Registration Requirements for Importers and Manufacturers of Prescription Drug Products Containing Ephedrine, Pseudoephedrine, or Phenylpropanolamine, 4973-4982 [2010-1968]
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Rules and Regulations
Federal Register
Vol. 75, No. 20
Monday, February 1, 2010
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
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new books are listed in the first FEDERAL
REGISTER issue of each week.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1309
[Docket No. DEA–294F]
RIN 1117–AB09
Registration Requirements for
Importers and Manufacturers of
Prescription Drug Products Containing
Ephedrine, Pseudoephedrine, or
Phenylpropanolamine
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AGENCY: Drug Enforcement
Administration (DEA), Justice.
ACTION: Final rule.
SUMMARY: The Drug Enforcement
Administration (DEA) is amending its
registration regulations to ensure that a
registration is obtained for every
location where ephedrine,
pseudoephedrine, or
phenylpropanolamine, or drug products
containing one of these chemicals, are
imported or manufactured. These
amendments will make it possible to
establish the system of quotas and
assessment of annual needs for the
importation and manufacture of these
chemicals that Congress mandated in
the Combat Methamphetamine
Epidemic Act of 2005.
DATES: This rule is effective March 3,
2010.
FOR FURTHER INFORMATION CONTACT:
Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion
Control, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, VA 22152; 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
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the Controlled Substances Import and
Export Act (CSIEA) (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
1316. These regulations are designed to
ensure that there is a sufficient supply
of controlled substances for legitimate
medical, scientific, 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, distribution, import, and
export 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 (21 U.S.C.
802(34)). Those classified as List II
chemicals may be used to manufacture
controlled substances (21 U.S.C.
802(35)).
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). Much of
CMEA is self-implementing; the
provisions related to importation of
ephedrine, pseudoephedrine, and
phenylpropanolamine, import quotas,
manufacturing quotas, and procurement
quotas became effective on March 9,
2006.
CMEA Requirements and Impact on
Registration
CMEA amended the CSA to include
ephedrine, pseudoephedrine, and
phenylpropanolamine in 21 U.S.C. 826
(Production quotas for controlled
substances) and 21 U.S.C. 952(a)
(Importation of controlled substances).
Congress essentially imposed the same
requirements for importation of
ephedrine, pseudoephedrine, and
phenylpropanolamine as are imposed
on narcotic raw materials—crude
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opium, poppy straw, concentrate of
poppy straw, and coca leaves. That is,
imports of ephedrine, pseudoephedrine,
and phenylpropanolamine are
prohibited except for such amounts as
the Attorney General (DEA by
delegation) finds to be necessary to
provide for medical, scientific, or other
legitimate purposes. Congress also
imposed the same requirements on the
manufacture of ephedrine,
pseudoephedrine, and
phenylpropanolamine as are established
for Schedule I and II controlled
substances. That is, Congress mandated
the establishment of a total need for
ephedrine, pseudoephedrine, and
phenylpropanolamine to be
manufactured each calendar year to
provide for the estimated medical,
scientific, research, and industrial needs
of the United States, for lawful export
requirements, and for the establishment
and maintenance of reserve stocks.
These requirements apply equally to
products containing these three List I
chemicals as they do to the List I
chemicals themselves.
Until the passage of CMEA, chemical
importers were required to notify DEA
of imports of ephedrine,
pseudoephedrine, and
phenylpropanolamine before or at the
time of importation under 21 U.S.C.
971. DEA had no authority to limit the
importation or manufacture of
ephedrine, pseudoephedrine, and
phenylpropanolamine, except for the
ability to suspend a proposed import
under 21 U.S.C. 971(c) on the ground
that it may be diverted to the
clandestine manufacture of a controlled
substance. Most of the ephedrine,
pseudoephedrine, and
phenylpropanolamine used in the
United States is imported rather than
manufactured domestically.
Ephedrine, pseudoephedrine, and
phenylpropanolamine are used to
produce drug products lawfully
marketed under the Federal Food, Drug
and Cosmetic Act (FFD&CA), many of
which are prescription drugs. DEA has
not subjected these prescription drug
products to all List I chemical regulatory
requirements because they are available
only in response to a prescription and
are stored in and dispensed at
pharmacies. These chemicals are also
used in over-the-counter (OTC) drug
products (lawfully marketed and
distributed under the FFD&CA as a non-
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prescription drug). These products have
been widely used in the illegal
manufacture of methamphetamine and
amphetamine. CMEA defined these OTC
drug products as scheduled listed
chemical products (21 U.S.C.
802(45)(A)). DEA has regulated the
distribution, import, and export of
scheduled listed chemical products.
There are firms manufacturing drug
products lawfully marketed under the
FFD&CA containing ephedrine,
pseudoephedrine, or
phenylpropanolamine that are not
registered with DEA at all because those
firms do not handle controlled
substances and the only products those
firms produce containing the three
chemicals are prescription drugs. There
are also firms that manufacture
scheduled listed chemical products, but
only distribute or dispense controlled
substances. Because those firms are
registered as controlled substance
distributors or dispensers, those firms
are not currently required to register as
chemical manufacturers. Finally, there
may be some firms that are not
registered that import prescription drug
products that contain the three
chemicals.
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Note: For a more detailed discussion of the
history of the regulation of ephedrine,
pseudoephedrine, and phenylpropanolamine
see the preamble to the Notice of Proposed
Rulemaking published on January 18, 2008
(73 FR 3432).
Because of the new CMEA mandates
for importation, import quotas, and
production quotas for ephedrine,
pseudoephedrine, and
phenylpropanolamine, DEA is revising
its registration provisions. As discussed
in the NPRM, the changes made by the
CMEA render current DEA regulations
inadequate for two reasons. First,
although DEA registers bulk
manufacturers of the three chemicals in
the United States and importers of the
bulk chemicals, some of those chemicals
are distributed to non-registered
companies that process them into
prescription drugs. Under 21 U.S.C. 826,
production quotas are available only to
registered manufacturers. DEA cannot
meet the CMEA mandate to establish an
annual need and import quotas, and
then issue individual quotas for each of
the chemicals unless all persons
manufacturing or procuring the
chemicals and manufacturing drug
products that contain the chemicals are
registered as manufacturers, even if the
distribution of the final drug products is
not regulated. DEA also must know the
quantity of prescription drug products
containing the three chemicals being
imported; without this information,
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DEA would not be able to determine an
assessment of annual need for the
chemicals. Any person importing
prescription drug products containing
any of the three chemicals must register
although the distribution of these
products would not be subject to DEA
regulation.
The second inadequacy is that the
existing language allows a controlled
substance distributor or dispenser to
avoid registration as a chemical
manufacturer if that person
manufactures scheduled listed chemical
products or other products containing a
List I chemical that is described and
included in the definition of ‘‘regulated
transaction’’ in 21 CFR
1300.02(b)(28)(i)(D). [DEA notes that
there may be a limited number of drug
products containing List I chemicals
other than ephedrine, pseudoephedrine,
and phenylpropanolamine which meet
this description.] Therefore, this
provision is being changed so that
controlled substance registrants will not
need to obtain a chemical registration
only if they engage in the same activity
for both drug products containing List I
chemicals and controlled substances as
is already the case for bulk manufacture,
imports, and exports. In this way, any
registrant that must obtain a quota to
manufacture or procure one or more of
the chemicals will be a registered
manufacturer, as required by the CSA.
DEA recognizes that this change
requires some manufacturers and
locations to register that had not
previously been subject to DEA
regulations; other registrants are
required to obtain separate registrations
for chemicals and controlled substances.
The new requirements, however, are
both consistent with the statutory
language on registration and the CMEA
amendments and with the intent of the
CMEA requirements to establish a
system of quotas for the manufacture of
these three chemicals and the products
that contain them. Without these
changes, DEA would not be able to meet
the CMEA mandates. In addition,
without these changes, companies that
manufacture and import prescription
drug products containing the three
chemicals would not be able to
purchase the chemicals legally nor
would the assessment of annual needs
reflect their requirements.
Explanation of DEA Categories of
Registration and Effect of This Rule
Regarding DEA Registration
The CSA defines the term
‘‘manufacture’’ to include the physical
manufacture of a chemical or product,
as well as the packaging, labeling,
repackaging, and relabeling of that
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product (21 U.S.C. 802(15)). Thus,
under the CSA, ‘‘manufacture’’ is
defined to include all of the following:
• The manufacturing of a substance
or chemical in bulk, either by extraction
from raw materials, chemical synthesis,
or a combination of extraction and
chemical synthesis.
• The processing of the substance or
chemical into products, such as drugs in
dosage form.
• The packaging or repackaging of the
processed substances or chemicals or
labeling or relabeling of containers
holding the chemicals.
After this final rule takes effect,
persons who manufacture or import
ephedrine, pseudoephedrine, or
phenylpropanolamine, or who
manufacture or import a product
containing ephedrine, pseudoephedrine,
or phenylpropanolamine, or who plan
to engage in such activities, will be
required to register with DEA if they are
not already registered for the
appropriate business activity. As
required by the CSA, registration is
location-specific; a person must obtain a
registration for each principal place of
business at one general physical
location where controlled substances or
List I chemicals are manufactured,
distributed, imported, or exported. If a
person manufactures controlled
substances at one location and drug
products containing ephedrine,
pseudoephedrine, or
phenylpropanolamine at another
location, the person will be required to
obtain a separate registration for each
location. Under the waiver previously
described in this rulemaking (21 CFR
1309.24(b)), persons who are currently
registered as controlled substances
manufacturers at a location where drug
products containing these List I
chemicals are also manufactured will
not be required to register separately to
conduct the same activity,
manufacturing, with these List I
chemicals. A controlled substances
registration for that one physical
location will cover both the
manufacturing of controlled substances
and drug products containing
ephedrine, pseudoephedrine, or
phenylpropanolamine, at that location.
Those controlled substances
manufacturers will, however, be
required to identify to DEA the List I
chemicals ephedrine, pseudoephedrine,
and phenylpropanolamine they handle
as part of their next registration renewal.
DEA notes that the manufacture of bulk
List I chemicals requires a separate
chemical registration; this is not a
change from existing regulations.
However, if a person manufactures a
drug product containing ephedrine,
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pseudoephedrine, or
phenylpropanolamine at a location, but
is registered to conduct other
(nonmanufacturing) activities with
controlled substances at that location
(e.g., distribution), the person will need
to obtain a List I chemical
manufacturing registration for the
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location. The following table indicates
the changes in registration requirements
for various business activities.
Previous
Final rule
Chemical Manufacturers (no Controlled Substances)
All bulk manufacturers of List I chemicals must register unless all of the
chemical produced is consumed internally and is not available for
use in products.
Manufacturers of scheduled listed chemical products must register if
they also distribute.
Manufacturers of prescription products ** containing List I chemicals do
not register
No change.
All manufacturers of drug products containing List I chemicals * must
register.
Chemical Distributors
Distributors of List I chemicals and scheduled listed chemical products
must register.
Distributors of prescription products ** containing List I chemicals do
not register
No change.
Chemical Importers and Exporters
Importers of List I chemicals and scheduled listed chemical products
must register.
Importers of prescription products ** containing List I chemicals do not
register if they import controlled substances
Exporters of List I chemicals and scheduled listed chemical products
must register.
Exporters of prescription products ** containing List I chemicals do not
register
Importers of List I chemicals and all drug products containing List I
chemicals * must register.
No change.
Manufacturers and Distributors of Controlled Substances and Drug Products Containing List I Chemicals
Manufacturers of both controlled substances and drug products containing List I chemicals may register as only controlled substance
manufacturers.
Manufacturers of drug products containing any List I chemical * who
distribute or dispense controlled substances may register for only
their controlled substance activity. A separate registration for the
chemical activity is permissible.
Distributors of both controlled substances and drug products containing
List I chemicals may register as only controlled substance distributors.
No change.
Manufacturers of controlled substances and drug products containing
any List I chemical * must register as controlled substances manufacturers. If they manufacture drug products containing any List I chemical * and only distribute or dispense controlled substances at the
same location, they must register separately for each activity.
No change.
