide effective controls and
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Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Rules and Regulations
procedures to guard against theft and
diversion of List I chemicals. Chemicals
must be stored in containers sealed in
such a manner as to indicate any
attempts at tampering with the
container. Where chemicals cannot be
stored in sealed containers, access to the
chemicals should be controlled through
physical means or through human or
electronic monitoring.
*
*
*
*
*
PART 1310—RECORDS AND
REPORTS OF LISTED CHEMICALS
AND CERTAIN MACHINES
5. The authority citation for part 1310
continues to read as follows:
I
Authority: 21 U.S.C. 802, 827(h), 830,
871(b), 890.
6. In § 1310.04, paragraph (f)(1)(ii) is
revised to read as follows:
I
§ 1310.04
Maintenance of records.
*
*
*
*
*
(f) * * *
(1) * * *
(ii) For List I chemicals that are
scheduled listed chemical products as
defined in § 1300.02, the thresholds
established in paragraphs (f)(1)(i) and (g)
of this section apply only to non-retail
distribution, import, and export. Sales
of these products at retail are subject to
the requirements of part 1314 of this
chapter.
*
*
*
*
*
I 7. Section 1310.05 is amended by
revising paragraph (f)(2) to read as
follows:
§ 1310.05
Reports.
*
*
*
*
*
(f) * * *
(2) Distributions of drug products by
retail distributors that may not include
face-to-face transactions to the extent
that such distributions are consistent
with the activities authorized for a retail
distributor as specified in
§ 1300.02(b)(29) of this chapter, except
that this paragraph does not apply to
sales of scheduled listed chemical
products at retail.
*
*
*
*
*
I 8. Remove § 1310.14.
I 9. Remove § 1310.15.
I 10. Add § 1310.16 to read as follows:
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§ 1310.16 Exemptions for certain
scheduled listed chemical products.
(a) Upon the application of a
manufacturer of a scheduled listed
chemical product, the Administrator
may by regulation provide that the
product is exempt from part 1314 of this
chapter if the Administrator determines
that the product cannot be used in the
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14:57 Sep 25, 2006
Jkt 208001
illicit manufacture of a controlled
substance.
(b) An application for an exemption
under this section must contain all of
the following information:
(1) The name and address of the
applicant.
(2) The exact trade name of the
scheduled listed chemical product for
which exemption is sought.
(3) The complete quantitative and
qualitative composition of the drug
product.
(4) A brief statement of the facts that
the applicant believes justify the
granting of an exemption under this
section.
(5) Certification by the applicant that
the product may be lawfully marketed
or distributed under the Federal, Food,
Drug, and Cosmetic Act.
(6) The identification of any
information on the application that is
considered by the applicant to be a trade
secret or confidential and entitled to
protection under U.S. laws restricting
the public disclosure of such
information by government employees.
(c) The Administrator may require the
applicant to submit additional
documents or written statements of fact
relevant to the application that he
deems necessary for determining if the
application should be granted.
(d) Within a reasonable period of time
after the receipt of a completed
application for an exemption under this
section, the Administrator shall notify
the applicant of acceptance or nonacceptance of the application. If the
application is not accepted, an
explanation will be provided. The
Administrator is not required to accept
an application if any of the information
required in paragraph (b) of this section
or requested under paragraph (c) of this
section is lacking or not readily
understood. The applicant may,
however, amend the application to meet
the requirements of paragraphs (b) and
(c) of this section.
(e) If the application is accepted for
filing, the Administrator shall issue and
publish in the Federal Register an order
on the application, which shall include
a reference to the legal authority under
which the order is based. This order
shall specify the date on which it shall
take effect.
(f) The Administrator shall permit any
interested person to file written
comments on or objections to the order.
If any comments or objections raise
significant issues regarding any findings
of fact or conclusions of law upon
which the order is based, the
Administrator shall immediately
suspend the effectiveness of the order
until he may reconsider the application
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Fmt 4700
Sfmt 4700
in light of the comments and objections
filed. Thereafter, the Administrator shall
reinstate, revoke, or amend the original
order as deemed appropriate.
I 11. Part 1314 is added to 21 CFR
Chapter II to read as follows:
PART 1314—RETAIL SALE OF
SCHEDULED LISTED CHEMICAL
PRODUCTS
Subpart A—General
1314.01 Scope.
1314.02 Applicability.
1314.03 Definitions.
1314.05 Requirements regarding packaging
of nonliquid forms.
1314.10 Effect on state laws.
1314.15 Loss reporting.
Subpart B—Sales by Regulated Sellers
1314.20 Restrictions on sales quantity.
1314.25 Requirements for retail
transactions.
1314.30 Recordkeeping for retail
transactions.
1314.35 Training of sales personnel.
1314.40 Self-certification.
1314.45 Privacy protections.
1314.50 Employment measures.
Subpart C—Mail-Order Sales
1314.100 Sales limits for mail-order sales.
1314.105 Verification of identity for mailorder sales.
1314.110 Reports for mail-order sales.
1314.115 Distributions not subject to
reporting requirements.
Subpart D—Order To Show Cause
1314.150 Order to show cause.
1314.155 Suspension pending final order.
Authority: 21 U.S.C. 802, 830, 842, 871(b),
875, 877.
Subpart A—General
§ 1314.01
Scope.
This part specifies the requirements
for retail sales of scheduled listed
chemical products to individuals for
personal use.
§ 1314.02
Applicability.
(a) This part applies to the following
regulated persons who sell scheduled
listed chemical products for personal
use:
(1) Regulated sellers of scheduled
listed chemical products sold at retail
for personal use through face-to-face
sales at stores or mobile retail vendors.
(2) Regulated persons who engage in
a transaction with a non-regulated
person and who ship the products to the
non-regulated person by the U.S. Postal
Service or by private or common
carriers.
(b) The requirements in subpart A
apply to all regulated persons subject to
this part. The requirements in subpart B
apply to regulated sellers as defined in
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§ 1300.02 of this chapter. The
requirements in subpart C apply to
regulated persons who ship the
products to the customer by the U.S.
Postal Service or by private or common
carriers.
§ 1314.03
Definitions.
As used in this part, the term ‘‘mailorder sale’’ means a retail sale of
scheduled listed chemical products for
personal use where a regulated person
uses or attempts to use the U.S. Postal
Service or any private or commercial
carrier to deliver the product to the
customer. Mail-order sale includes
purchase orders submitted by phone,
mail, fax, Internet, or any method other
than face-to-face transaction.
§ 1314.05 Requirements regarding
packaging of nonliquid forms.
A regulated seller or mail order
distributor may not sell a scheduled
listed chemical product in nonliquid
form (including gel caps) unless the
product is packaged either in blister
packs, with each blister containing no
more than two dosage units or, if blister
packs are technically infeasible, in unit
dose packets or pouches.
§ 1314.10
Effect on State laws.
Nothing in this part preempts State
law on the same subject matter unless
there is a positive conflict between this
part and a State law so that the two
cannot consistently stand together.
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§ 1314.15
Loss reporting.
(a) Each regulated person must report
to the Special Agent in Charge of the
DEA Divisional Office for the area in
which the regulated person making the
report is located, any unusual or
excessive loss or disappearance of a
scheduled listed chemical product
under the control of the regulated
person. The regulated person
responsible for reporting a loss in-transit
is the supplier.
(b) Each report submitted under
paragraph (a) of this section must,
whenever possible, be made orally to
the DEA Divisional Office for the area in
which the regulated person making the
report is located at the earliest
practicable opportunity after the
regulated person becomes aware of the
circumstances involved.
(c) Written reports of losses must be
filed within 15 days after the regulated
person becomes aware of the
circumstances of the event.
(d) A report submitted under this
section must include a description of
the circumstances of the loss (in-transit,
theft from premises, etc.).
(e) A suggested format for the report
is provided below:
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Regulated Person
Registration number (if applicable) llll
Name llllllllllllllllll
Business address llllllllllll
City llllllllllllllllll
State llllllllllllllllll
Zip lllllllllllllllllll
Business phone lllllllllllll
Date of loss lllllllllllllll
Type of loss lllllllllllllll
Description of circumstances lllllll
Subpart B—Sales by Regulated Sellers
§ 1314.20
Restrictions on sales quantity.
(a) Without regard to the number of
transactions, a regulated seller
(including a mobile retail vendor) may
not in a single calendar day sell any
purchaser more than 3.6 grams of
ephedrine base, 3.6 grams of
pseudoephedrine base, or 3.6 grams of
phenylpropanolamine base in
scheduled listed chemical products.
(b) A mobile retail vendor may not in
any 30-day period sell an individual
purchaser more than 7.5 grams of
ephedrine base, 7.5 grams of
pseudoephedrine base, or 7.5 grams of
phenylpropanolamine base in
scheduled listed chemical products.
§ 1314.25 Requirements for retail
transactions.
(a) Each regulated seller must ensure
that sales of a scheduled listed chemical
product at retail are made in accordance
with this section and § 1314.20.
(b) The regulated seller must place the
product so that customers do not have
direct access to the product before the
sale is made (in this paragraph referred
to as ‘‘behind-the-counter’’ placement).
For purposes of this paragraph, a
behind-the-counter placement of a
product includes circumstances in
which the product is stored in a locked
cabinet that is located in an area of the
facility where customers do have direct
access. Mobile retail vendors must place
the product in a locked cabinet.
(c) The regulated seller must deliver
the product directly into the custody of
the purchaser.
§ 1314.30 Recordkeeping for retail
transactions.
(a)(1) Except for purchase by an
individual of a single sales package
containing not more than 60 milligrams
of pseudoephedrine, the regulated seller
must maintain, in accordance with
criteria issued by the Administrator, a
written or electronic list of each
scheduled listed chemical product sale
that identifies the products by name, the
quantity sold, the names and addresses
of the purchasers, and the dates and
times of the sales (referred to as the
‘‘logbook’’). The logbook may be
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maintained on paper or in electronic
form.
(2) Effective November 27, 2006, if a
logbook is maintained on paper, it must
be created and maintained in a bound
record book.
(b) The regulated seller must not sell
a scheduled listed chemical product at
retail unless the purchaser does the
following:
(1) Presents an identification card that
provides a photograph and is issued by
a State or the Federal Government, or a
document that, with respect to
identification, is considered acceptable
for purposes of 8 CFR 274a.2(b)(1)(v)(A)
and 274a.2(b)(1)(v)(B).
(2) Signs the logbook and enters in the
logbook his or her name, address, and
the date and time of the sale.
(c) For records created electronically,
the regulated seller may use an
electronic signature system to capture
the signature and may have the
computer automatically enter the date
and time of the sale. The regulated seller
may ask the purchaser for their name
and address and enter information if it
is not feasible for the purchaser to enter
the information electronically.
(d) The regulated seller must
determine that the name entered in the
logbook corresponds to the name
provided on identification presented
and that the date and time entered are
correct.
(e) The regulated seller must enter in
the logbook the name of the product and
the quantity sold. Examples of methods
of recording the quantity sold include
the weight of the product per package
and number of packages of each
chemical, the cumulative weight of the
product for each chemical, or quantity
of product by Universal Product Code.
These examples do not exclude other
methods of displaying the quantity sold.
For electronic records, the regulated
seller may use a point-of-sale and bar
code reader. Such electronic records
must be provided pursuant to paragraph
(i) of this section in a human readable
form such that the requirements of
paragraph (a)(1) of this section are
satisfied.
(f) The regulated seller must include
in the logbook or display by the
logbook, the following notice:
Warning: Section 1001 of Title 18, United
States Code, states that whoever, with respect
to the logbook, knowingly and willfully
falsifies, conceals, or covers up by any trick,
scheme, or device a material fact, or makes
any materially false, fictitious, or fraudulent
statement or representation, or makes or uses
any false writing or document knowing the
same to contain any materially false,
fictitious, or fraudulent statement or entry,
shall be fined not more than $250,000 if an
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individual or $500,000 if an organization,
imprisoned not more than five years, or both.
(g) The regulated seller must maintain
each entry in the logbook for not fewer
than 2 years after the date on which the
entry is made.
(h) A record under this section must
be kept at the regulated seller’s place of
business where the transaction
occurred, except that records may be
kept at a single, central location of the
regulated seller if the regulated seller
has notified the Administration of the
intention to do so. Written notification
must be submitted by registered or
certified mail, return receipt requested,
to the Special Agent in Charge of the
DEA Divisional Office for the area in
which the records are required to be
kept.
(i) The records required to be kept
under this section must be readily
retrievable and available for inspection
and copying by authorized employees of
the Administration under the provisions
of 21 U.S.C. 880.
(j) A record developed and
maintained to comply with a State law
may be used to meet the requirements
of this section if the record includes the
information specified in this section.
§ 1314.35
Training of sales personnel.
Each regulated seller must ensure that
its sales of a scheduled listed chemical
product at retail are made in accordance
with the following:
(a) In the case of individuals who are
responsible for delivering the products
into the custody of purchasers or who
deal directly with purchasers by
obtaining payments for the products, the
regulated seller has submitted to the
Administration a self-certification that
all such individuals have, in accordance
with criteria issued by the
Administration, undergone training
provided by the regulated seller to
ensure that the individuals understand
the requirements that apply under this
part.
(b) The regulated seller maintains a
copy of each self-certification and all
records demonstrating that individuals
referred to in paragraph (a) of this
section have undergone the training.
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§ 1314.40
Self-certification.
(a) A regulated seller must submit to
the Administration the self-certification
referred to in § 1314.35(a) in order to
sell any scheduled listed chemical
product. The certification is not
effective for purposes of this section
unless, in addition to provisions
regarding the training of individuals
referred to in § 1314.35(a), the
certification includes a statement that
the regulated seller understands each of
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Jkt 208001
the requirements that apply under this
part and agrees to comply with the
requirements.
(b) When a regulated seller files the
initial self-certification, the
Administration will assign the regulated
seller to one of twelve groups. The
expiration date of the self-certification
for all regulated sellers in any group
will be the last day of the month
designated for that group. In assigning a
regulated seller to a group, the
Administration may select a group with
an expiration date that is not less than
12 months or more than 23 months from
the date of the self-certification. After
the initial certification period, the
regulated seller must update the selfcertifications annually.
(c) The regulated seller must provide
a separate certification for each place of
business at which the regulated seller
sells scheduled listed chemical products
at retail.
§ 1314.45
Privacy protections.
To protect the privacy of individuals
who purchase scheduled listed
chemical products, the disclosure of
information in logbooks under § 1314.15
is restricted as follows:
(a) The information shall be disclosed
as appropriate to the Administration
and to State and local law enforcement
agencies.
(b) The information in the logbooks
shall not be accessed, used, or shared
for any purpose other than to ensure
compliance with this title or to facilitate
a product recall to protect public health
and safety.
(c) A regulated seller who in good
faith releases information in a logbook
to Federal, State, or local law
enforcement authorities is immune from
civil liability for the release unless the
release constitutes gross negligence or
intentional, wanton, or willful
misconduct.
§ 1314.50
Employment measures.
A regulated seller may take reasonable
measures to guard against employing
individuals who may present a risk with
respect to the theft and diversion of
scheduled listed chemical products,
which may include, notwithstanding
State law, asking applicants for
employment whether they have been
convicted of any crime involving or
related to such products or controlled
substances.
Subpart C—Mail-Order Sales
§ 1314.100
sales.
Sales limits for mail-order
(a) Each regulated person who makes
a sale at retail of a scheduled listed
chemical product and is required under
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§ 1310.03(c) of this chapter to submit a
report of the sales transaction to the
Administration may not in a single
calendar day sell to any purchaser more
than 3.6 grams of ephedrine base, 3.6
grams of pseudoephedrine base, or 3.6
grams of phenylpropanolamine base in
scheduled listed chemical products.
(b) Each regulated person who makes
a sale at retail of a scheduled listed
chemical product and is required under
§ 1310.03(c) of this chapter to submit a
report of the sales transaction to the
Administration may not in any 30-day
period sell to an individual purchaser
more than 7.5 grams of ephedrine base,
7.5 grams of pseudoephedrine base, or
7.5 grams of phenylpropanolamine base
in scheduled listed chemical products.
§ 1314.105 Verification of identity for mailorder sales.
(a) Each regulated person who makes
a sale at retail of a scheduled listed
chemical product and is required under
§ 1310.03(c) of this chapter to submit a
report of the sales transaction to the
Administration must, prior to shipping
the product, receive from the purchaser
a copy of an identification card that
provides a photograph and is issued by
a State or the Federal Government, or a
document that, with respect to
identification, is considered acceptable
for purposes of 8 CFR 274a.2(b)(1)(v)(A)
and 274a.2(b)(1)(v)(B). Prior to shipping
the product, the regulated person must
determine that the name and address on
the identification correspond to the
name and address provided by the
purchaser as part of the sales
transaction. If the regulated person
cannot verify the identities of both the
purchaser and the recipient, the person
may not ship the scheduled listed
chemical product.
(b) If the product is being shipped to
a third party, the regulated person must
comply with the requirements of
paragraph (a) to verify that both the
purchaser and the person to whom the
product is being shipped live at the
addresses provided. If the regulated
person cannot verify the identities of
both the purchaser and the recipient,
the person may not ship the scheduled
listed chemical product.
§ 1314.110
Reports for mail-order sales.
(a) Each regulated person required to
report under § 1310.03(c) of this chapter
must either:
(1) Submit a written report,
containing the information set forth in
paragraph (b) of this section, on or
before the 15th day of each month
following the month in which the
distributions took place. The report
must be submitted under company
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letterhead, signed by the person
authorized to sign on behalf of the
regulated seller, to the Drug and
Chemical Evaluation Section, Office of
Diversion Control, Drug Enforcement
Administration, Washington, DC 20537;
or
(2) Upon request to and approval by
the Administration, submit the report in
electronic form, either via computer
disk or direct electronic data
transmission, in such form as the
Administration shall direct. Requests to
submit reports in electronic form should
be submitted to the Drug and Chemical
Evaluation Section, Office of Diversion
Control, Drug Enforcement
Administration, Washington, DC 20537,
ATTN: Electronic Reporting.