Importers/Exporters of Controlled Substances and Drug Products Containing List I Chemicals
Importers of both
List I chemicals
Exporters of both
List I chemicals
controlled substances and drug products containing
must register as controlled substance importers.
controlled substances and drug products containing
must register as controlled substance exporters.
No change.
No change.
Manufacturers, Distributors, Importers, and Exporters of Bulk List I Chemicals
Manufacturers, distributors, importers, and exporters of bulk List I
chemicals must register, regardless of whether they handle controlled substances.
No change.
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* ‘‘drug products containing List I chemicals’’ refers to scheduled listed chemical products or other products containing a List I chemical that is
described and included in the definition of ‘‘regulated transaction’’ in 21 CFR 1300.02(b)(28)(i)(D). Such drug products must be in packaged/labeled form as required under the FFD&CA for lawful marketing.
** ‘‘Prescription products,’’ for purposes of this table, refers to ‘‘any transaction in a List I chemical that is contained in a drug that may be marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act * * *’’ (21 U.S.C. 802(39)(A)(iv)). To comply
with the marketing and distribution requirements of the FFD&CA for prescription drugs, such drugs must be packaged and labeled in accordance
with the FFD&CA as prescription drugs.
Notice of Proposed Rulemaking
On January 18, 2008, DEA published
a Notice of Proposed Rulemaking
(NPRM) (73 FR 3432) proposing that
persons who manufacture or import a
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prescription drug product containing
ephedrine, pseudoephedrine, or
phenylpropanolamine be required to
register with DEA, even if the
distribution of the final drug product is
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not regulated. Further, the rule
proposed clarification that controlled
substance registrants need not obtain a
separate chemical registration only if
they engage in the same activity for both
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drug products containing List I
chemicals and controlled substances.
Discussion of Comments
DEA received three comments on the
proposed rule. Commenters included
two individuals and one DEA-registered
manufacturer.
Support for proposed rule: One
commenter strongly supported any
amendments to the regulations
necessary to help regulate the
importation and manufacture of
chemicals used in the illicit
manufacture of methamphetamine.
DEA Response: DEA appreciates the
support for this rulemaking. As noted
previously, this regulation is necessary
to fully implement the provisions of the
CMEA related to quotas for the List I
chemicals ephedrine, pseudoephedrine,
and phenylpropanolamine.
Opposition to NPRM: Another
commenter stated that the proposed rule
was shortsighted and ill-equipped to
meet the goal of the CMEA. The
commenter believed that market
demand, not a governmental agency,
should determine how much ephedrine,
pseudoephedrine, and
phenylpropanolamine should be
imported.
DEA Response: This regulation
addresses neither the establishment of
procedures for the implementation of
quotas nor the quotas themselves.
Rather, this rule revises DEA regulations
to require certain persons to obtain a
DEA registration so that they may apply
for quota. As discussed previously, the
CMEA amended the CSA to require
production quotas for manufacturers
handling the List I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine. CMEA also
authorized the Attorney General (DEA
by delegation), to establish import
quotas for ephedrine, pseudoephedrine,
and phenylpropanolamine. The CSA
requires that quotas be issued to
registrants. Were DEA not to issue this
rule, it would have no mechanism to
permit the registration of persons
handling prescription drug products
containing ephedrine, pseudoephedrine,
or phenylpropanolamine. If these
persons were not permitted to register,
there would be no mechanism by which
they would be permitted to apply for
import or production quotas. Therefore,
these persons would have no means by
which to acquire the List I chemicals
ephedrine, pseudoephedrine, or
phenylpropanolamine necessary for
them to conduct business.
Registration of analytical laboratories
and researchers: The third commenter
requested DEA clarification of the scope
of the proposed revision to 21 CFR
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1309.24(c). The commenter believed
that DEA intended to include controlled
substances analytical laboratories in the
waiver for controlled substances
importer registrants who are permitted
to import drug products regulated
pursuant to 21 U.S.C. 802(39)(A)(iv).
The commenter indicated its support for
an allowance to permit controlled
substances analytical laboratory
registrants to be able to import List I
chemical product samples for testing
purposes.
DEA Response: DEA believes that the
commenter has misunderstood the
waiver of the requirement of registration
provided in 21 CFR 1309.24(c), as well
as the authority granted to controlled
substances researchers and persons
permitted to conduct chemical analysis
to import certain substances.
As proposed to be revised in the
NPRM, 21 CFR 1309.24(c) states:
The requirement of registration is waived
for any person who imports or exports a
scheduled listed chemical product or other
product containing a List I chemical that is
described and included in the definition of
‘‘regulated transaction’’ in
§ 1300.02(b)(28)(i)(D), if that person is
registered with the Administration to engage
in the same activity with a controlled
substance.1
The definition of ‘‘regulated
transaction’’ describes the following:
‘‘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, * * *’’
(21 U.S.C. 802(39)(A)(iv), 21 CFR
1300.02(b)(28)(i)(D)).
A scheduled listed chemical product
is defined as a product that contains
ephedrine, pseudoephedrine, or
phenylpropanolamine that may be
marketed or distributed lawfully in the
United States under the FFD&CA as a
nonprescription drug (21 U.S.C.
802(45)(A), 21 CFR 1300.02(b)(34)(i))).
As discussed previously, for a drug to
be ‘‘marketed or distributed lawfully in
the United States under the Federal
Food, Drug, and Cosmetic Act,’’ such
drug product must be in packaged/
labeled form as required under the
1 Prior to the proposed revision, 21 CFR
1309.24(c) stated: ‘‘The requirement of registration
is waived for any person who imports or exports a
product containing a List I chemical that is
regulated pursuant to § 1300.02(b)(28)(i)(D), if that
person is registered with the Administration to
engage in the same activity with a controlled
substance.’’ The revision DEA proposed sought
merely to provide specificity regarding those
products regulated pursuant to 21 CFR
1300.02(b)(28)(i)(D) and did not change the
requirements regarding to whom the waiver of the
requirement of registration applied.
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FFD&CA. Thus, regardless of whether
the product being imported or exported
is a scheduled listed chemical product
or another drug product containing a
List I chemical, for a person to use the
waiver granted in 21 CFR 1309.24(c) to
import a drug containing a List I
chemical, that drug must be in a
packaged/labeled form in compliance
with the marketing and distribution
requirements of the FFD&CA.
Thus, the waiver pertains only to
those products which are fully
formulated and packaged pursuant to
the FFD&CA, not to the importation of
bulk chemical, which would include
any product not fully formulated,
packaged, and labeled as required to
meet the terms of the waiver, as well as
any chemical in an unfinished form
(e.g., bulk powder, bulk liquid). DEA
questions whether any person
conducting research or chemical
analysis involving a List I chemical or
a product containing a List I chemical
would choose to import a product
meeting the marketing/distribution
requirements of the FFD&CA. As has
been discussed previously, if a person
were to import a List I chemical, or a
product containing a List I chemical,
which did not meet the criteria for
lawful distribution or marketing under
the FFD&CA, then that person would be
required to obtain a separate registration
as a chemical importer to conduct the
importation.
The commenter appears to believe
that controlled substances research and
chemical analysis registrants are
permitted to import List I chemicals
based on their controlled substance
research or chemical analysis
registration. For Schedule I researchers,
the regulations provide the following
regarding coincident activities: ‘‘A
researcher may manufacture or import
the basic class of substance or
substances for which registration was
issued, provided that such manufacture
or import is set forth in the protocol
required in § 1301.18 * * *’’ (21 CFR
1301.13(e)(1)(v)). That coincident
activity clearly limits the importation
authority only to those controlled
substances set forth in the researcher
protocol, and does not grant any
authority related to importation of List
I chemicals for any purpose, including
research. Thus, a Schedule I researcher
would be required to obtain a separate
chemical importer registration to import
any List I chemical for any purpose,
regardless of whether that chemical was
lawfully marketed or distributed under
the FFD&CA.
For Schedule II–V researchers, the
regulations provide the following
regarding coincident activities: ‘‘May
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conduct chemical analysis with
controlled substances in those
schedules for which registration was
issued; * * * import such substances
for research purposes; * * *’’ (21 CFR
1301.13(e)(1)(vi)). Again, the
importation of the substances is based
on the activity of research, not on the
importation activity itself.
For persons conducting chemical
analysis, the regulations provide the
following regarding coincident
activities:
May manufacture and import controlled
substances for analytical or instructional
activities; may distribute such substances to
persons registered or authorized to conduct
chemical analysis, instructional activities, or
research with such substances and to persons
exempted from registration pursuant to
§ 1301.24; may export such substances to
persons in other countries performing
chemical analysis or enforcing laws related to
controlled substances or drugs in those
countries; and may conduct instructional
activities with controlled substances. (21 CFR
1301.13(e)(1)(x))
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Again, the importation of the substances
is based on the activity of chemical
analysis, not on the importation activity
itself.
Conversely, the language of 21 CFR
1309.24(c) contemplates that the person
importing the product containing the
List I chemical is ‘‘registered with the
Administration to engage in the same
activity [importation] with a controlled
substance.’’ The activity of a controlled
substances researcher is not the same as
the activity of a controlled substances
importer. Nor is the activity of a
controlled substances chemical analyst
the same as the activity of a controlled
substances importer. As discussed
above, researchers have very limited
authority to import controlled
substances, based specifically on the
research being conducted. Those
conducting chemical analysis have
similarly limited authority related solely
to the analysis of controlled substances.
Based on the comment received, and
to clarify that the waiver of the
requirement of registration in 21 CFR
1309.24(c) is intended for importers and
exporters of controlled substances, DEA
is revising the language of 21 CFR
1309.24(c) to state that:
The requirement of registration is waived
for any person who imports or exports a
scheduled listed chemical product or other
product containing a List I chemical that is
described and included in the definition of
‘‘regulated transaction’’ in
§ 1300.02(b)(28)(i)(D), if that person is
registered with the Administration to import
or export a controlled substance.
DEA notes that if a controlled
substances researcher or registrant
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permitted to conduct chemical analysis
receives the List I chemicals from
another registrant, e.g., a person
registered to import, manufacture, or
distribute List I chemicals, and if the
researcher or chemical analyst does not
further distribute the List I chemicals,
that researcher or chemical analyst
would be considered to be a List I
chemical end-user and would not be
required to be registered with DEA to
receive the List I chemicals.
Requirements of This Final Rule
DEA is requiring that a person who
manufactures or imports a prescription
drug product containing ephedrine,
pseudoephedrine, or
phenylpropanolamine must comply
with the following:
Registration. Any person who
manufactures or imports a drug product
containing ephedrine, pseudoephedrine,
or phenylpropanolamine, or who
proposes to engage in the manufacture
or importation of a drug product
containing ephedrine, pseudoephedrine,
or phenylpropanolamine, is required to
obtain a registration under the CSA (21
U.S.C. 822 and 958). Regulations
describing registration for List I
chemical handlers are set forth in 21
CFR Part 1309.
A separate registration is required for
manufacturing, distributing, importing,
and exporting, except that a person
registered to manufacture or import a
List I chemical or a product containing
ephedrine, pseudoephedrine, or
phenylpropanolamine may distribute
that List I chemical or drug product
without obtaining a separate registration
to do so. A separate registration is
required for each principal place of
business at one general physical
location where the List I chemicals are
manufactured, distributed, imported, or
exported by a person (21 CFR 1309.23).
As a result of the change, any person
manufacturing or importing a
prescription drug product containing
ephedrine, pseudoephedrine, or
phenylpropanolamine is subject to the
registration requirement under the CSA.
DEA recognizes, however, that it is not
possible for persons who are newly
subject to the registration requirement to
complete and submit an application for
registration and for DEA to issue
registrations for those activities
immediately. Therefore, to allow
continued legitimate commerce, DEA is
establishing in 21 CFR 1309.25 a
temporary exemption from the
registration requirement for persons
desiring to engage in manufacturing or
importing prescription drug products
containing ephedrine, pseudoephedrine,
or phenylpropanolamine, provided that
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DEA receives a properly completed
application for registration on or before
March 3, 2010. The temporary
exemption for such persons will remain
in effect until DEA takes final action on
their application for registration.
The temporary exemption applies
solely to the registration requirement;
all other chemical control requirements,
including recordkeeping and reporting,
will remain in effect. Additionally, the
temporary exemption does not suspend
applicable Federal criminal laws
relating to these chemicals, nor does it
supersede State or local laws or
regulations. All manufacturers and
importers of ephedrine,
pseudoephedrine, or
phenylpropanolamine, or any product
containing any of these three List I
chemicals, must comply with applicable
State and local requirements in addition
to the CSA regulatory controls.
DEA notes that warehouses are
exempt from the requirement of
registration and may lawfully possess
List I chemicals, if the possession of
those chemicals is in the usual course
of business (21 U.S.C. 822(c)(2), 21
U.S.C. 957(b)(1)(B)). For purposes of this
exemption, the warehouse must receive
the List I chemical from a DEA
registrant and shall only distribute the
List I chemical back to the DEA
registrant and registered location from
which it was received. All other
activities conducted by a warehouse do
not fall under this exemption; a
warehouse that distributes List I
chemicals to persons other than the
registrant and registered location from
which they were obtained is conducting
distribution activities and is required to
register as such (21 CFR 1309.23(b)(1)).
Importation. All persons importing
ephedrine, pseudoephedrine, or
phenylpropanolamine, or drug products
containing ephedrine, pseudoephedrine,
or phenylpropanolamine are required to
comply with all requirements regarding
importation.
Records and Reports. The CSA (21
U.S.C. 830) requires certain records to
be kept and reports to be made
involving listed chemicals. Regulations
describing recordkeeping and reporting
requirements are set forth in 21 CFR
Part 1310. A record must be made and
maintained for two years after the date
of a regulated transaction involving a
List I chemical. Each regulated bulk
manufacturer of a regulated mixture
must submit manufacturing, inventory,
and use data on an annual basis (21 CFR
1310.05(d)). Bulk manufacturers
producing the chemicals solely for
internal consumption are not required
to submit this information; internal
consumption does not include using the
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chemical to produce drug products.
Existing standard industry reports
containing the required information are
acceptable, provided the information is
readily retrievable from the report.
Under 21 CFR 1310.05, regulated
persons are required to report to DEA
any regulated transaction involving an
extraordinary quantity, an uncommon
method of payment or delivery, or any
other circumstance that the regulated
person believes may indicate that the
listed chemical will be used in violation
of the CSA. Regulated persons are also
required to report to DEA any proposed
regulated transaction with a person
whose description or other identifying
information has been furnished to the
regulated person. Finally, regulated
persons are required to report any
unusual or excessive loss or
disappearance of a listed chemical.
Security. All applicants and
registrants must provide effective
controls against theft and diversion of
chemicals as described in 21 CFR
1309.71.
Administrative Inspection. Places,
including factories, warehouses, or
other establishments and conveyances,
where regulated persons may lawfully
hold, manufacture, distribute, dispense,
administer, or otherwise dispose of
ephedrine, pseudoephedrine, or
phenylpropanolamine, or products
containing ephedrine, pseudoephedrine,
or phenylpropanolamine, or where
records relating to those activities are
maintained, are controlled premises as
defined in 21 CFR 1316.02(c). The CSA
(21 U.S.C. 880) allows for administrative
inspections of these controlled premises
as provided in 21 CFR Part 1316,
Subpart A.
Section by Section Description of Final
Rule Changes
DEA is revising the authority citation
for 21 CFR part 1309 to add 21 U.S.C.
802, definitions, and 21 U.S.C. 952,
importation of controlled substances, to
the authority for that part.
DEA is amending 21 CFR 1309.11 and
1309.12 to replace ‘‘manufacture for
distribution’’ with ‘‘manufacture.’’ In
addition, in both sections, DEA is
removing references to retail
distributors. In amendments to 21
U.S.C. 823(h) the CMEA expressly
stated that distributors of scheduled
listed chemical products at retail are not
required to register under the CSA. To
avoid confusion, DEA decided to
address all registration revisions related
to CMEA implementation in this
rulemaking.
Section 1309.21 is revised to state that
every person who manufactures or
proposes to manufacture a List I
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chemical or a drug product containing
a List I chemical must register. The
change requires manufacturers of
prescription drug products containing
ephedrine, pseudoephedrine, or
phenylpropanolamine to register even
though they are not required to register
to distribute or export the products.
DEA is also adding a table to the
section, similar to the table in 21 CFR
1301.13 on controlled substance
registration requirements, to summarize
the requirements for each business
activity. As discussed above, this
revision does not alter the registration
requirements for bulk manufacturers of
List I chemicals and for manufacturers
of scheduled listed chemical products.
Section 1309.22 is revised to remove
retail distributing as a registration
activity and to add manufacturing. As
explained above, CMEA explicitly states
that retail distributors of scheduled
listed chemical products are not
required to register. DEA is also adding
a new paragraph to state that a person
registered to manufacture a List I
chemical is authorized to distribute that
chemical under the manufacturing
registration. The registrant may not
distribute, under a manufacturer’s
registration, any List I chemical that is
not covered in the manufacturing
registration. This limitation parallels the
existing limitation for importers.
In 21 CFR 1309.24, paragraph (b) is
revised to clarify that a person who
manufactures or distributes a scheduled
listed chemical product or other product
containing a List I chemical that is
described and included in the definition
of ‘‘regulated transaction’’ in 21 CFR
1300.02(b)(28)(i)(D) is exempted from
registration only if registered to conduct
the same activity with controlled
substances. Paragraph (c) is revised to
clarify that a person who imports or
exports a scheduled listed chemical
product or other product containing a
List I chemical that is described and
included in the definition of ‘‘regulated
transaction’’ in 21 CFR
1300.02(b)(28)(i)(D) is exempted from
registration only if registered to conduct
the same activity with controlled
substances. Paragraph (e) waiving
registration for retail distributors is
removed because CMEA statutorily does
not require them to register. The
remaining paragraphs (f) through (l) are
redesignated as (e) through (k). DEA
notes that the waiver of the requirement
of registration continues for bulk
manufacturers who manufacture and
consume all of the List I chemical
internally.
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Regulatory Certifications
Regulatory Flexibility Act
The Deputy Assistant Administrator
hereby certifies that this rulemaking has
been drafted in accordance with the
provisions of the Regulatory Flexibility
Act (5 U.S.C. 601–612). CMEA amended
the CSA to require production quotas
for manufacturers handling the List I
chemicals ephedrine, pseudoephedrine,
and phenylpropanolamine. CMEA also
authorized the Attorney General, DEA
by delegation, to establish import quotas
for ephedrine, pseudoephedrine, and
phenylpropanolamine. The CSA
requires that quotas be issued to
registrants. Were DEA not to issue this
rule, it would have no mechanism to
permit the registration of persons
handling prescription drug products
containing ephedrine, pseudoephedrine,
or phenylpropanolamine. If these
persons were not permitted to register,
there would be no mechanism by which
they would be permitted to apply for
production or import quotas. Therefore,
these persons would have no means by
which to acquire the List I chemicals
ephedrine, pseudoephedrine, or
phenylpropanolamine necessary for
them to conduct business.
This rule codifies provisions
necessary for implementation of the
Combat Methamphetamine Epidemic
Act. As discussed further below, DEA
has examined the potential impacts of
this rule. DEA has no basis for
estimating the number of firms that may
be small, but given the definition of
small entities, it is likely that a
substantial number of the new
registrants will be small. The cost of
compliance, however, will not impose a
significant economic burden. The only
cost is the $2,293 registration fee for
manufacturers, and the $1,147
registration fee for importers,
respectively. The recordkeeping and
reporting requirements can be met using
existing business and manufacturing
records. The security provisions are
general and require the registrant to
provide effective controls and
procedures to guard against theft and
diversion of List I chemicals. Any
manufacturer approved by the FDA and
complying with good manufacturing
practices or currently registered to
handle controlled substances will have
internal controls that meet this
requirement. The smallest
pharmaceutical firms (with 1 to 4
employees) had an average value of
shipments of $824,000 in 2002
($886,000 in 2007 dollars, based on
GDP). Even for these firms, which are
unlikely to be producing the covered
drug products, the $2,293 registration
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fee will represent less than 0.3 percent
of sales and, therefore, is not a
significant burden. Therefore, this rule
will not have a significant economic
impact on a substantial number of small
entities.
Executive Order 12866
The Deputy Assistant 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 necessary to implement statutory
provisions. DEA has, nonetheless,
reviewed the potential costs.
DEA has a limited basis for
determining the number of
manufacturers of prescription drug
products that will need to obtain a DEA
registration for the first time. DEA
reviewed a list of pseudoephedrine
products and ephedrine prescription
drug products and identified 230 firms
based on their labeler codes. Of all firms
identified, 164 do not appear to be
registered with DEA as manufacturers
and 95 are not registered as either
manufacturers or controlled substance
distributors. The firms currently
registered to manufacture controlled
substances may not manufacture List I
chemical drugs at the same locations.
Seventy firms are currently registered as
controlled substance distributors. There
may be some firms that import
prescription drug products that are not
now registered to import either
controlled substances or List I
chemicals. DEA estimates that
approximately 200 firms may have to
obtain a new DEA registration. As noted
above, the only cost imposed by the rule
is the registration fee of $2,293 for the
registration of each manufacturing
location, and $1,147 for each importing
location. The total cost of these rule
changes will be less than $500,000. The
cost to individual firms is relatively
small, compared with their revenues.
The benefit of the rule is that it will
make it possible for DEA to meet the
statutory mandate to assess the annual
need for the chemicals accurately and
provide manufacturers with the quotas
they need to continue to produce drug
products containing the three
chemicals. As DEA noted previously,
the CSA provides that quotas may only
be issued to registrants. Were DEA not
to issue this rule, it would have no
mechanism to permit the registration of
persons handling prescription drug
products containing ephedrine,
pseudoephedrine, or
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phenylpropanolamine. If these persons
were not permitted to register, there
would be no mechanism by which they
would be permitted to apply for
production or import quotas. Therefore,
these persons would have no means by
which to acquire the List I chemicals
ephedrine, pseudoephedrine, or
phenylpropanolamine necessary for
them to conduct business.
Paperwork Reduction Act
This Final Rule requires that certain
persons who were not previously
registered with DEA obtain a
registration to handle the List I
chemicals ephedrine, pseudoephedrine,
and phenylpropanolamine. Specifically,
persons manufacturing prescription
drug products containing ephedrine,
pseudoephedrine, or
phenylpropanolamine were not
previously required to register, but now
are required to obtain a registration so
that they may be eligible to apply for
individual quotas for these List I
chemicals. Additionally, importers of
prescription drug products containing
ephedrine, pseudoephedrine, or
phenylpropanolamine who were not
previously registered as List I chemical
importers now are required to register so
that they may be eligible to apply for
import quotas for ephedrine,
pseudoephedrine, and
phenylpropanolamine. DEA estimates
that approximately 200 firms will have
to obtain a new DEA registration. DEA
assumes that these firms will complete
the registration application
electronically, with each application
taking 15 minutes to complete. The
receipt of these additional applications
increases the hour burden by 50 hours
annually. Therefore, DEA is revising an
existing approved information
collection, ‘‘Application for Registration
under Domestic Chemical Diversion
Control Act of 1993 and Renewal
Application for Registration Under
Domestic Chemical Diversion Control
Act of 1993’’ (OMB # 1117–0031), to
reflect the increase in population
associated with this rule.
Further, DEA is amending the forms
associated with the existing approved
information collection ‘‘Application for
Registration (DEA Form 225) and
Application for Registration Renewal
(DEA Form 225a)’’ (OMB # 1117–0012)
to include a listing of all List I
chemicals on the application forms.
Currently, controlled substances
registrant applicants, who use these
forms to apply for DEA registration, are
not required to identify the List I
chemicals they handle. Without this
identification, it is not possible for these
persons to apply for individual quotas
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4979
for these chemicals. The addition of the
List I chemicals will allow persons to
identify which chemicals they handle.
New applicants are required to identify
the List I chemicals they handle upon
their initial application; persons
renewing their registration will identify
the chemicals at the time of their
renewal. This information must merely
be verified for each succeeding renewal.
Thus, the addition of this list will not
have a measurable effect on the time
needed to complete the application.
Therefore, DEA is not revising the
collection itself, but rather is making
changes only to the application forms
themselves.