(b) Each monthly report must provide
the following information for each
distribution:
(1) Supplier name and registration
number;
(2) Purchaser’s name and address;
(3) Name/address shipped to (if
different from purchaser’s name/
address);
(4) Method used to verify the identity
of the purchaser and, where applicable,
person to whom product is shipped;
(5) Name of the chemical contained in
the scheduled listed chemical product
and total quantity shipped (e.g.
pseudoephedrine, 3 grams);
(6) Date of shipment;
(7) Product name;
(8) Dosage form (e.g., tablet, liquid);
(9) Dosage strength (e.g., 30mg, 60mg,
per dose etc.);
(10) Number of dosage units (e.g., 100
doses per package);
(11) Package type (blister pack, etc.);
(12) Number of packages;
(13) Lot number.
rmajette on PROD1PC67 with RULES1
§ 1314.115 Distributions not subject to
reporting requirements.
(a) The following distributions to
nonregulated persons are not subject to
the reporting requirements in
§ 1314.110:
(1) Distributions of sample packages
when those packages contain not more
than two solid dosage units or the
equivalent of two dosage units in liquid
form, not to exceed 10 milliliters of
liquid per package, and not more than
one package is distributed to an
individual or residential address in any
30-day period.
(2) Distributions by retail distributors
that may not include face-to-face
transactions to the extent that such
distributions are consistent with the
activities authorized for a retail
distributor as specified in
§ 1300.02(b)(29) of this chapter, except
that this paragraph (a)(2) does not apply
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14:57 Sep 25, 2006
Jkt 208001
to sales of scheduled listed chemical
products at retail.
(3) Distributions to a resident of a long
term care facility or distributions to a
long term care facility for dispensing to
or for use by a resident of that facility.
(4) Distributions in accordance with a
valid prescription.
(b) The Administrator may revoke any
or all of the exemptions listed in
paragraph (a) of this section for an
individual regulated person if the
Administrator finds that drug products
distributed by the regulated person are
being used in violation of the
regulations in this chapter or the
Controlled Substances Act.
Subpart D—Order to Show Cause
§ 1314.150
Order To show cause.
(a) If, upon information gathered by
the Administration regarding any
regulated seller or a distributor required
to submit reports under § 1310.03(c) of
this chapter, the Administrator
determines that a regulated seller or
distributor required to submit reports
under § 1310.03(c) of this chapter has
sold a scheduled listed chemical
product in violation of Section 402 of
the Act (21 U.S.C. 842(a)(12) or (13)),
the Administrator will serve upon the
regulated seller or distributor an order
to show cause why the regulated seller
or distributor should not be prohibited
from selling scheduled listed chemical
products.
(b) The order to show cause shall call
upon the regulated seller or distributor
to appear before the Administrator at a
time and place stated in the order,
which shall not be less than 30 days
after the date of receipt of the order. The
order to show cause shall also contain
a statement of the legal basis for such
hearing and for the prohibition and a
summary of the matters of fact and law
asserted.
(c) Upon receipt of an order to show
cause, the regulated seller or distributor
must, if he desires a hearing, file a
request for a hearing as specified in
subpart D of part 1316 of this chapter.
If a hearing is requested, the
Administrator shall hold a hearing at
the time and place stated in the order,
as provided in part 1316 of this chapter.
(d) When authorized by the
Administrator, any agent of the
Administration may serve the order to
show cause.
§ 1314.155
order.
Suspension pending final
(a) The Administrator may suspend
the right to sell scheduled listed
chemical products simultaneously with,
or at any time subsequent to, the service
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56027
upon the seller or distributor required to
file reports under § 1310.03(c) of this
chapter of an order to show cause why
the regulated seller or distributor should
not be prohibited from selling
scheduled listed chemical products, in
any case where he finds that there is an
imminent danger to the public health or
safety. If the Administrator so suspends,
he shall serve with the order to show
cause under § 1314.150 an order of
immediate suspension that shall contain
a statement of his findings regarding the
danger to public health or safety.
(b) Upon service of the order of
immediate suspension, the regulated
seller or distributor shall, as instructed
by the Administrator:
(1) Deliver to the nearest office of the
Administration or to authorized agents
of the Administration all of the
scheduled listed chemical products in
his or her possession; or
(2) Place all of the scheduled listed
chemical products under seal as
described in Section 304 of the Act (21
U.S.C. 824(f)).
(c) Any suspension shall continue in
effect until the conclusion of all
proceedings upon the prohibition,
including any judicial review, unless
sooner withdrawn by the Administrator
or dissolved by a court of competent
jurisdiction. Any regulated seller or
distributor whose right to sell scheduled
listed chemical products is suspended
under this section may request a hearing
on the suspension at a time earlier than
specified in the order to show cause
under § 1314.150, which request shall
be granted by the Administrator, who
shall fix a date for such hearing as early
as reasonably possible.
Dated: September 20, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 06–8194 Filed 9–21–06; 10:25 am]
BILLING CODE 4410–09–P
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety
Administration
49 CFR Part 593
[Docket No. NHTSA–2006–25686]
List of Nonconforming Vehicles
Decided To Be Eligible for Importation
National Highway Traffic
Safety Administration (NHTSA), DOT.
ACTION: Final rule.
AGENCY:
SUMMARY: This document revises the list
of vehicles not originally manufactured
to conform to the Federal motor vehicle
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]]>Agencies
[Federal Register Volume 71, Number 186 (Tuesday, September 26, 2006)]
[Rules and Regulations]
[Pages 56008-56027]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-8194]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1300, 1309, 1310, 1314
[Docket No. DEA-291I]
RIN 1117-AB05
Retail Sales of Scheduled Listed Chemical Products; Self-
Certification of Regulated Sellers of Scheduled Listed Chemical
Products
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Interim final rule with request for comment.
-----------------------------------------------------------------------
SUMMARY: In March 2006, the President signed the Combat Methamphetamine
Epidemic Act of 2005, which establishes new requirements for retail
sales of over-the-counter (nonprescription) products containing the
List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
The three chemicals can be used to manufacture methamphetamine
illegally. DEA is promulgating this rule to incorporate the statutory
provisions and make its regulations consistent with the new
requirements. This action establishes daily and 30-day limits on the
sales of scheduled listed chemical products to individuals and requires
recordkeeping on most sales.
DATES: Effective Dates: September 21, 2006, except that Sec. Sec.
1314.20, 1314.25, and 1314.30 (with the exception of Sec.
1314.30(a)(2)) are effective September 30, 2006. Section 1314.30(a)(2)
is effective November 27, 2006.
Comment Date: Written comments must be postmarked on or before
November 27, 2006.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-291I'' on all written and electronic correspondence.
Written comments being sent via regular mail should be sent to the
Deputy Administrator, Drug Enforcement Administration, Washington, DC
20537, Attention: DEA Federal Register Representative/ODL. Written
comments sent via express mail should be sent to DEA Headquarters,
Attention: DEA Federal Register Representative/ODL, 2401 Jefferson-
Davis Highway, Alexandria, VA 22301. Comments may be directly sent to
DEA electronically by sending an electronic message to
dea.diversion.policy@usdoj.gov. Comments may also be sent
electronically through https://www.regulations.gov using the electronic
comment form provided on that site. An electronic copy of this document
is also available at the https://www.regulations.gov Web site. DEA will
accept attachments to electronic comments in Microsoft word,
WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept
any file format other than those specifically listed here.
FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537; telephone: (202) 307-7297.
SUPPLEMENTARY INFORMATION:
DEA's Legal Authority
DEA implements the Comprehensive Drug Abuse Prevention and Control
Act of 1970, often referred to as the Controlled Substances Act (CSA)
and the Controlled Substances Import and Export Act (21 U.S.C. 801-
971), as amended. DEA publishes the implementing regulations for these
statutes in Title 21 of the Code of Federal Regulations (CFR), Parts
1300 to 1399. These regulations are designed to ensure that there is a
sufficient supply of controlled substances for legitimate medical,
scientific, research, and industrial purposes and to deter the
diversion of controlled substances to illegal purposes. The CSA
mandates that DEA establish a closed system of control for
manufacturing, distributing, and dispensing controlled substances. Any
person who manufactures, distributes, dispenses, imports, exports, or
conducts research or chemical analysis with controlled substances must
register with DEA (unless exempt) and comply with the applicable
requirements for the activity. The CSA as amended also requires DEA to
regulate the manufacture and distribution of chemicals that may be used
to manufacture controlled substances illegally. Listed chemicals that
are classified as List I chemicals are important to the manufacture of
controlled substances. Those classified as List II chemicals may be
used to manufacture controlled substances.
On March 9, 2006, the President signed the Combat Methamphetamine
Epidemic Act of 2005 (CMEA), which is Title VII of the USA PATRIOT
Improvement and Reauthorization Act of 2005 (Pub. L. 109-177). DEA is
promulgating this rule as an interim final rule rather than a proposed
rule because the changes being made codify statutory provisions, some
of which are already in effect. Parts of the statute are self-
implementing; certain changes related to retail sales became effective
upon signature (March 9, 2006), others
[[Page 56009]]
became effective on April 8, 2006, and still others will become
effective September 30, 2006. An agency may find good cause to exempt a
rule from certain provisions of the Administrative Procedure Act (APA)
(5 U.S.C. 553), including notice of proposed rulemaking and the
opportunity for public comment, if it is determined to be unnecessary,
impracticable, or contrary to the public interest. Many of the
requirements of the Combat Methamphetamine Epidemic Act of 2005
included in this rulemaking were set out in such detail as to be self-
implementing. Therefore the changes in this rulemaking provide
conforming amendments to make the language of the regulations
consistent with that of the law. DEA is accepting comments on other
aspects of this rulemaking, particularly those not specifically
mandated by the Combat Methamphetamine Epidemic Act of 2005.