The Department of Justice, Drug
Enforcement Administration, submitted
an information collection request to the
Office of Management and Budget
(OMB) for review and clearance in
accordance with review procedures of
the Paperwork Reduction Act of 1995.
The proposed information collection
was published in the NPRM to obtain
comments from the public and affected
agencies. No comments were received.
Overview of Information Collection
1117–0031
(1) Type of information collection:
Revision of an existing collection.
(2) Title of form/collection:
Application for Registration under
Domestic Chemical Diversion Control
Act of 1993 and Renewal Application
for Registration Under Domestic
Chemical Diversion Control Act of 1993.
(3) Agency form number, if any, and
the applicable component of the
Department of Justice sponsoring the
collection:
Form Number: DEA Forms 510 and
510a.
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: Not-for-profit, government
agencies.
Abstract: The Domestic Chemical
Diversion Control Act requires that
manufacturers, distributors, importers,
and exporters of List I chemicals which
may be diverted in the United States for
the production of illicit drugs must
register with DEA. Registration provides
a system to aid in the tracking of the
distribution of List I chemicals.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: DEA estimates that 1,805
persons respond to this collection
annually. DEA estimates that it takes 30
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minutes for an average respondent to
respond when completing the
application on paper, and 15 minutes
for an average respondent to respond
when completing an application
electronically. This application is
submitted annually.
(6) An estimate of the total public
burden (in hours) associated with the
collection: DEA estimates that this
collection has a public burden of 612
hours annually.
Respondents
Burden (hours)
Total hour burden
DEA–510 (paper) ...................................................................................................
DEA–510 (electronic) .............................................................................................
DEA–510a (paper) .................................................................................................
DEA–510a (electronic) ...........................................................................................
60
325
580
840
0.5
0.25
0.5
0.25
30
81.25
290
210
Total ................................................................................................................
1,805
................................
611.25
Executive Order 12988
This regulation meets the applicable
standards set forth in 3(a) and 3(b)(2) of
Executive Order 12988 Civil Justice
Reform.
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.
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 $120,000,000 or more
(adjusted for inflation) in any one year,
and will not significantly or uniquely
affect small governments. Therefore, no
actions were deemed necessary under
the provisions of the Unfunded
Mandates Reform Act of 1995.
Congressional Review Act
This rule is not a major rule as
defined by section 804 of the Small
Business Regulatory Enforcement
Fairness Act of 1996 (Congressional
Review Act). This rule will not result in
an annual effect on the economy of
$100,000,000 or more; 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.
List of Subjects in 21 CFR Part 1309
Administrative practice and
procedure; Drug traffic control; Exports;
Imports; Security measures.
■ For the reasons set out above, 21 CFR
part 1309 is amended as follows:
PART 1309—REGISTRATION OF
MANUFACTURERS, DISTRIBUTORS,
IMPORTERS AND EXPORTERS OF
LIST I CHEMICALS
1. The authority citation for part 1309
is revised to read as follows:
■
Authority: 21 U.S.C. 802, 821, 822, 823,
824, 830, 871(b), 875, 877, 886a, 952, 958.
2. Section 1309.11 is revised to read
as follows:
■
§ 1309.11
Fee amounts.
(a) For each application for
registration or reregistration to
manufacture the applicant shall pay an
annual fee of $2,293.
(b) For each application for
registration or reregistration to
distribute, import, or export a List I
chemical, the applicant shall pay an
annual fee of $1,147.
3. Section 1309.12 is revised to read
as follows:
■
§ 1309.12
refund.
Time and method of payment;
(a) For each application for
registration or reregistration to
manufacture, distribute, import, or
export, the applicant shall pay the fee
when the application for registration or
reregistration is submitted for filing.
(b) Payments should be made in the
form of a credit card; a personal,
certified, or cashier’s check; or a money
order made payable to ‘‘Drug
Enforcement Administration.’’ Payments
made in the form of stamps, foreign
currency, or third party endorsed checks
will not be accepted. These application
fees are not refundable.
■ 4. Section 1309.21 is revised to read
as follows:
§ 1309.21
Persons required to register.
(a) Unless exempted by law or under
§§ 1309.24 through 1309.26 or
§§ 1310.12 through 1310.13 of this
chapter, the following persons must
annually obtain a registration specific to
the List I chemicals to be handled:
(1) Every person who manufactures or
imports or proposes to manufacture or
import a List I chemical or a drug
product containing ephedrine,
pseudoephedrine, or
phenylpropanolamine.
(2) Every person who distributes or
exports or proposes to distribute or
export any List I chemical, other than
those List I chemicals contained in a
product exempted under
§ 1300.02(b)(28)(i)(D) of this chapter.
(b) Only persons actually engaged in
the activities are required to obtain a
registration; related or affiliated persons
who are not engaged in the activities are
not required to be registered. (For
example, a stockholder or parent
corporation of a corporation distributing
List I chemicals is not required to obtain
a registration.)
(c) The registration requirements are
summarized in the following table:
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SUMMARY OF REGISTRATION REQUIREMENTS AND LIMITATIONS
Business activity
Chemicals
DEA forms
Manufacturing ...
List I, Drug products containing
ephedrine, pseudoephedrine,
phenylpropanolamine.
New—510 .........
Renewal—510a
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Application fee
Registration
period
(years)
$2,293
2,293
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Coincident activities allowed
1
May distribute that chemical for
which registration was issued;
may not distribute any chemical for which not registered.
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4981
SUMMARY OF REGISTRATION REQUIREMENTS AND LIMITATIONS—Continued
Chemicals
DEA forms
Distributing ........
New—510 .........
Renewal—510a
New—510 .........
Renewal—510a
1,147
1,147
1,147
1,147
1
Importing ...........
List I, Scheduled listed chemical
products.
List I, Drug Products containing
ephedrine, pseudoephedrine,
phenylpropanolamine.
Exporting ...........
List I, Scheduled listed chemical
products.
New—510 .........
Renewal—510a
1,147
1,147
1
§ 1309.24 Waiver of registration
requirement for certain activities.
5. Section 1309.22 is revised to read
as follows:
■
§ 1309.22 Separate registration for
independent activities.
(a) The following groups of activities
are deemed to be independent of each
other:
(1) Manufacturing of List I chemicals
or drug products containing ephedrine,
pseudoephedrine, or
phenylpropanolamine.
(2) Distributing of List I chemicals and
scheduled listed chemical products.
(3) Importing List I chemicals or drug
products containing ephedrine,
pseudoephedrine, or
phenylpropanolamine.
(4) Exporting List I chemicals and
scheduled listed chemical products.
(b) Except as provided in paragraphs
(c) and (d) of this section, every person
who engages in more than one group of
independent activities must obtain a
separate registration for each group of
activities, unless otherwise exempted by
the Act or §§ 1309.24 through 1309.26.
(c) A person registered to import any
List I chemical shall be authorized to
distribute that List I chemical after
importation, but no other chemical that
the person is not registered to import.
(d) A person registered to
manufacture any List I chemical shall be
authorized to distribute that List I
chemical after manufacture, but no
other chemical that the person is not
registered to manufacture.
■ 6. In § 1309.23, paragraph (a) is
revised to read as follows:
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§ 1309.23 Separate registration for
separate locations.
(a) A separate registration is required
for each principal place of business at
one general physical location where List
I chemicals are manufactured,
distributed, imported, or exported by a
person.
*
*
*
*
*
■ 7. Section 1309.24 is revised to read
as follows:
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16:55 Jan 29, 2010
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Application fee
Registration
period
(years)
Business activity
(a) The requirement of registration is
waived for any agent or employee of a
person who is registered to engage in
any group of independent activities, if
the agent or employee is acting in the
usual course of his or her business or
employment.
(b) The requirement of registration is
waived for any person who
manufactures or distributes a scheduled
listed chemical product or other product
containing a List I chemical that is
described and included in the definition
of ‘‘regulated transaction’’ in
§ 1300.02(b)(28)(i)(D) of this chapter, if
that person is registered with the
Administration to engage in the same
activity with a controlled substance.
(c) The requirement of registration is
waived for any person who imports or
exports a scheduled listed chemical
product or other product containing a
List I chemical that is described and
included in the definition of ‘‘regulated
transaction’’ in § 1300.02(b)(28)(i)(D) of
this chapter, if that person is registered
with the Administration to engage in the
same activity with a controlled
substance.
(d) The requirement of registration is
waived for any person who only
distributes a prescription drug product
containing a List I chemical that is
regulated pursuant to
§ 1300.02(b)(28)(i)(D) of this chapter.
(e) The requirement of registration is
waived for any person whose activities
with respect to List I chemicals are
limited to the distribution of red
phosphorus, white phosphorus, or
hypophosphorous acid (and its salts) to
another location operated by the same
firm solely for internal end-use, or an
EPA or State licensed waste treatment or
disposal firm for the purpose of waste
disposal.
(f) The requirement of registration is
waived for any person whose
distribution of red phosphorus or white
phosphorus is limited solely to residual
quantities of chemical returned to the
producer, in reusable rail cars and
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Coincident activities allowed
1
May distribute that chemical for
which registration was issued;
may not distribute any chemical for which not registered.
intermodal tank containers which
conform to International Standards
Organization specifications (with
capacities greater than or equal to 2,500
gallons in a single container).
(g) The requirement of registration is
waived for any person whose activities
with respect to List I chemicals are
limited solely to the distribution of
Lugol’s Solution (consisting of 5 percent
iodine and 10 percent potassium iodide
in an aqueous solution) in original
manufacturer’s packaging of one fluid
ounce (30 ml) or less.
(h) The requirement of registration is
waived for any manufacturer of a List I
chemical, if that chemical is produced
solely for internal consumption by the
manufacturer and there is no
subsequent distribution or exportation
of the List I chemical.
(i) If any person exempted under
paragraph (b), (c), (d), (e), or (f) of this
section also engages in the distribution,
importation, or exportation of a List I
chemical, other than as described in
such paragraph, the person shall obtain
a registration for the activities, as
required by § 1309.21.
(j) The Administrator may, upon
finding that continuation of the waiver
would not be in the public interest,
suspend or revoke a waiver granted
under paragraph (b), (c), (d), (e), or (f) of
this section pursuant to the procedures
set forth in §§ 1309.43 through 1309.46
and §§ 1309.51 through 1309.55. In
considering the revocation or
suspension of a person’s waiver granted
pursuant to paragraph (b) or (c) of this
section, the Administrator shall also
consider whether action to revoke or
suspend the person’s controlled
substance registration pursuant to
section 304 of the Act (21 U.S.C. 824)
is warranted.
(k) Any person exempted from the
registration requirement under this
section must comply with the security
requirements set forth in §§ 1309.71
through 1309.73 and the recordkeeping
and reporting requirements set forth
under Parts 1310, 1313, 1314, and 1315
of this chapter.
E:\FR\FM\01FER1.SGM
01FER1
4982
Federal Register / Vol. 75, No. 20 / Monday, February 1, 2010 / Rules and Regulations
8. Section 1309.25 is amended by
adding a new paragraph (c) to read as
follows:
■
§ 1309.25 Temporary exemption from
registration for chemical registration
applicants.
*
*
*
*
*
(c) Each person required by sections
302 or 1007 of the Act (21 U.S.C. 822
or 957) to obtain a registration to
manufacture or import prescription drug
products containing ephedrine,
pseudoephedrine, or
phenylpropanolamine is temporarily
exempted from the registration
requirement, provided that the person
submits a proper application for
registration on or before March 3, 2010.
The exemption will remain in effect for
each person who has made such
application until the Administration has
approved or denied the application.
This exemption applies only to
registration; all other chemical control
requirements set forth in this part and
parts 1310, 1313, and 1315 of this
chapter remain in full force and effect.
Dated: January 22, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control.
[FR Doc. 2010–1968 Filed 1–29–10; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
28 CFR Part 0
[Docket No. DEA–315F]
Redelegation of Functions; Delegation
of Authority to Drug Enforcement
Administration Official
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Final rule.
pwalker on DSK8KYBLC1PROD with RULES
AGENCY:
SUMMARY: Under delegated authority,
the Administrator of the Drug
Enforcement Administration (DEA),
Department of Justice, is amending the
appendix to the Justice Department
regulations to redelegate certain
functions and authority which were
vested in the Attorney General by the
Controlled Substances Act and
subsequently delegated to the
Administrator of DEA.
DATES: Effective Dates: This Final Rule
is effective February 1, 2010.
FOR FURTHER INFORMATION CONTACT:
Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion
VerDate Nov<24>2008
16:55 Jan 29, 2010
Jkt 220001
Control, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, VA 22152, Telephone (202)
307–7297.
SUPPLEMENTARY INFORMATION: 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.
Retail Sales Provisions of the Combat
Methamphetamine Epidemic Act of
2005
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). Among other
things, the CMEA amended 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 created a new category
of products called scheduled listed
chemical products. A scheduled listed
chemical product is defined as a
product that contains ephedrine,
pseudoephedrine, or
phenylpropanolamine that may be
marketed or distributed lawfully in the
United States under the Federal Food,
Drug, and Cosmetic Act as a
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
nonprescription drug (21 U.S.C.
802(45)(A), 21 CFR 1300.02(b)(34)(i))).
CMEA established provisions
regarding the retail sale of these
scheduled listed chemical products by
regulated sellers (i.e., retail distributors
including mobile retail vendors) and
distributors required to submit reports
under 21 U.S.C. 830(b)(3) (i.e., mail
order distributors). These requirements,
which were promulgated in 21 CFR,
part 1314, include, but are not limited
to:
• Packaging requirements for
nonliquid forms of scheduled listed
chemical products (i.e., 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) (21 CFR 1314.05).
• Daily sales limits (21 CFR 1314.20).
• Product placement (i.e., placing the
product so that customers do not have
direct access before the sale is made,
referred to as ‘‘behind the counter’’
placement, including circumstances in
which the product is stored in a locked
cabinet located in an area of the facility
where customers do have direct access)
(21 CFR 1314.25(b)).
• Recordkeeping (i.e., logbook
provisions) (21 CFR 1314.30).
• Employee training (21 CFR
1314.35).
• Self-certification (21 CFR 1314.40).
Redelegation of Authority
The Attorney General has delegated
his functions under the CSA to the
Administrator of the Drug Enforcement
Administration (21 U.S.C. 871(a) and 28
CFR 0.100(b)). The Attorney General has
also authorized the Administrator to
redelegate any of his functions under
the CSA to any subordinates (28 CFR
0.104). To further enhance the
administration of the CSA and its
regulations, the Administrator is
redelegating to the Deputy Assistant
Administrator, Office of Diversion
Control, Drug Enforcement
Administration, and the authority to
exercise all necessary functions with
respect to the promulgation and
implementation of regulations in 21
CFR, part 1314. This redelegation will
empower the Deputy Assistant
Administrator, among other things, to
exercise signing authority for any rules,
regulations, or procedures which he
may deem necessary for the efficient
execution of the retail sales provisions
contained in part 1314. Final orders in
connection with the suspension or
revocation of a regulated seller’s or mail
order distributor’s right to sell
scheduled listed chemical products
shall continue to be made by the Deputy
E:\FR\FM\01FER1.SGM
01FER1
]]>Agencies
[Federal Register Volume 75, Number 20 (Monday, February 1, 2010)]
[Rules and Regulations]
[Pages 4973-4982]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-1968]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 75, No. 20 / Monday, February 1, 2010 / Rules
and Regulations
[[Page 4973]]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1309
[Docket No. DEA-294F]
RIN 1117-AB09
Registration Requirements for Importers and Manufacturers of
Prescription Drug Products Containing Ephedrine, Pseudoephedrine, or
Phenylpropanolamine
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration (DEA) is amending its
registration regulations to ensure that a registration is obtained for
every location where ephedrine, pseudoephedrine, or
phenylpropanolamine, or drug products containing one of these
chemicals, are imported or manufactured. These amendments will make it
possible to establish the system of quotas and assessment of annual
needs for the importation and manufacture of these chemicals that
Congress mandated in the Combat Methamphetamine Epidemic Act of 2005.
DATES: This rule is effective March 3, 2010.
FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, 8701 Morrissette Drive, Springfield, VA 22152;
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 (CSIEA) (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 1316. These regulations are designed to ensure that there
is a sufficient supply of controlled substances for legitimate medical,
scientific, 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, distribution, import, and export 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 (21 U.S.C. 802(34)). Those
classified as List II chemicals may be used to manufacture controlled
substances (21 U.S.C. 802(35)).
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). Much of
CMEA is self-implementing; the provisions related to importation of
ephedrine, pseudoephedrine, and phenylpropanolamine, import quotas,
manufacturing quotas, and procurement quotas became effective on March
9, 2006.
CMEA Requirements and Impact on Registration
CMEA amended the CSA to include ephedrine, pseudoephedrine, and
phenylpropanolamine in 21 U.S.C. 826 (Production quotas for controlled
substances) and 21 U.S.C. 952(a) (Importation of controlled
substances). Congress essentially imposed the same requirements for
importation of ephedrine, pseudoephedrine, and phenylpropanolamine as
are imposed on narcotic raw materials--crude opium, poppy straw,
concentrate of poppy straw, and coca leaves. That is, imports of
ephedrine, pseudoephedrine, and phenylpropanolamine are prohibited
except for such amounts as the Attorney General (DEA by delegation)
finds to be necessary to provide for medical, scientific, or other
legitimate purposes. Congress also imposed the same requirements on the
manufacture of ephedrine, pseudoephedrine, and phenylpropanolamine as
are established for Schedule I and II controlled substances. That is,
Congress mandated the establishment of a total need for ephedrine,
pseudoephedrine, and phenylpropanolamine to be manufactured each
calendar year to provide for the estimated medical, scientific,
research, and industrial needs of the United States, for lawful export
requirements, and for the establishment and maintenance of reserve
stocks. These requirements apply equally to products containing these
three List I chemicals as they do to the List I chemicals themselves.
Until the passage of CMEA, chemical importers were required to
notify DEA of imports of ephedrine, pseudoephedrine, and
phenylpropanolamine before or at the time of importation under 21
U.S.C. 971. DEA had no authority to limit the importation or
manufacture of ephedrine, pseudoephedrine, and phenylpropanolamine,
except for the ability to suspend a proposed import under 21 U.S.C.
971(c) on the ground that it may be diverted to the clandestine
manufacture of a controlled substance. Most of the ephedrine,
pseudoephedrine, and phenylpropanolamine used in the United States is
imported rather than manufactured domestically.
Ephedrine, pseudoephedrine, and phenylpropanolamine are used to
produce drug products lawfully marketed under the Federal Food, Drug
and Cosmetic Act (FFD&CA), many of which are prescription drugs. DEA
has not subjected these prescription drug products to all List I
chemical regulatory requirements because they are available only in
response to a prescription and are stored in and dispensed at
pharmacies. These chemicals are also used in over-the-counter (OTC)
drug products (lawfully marketed and distributed under the FFD&CA as a
non-
[[Page 4974]]
prescription drug). These products have been widely used in the illegal
manufacture of methamphetamine and amphetamine. CMEA defined these OTC
drug products as scheduled listed chemical products (21 U.S.C.
802(45)(A)). DEA has regulated the distribution, import, and export of
scheduled listed chemical products.
There are firms manufacturing drug products lawfully marketed under
the FFD&CA containing ephedrine, pseudoephedrine, or
phenylpropanolamine that are not registered with DEA at all because
those firms do not handle controlled substances and the only products
those firms produce containing the three chemicals are prescription
drugs. There are also firms that manufacture scheduled listed chemical
products, but only distribute or dispense controlled substances.
Because those firms are registered as controlled substance distributors
or dispensers, those firms are not currently required to register as
chemical manufacturers. Finally, there may be some firms that are not
registered that import prescription drug products that contain the
three chemicals.
Note: For a more detailed discussion of the history of the
regulation of ephedrine, pseudoephedrine, and phenylpropanolamine
see the preamble to the Notice of Proposed Rulemaking published on
January 18, 2008 (73 FR 3432).
Because of the new CMEA mandates for importation, import quotas,
and production quotas for ephedrine, pseudoephedrine, and
phenylpropanolamine, DEA is revising its registration provisions. As
discussed in the NPRM, the changes made by the CMEA render current DEA
regulations inadequate for two reasons. First, although DEA registers
bulk manufacturers of the three chemicals in the United States and
importers of the bulk chemicals, some of those chemicals are
distributed to non-registered companies that process them into
prescription drugs. Under 21 U.S.C. 826, production quotas are
available only to registered manufacturers. DEA cannot meet the CMEA
mandate to establish an annual need and import quotas, and then issue
individual quotas for each of the chemicals unless all persons
manufacturing or procuring the chemicals and manufacturing drug
products that contain the chemicals are registered as manufacturers,
even if the distribution of the final drug products is not regulated.
DEA also must know the quantity of prescription drug products
containing the three chemicals being imported; without this
information, DEA would not be able to determine an assessment of annual
need for the chemicals. Any person importing prescription drug products
containing any of the three chemicals must register although the
distribution of these products would not be subject to DEA regulation.
The second inadequacy is that the existing language allows a
controlled substance distributor or dispenser to avoid registration as
a chemical manufacturer if that person manufactures scheduled listed
chemical products or other products containing a List I chemical that
is described and included in the definition of ``regulated
transaction'' in 21 CFR 1300.02(b)(28)(i)(D). [DEA notes that there may
be a limited number of drug products containing List I chemicals other
than ephedrine, pseudoephedrine, and phenylpropanolamine which meet
this description.] Therefore, this provision is being changed so that
controlled substance registrants will not need to obtain a chemical
registration only if they engage in the same activity for both drug
products containing List I chemicals and controlled substances as is
already the case for bulk manufacture, imports, and exports. In this
way, any registrant that must obtain a quota to manufacture or procure
one or more of the chemicals will be a registered manufacturer, as
required by the CSA.
DEA recognizes that this change requires some manufacturers and
locations to register that had not previously been subject to DEA
regulations; other registrants are required to obtain separate
registrations for chemicals and controlled substances. The new
requirements, however, are both consistent with the statutory language
on registration and the CMEA amendments and with the intent of the CMEA
requirements to establish a system of quotas for the manufacture of
these three chemicals and the products that contain them. Without these
changes, DEA would not be able to meet the CMEA mandates. In addition,
without these changes, companies that manufacture and import
prescription drug products containing the three chemicals would not be
able to purchase the chemicals legally nor would the assessment of
annual needs reflect their requirements.
Explanation of DEA Categories of Registration and Effect of This Rule
Regarding DEA Registration
The CSA defines the term ``manufacture'' to include the physical
manufacture of a chemical or product, as well as the packaging,
labeling, repackaging, and relabeling of that product (21 U.S.C.
802(15)). Thus, under the CSA, ``manufacture'' is defined to include
all of the following:
The manufacturing of a substance or chemical in bulk,
either by extraction from raw materials, chemical synthesis, or a
combination of extraction and chemical synthesis.
The processing of the substance or chemical into products,
such as drugs in dosage form.
The packaging or repackaging of the processed substances
or chemicals or labeling or relabeling of containers holding the
chemicals.
After this final rule takes effect, persons who manufacture or
import ephedrine, pseudoephedrine, or phenylpropanolamine, or who
manufacture or import a product containing ephedrine, pseudoephedrine,
or phenylpropanolamine, or who plan to engage in such activities, will
be required to register with DEA if they are not already registered for
the appropriate business activity. As required by the CSA, registration
is location-specific; a person must obtain a registration for each
principal place of business at one general physical location where
controlled substances or List I chemicals are manufactured,
distributed, imported, or exported. If a person manufactures controlled
substances at one location and drug products containing ephedrine,
pseudoephedrine, or phenylpropanolamine at another location, the person
will be required to obtain a separate registration for each location.
Under the waiver previously described in this rulemaking (21 CFR
1309.24(b)), persons who are currently registered as controlled
substances manufacturers at a location where drug products containing
these List I chemicals are also manufactured will not be required to
register separately to conduct the same activity, manufacturing, with
these List I chemicals. A controlled substances registration for that
one physical location will cover both the manufacturing of controlled
substances and drug products containing ephedrine, pseudoephedrine, or
phenylpropanolamine, at that location. Those controlled substances
manufacturers will, however, be required to identify to DEA the List I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine they
handle as part of their next registration renewal. DEA notes that the
manufacture of bulk List I chemicals requires a separate chemical
registration; this is not a change from existing regulations.