Combat Methamphetamine Epidemic Act of 2005
The Combat Methamphetamine Epidemic Act of 2005 (CMEA) amends the
CSA to change the regulations for selling nonprescription products that
contain ephedrine, pseudoephedrine, and phenylpropanolamine, their
salts, optical isomers, and salts of optical isomers. CMEA creates a
new category of products called ``scheduled listed chemical products.''
Ephedrine, pseudoephedrine, and phenylpropanolamine are List I
chemicals because they are used in, and important to, the illegal
manufacture of methamphetamine. Products containing these List I
chemicals also have legitimate medical uses. Ephedrine is used in some
products for treating asthma. Pseudoephedrine, a decongestant, is a
common ingredient in cold and allergy medications. In November 2000,
the Food and Drug Administration (FDA) issued a public health advisory
concerning phenylpropanolamine and requested that all drug companies
discontinue marketing products containing phenylpropanolamine due to
risk of hemorrhagic stroke. In response, many companies voluntarily
reformulated their products to exclude phenylpropanolamine.
Subsequently, on December 22, 2005, FDA published a Notice of Proposed
Rulemaking (70 FR 75988) proposing to categorize all over-the-counter
nasal decongestants and weight control drug products containing
phenylpropanolamine preparations as Category II, nonmonograph, i.e.,
not generally recognized as being safe for human consumption. Most
products containing phenylpropanolamine intended for humans have been
withdrawn from the market, but phenylpropanolamine is still sold by
prescription for veterinary uses.
Under previous CSA amendments (the Comprehensive Methamphetamine
Control Act of 1996 (MCA) and the Methamphetamine Anti-Proliferation
Act of 2000 (MAPA)), Congress limited the quantity of products
containing ephedrine, pseudoephedrine, and phenylpropanolamine that
could be sold as nonprescription drugs at retail (which were, along
with certain liquid products, defined as ``ordinary over-the-counter
pseudoephedrine or phenylpropanolamine products'') without
recordkeeping, but generally exempted products sold in blister packs
sold by ``retail distributors''. The MCA established thresholds for
these drug products, including a threshold of 24 grams of combination
ephedrine products; single-entity ephedrine products had been regulated
by the Domestic Chemical Diversion Control Act of 1993 (Pub. L. 103-
200). MAPA reduced existing thresholds for pseudoephedrine and
phenylpropanolamine to 9 grams per transaction, with each package
containing not more than 3 grams of pseudoephedrine base or
phenylpropanolamine base, but retained the so-called ``blister pack''
exemption. Because most retail outlets did not want to create and
maintain records of sales or register as a retail distributor, the
threshold for recordkeeping functioned for practical purposes similarly
to a sales limit. Much of the product was also sold in blister packs.
Congress determined that the existing limits were not sufficient to
prevent people from buying these products and using them to illegally
manufacture methamphetamine. In the Combat Methamphetamine Epidemic Act
of 2005, Congress adopted provisions that do the following:
Limit the quantity of each of the chemicals that may be
sold to an individual in a day to 3.6 grams of the chemical, without
regard to the number of transactions.
For nonliquids, limit packaging to blister packs
containing no more than 2 dosage units per blister. Where blister packs
are not technically feasible, the product must be packaged in unit dose
packets or pouches.
Require regulated sellers to place the products behind the
counter or in locked cabinets.
Require regulated sellers to check the identity of
purchasers and maintain a log of each sale that includes the
purchaser's name and address, signature of the purchaser, product sold,
quantity sold, date, and time.
Require regulated sellers to maintain the logbook for at
least two years.
Require regulated sellers to train employees in the
requirements of the law and certify to DEA that the training has
occurred.
For mobile retail vendors and mail order sales, require
sellers to limit sales to an individual in a 30-day period to 7.5
grams.
For individuals, limit purchases in a 30-day period to 9
grams, of which not more than 7.5 grams may be imported by means of a
common or contract carrier or the U.S. Postal Service.
The numbers of dosage units and milliliters (mL) that may be
purchased under the sales limits are shown in Table 1 below. As noted
previously, the FDA issued a voluntary recall on phenylpropanolamine
products as being unsafe for humans so no phenylpropanolamine over-the-
counter (OTC) product should be available for human consumption.
Veterinary use is by prescription only.
Table 1.--Number of Tablets/Milliliters That Equal Retail Transaction
Limits (as Base) for Scheduled Listed Chemical Products
------------------------------------------------------------------------
Transaction limits
Scheduled listed chemical product --------------------------------
3.6 gm 7.5 gm 9.0 gm
------------------------------------------------------------------------
Tablets
------------------------------------------------------------------------
Ephedrine:
25 mg Ephedrine HCl................ 175 366 439
25 mg Ephedrine Sulfate............ 186 389 466
Pseudoephedrine (as HCl):
[[Page 56010]]
30 mg Pseudoephedrine HCl.......... 146 305 366
60 mg Pseudoephedrine HCl.......... 73 152 183
120 mg Pseudoephedrine HCl......... 36 76 91
Pseudoephedrine (as Sulfate):
30 mg Pseudoephedrine Sulfate...... 155 324 389
60 mg Pseudoephedrine Sulfate...... 77 162 194
120 mg Pseudoephedrine Sulfate..... 38 81 97
240 mg Pseudoephedrine Sulfate..... 19 40 48
------------------------------------------------------------------------
Number of mL
------------------------------------------------------------------------
Ephedrine:
6.25 mg/5 ml Ephedrine HCl......... 3,515 7,323 8,788
Pseudoephedrine (as HCl):
15 mg/1.6 mL Pseudoephedrine HCl... 468 976 1,171
7.5 mg/5 mL Pseudoephedrine HCl.... 2,929 6,103 7,323
15 mg/5 mL Pseudoephedrine HCl..... 1,464 3,051 3,661
15 mg/2.5 mL Pseudoephedrine HCl... 732 1,525 1,830
30 mg/5 mL Pseudoephedrine HCl..... 732 1,525 1,830
30 mg/2.5 mL Pseudoephedrine HCl... 366 762 915
60 mg/5 mL Pseudoephedrine HCl..... 366 762 915
------------------------------------------------------------------------
Provisions of CMEA
Overview. Before CMEA, requirements for sales of products
containing ephedrine, pseudoephedrine, and phenylpropanolamine, which
were then called regulated drug products or drug products regulated
pursuant to 21 CFR 1300.02(b)(28)(i)(D), distinguished between in-
person sales to a purchaser (retail distribution) and mail order sales,
which covered any sale where the product is shipped using the Postal
Service or any common or private carrier. Mail order sellers had to
file monthly reports with DEA if they sold a purchaser drug products
containing more than a threshold quantity (9 grams for pseudoephedrine
and phenylpropanolamine (maximum per package of 3 grams), 24 grams for
ephedrine combination products), regardless of how the products were
packaged. Retailers conducting face-to-face transactions had to
maintain records for sales above the same thresholds except that, as
noted above, sales of products in blister packs generally were not
covered. The status of such sales was discussed in detail in an
interpretive rule (69 FR 2862, January 14, 2004; corrected at 69 FR
3198, January 22, 2004). Either type of seller had to register with DEA
if they sold the products to individuals in amounts above the threshold
quantity. Only two persons are registered as retail distributors.
The CMEA provisions on retail sales create differing requirements
for the various types of retail sales. As discussed further below,
Table 2 summarizes the applicability of the CMEA provisions as well as
existing DEA provisions to the different types of sellers.
Table 2.--Summary of Requirements by Type of Seller
----------------------------------------------------------------------------------------------------------------
Regulated sellers
(store) Mobile retail vendors Mail order sellers
----------------------------------------------------------------------------------------------------------------
Daily sales limit.................... 3.6 gm/chemical........ 3.6 gm/chemical........ 3.6 gm/chemical.
30-day sales limit................... ....................... 7.5 gm................. 7.5 gm.
Blister packs........................ Yes.................... Yes.................... Yes.
Storage.............................. Behind the counter Locked cabinet......... NA.
Locked cabinet.
Logbook.............................. Yes.................... Yes.................... NA.
Customer ID.......................... Examine photo ID....... Examine photo ID....... Verify ID.
Train employees...................... Yes.................... Yes.................... NA.
Self-Certify......................... Yes.................... Yes.................... NA.
Notice of misrepresentation.......... Yes.................... Yes.................... NA.
Monthly reports...................... No..................... No..................... Yes.
Theft and loss reports............... Yes.................... Yes.................... Yes.
----------------------------------------------------------------------------------------------------------------
CMEA defines nonprescription drug products containing ephedrine,
pseudoephedrine, or phenylpropanolamine as ``scheduled listed chemical
products.'' Direct, in-person sales to a customer, whether at a
permanent store or movable site (e.g., kiosk, flea market), are subject
to new requirements for training of employees who take part in the sale
of scheduled listed chemical products and certification to DEA that the
employees have been trained. These sellers, called ``regulated
sellers'' in CMEA, must also check photo identifications of purchasers
and maintain specific records of each sale of scheduled listed chemical
products. Under CMEA, the
[[Page 56011]]
only sales exempt from recordkeeping are sales of single packages of
pseudoephedrine where the package contains not more than 60 milligrams.
DEA will issue future guidance to further clarify remaining questions
about how regulated entities may meet this regulation's training
requirements.
The recordkeeping and reporting requirements for mail order sales
basically remain the same as under the previous regulations, except
that a waiver in the prior law that covered non face-to-face
distributions by retail distributors has been eliminated for scheduled
listed chemical products. As a result, retail stores that deliver these
products to customers by mail or delivery services will need to comply
with the provisions for mail order sales reporting for these
transactions. Mail order sellers must file monthly reports with DEA.
CMEA adds the requirement that these sellers verify the purchaser's
identity prior to shipping.
As noted above, CMEA changes the limits on retail sales. Daily
sales are now limited to a maximum of 3.6 grams of each chemical in
scheduled listed chemical products. Mobile retail vendors and mail
order vendors must also limit sales to an individual purchaser to 7.5
grams of each chemical in scheduled listed chemical products in any 30-
day period. CMEA limits purchases by an individual purchaser to 9 grams
of each chemical in scheduled listed chemical products in any 30-day
period, not more than 7.5 grams of which may be imported by means of a
private or commercial carrier or the U.S. Postal Service. Any imports
of scheduled listed chemical products subject to the 7.5 gram purchase
limit under CMEA must also otherwise comply with all other applicable
Federal and State laws regarding their importation, including the
Federal, Food, Drug, and Cosmetic Act. This provision is not included
in this rule, but will be addressed in other rulemakings DEA is
promulgating to implement the various provisions of the Combat
Methamphetamine Epidemic Act of 2005. Finally, CMEA exempts all retail
sellers and mail order distributors selling the products at retail from
registration. The following sections discuss each of the statutory
provisions in more detail.
Definitions. CMEA revises the definition of ``regulated
transaction,'' adds several new definitions, and removes the definition
of ``ordinary over-the-counter pseudoephedrine or phenylpropanolamine
product.'' CMEA adds a definition of ``scheduled listed chemical
product,'' which means any nonprescription product that contains
ephedrine, pseudoephedrine, or phenylpropanolamine and is marketed
lawfully under the Federal Food, Drug, and Cosmetic Act. References to
ephedrine, pseudoephedrine, or phenylpropanolamine include their salts,
optical isomers, and salts of optical isomers. CMEA exempts scheduled
listed chemical products sold at retail by a regulated seller or by
persons that sell the product for personal use and ship the product by
mail or private or common carriers (mail order sellers) from the
definition of regulated transaction. It also removes other references
to the sale of these chemicals in drug products from the definition of
regulated transactions. DEA notes that further clarification regarding
regulated transactions will be addressed in a separate rulemaking.
These changes remove retail sellers and mail order sellers from the
registration system; in practice, retail and mail order sellers have
not registered because they limited sales to below threshold quantities
and to products sold in blister packs. At present, only two persons are
registered as retail distributors.
CMEA adds definitions of ``regulated seller,'' to mean a retail
distributor (including a pharmacy and mobile retail vendors), and ``at
retail,'' to mean sale or purchase for personal use. It also revises
the definition of ``retail distributor'' to remove the sentence
referring to below threshold quantities. This change subjects all
sales, except for sales of single packages containing not more than 60
milligrams of pseudoephedrine, to recordkeeping requirements.
Sales limits. Effective April 8, 2006, CMEA limits sales to an
individual to 3.6 grams per day of each chemical in scheduled listed
chemical products regardless of the number of purchases. Mobile retail
vendors and mail order sellers may not sell an individual more than 7.5
grams of each chemical in scheduled listed chemical products in a 30-
day period. A seller who violates these provisions is subject to civil
penalties and possible criminal penalties.
Purchase limits. CMEA imposes a 9 gram purchase limit in a 30-day
period on individuals. Not more than 7.5 grams of the 9 grams may be
imported by means of common/contract carrier or the U.S. Postal
Service. Any imports of scheduled listed chemical products subject to
the 7.5 gram purchase limit under CMEA must also otherwise comply with
all other applicable Federal and State laws regarding their
importation, including the Federal, Food, Drug, and Cosmetic Act. This
provision is not included in this rule, but will be addressed in other
rulemakings DEA is promulgating to implement the various provisions of
the Combat Methamphetamine Epidemic Act of 2005. In other rulemakings
based on new CMEA provisions, imports, other than this 30-day
individual limit, are limited to DEA registrants that have been issued
a quota to import. (These rulemakings will be separately published in
the Federal Register.) A purchaser who violates these limits is subject
to criminal penalties.
Thirty-day limit. CMEA creates a 30-day sales limit. DEA interprets
this to mean a rolling calendar where the sales limit is based on sales
to the purchaser in the previous 30 days. DEA interprets the per day
limit to refer to midnight to midnight, not a rolling 24-hour clock.
Blister packs. Effective April 8, 2006, nonliquid forms of
scheduled listed chemical products (including gel capsules) must be
sold only in blister packs, with no more than two dosage units per
blister unless blister packs are technically infeasible. In that case,
the dosage units must be in unit dose packets or pouches.
Product placement: Behind counter or locked cabinet. CMEA requires
that on and after September 30, 2006, scheduled listed chemical
products must be stored behind the counter or, if in an area where the
public has access, in a locked cabinet. Although DEA is not including
cabinet specifications in the rule, a locked cabinet should be
substantial enough that it cannot be easily picked up and removed. In a
store setting, the cabinet should be similar to those used to store
items, such as cigarettes, that can be accessed only by sales staff.
Logbooks. CMEA requires retail sellers to maintain logbooks on and
after September 30, 2006. If a retailer maintains the logbook on paper,
DEA is requiring that the logbook be bound, as is currently the case
for records of sales of Schedule V controlled substances that are sold
without a prescription. Bound blank logbooks and ledger books meeting
DEA's regulatory requirements are readily available on the commercial
market. If the logbook is maintained electronically, the records must
be readily retrievable by the seller and any DEA or other authorized
law enforcement official. Logs must be kept for two years from the date
the entry was made. The logs must include the information entered by
the purchaser (name, address, signature, date, and time of sale) and
the quantity and form of the product sold.
Where the record is entered electronically, the computer system may
enter the date and time automatically. An electronic signature system,
such as
[[Page 56012]]
the ones many stores use for credit card purchases, may be employed to
capture the signature for electronic logs. The information that the
seller must enter may be accomplished through a point-of-sales system
and bar code reader.
DEA is aware that in some cases, such as pharmacy counters where
the computer is behind the pharmacy counter, it may be difficult for
the purchaser to enter the information electronically. DEA is seeking
comments on whether systems currently used to capture signatures for
credit or debit card purchases can be reprogrammed to allow customers
to enter name and address, as well as the signature. DEA also
recognizes that some purchasers will find it difficult or impossible to
enter the information themselves. In these cases, the seller should ask
for the name and address and enter it, rather than simply copy it off
the photo ID. Regardless of how the information is entered, however,
there must be a mechanism to allow the customer to sign the logbook.
Verification of photo ID. CMEA requires on and after September 30,
2006, that an individual must present an identification card that
includes a photograph and is issued by a State or the Federal
government or a document considered acceptable under 8 CFR
274a.2(b)(1)(v)(A) and (B). Those documents currently include the
following:
United States passport (unexpired or expired).
Alien Registration Receipt Card or Permanent Resident
Card, Form I-551.
An unexpired foreign passport that contains a temporary I-
551 stamp.
An unexpired Employment Authorization Document issued by
the Immigration And Naturalization Service which contains a photograph,
Form I-766; Form I-688, Form I-688A, or Form I-688B.
In the case of a nonimmigrant alien authorized to work for
a specific employer incident to status, an unexpired foreign passport
with an Arrival-Departure Record, Form I-94, bearing the same name as
the passport and containing an endorsement of the alien's nonimmigrant
status, so long as the period of endorsement has not yet expired and
the proposed employment is not in conflict with any restrictions or
limitations identified on the Form I-94.
For individuals 16 years of age or older:
A driver's license or identification card containing a
photograph, issued by a State or an outlying possession of the United
States. If the driver's license or identification card does not contain
a photograph, identifying information shall be included such as: Name,
date of birth, sex, height, color of eyes, and address.
School identification card with a photograph.
Voter's registration card.
U.S. military card or draft record.
Identification card issued by Federal, State, or local
government agencies or entities. If the identification card does not
contain a photograph, identifying information shall be included such
as: Name, date of birth, sex, height, color of eyes, and address.
Military dependent's identification card.
Native American tribal documents.
United States Coast Guard Merchant Mariner Card.
Driver's license issued by a Canadian government
authority.
For individuals under age 18 who are unable to produce a document
from the list above of acceptable documents for persons age 16 years
and older:
School record or report card.
Clinic doctor or hospital record.
Daycare or nursery school record.
The list of acceptable forms of identification, as cited in CMEA,
may change (``in effect on or after the date of enactment''). DEA has
no discretion to alter the list.