However, if a person manufactures a drug product containing
ephedrine,
[[Page 4975]]
pseudoephedrine, or phenylpropanolamine at a location, but is
registered to conduct other (nonmanufacturing) activities with
controlled substances at that location (e.g., distribution), the person
will need to obtain a List I chemical manufacturing registration for
the location. The following table indicates the changes in registration
requirements for various business activities.
------------------------------------------------------------------------
Previous Final rule
------------------------------------------------------------------------
Chemical Manufacturers (no Controlled Substances)
------------------------------------------------------------------------
All bulk manufacturers of List I No change.
chemicals must register unless all of
the chemical produced is consumed
internally and is not available for
use in products.
Manufacturers of scheduled listed All manufacturers of drug
chemical products must register if products containing List I
they also distribute. chemicals * must register.
Manufacturers of prescription products
** containing List I chemicals do not
register
------------------------------------------------------------------------
Chemical Distributors
------------------------------------------------------------------------
Distributors of List I chemicals and No change.
scheduled listed chemical products
must register.
Distributors of prescription products
** containing List I chemicals do not
register
------------------------------------------------------------------------
Chemical Importers and Exporters
------------------------------------------------------------------------
Importers of List I chemicals and Importers of List I chemicals
scheduled listed chemical products and all drug products
must register. containing List I chemicals *
must register.
Importers of prescription products **
containing List I chemicals do not
register if they import controlled
substances
Exporters of List I chemicals and No change.
scheduled listed chemical products
must register.
Exporters of prescription products **
containing List I chemicals do not
register
------------------------------------------------------------------------
Manufacturers and Distributors of Controlled Substances and Drug
Products Containing List I Chemicals
------------------------------------------------------------------------
Manufacturers of both controlled No change.
substances and drug products
containing List I chemicals may
register as only controlled substance
manufacturers.
Manufacturers of drug products Manufacturers of controlled
containing any List I chemical * who substances and drug products
distribute or dispense controlled containing any List I chemical
substances may register for only their * must register as controlled
controlled substance activity. A substances manufacturers. If
separate registration for the chemical they manufacture drug products
activity is permissible. containing any List I chemical
* and only distribute or
dispense controlled substances
at the same location, they
must register separately for
each activity.
Distributors of both controlled No change.
substances and drug products
containing List I chemicals may
register as only controlled substance
distributors.
------------------------------------------------------------------------
Importers/Exporters of Controlled Substances and Drug Products
Containing List I Chemicals
------------------------------------------------------------------------
Importers of both controlled substances No change.
and drug products containing List I
chemicals must register as controlled
substance importers.
Exporters of both controlled substances No change.
and drug products containing List I
chemicals must register as controlled
substance exporters.
------------------------------------------------------------------------
Manufacturers, Distributors, Importers, and Exporters of Bulk List I
Chemicals
------------------------------------------------------------------------
Manufacturers, distributors, importers, No change.
and exporters of bulk List I chemicals
must register, regardless of whether
they handle controlled substances.
------------------------------------------------------------------------
* ``drug products containing List I chemicals'' refers to scheduled
listed chemical products or other products containing a List I
chemical that is described and included in the definition of
``regulated transaction'' in 21 CFR 1300.02(b)(28)(i)(D). Such drug
products must be in packaged/labeled form as required under the FFD&CA
for lawful marketing.
** ``Prescription products,'' for purposes of this table, refers to
``any transaction in a List I chemical that is contained in a drug
that may be marketed or distributed lawfully in the United States
under the Federal Food, Drug, and Cosmetic Act * * *'' (21 U.S.C.
802(39)(A)(iv)). To comply with the marketing and distribution
requirements of the FFD&CA for prescription drugs, such drugs must be
packaged and labeled in accordance with the FFD&CA as prescription
drugs.
Notice of Proposed Rulemaking
On January 18, 2008, DEA published a Notice of Proposed Rulemaking
(NPRM) (73 FR 3432) proposing that persons who manufacture or import a
prescription drug product containing ephedrine, pseudoephedrine, or
phenylpropanolamine be required to register with DEA, even if the
distribution of the final drug product is not regulated. Further, the
rule proposed clarification that controlled substance registrants need
not obtain a separate chemical registration only if they engage in the
same activity for both
[[Page 4976]]
drug products containing List I chemicals and controlled substances.
Discussion of Comments
DEA received three comments on the proposed rule. Commenters
included two individuals and one DEA-registered manufacturer.
Support for proposed rule: One commenter strongly supported any
amendments to the regulations necessary to help regulate the
importation and manufacture of chemicals used in the illicit
manufacture of methamphetamine.
DEA Response: DEA appreciates the support for this rulemaking. As
noted previously, this regulation is necessary to fully implement the
provisions of the CMEA related to quotas for the List I chemicals
ephedrine, pseudoephedrine, and phenylpropanolamine.
Opposition to NPRM: Another commenter stated that the proposed rule
was shortsighted and ill-equipped to meet the goal of the CMEA. The
commenter believed that market demand, not a governmental agency,
should determine how much ephedrine, pseudoephedrine, and
phenylpropanolamine should be imported.
DEA Response: This regulation addresses neither the establishment
of procedures for the implementation of quotas nor the quotas
themselves. Rather, this rule revises DEA regulations to require
certain persons to obtain a DEA registration so that they may apply for
quota. As discussed previously, the CMEA amended the CSA to require
production quotas for manufacturers handling the List I chemicals
ephedrine, pseudoephedrine, and phenylpropanolamine. CMEA also
authorized the Attorney General (DEA by delegation), to establish
import quotas for ephedrine, pseudoephedrine, and phenylpropanolamine.
The CSA requires that quotas be issued to registrants. Were DEA not to
issue this rule, it would have no mechanism to permit the registration
of persons handling prescription drug products containing ephedrine,
pseudoephedrine, or phenylpropanolamine. If these persons were not
permitted to register, there would be no mechanism by which they would
be permitted to apply for import or production quotas. Therefore, these
persons would have no means by which to acquire the List I chemicals
ephedrine, pseudoephedrine, or phenylpropanolamine necessary for them
to conduct business.
Registration of analytical laboratories and researchers: The third
commenter requested DEA clarification of the scope of the proposed
revision to 21 CFR 1309.24(c). The commenter believed that DEA intended
to include controlled substances analytical laboratories in the waiver
for controlled substances importer registrants who are permitted to
import drug products regulated pursuant to 21 U.S.C. 802(39)(A)(iv).
The commenter indicated its support for an allowance to permit
controlled substances analytical laboratory registrants to be able to
import List I chemical product samples for testing purposes.
DEA Response: DEA believes that the commenter has misunderstood the
waiver of the requirement of registration provided in 21 CFR
1309.24(c), as well as the authority granted to controlled substances
researchers and persons permitted to conduct chemical analysis to
import certain substances.
As proposed to be revised in the NPRM, 21 CFR 1309.24(c) states:
The requirement of registration is waived for any person who
imports or exports a scheduled listed chemical product or other
product containing a List I chemical that is described and included
in the definition of ``regulated transaction'' in Sec.
1300.02(b)(28)(i)(D), if that person is registered with the
Administration to engage in the same activity with a controlled
substance.\1\
---------------------------------------------------------------------------
\1\ Prior to the proposed revision, 21 CFR 1309.24(c) stated:
``The requirement of registration is waived for any person who
imports or exports a product containing a List I chemical that is
regulated pursuant to Sec. 1300.02(b)(28)(i)(D), if that person is
registered with the Administration to engage in the same activity
with a controlled substance.'' The revision DEA proposed sought
merely to provide specificity regarding those products regulated
pursuant to 21 CFR 1300.02(b)(28)(i)(D) and did not change the
requirements regarding to whom the waiver of the requirement of
registration applied.
The definition of ``regulated transaction'' describes the
following: ``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, * * *'' (21 U.S.C. 802(39)(A)(iv), 21 CFR
1300.02(b)(28)(i)(D)).
A scheduled listed chemical product is defined as a product that
contains ephedrine, pseudoephedrine, or phenylpropanolamine that may be
marketed or distributed lawfully in the United States under the FFD&CA
as a nonprescription drug (21 U.S.C. 802(45)(A), 21 CFR
1300.02(b)(34)(i))).
As discussed previously, for a drug to be ``marketed or distributed
lawfully in the United States under the Federal Food, Drug, and
Cosmetic Act,'' such drug product must be in packaged/labeled form as
required under the FFD&CA. Thus, regardless of whether the product
being imported or exported is a scheduled listed chemical product or
another drug product containing a List I chemical, for a person to use
the waiver granted in 21 CFR 1309.24(c) to import a drug containing a
List I chemical, that drug must be in a packaged/labeled form in
compliance with the marketing and distribution requirements of the
FFD&CA.
Thus, the waiver pertains only to those products which are fully
formulated and packaged pursuant to the FFD&CA, not to the importation
of bulk chemical, which would include any product not fully formulated,
packaged, and labeled as required to meet the terms of the waiver, as
well as any chemical in an unfinished form (e.g., bulk powder, bulk
liquid). DEA questions whether any person conducting research or
chemical analysis involving a List I chemical or a product containing a
List I chemical would choose to import a product meeting the marketing/
distribution requirements of the FFD&CA. As has been discussed
previously, if a person were to import a List I chemical, or a product
containing a List I chemical, which did not meet the criteria for
lawful distribution or marketing under the FFD&CA, then that person
would be required to obtain a separate registration as a chemical
importer to conduct the importation.
The commenter appears to believe that controlled substances
research and chemical analysis registrants are permitted to import List
I chemicals based on their controlled substance research or chemical
analysis registration. For Schedule I researchers, the regulations
provide the following regarding coincident activities: ``A researcher
may manufacture or import the basic class of substance or substances
for which registration was issued, provided that such manufacture or
import is set forth in the protocol required in Sec. 1301.18 * * *''
(21 CFR 1301.13(e)(1)(v)). That coincident activity clearly limits the
importation authority only to those controlled substances set forth in
the researcher protocol, and does not grant any authority related to
importation of List I chemicals for any purpose, including research.
Thus, a Schedule I researcher would be required to obtain a separate
chemical importer registration to import any List I chemical for any
purpose, regardless of whether that chemical was lawfully marketed or
distributed under the FFD&CA.
For Schedule II-V researchers, the regulations provide the
following regarding coincident activities: ``May
[[Page 4977]]
conduct chemical analysis with controlled substances in those schedules
for which registration was issued; * * * import such substances for
research purposes; * * *'' (21 CFR 1301.13(e)(1)(vi)). Again, the
importation of the substances is based on the activity of research, not
on the importation activity itself.
For persons conducting chemical analysis, the regulations provide
the following regarding coincident activities:
May manufacture and import controlled substances for analytical
or instructional activities; may distribute such substances to
persons registered or authorized to conduct chemical analysis,
instructional activities, or research with such substances and to
persons exempted from registration pursuant to Sec. 1301.24; may
export such substances to persons in other countries performing
chemical analysis or enforcing laws related to controlled substances
or drugs in those countries; and may conduct instructional
activities with controlled substances. (21 CFR 1301.13(e)(1)(x))
Again, the importation of the substances is based on the activity of
chemical analysis, not on the importation activity itself.
Conversely, the language of 21 CFR 1309.24(c) contemplates that the
person importing the product containing the List I chemical is
``registered with the Administration to engage in the same activity
[importation] with a controlled substance.'' The activity of a
controlled substances researcher is not the same as the activity of a
controlled substances importer. Nor is the activity of a controlled
substances chemical analyst the same as the activity of a controlled
substances importer. As discussed above, researchers have very limited
authority to import controlled substances, based specifically on the
research being conducted. Those conducting chemical analysis have
similarly limited authority related solely to the analysis of
controlled substances.