Notice on misrepresentations. CMEA requires that on and after
September 30, 2006, the logbooks include a notice to purchasers that
entering false statements or misrepresentations may subject the
purchaser to criminal penalties under section 1001 of title 18 of the
U.S. Code. DEA is requiring the inclusion of the following language in
all logbooks:
Warning: Section 1001 of Title 18, United States Code, states
that whoever, with respect to the logbook, knowingly and willfully
falsifies, conceals, or covers up by any trick, scheme, or device a
material fact, or makes any materially false, fictitious, or
fraudulent statement or representation, or makes or uses any false
writing or document knowing the same to contain any materially
false, fictitious, or fraudulent statement or entry, shall be fined
not more than $250,000 if an individual or $500,000 if an
organization, imprisoned not more than five years, or both.
With both a bound logbook and electronic log, inclusion of this
notice may present difficulties. If the purchaser is not able to enter
the information electronically in a store, providing the notice
electronically will not meet the requirements. If not feasible in these
situations, one alternative is that the seller prominently display the
notice where the purchaser will see it when entering or providing the
information.
Verification of identity for mail order sales. The Controlled
Substances Act (21 U.S.C. Sec. 830(b)(3)) requires that each regulated
person, as defined in the Act, who engages in a transaction that
involves ephedrine, pseudoephedrine, or phenylpropanolamine (including
drug products containing these chemicals) and uses or attempts to use
the Postal Service or any private or commercial carrier shall, on a
monthly basis, submit a report of each transaction conducted during the
previous month to DEA. Data contained in the report includes, but is
not limited to: Name of purchaser; quantity and form of ephedrine,
pseudoephedrine, or phenylpropanolamine purchased; and the address to
which such ephedrine, pseudoephedrine, or phenylpropanolamine was sent.
DEA has specified further information regarding mail order reports by
regulation (21 CFR 1310.05).
CMEA requires that effective April 8, 2006, the mail order seller
confirm the identity of the purchaser prior to shipping the product.
CMEA requires DEA to establish procedures for this identity
verification by regulation. To parallel the identification requirements
for regulated sellers, and to provide reasonable assurance that the
person purchasing the product is who they claim to be, DEA is requiring
that mail order sellers verify the identity of the purchaser by
obtaining a copy of an identification card that includes a photograph
and is issued by a State or the Federal government or a document
considered acceptable under 8 CFR 274a.2(b)(1)(v)(A) and (B). Such a
copy may be obtained through use of the Postal Service, facsimile
transmission of a photocopy, or the scanning and transmission of the
identification card, among other examples. The mail order seller must
determine that the name and address on the identification card
correspond to the name and address provided to the mail order seller as
part of the sales transaction. If the information cannot be confirmed,
the seller may not ship the items.
Selling at retail. CMEA requires that on and after September 30,
2006, a regulated seller must not sell scheduled listed chemical
products unless it has self-certified to DEA, through DEA's Web site.
The self-certification requires the regulated seller to confirm the
following:
Its employees who will be engaged in the sale of scheduled
listed chemical products have undergone training regarding provisions
of CMEA.
Records of the training are maintained.
Sales to individuals do not exceed 3.6 grams of ephedrine,
pseudoephedrine, or phenylpropanolamine per day. (Mobile
[[Page 56013]]
retail vendors must also confirm that sales to an individual in a 30-
day period do not exceed 7.5 grams.)
Nonliquid forms are packaged as required.
Scheduled listed chemical products are stored behind the
counter or in a locked cabinet.
A written or electronic logbook containing the required
information on sales of these products is properly maintained.
The logbook information will be disclosed only to Federal,
State, or local law enforcement and only to ensure compliance with
Title 21 of the United States Code or to facilitate a product recall.
The seller must train its employees and self-certify before either the
seller or individual employees may sell scheduled listed chemical
products. The self-certification is subject to the provisions of 18
U.S.C. 1001. A regulated seller who knowingly or willfully self-
certifies to facts that are not true is subject to fines and
imprisonment.
Training. DEA has developed training that it has made available on
its Web site (https://www.deadiversion.usdoj.gov). Employers must use
the content of this training in the training of their employees who
sell scheduled listed chemical products. An employer may include
additional content to DEA's, but DEA's content must be included in the
training. For example, a regulated seller may elect to incorporate
DEA's content into initial training for new employees.
Training records. On and after September 30, 2006, each employee of
a regulated seller who is responsible for delivering scheduled listed
chemical products to purchasers or who deals directly with purchasers
by obtaining payment for the scheduled listed chemical products must
undergo training and must sign an acknowledgement of training received
prior to selling scheduled listed chemical products. This record must
be kept in the employee's personnel file.
Self-certification. On and after September 30, 2006, the regulated
seller must self-certify to DEA as described above. DEA has established
a Web page that will allow regulated sellers to complete the self-
certification on-line and submit it to DEA electronically. A self-
certification certificate will be generated by DEA upon receipt of the
application. The regulated seller will print this self-certification
certificate, or if the regulated seller is unable to print it, DEA will
print and mail the certificate to the self-certifier. The regulated
sellers will be classified into three categories: Chain stores that are
currently controlled substance registrants, chain stores that are not
registrants, and individual outlets. Chain stores wishing to file self-
certifications for more than 10 locations will have to print or copy
the form electronically and submit the information to DEA by mail. DEA
will work with these persons to facilitate this process. Persons
interested in this self-certification option should contact DEA for
assistance. For current DEA registrants, the system will pre-populate
the form with basic information.
Because CMEA specifically states that a separate self-certification
is required for each separate location at which scheduled listed
chemical products are sold, mobile retail vendors must self-certify for
each location at which sales transactions occur. This self-
certification for locations is required even if the same person or
persons sell at each of the different locations.
DEA requests comments on who should be authorized to sign the self-
certification for the regulated seller. The person should be in a
position to know that all employees who require training have been
trained and that the retail outlet is complying with all other
requirements and should be authorized to sign documents for the
regulated seller.
Time for self-certification. CMEA requires that regulated sellers
self-certify by September 30, 2006. Although CMEA appears to link self-
certification to training of each individual who will deliver the
products to customers, the high rate of employee turnover in the retail
sector could require frequent submissions of self-certifications if the
regulated seller needed to recertify each time a new employee is
trained. DEA, therefore, will require regulated sellers to self-certify
by September 30, 2006. When regulated sellers file the initial self-
certification, DEA will assign them to groups. Each group will have an
expiration date that will be the last day of a month from 12 to 23
months after the initial filing. After the second self-certification,
regulated sellers will be required to self-certify annually. It is the
responsibility of the regulated seller to ensure that all employees
have been trained prior to self-certifying each time. It is also the
responsibility of the regulated seller to ensure that they self-certify
before the self-certification lapses. DEA requests comments on annual
self-certifications versus certifications whenever new employees are
trained or quarterly self-certification.
Fee for self-certification. In a separate Notice of Proposed
Rulemaking, DEA is proposing that regulated sellers who are not DEA
registrants pay a fee for self-certification. While DEA is not making
this fee effective with this Interim Rule, DEA is providing background
discussion and rationale for this decision here so that all persons
will be aware of this issue.
Section 886a of the CSA defines the Diversion Control Program as
``the controlled substance and chemical diversion control activities of
the Drug Enforcement Administration,'' which are further defined as the
``activities related to the registration and control of the
manufacture, distribution and dispensing, importation and exportation
of controlled substances and listed chemicals.'' The CSA also states
that reimbursements from the Diversion Control Fee Account ``* * *
shall be made without distinguishing between expenses related to
controlled substances activities and expenses related to chemical
activities.'' [Pub. L. 108-447 Consolidated Appropriations Act of
2005].
In addition, Section 111(b)(3) of the Departments of Commerce,
Justice, and State, the Judiciary, and Related Agencies Appropriations
Act of 1993 (Pub. L. 102-395), codified at 21 U.S.C. 886a(3), requires
that ``fees charged by the Drug Enforcement Administration under its
diversion control program shall be set at a level that ensures the
recovery of the full costs of operating the various aspects of that
program.''
CMEA implements new requirements governing the sale of scheduled
listed chemical products, defined as nonprescription drug products
containing ephedrine, pseudoephedrine, or phenylpropanolamine. CMEA
requires self-certification for all regulated sellers of scheduled
listed chemical products. CMEA also exempts retail distributors from
registration requirements under the CSA; however, in practice, retail
distributors have not previously registered with DEA because they
limited their sales to below threshold quantities and to products sold
in blister packs.
DEA considers the self-certification requirements of the CMEA to
fall within the legal definition of control as governed by Section 886a
of the CSA (see above). Accordingly, these activities fall under the
general operation of the Diversion Control Program and are subject to
the requirements of the Appropriations Act of 1993 that mandates that
fees charged shall be set at a level that ensures the recovery of the
full costs of operating the various aspects of the Diversion Control
Program. The self-certification requirements of CMEA fall under these
[[Page 56014]]
``various aspects.'' Therefore, in its Notice of Proposed Rulemaking,
DEA will propose to charge a fee for each self-certification to comply
with these statutory requirements.
DEA is proposing, in its separate Notice of Proposed Rulemaking,
that the fee for self-certification will cover all associated costs,
including the initial one-time costs of setting up the self-
certification program, Web site, and programmatic infrastructure, as
well as ongoing costs associated with the provision of self-
certifications, call center support, maintenance of the self-
certification system, printing costs for certificates that regulated
sellers cannot print, financial management, and other related costs.
DEA must establish a program to train its employees to provide
information regarding, and accept, self-certifications and must
establish the infrastructure necessary for the program. Required
systems include creation of history, renewal cycles, investigative
tools, business validation rules, and development and maintenance of
the self-certification Web site.
In its Notice of Proposed Rulemaking, DEA is proposing that when
regulated sellers submit a self-certification online via the DEA self-
certification Web site that they pay a fee by credit card at the time
of self-certification. DEA calculated this fee based on estimated set-
up costs in Fiscal Year 2006 ($117,198) and Fiscal Year 2007 operating
costs ($1,624,443) totaling $1,741,641, as shown below in Table 3. The
initial systems development and set-up costs will not be repeated in
subsequent years. The operational and maintenance costs for Fiscal Year
2008 are estimated to be $1,099,782. Total annual costs associated with
operating the self-certification process include staff costs,
operational and administrative costs, Web hosting, monitoring and
maintenance costs (including hardware and software maintenance), and
annual inflation adjustments. Therefore, DEA will propose in its
separate Notice of Proposed Rulemaking, that the 89,000 persons DEA
estimates will self-certify with the Administration would pay a self-
certification fee of $32 for the Fiscal Year 2006 through Fiscal Year
2008 period.
To calculate the fee, DEA divided the total costs for Fiscal Years
2006 through 2008 by the anticipated population of affected regulated
sellers of 89,000. DEA estimates 89,000 current retail vendors of
scheduled listed chemical products. All costs are shown in the table
below for Fiscal Years 2006 through 2008. The self-certification costs
reflect the cost per each self-certification per each facility as
required by CMEA.
Table 3.--Self-Certification Costs and Fee Calculation
----------------------------------------------------------------------------------------------------------------
Project detail 2006 * 2007 2008 Total cost
----------------------------------------------------------------------------------------------------------------
Planning \1\............................................ $3,029 $36,343 $37,002 $76,373
Design, Development, Deployment \2\..................... 43,512 703,863 71,662 819,037
Call center, Finance, Mail room, Printing \3\........... 59,253 711,034 723,916 1,494,203
Maintenance \4\......................................... 11,405 173,203 176,341 360,949
Enhancements \5\........................................ ............ 90,861 90,861
-------------------------------------------------------
Total............................................... 117,198 1,624,443 1,099,782 2,841,423
=======================================================
Population.............................................. ............ 89,000 89,000 ............
Cost per certification.................................. ............ ............ ............ 31.92
----------------------------------------------------------------------------------------------------------------
\1\ Planning is the costs to the government to plan the development, design, and implementation of the self-
certification online system. This item is the costs of three percent of the time used by five government
employees to supervise and manage software development.
\2\ Design, development and deployment of the online self-certification system represents the cost to pay
contract programmers, web designers, system administrators and database administrators to design, develop, and
deploy the new application. These costs include testing and quality assurance of the new software and
establishment of new security controls. The self-certification system will be designed with business
validation rules and provide investigative tools to ensure compliance with the new legislation.
\3\ Call Center, finance, mail room and printing represent the following costs.
DEA currently operates a registration Call Center. Based on current Call Center customer service
representative costs, this item includes the cost of the additional time required to respond to inquiries
regarding the CMEA self-certification program. DEA provides call center assistance to approximately 400,000
persons annually. DEA estimates that CMEA will increase that population by 89,000 persons, a 23% increase.
DEA currently operates a registration Finance Center. Based on current Finance Center employee costs,
this item includes the cost of the additional time required to process fees collected from CMEA self-
certifications.
DEA currently operates a registration Mail Room. Based on current Mail Room clerical costs, this item
includes cost of employee time for handling and mailing out of CMEA self-certification certificates if the
self-certifier is unable to print the certificate.
DEA currently operates a Printing and Mailing Facility. Based on current Printing Costs, this item
includes paper, toner, envelope, and postage costs to mail out the CMEA self-certification certificates.
\4\ Maintenance. This item includes all employee salaries, hardware maintenance, and software license costs
associated with the daily operation of the self-certification system.
\5\ Enhancements. This item is the enhancement of the system to add the ability to maintain a history of changes
to records and to allow for yearly renewal of records.
* 2006 is for 1 month of operations.
To minimize administrative and collection burdens, it is DEA's
policy to round to the nearest dollar when calculating fees. The annual
self-certification fee will be clearly defined on the self-
certification Web site. However, in setting this fee DEA notes that it
is based on assumptions about the total number of regulated sellers who
will be required to self-certify. Should the total number of regulated
sellers be significantly more or less than 89,000, DEA may adjust the
self-certification fee as appropriate through future rulemakings. In
any case, DEA will not exceed its operating budget as authorized by
Congress.
In implementing this fee, DEA also notes that many of the affected
regulated sellers are already registered with DEA to dispense
controlled substances and therefore already pay a registration/
reregistration fee to DEA. While these existing registrants are
required by the CMEA to self-certify with DEA if selling scheduled
listed chemical products, in its Notice of Proposed Rulemaking, DEA is
proposing that the self-certification fee be waived upon submission of
an active DEA registration number.
Other DEA activities associated with self-certification and
compliance with CMEA include enforcement and judicial proceedings. CMEA
gives DEA the authority to prohibit a regulated seller
[[Page 56015]]
from selling scheduled listed chemical products for certain violations
of CMEA. If DEA issues an order to a regulated seller prohibiting that
regulated seller from selling scheduled listed chemical products, the
regulated seller is entitled to an administrative hearing if the seller
files a timely request for a hearing. The costs of these enforcement
activities and the subsequent proceedings must be supported through
fees pursuant to the above described statutory requirements. DEA notes
that these costs are not recovered in these fee calculations as DEA is
uncertain of their utilization. However, once DEA is able to determine
the frequency of use of these tools, and their associated costs, these
costs will be recovered through fees associated with self-certification
as established in future rulemakings.
Relationship to State Laws
Many States have enacted laws and/or regulations that impose
conditions on the sale of scheduled listed chemical products.
Eight states have enacted and six others have proposed
legislation that makes these products Schedule V controlled substances.
Among other requirements, Schedule V substances may be sold only by a
pharmacist to individuals who are at least 18. A logbook of the sales
must be maintained.
Sixteen states have passed laws limiting sales to a
pharmacist or pharmacy technicians or requiring that the products be
stored behind the counter.
Twenty-seven states require a photo ID for such purchases.
Twenty-six states require a signed logbook.
Twenty-seven states impose single transaction limits.
Nineteen states have monthly or weekly limits.
Twenty-seven states have exemptions for prescription drugs
and various forms of over-the-counter (OTC) drugs (liquids, pediatric
forms, etc.).
One state requires a prescription to purchase these
products.
As the list indicates, the State laws vary considerably. Some parts
of a State law may be less stringent than the CMEA requirements; other
parts may be more stringent. CMEA does not preempt those requirements
under State laws/regulations that are more stringent than the CMEA
requirements. Simply put, all persons subject to CMEA must comply with
the CMEA and the laws in the State(s) in which they sell scheduled
listed chemical products at retail. Where the CMEA is less stringent
than a State law (e.g., the State limits sales to licensed pharmacists
or pharmacy technicians where CMEA does not), the State requirements
continue to be in force. If there are State requirements that are less
stringent than the CMEA provisions (e.g., higher daily limits,
exemptions of some products), CMEA supersedes the provisions. DEA
emphasizes that if State requirements for records cover the information
CMEA mandates, the record created to meet the State law is sufficient
to meet DEA's regulation.
Regarding quantity sold, units may be specified in terms of the
weight of the product or in terms of the number of packages sold.
Logbook systems that display the quantity of the product sold by UPC
code are sufficient to meet DEA's requirements. These options do not
exclude other methods of displaying the quantity sold.
DEA is accepting public comment on the interaction between state
and federal logbook requirements. In addition, DEA is accepting public
comment on the broader interplay and potential overlap between state
regulations and CMEA requirements, and whether compliance with state
regulations, if comparable to or more stringent than an associated CMEA
requirement, should constitute compliance with such Federal
requirement.
Discussion of the Rule
To make the rule easier to follow for regulated sellers and mail
order/Internet sellers, DEA is creating a new part 1314 that will
include all requirements related to the sale of scheduled listed
chemical products to end users. Regulations for the retail sale of
these products that currently exist in part 1310 will either be moved,
if still applicable, or removed. The new statutory definitions of
``scheduled listed chemical product,'' ``regulated seller,'' ``mobile
retail vendor,'' and ``at retail'' are being added to part 1300
(Definitions). The definition of ``retail distributor'' is also being
revised. Most of the new provisions in this Interim Final Rule are
drawn from section 711 of the USA PATRIOT Improvement and
Reauthorization Act of 2005.
Part 1314 is divided into four subparts. Subpart A contains
requirements that apply to any retail sale. Subpart B applies to sales
by regulated sellers (i.e., sales for personal use, both in number of
sales and volume of sales, either directly to walk-in customers or in
face-to-face transactions, by stores or mobile retail vendors). Subpart
C applies to retail sales that are shipped by mail or common or private
carriers, regardless of how those sales are ordered. Subpart D contains
the procedural requirements for issuing and responding to an order to
show cause why the regulated seller or distributor should not be
prohibited from selling scheduled listed chemical products.