Based on the comment received, and to clarify that the waiver of
the requirement of registration in 21 CFR 1309.24(c) is intended for
importers and exporters of controlled substances, DEA is revising the
language of 21 CFR 1309.24(c) to state that:
The requirement of registration is waived for any person who
imports or exports a scheduled listed chemical product or other
product containing a List I chemical that is described and included
in the definition of ``regulated transaction'' in Sec.
1300.02(b)(28)(i)(D), if that person is registered with the
Administration to import or export a controlled substance.
DEA notes that if a controlled substances researcher or registrant
permitted to conduct chemical analysis receives the List I chemicals
from another registrant, e.g., a person registered to import,
manufacture, or distribute List I chemicals, and if the researcher or
chemical analyst does not further distribute the List I chemicals, that
researcher or chemical analyst would be considered to be a List I
chemical end-user and would not be required to be registered with DEA
to receive the List I chemicals.
Requirements of This Final Rule
DEA is requiring that a person who manufactures or imports a
prescription drug product containing ephedrine, pseudoephedrine, or
phenylpropanolamine must comply with the following:
Registration. Any person who manufactures or imports a drug product
containing ephedrine, pseudoephedrine, or phenylpropanolamine, or who
proposes to engage in the manufacture or importation of a drug product
containing ephedrine, pseudoephedrine, or phenylpropanolamine, is
required to obtain a registration under the CSA (21 U.S.C. 822 and
958). Regulations describing registration for List I chemical handlers
are set forth in 21 CFR Part 1309.
A separate registration is required for manufacturing,
distributing, importing, and exporting, except that a person registered
to manufacture or import a List I chemical or a product containing
ephedrine, pseudoephedrine, or phenylpropanolamine may distribute that
List I chemical or drug product without obtaining a separate
registration to do so. A separate registration is required for each
principal place of business at one general physical location where the
List I chemicals are manufactured, distributed, imported, or exported
by a person (21 CFR 1309.23).
As a result of the change, any person manufacturing or importing a
prescription drug product containing ephedrine, pseudoephedrine, or
phenylpropanolamine is subject to the registration requirement under
the CSA. DEA recognizes, however, that it is not possible for persons
who are newly subject to the registration requirement to complete and
submit an application for registration and for DEA to issue
registrations for those activities immediately. Therefore, to allow
continued legitimate commerce, DEA is establishing in 21 CFR 1309.25 a
temporary exemption from the registration requirement for persons
desiring to engage in manufacturing or importing prescription drug
products containing ephedrine, pseudoephedrine, or phenylpropanolamine,
provided that DEA receives a properly completed application for
registration on or before March 3, 2010. The temporary exemption for
such persons will remain in effect until DEA takes final action on
their application for registration.
The temporary exemption applies solely to the registration
requirement; all other chemical control requirements, including
recordkeeping and reporting, will remain in effect. Additionally, the
temporary exemption does not suspend applicable Federal criminal laws
relating to these chemicals, nor does it supersede State or local laws
or regulations. All manufacturers and importers of ephedrine,
pseudoephedrine, or phenylpropanolamine, or any product containing any
of these three List I chemicals, must comply with applicable State and
local requirements in addition to the CSA regulatory controls.
DEA notes that warehouses are exempt from the requirement of
registration and may lawfully possess List I chemicals, if the
possession of those chemicals is in the usual course of business (21
U.S.C. 822(c)(2), 21 U.S.C. 957(b)(1)(B)). For purposes of this
exemption, the warehouse must receive the List I chemical from a DEA
registrant and shall only distribute the List I chemical back to the
DEA registrant and registered location from which it was received. All
other activities conducted by a warehouse do not fall under this
exemption; a warehouse that distributes List I chemicals to persons
other than the registrant and registered location from which they were
obtained is conducting distribution activities and is required to
register as such (21 CFR 1309.23(b)(1)).
Importation. All persons importing ephedrine, pseudoephedrine, or
phenylpropanolamine, or drug products containing ephedrine,
pseudoephedrine, or phenylpropanolamine are required to comply with all
requirements regarding importation.
Records and Reports. The CSA (21 U.S.C. 830) requires certain
records to be kept and reports to be made involving listed chemicals.
Regulations describing recordkeeping and reporting requirements are set
forth in 21 CFR Part 1310. A record must be made and maintained for two
years after the date of a regulated transaction involving a List I
chemical. Each regulated bulk manufacturer of a regulated mixture must
submit manufacturing, inventory, and use data on an annual basis (21
CFR 1310.05(d)). Bulk manufacturers producing the chemicals solely for
internal consumption are not required to submit this information;
internal consumption does not include using the
[[Page 4978]]
chemical to produce drug products. Existing standard industry reports
containing the required information are acceptable, provided the
information is readily retrievable from the report.
Under 21 CFR 1310.05, regulated persons are required to report to
DEA any regulated transaction involving an extraordinary quantity, an
uncommon method of payment or delivery, or any other circumstance that
the regulated person believes may indicate that the listed chemical
will be used in violation of the CSA. Regulated persons are also
required to report to DEA any proposed regulated transaction with a
person whose description or other identifying information has been
furnished to the regulated person. Finally, regulated persons are
required to report any unusual or excessive loss or disappearance of a
listed chemical.
Security. All applicants and registrants must provide effective
controls against theft and diversion of chemicals as described in 21
CFR 1309.71.
Administrative Inspection. Places, including factories, warehouses,
or other establishments and conveyances, where regulated persons may
lawfully hold, manufacture, distribute, dispense, administer, or
otherwise dispose of ephedrine, pseudoephedrine, or
phenylpropanolamine, or products containing ephedrine, pseudoephedrine,
or phenylpropanolamine, or where records relating to those activities
are maintained, are controlled premises as defined in 21 CFR
1316.02(c). The CSA (21 U.S.C. 880) allows for administrative
inspections of these controlled premises as provided in 21 CFR Part
1316, Subpart A.
Section by Section Description of Final Rule Changes
DEA is revising the authority citation for 21 CFR part 1309 to add
21 U.S.C. 802, definitions, and 21 U.S.C. 952, importation of
controlled substances, to the authority for that part.
DEA is amending 21 CFR 1309.11 and 1309.12 to replace ``manufacture
for distribution'' with ``manufacture.'' In addition, in both sections,
DEA is removing references to retail distributors. In amendments to 21
U.S.C. 823(h) the CMEA expressly stated that distributors of scheduled
listed chemical products at retail are not required to register under
the CSA. To avoid confusion, DEA decided to address all registration
revisions related to CMEA implementation in this rulemaking.
Section 1309.21 is revised to state that every person who
manufactures or proposes to manufacture a List I chemical or a drug
product containing a List I chemical must register. The change requires
manufacturers of prescription drug products containing ephedrine,
pseudoephedrine, or phenylpropanolamine to register even though they
are not required to register to distribute or export the products. DEA
is also adding a table to the section, similar to the table in 21 CFR
1301.13 on controlled substance registration requirements, to summarize
the requirements for each business activity. As discussed above, this
revision does not alter the registration requirements for bulk
manufacturers of List I chemicals and for manufacturers of scheduled
listed chemical products.
Section 1309.22 is revised to remove retail distributing as a
registration activity and to add manufacturing. As explained above,
CMEA explicitly states that retail distributors of scheduled listed
chemical products are not required to register. DEA is also adding a
new paragraph to state that a person registered to manufacture a List I
chemical is authorized to distribute that chemical under the
manufacturing registration. The registrant may not distribute, under a
manufacturer's registration, any List I chemical that is not covered in
the manufacturing registration. This limitation parallels the existing
limitation for importers.
In 21 CFR 1309.24, paragraph (b) is revised to clarify that a
person who manufactures or distributes a scheduled listed chemical
product or other product containing a List I chemical that is described
and included in the definition of ``regulated transaction'' in 21 CFR
1300.02(b)(28)(i)(D) is exempted from registration only if registered
to conduct the same activity with controlled substances. Paragraph (c)
is revised to clarify that a person who imports or exports a scheduled
listed chemical product or other product containing a List I chemical
that is described and included in the definition of ``regulated
transaction'' in 21 CFR 1300.02(b)(28)(i)(D) is exempted from
registration only if registered to conduct the same activity with
controlled substances. Paragraph (e) waiving registration for retail
distributors is removed because CMEA statutorily does not require them
to register. The remaining paragraphs (f) through (l) are redesignated
as (e) through (k). DEA notes that the waiver of the requirement of
registration continues for bulk manufacturers who manufacture and
consume all of the List I chemical internally.
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Assistant Administrator hereby certifies that this
rulemaking has been drafted in accordance with the provisions of the
Regulatory Flexibility Act (5 U.S.C. 601-612). CMEA amended the CSA to
require production quotas for manufacturers handling the List I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. CMEA
also authorized the Attorney General, DEA by delegation, to establish
import quotas for ephedrine, pseudoephedrine, and phenylpropanolamine.
The CSA requires that quotas be issued to registrants. Were DEA not to
issue this rule, it would have no mechanism to permit the registration
of persons handling prescription drug products containing ephedrine,
pseudoephedrine, or phenylpropanolamine. If these persons were not
permitted to register, there would be no mechanism by which they would
be permitted to apply for production or import quotas. Therefore, these
persons would have no means by which to acquire the List I chemicals
ephedrine, pseudoephedrine, or phenylpropanolamine necessary for them
to conduct business.
This rule codifies provisions necessary for implementation of the
Combat Methamphetamine Epidemic Act. As discussed further below, DEA
has examined the potential impacts of this rule. DEA has no basis for
estimating the number of firms that may be small, but given the
definition of small entities, it is likely that a substantial number of
the new registrants will be small. The cost of compliance, however,
will not impose a significant economic burden. The only cost is the
$2,293 registration fee for manufacturers, and the $1,147 registration
fee for importers, respectively. The recordkeeping and reporting
requirements can be met using existing business and manufacturing
records. The security provisions are general and require the registrant
to provide effective controls and procedures to guard against theft and
diversion of List I chemicals. Any manufacturer approved by the FDA and
complying with good manufacturing practices or currently registered to
handle controlled substances will have internal controls that meet this
requirement. The smallest pharmaceutical firms (with 1 to 4 employees)
had an average value of shipments of $824,000 in 2002 ($886,000 in 2007
dollars, based on GDP). Even for these firms, which are unlikely to be
producing the covered drug products, the $2,293 registration
[[Page 4979]]
fee will represent less than 0.3 percent of sales and, therefore, is
not a significant burden. Therefore, this rule will not have a
significant economic impact on a substantial number of small entities.
Executive Order 12866
The Deputy Assistant Administrator further certifies that this
rulemaking has been drafted in accordance with the principles in
Executive Order 12866 Sec. 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 necessary to implement statutory provisions. DEA has,
nonetheless, reviewed the potential costs.
DEA has a limited basis for determining the number of manufacturers
of prescription drug products that will need to obtain a DEA
registration for the first time. DEA reviewed a list of pseudoephedrine
products and ephedrine prescription drug products and identified 230
firms based on their labeler codes. Of all firms identified, 164 do not
appear to be registered with DEA as manufacturers and 95 are not
registered as either manufacturers or controlled substance
distributors. The firms currently registered to manufacture controlled
substances may not manufacture List I chemical drugs at the same
locations. Seventy firms are currently registered as controlled
substance distributors. There may be some firms that import
prescription drug products that are not now registered to import either
controlled substances or List I chemicals. DEA estimates that
approximately 200 firms may have to obtain a new DEA registration. As
noted above, the only cost imposed by the rule is the registration fee
of $2,293 for the registration of each manufacturing location, and
$1,147 for each importing location. The total cost of these rule
changes will be less than $500,000. The cost to individual firms is
relatively small, compared with their revenues. The benefit of the rule
is that it will make it possible for DEA to meet the statutory mandate
to assess the annual need for the chemicals accurately and provide
manufacturers with the quotas they need to continue to produce drug
products containing the three chemicals. As DEA noted previously, the
CSA provides that quotas may only be issued to registrants. Were DEA
not to issue this rule, it would have no mechanism to permit the
registration of persons handling prescription drug products containing
ephedrine, pseudoephedrine, or phenylpropanolamine. If these persons
were not permitted to register, there would be no mechanism by which
they would be permitted to apply for production or import quotas.
Therefore, these persons would have no means by which to acquire the
List I chemicals ephedrine, pseudoephedrine, or phenylpropanolamine
necessary for them to conduct business.
Paperwork Reduction Act
This Final Rule requires that certain persons who were not
previously registered with DEA obtain a registration to handle the List
I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
Specifically, persons manufacturing prescription drug products
containing ephedrine, pseudoephedrine, or phenylpropanolamine were not
previously required to register, but now are required to obtain a
registration so that they may be eligible to apply for individual
quotas for these List I chemicals. Additionally, importers of
prescription drug products containing ephedrine, pseudoephedrine, or
phenylpropanolamine who were not previously registered as List I
chemical importers now are required to register so that they may be
eligible to apply for import quotas for ephedrine, pseudoephedrine, and
phenylpropanolamine. DEA estimates that approximately 200 firms will
have to obtain a new DEA registration. DEA assumes that these firms
will complete the registration application electronically, with each
application taking 15 minutes to complete. The receipt of these
additional applications increases the hour burden by 50 hours annually.
Therefore, DEA is revising an existing approved information collection,
``Application for Registration under Domestic Chemical Diversion
Control Act of 1993 and Renewal Application for Registration Under
Domestic Chemical Diversion Control Act of 1993'' (OMB 1117-
0031), to reflect the increase in population associated with this rule.
Further, DEA is amending the forms associated with the existing
approved information collection ``Application for Registration (DEA
Form 225) and Application for Registration Renewal (DEA Form 225a)''
(OMB 1117-0012) to include a listing of all List I chemicals
on the application forms. Currently, controlled substances registrant
applicants, who use these forms to apply for DEA registration, are not
required to identify the List I chemicals they handle. Without this
identification, it is not possible for these persons to apply for
individual quotas for these chemicals. The addition of the List I
chemicals will allow persons to identify which chemicals they handle.
New applicants are required to identify the List I chemicals they
handle upon their initial application; persons renewing their
registration will identify the chemicals at the time of their renewal.
This information must merely be verified for each succeeding renewal.
Thus, the addition of this list will not have a measurable effect on
the time needed to complete the application. Therefore, DEA is not
revising the collection itself, but rather is making changes only to
the application forms themselves.
The Department of Justice, Drug Enforcement Administration,
submitted an information collection request to the Office of Management
and Budget (OMB) for review and clearance in accordance with review
procedures of the Paperwork Reduction Act of 1995. The proposed
information collection was published in the NPRM to obtain comments
from the public and affected agencies. No comments were received.
Overview of Information Collection 1117-0031
(1) Type of information collection: Revision of an existing
collection.
(2) Title of form/collection: Application for Registration under
Domestic Chemical Diversion Control Act of 1993 and Renewal Application
for Registration Under Domestic Chemical Diversion Control Act of 1993.
(3) Agency form number, if any, and the applicable component of the
Department of Justice sponsoring the collection:
Form Number: DEA Forms 510 and 510a.
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: Not-for-profit, government agencies.
Abstract: The Domestic Chemical Diversion Control Act requires that
manufacturers, distributors, importers, and exporters of List I
chemicals which may be diverted in the United States for the production
of illicit drugs must register with DEA. Registration provides a system
to aid in the tracking of the distribution of List I chemicals.
(5) An estimate of the total number of respondents and the amount
of time estimated for an average respondent to respond: DEA estimates
that 1,805 persons respond to this collection annually. DEA estimates
that it takes 30
[[Page 4980]]
minutes for an average respondent to respond when completing the
application on paper, and 15 minutes for an average respondent to
respond when completing an application electronically. This application
is submitted annually.
(6) An estimate of the total public burden (in hours) associated
with the collection: DEA estimates that this collection has a public
burden of 612 hours annually.
----------------------------------------------------------------------------------------------------------------
Respondents Burden (hours) Total hour burden
----------------------------------------------------------------------------------------------------------------
DEA-510 (paper)...................................... 60 0.5 30
DEA-510 (electronic)................................. 325 0.25 81.25
DEA-510a (paper)..................................... 580 0.5 290
DEA-510a (electronic)................................ 840 0.25 210
������������������������������������������������������
Total............................................ 1,805 .................. 611.25
----------------------------------------------------------------------------------------------------------------
Executive Order 12988
This regulation meets the applicable standards set forth in 3(a)
and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
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. 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
$120,000,000 or more (adjusted for inflation) in any one year, and will
not significantly or uniquely affect small governments. Therefore, no
actions were deemed necessary under the provisions of the Unfunded
Mandates Reform Act of 1995.
Congressional Review Act
This rule is not a major rule as defined by section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996
(Congressional Review Act). This rule will not result in an annual
effect on the economy of $100,000,000 or more; 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 foreign-based companies
in domestic and export markets.
List of Subjects in 21 CFR Part 1309
Administrative practice and procedure; Drug traffic control;
Exports; Imports; Security measures.
0
For the reasons set out above, 21 CFR part 1309 is amended as follows:
PART 1309--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS
AND EXPORTERS OF LIST I CHEMICALS
0
1. The authority citation for part 1309 is revised to read as follows:
Authority: 21 U.S.C. 802, 821, 822, 823, 824, 830, 871(b), 875,
877, 886a, 952, 958.
0
2. Section 1309.11 is revised to read as follows:
Sec. 1309.11 Fee amounts.
(a) For each application for registration or reregistration to
manufacture the applicant shall pay an annual fee of $2,293.
(b) For each application for registration or reregistration to
distribute, import, or export a List I chemical, the applicant shall
pay an annual fee of $1,147.
0
3. Section 1309.12 is revised to read as follows:
Sec. 1309.12 Time and method of payment; refund.
(a) For each application for registration or reregistration to
manufacture, distribute, import, or export, the applicant shall pay the
fee when the application for registration or reregistration is
submitted for filing.
(b) Payments should be made in the form of a credit card; a
personal, certified, or cashier's check; or a money order made payable
to ``Drug Enforcement Administration.'' Payments made in the form of
stamps, foreign currency, or third party endorsed checks will not be
accepted. These application fees are not refundable.
0
4. Section 1309.21 is revised to read as follows:
Sec. 1309.21 Persons required to register.
(a) Unless exempted by law or under Sec. Sec. 1309.24 through
1309.26 or Sec. Sec. 1310.12 through 1310.13 of this chapter, the
following persons must annually obtain a registration specific to the
List I chemicals to be handled:
(1) Every person who manufactures or imports or proposes to
manufacture or import a List I chemical or a drug product containing
ephedrine, pseudoephedrine, or phenylpropanolamine.
(2) Every person who distributes or exports or proposes to
distribute or export any List I chemical, other than those List I
chemicals contained in a product exempted under Sec.
1300.02(b)(28)(i)(D) of this chapter.
(b) Only persons actually engaged in the activities are required to
obtain a registration; related or affiliated persons who are not
engaged in the activities are not required to be registered. (For
example, a stockholder or parent corporation of a corporation
distributing List I chemicals is not required to obtain a
registration.)
(c) The registration requirements are summarized in the following
table:
Summary of Registration Requirements and Limitations
----------------------------------------------------------------------------------------------------------------
Coincident
Business activity Chemicals DEA forms Application fee Registration activities
period (years) allowed
----------------------------------------------------------------------------------------------------------------
Manufacturing........ List I, Drug New--510............ $2,293 1 May distribute
products Renewal--510a....... 2,293 that chemical
containing for which
ephedrine, registration
pseudoephedrine was issued;
, may not
phenylpropanola distribute any
mine. chemical for
which not
registered.
[[Page 4981]]
Distributing......... List I, New--510............ 1,147 1 ...............
Scheduled Renewal--510a....... 1,147
listed chemical
products.
Importing............ List I, Drug New--510............ 1,147 1 May distribute
Products Renewal--510a....... 1,147 that chemical
containing for which
ephedrine, registration
pseudoephedrine was issued;
, may not
phenylpropanola distribute any
mine. chemical for
which not
registered.
Exporting............ List I, New--510............ 1,147 1 ...............
Scheduled Renewal--510a....... 1,147
listed chemical
products.
----------------------------------------------------------------------------------------------------------------
0
5. Section 1309.22 is revised to read as follows:
Sec. 1309.22 Separate registration for independent activities.
(a) The following groups of activities are deemed to be independent
of each other:
(1) Manufacturing of List I chemicals or drug products containing
ephedrine, pseudoephedrine, or phenylpropanolamine.
(2) Distributing of List I chemicals and scheduled listed chemical
products.
(3) Importing List I chemicals or drug products containing
ephedrine, pseudoephedrine, or phenylpropanolamine.
(4) Exporting List I chemicals and scheduled listed chemical
products.
(b) Except as provided in paragraphs (c) and (d) of this section,
every person who engages in more than one group of independent
activities must obtain a separate registration for each group of
activities, unless otherwise exempted by the Act or Sec. Sec. 1309.24
through 1309.26.
(c) A person registered to import any List I chemical shall be
authorized to distribute that List I chemical after importation, but no
other chemical that the person is not registered to import.
(d) A person registered to manufacture any List I chemical shall be
authorized to distribute that List I chemical after manufacture, but no
other chemical that the person is not registered to manufacture.
0
6. In Sec. 1309.23, paragraph (a) is revised to read as follows:
Sec. 1309.23 Separate registration for separate locations.
(a) A separate registration is required for each principal place of
business at one general physical location where List I chemicals are
manufactured, distributed, imported, or exported by a person.
* * * * *
0
7. Section 1309.24 is revised to read as follows:
Sec. 1309.24 Waiver of registration requirement for certain
activities.
(a) The requirement of registration is waived for any agent or
employee of a person who is registered to engage in any group of
independent activities, if the agent or employee is acting in the usual
course of his or her business or employment.
(b) The requirement of registration is waived for any person who
manufactures or distributes a scheduled listed chemical product or
other product containing a List I chemical that is described and
included in the definition of ``regulated transaction'' in Sec.
1300.02(b)(28)(i)(D) of this chapter, if that person is registered with
the Administration to engage in the same activity with a controlled
substance.
(c) The requirement of registration is waived for any person who
imports or exports a scheduled listed chemical product or other product
containing a List I chemical that is described and included in the
definition of ``regulated transaction'' in Sec. 1300.02(b)(28)(i)(D)
of this chapter, if that person is registered with the Administration
to engage in the same activity with a controlled substance.
(d) The requirement of registration is waived for any person who
only distributes a prescription drug product containing a List I
chemical that is regulated pursuant to Sec. 1300.02(b)(28)(i)(D) of
this chapter.
(e) The requirement of registration is waived for any person whose
activities with respect to List I chemicals are limited to the
distribution of red phosphorus, white phosphorus, or hypophosphorous
acid (and its salts) to another location operated by the same firm
solely for internal end-use, or an EPA or State licensed waste
treatment or disposal firm for the purpose of waste disposal.
(f) The requirement of registration is waived for any person whose
distribution of red phosphorus or white phosphorus is limited solely to
residual quantities of chemical returned to the producer, in reusable
rail cars and intermodal tank containers which conform to International
Standards Organization specifications (with capacities greater than or
equal to 2,500 gallons in a single container).
(g) The requirement of registration is waived for any person whose
activities with respect to List I chemicals are limited solely to the
distribution of Lugol's Solution (consisting of 5 percent iodine and 10
percent potassium iodide in an aqueous solution) in original
manufacturer's packaging of one fluid ounce (30 ml) or less.
(h) The requirement of registration is waived for any manufacturer
of a List I chemical, if that chemical is produced solely for internal
consumption by the manufacturer and there is no subsequent distribution
or exportation of the List I chemical.
(i) If any person exempted under paragraph (b), (c), (d), (e), or
(f) of this section also engages in the distribution, importation, or
exportation of a List I chemical, other than as described in such
paragraph, the person shall obtain a registration for the activities,
as required by Sec. 1309.21.
(j) The Administrator may, upon finding that continuation of the
waiver would not be in the public interest, suspend or revoke a waiver
granted under paragraph (b), (c), (d), (e), or (f) of this section
pursuant to the procedures set forth in Sec. Sec. 1309.43 through
1309.46 and Sec. Sec. 1309.51 through 1309.55. In considering the
revocation or suspension of a person's waiver granted pursuant to
paragr