Sections 1314.01 and 1314.02 simply state the scope and
applicability of the part. Section 1314.03 defines ``mail order sales''
using the language from Sec. 1310.03(c) and further clarifies that
mail order includes any retail sale for personal use where the product
is shipped by U.S. mail or by private or common carriers whether the
order is received by mail, phone, fax, the Internet, or any method
other than a face-to-face transaction.
Section 1314.05 incorporates the statutory requirement for blister
packs for nonliquids unless such packaging is not technically feasible.
Section 1314.10 states the regulations do not preempt State laws
unless there is a positive conflict between the laws and the
regulations such that the two cannot consistently stand together. This
language is drawn from 21 U.S.C. 903.
Section 1314.15 copies the requirements for reporting losses,
including thefts, that currently exist in Sec. 1310.06. DEA emphasizes
that thefts must be reported as well as unusual or excessive losses or
disappearances.
In subpart B, Sec. 1314.20 includes the statutory requirements
limiting sales, the daily limit of 3.6 grams and the 30-day mobile
retail vendor limit of 7.5 grams. The 30-day limit of 9 grams applies
to purchasers who are not addressed by this regulation. As noted
previously, this provision is not included in this rule, but will be
addressed in other rulemakings DEA is promulgating to implement the
various provisions of the Combat Methamphetamine Epidemic Act of 2005.
Section 1314.25 incorporates CMEA's provisions for storing the
products behind the counter or in a locked cabinet. Mobile retail
vendors are required to store the product in a locked cabinet.
Section 1314.30 covers recordkeeping (logbook) requirements from
CMEA as well as requirements currently in Sec. 1310.04. In addition to
CMEA's requirements, DEA has copied the existing requirements from part
1310 relative to where the records must be kept (at the place of
business or at a central location if DEA has been notified). DEA is
including in this section language stating that if a regulated seller
is already maintaining records of these sales under State law, those
records may be used to meet this requirement if they include the
information specified in CMEA.
[[Page 56016]]
The part 1310 requirements incorporated into the amended
regulations do not include the provision that a regulated seller with
multiple locations must have a system to detect a person purchasing
from multiple locations owned or operated by the regulated seller. CMEA
in section 711(f) provides for a civil penalty for a person who sells
at retail a scheduled listed chemical product in violation of the daily
3.6 gram sales limit, ``knowing at the time of the transaction involved
(independent of consulting the logbook * * *) that the transaction is a
violation.'' While the availability of civil penalties is not
necessarily co-extensive with the chemical control requirements of the
new law, DEA is not mandating, by this rule, that regulated sellers,
other than mail order and mobile retail vendors, track multiple sales
to individuals on a single day within the same retail outlet or across
outlets of the same company. CMEA explicitly requires mail order
outlets and mobile retail vendors to limit sales to an individual to
7.5 grams in a 30-day period; it imposes no similar requirement on
other retail sellers to limit 30-day sales to individuals. The 30-day
limit of 9 grams is imposed on the purchaser, not the seller.
Section 1314.35 incorporates the statutory requirements for
training of sales personnel. DEA has developed training material, which
it has made available on its Web site (https://
www.deadiversion.usdoj.gov).
Section 1314.40 covers CMEA's requirements on self-certification.
As discussed above, DEA is setting an annual period for renewal of the
certification.
DEA has developed a web site that will allow many regulated sellers
to complete and submit the self-certification form on line and print
out a self-certification certificate for their records. The information
required will include the name and address of the location and a point
of contact. The regulated sellers will be classified into three
categories: Chain stores that are currently controlled substance
registrants, chain stores that are not registrants, and individual
outlets. Chain stores wishing to file self-certifications for more than
10 locations will have to print or copy the form electronically and
submit the information to DEA by mail. DEA will work with these persons
to facilitate this process. Persons interested in this self-
certification option should contact DEA for assistance. For current DEA
registrants, the system will pre-populate the form with basic
information.
Section 1314.45 incorporates the privacy protection provisions of
CMEA. These provisions define who may access the sales records and the
use to which the data may be put. They also provide a good faith
protection to regulated sellers that release the data to law
enforcement authorities.
Section 1314.50 includes CMEA's provision that states that a seller
may take reasonable measures to guard against employing people who may
present a risk of diversion. The measures may include asking about
convictions of any crimes involving controlled substances or scheduled
listed chemical products.
In subpart C, Sec. 1314.100 incorporates the daily and 30-day
sales limits for mail order sales. Section 1314.105 provides the above
described requirements for verifying identity of the purchaser prior to
shipment of the product. Section 1314.110 covers reports on mail order
sales and is copied from Sec. 1310.06. Finally, Sec. 1314.115 copies
language from Sec. 1310.05(f) on distributions not subject to
reporting (sample packages, sales to long-term care facilities,
prescription drugs).
CMEA added to 21 U.S.C. 842 a provision that authorizes DEA to
prohibit a regulated seller or a mail order seller from selling
scheduled listed chemical products if the seller is found to be
knowingly or recklessly in violation of the provisions controlling
retail sales. To take this step, DEA must issue an order to show cause,
as it does to suspend or revoke registrations. DEA is including in
subpart D in Sec. Sec. 1314.150 and 1314.155 provisions on the process
of issuing and responding to an order to show cause. These sections are
taken from part 1309 and are the same as DEA uses to issue and reach a
conclusion on orders to show cause under other DEA programs. If DEA
issues an order to show cause, the regulated seller or mail order
distributor must respond to the order to show cause within 30 days of
service of the order to show cause. The regulated seller or mail order
seller may request a hearing. The seller may continue to sell scheduled
listed chemical products until DEA issues a final order. If DEA finds
that a regulated seller or mail order distributor poses an imminent
danger to public health or safety, DEA may suspend the seller's right
to sell scheduled listed chemical products pending a final decision on
the order to show cause.
Other Changes
As noted above, CMEA's new definitions will be added to Sec.
1300.02. In addition, the definition of ``regulated transaction'' is
revised as mandated by section 712 of CMEA.
In Sec. 1309.71, paragraph (a)(2), which requires certain
ephedrine products to be stored behind the counter, is being removed
because the new CMEA requirements supersede it. CMEA imposes the same
restrictions on all scheduled listed chemical products unless they are
stored in a locked cabinet in areas where the public has access.
In Sec. 1310.04, paragraph (f)(1)(ii) is revised to indicate that
the thresholds presented in the previous paragraph and in paragraph (g)
for ephedrine, pseudoephedrine, and phenylpropanolamine apply only to
non-retail distribution, import, and export and references part 1314
for retail sales. The table of thresholds for retail distribution has
been removed.
In Sec. 1310.05, paragraph (f)(2) is revised to remove retail
sales of scheduled listed chemical products.
Sections 1310.14 and 1310.15 are being removed because the CSA no
longer treats certain ephedrine products differently from other
scheduled listed chemical products. These sections are being replaced
by new Sec. 1310.16, which states that a manufacturer may apply to
have a scheduled listed chemical product exempted from the requirements
if DEA determines that the product cannot be used in the illicit
manufacture of methamphetamine. DEA is adopting the application process
that currently applies to ephedrine products that include other
medically significant ingredients (Sec. 1310.14).
Regulatory Certifications
Administrative Procedure Act (5 U.S.C. 553)
The Administrative Procedure Act (APA) generally requires that
agencies, prior to issuing a new rule, publish a Notice of Proposed
Rulemaking in the Federal Register. The APA also provides, however,
that agencies may be excepted from this requirement when ``the agency
for good cause finds (and incorporates the finding and a brief
statement of reasons therefore in the rules issued) that notice and
public procedure thereon are impracticable, unnecessary, or contrary to
the public interest.'' 5 U.S.C. 553(b)(B).
With publication of this interim rule, DEA is invoking this ``good
cause'' exception to the APA's notice requirement based on the
combination of several extraordinary factors. CMEA requires that on and
after September 30, 2006, regulated sellers selling scheduled listed
chemical products at retail shall self-certify with DEA in order to
[[Page 56017]]
continue to sell these products. CMEA imposes sales limits, purchase
limits, product placement requirements, mail order customer
identification requirements, and other requirements, some of which must
be specified by regulation, all with an effective date of September 30,
2006. Based on the effective date of this law, it is impracticable for
DEA to comply with the APA's notice and comment requirements due to the
limited time involved. Were DEA not to publish this Interim Rule with
Request for Comment, regulated sellers selling scheduled listed
chemical products at retail would not be able to self-certify by the
date specified in the law. Were this not to occur, these regulated
sellers would be forced to stop selling scheduled listed chemical
products, or violate the law by doing so. Mail order distributors would
also have difficulty, as DEA is required by regulation to establish
procedures for these persons to identify their customers prior to
shipping product. Without these regulations, mail order distributors
would not be able to sell scheduled listed chemical products.
Therefore, DEA also finds that it is contrary to the public interest
not to issue these regulations as an Interim Rule, thereby allowing
regulated sellers and mail order distributors to fully comply with the
requirements of CMEA. While the CMEA was signed into law in March of
2006, most of the law must be in effect by September 30, 2006. The
broad scope of the new law, as well as the expedited effective dates,
is a clear reflection of Congress's concern about the nation's growing
methamphetamine epidemic and its desire to act quickly
