Registration Requirements for Importers and Manufacturers of Prescription Drug Products Containing Ephedrine, Pseudoephedrine, or Phenylpropanolamine, 3432-3441 [E8-774]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 73, Number 13 (Friday, January 18, 2008)]
[Proposed Rules]
[Pages 3432-3441]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-774]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1309

[Docket No. DEA-294P]
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: Notice of proposed rulemaking.

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SUMMARY: The Combat Methamphetamine Epidemic Act of 2005 (CMEA), which 
was enacted on March 9, 2006, requires DEA to establish an assessment 
of annual need for the importation and manufacture of ephedrine, 
pseudoephedrine, and phenylpropanolamine. Because of the new CMEA 
mandates for importation, import quotas, and production quotas for 
these chemicals, DEA must revise its registration provisions. 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 the 
Controlled Substances Act, section 826, production quotas are available 
only to registered manufacturers. DEA cannot meet the CMEA mandate to 
establish annual need and import quotas, and then issue individual 
quotas for each of the chemicals unless all manufacturers 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 these 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.
    Second, persons currently registered to import, distribute, or 
dispense controlled substances who manufacture drug products using 
ephedrine, pseudoephedrine, or phenylpropanolamine, are not necessarily 
registered to do so. This must also be changed so that controlled 
substance registrants will only receive a waiver from the requirement 
of separate chemical registration if they engage in the same activity 
for both lawfully marketed 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.
    Were DEA not to issue this rule, it would have no mechanism to 
issue production or import quotas for persons handling prescription 
drug products containing ephedrine, pseudoephedrine, or 
phenylpropanolamine. If these persons were not required 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.
    Accordingly, DEA is proposing to amend its registration regulations 
to ensure that every location that manufactures or imports one of these 
chemicals or drug products that contain ephedrine, pseudoephedrine, or 
phenylpropanolamine is a DEA registered manufacturer or importer. These 
amendments will make it possible to establish the system of quotas and 
assessment of annual needs for the manufacturing that Congress

[[Page 3433]]

mandated for ephedrine, pseudoephedrine, and phenylpropanolamine.

DATES: Written comments must be postmarked, and electronic comments 
must be sent, on or before March 18, 2008.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-204'' on all written and electronic correspondence. 
Written comments being sent via regular mail should be sent to the 
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration, Washington, DC 20537, Attention: DEA 
Federal Register Representative/ODL. Written comments sent via express 
mail should be sent to DEA Headquarters, Attention: DEA Federal 
Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, 
VA 22301. Comments may be directly sent to DEA electronically by 
sending an electronic message to dea.diversion.policy@usdoj.gov. 
Comments may also be sent electronically through https://
www.regulations.gov using the electronic comment form provided on that 
site. An electronic copy of this document is also available at the 
https://www.regulations.gov Web site. DEA will accept attachments to 
electronic comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel 
file formats only. DEA will not accept any file formats other than 
those specifically listed here.
    Posting of Public Comments: Please note that all comments received 
are considered part of the public record and made available for public 
inspection online at https://www.regulations.gov and in the Drug 
Enforcement Administration's public docket. Such information includes 
personal identifying information (such as your name, address, etc.) 
voluntarily submitted by the commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph of your comment. You must 
also prominently identify confidential business information to be 
redacted within the comment. If a comment has so much confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be posted online or made available in the 
public docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted 
and the comment, in redacted form, will be posted online and placed in 
the Drug Enforcement Administration's public docket file. If you wish 
to inspect the agency's public docket file in person by appointment, 
please see the FOR FURTHER INFORMATION CONTACT paragraph.

FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington DC 20537 at (202) 307-7297.

SUPPLEMENTARY INFORMATION: 

DEA's Legal Authority

    DEA implements the Comprehensive Drug Abuse Prevention and Control 
Act of 1970, often referred to as the Controlled Substances Act (CSA) 
and the Controlled Substances Import and Export Act (21 U.S.C. 801-
971), as amended. DEA publishes the implementing regulations for these 
statutes in Title 21 of the Code of Federal Regulations (CFR), Parts 
1300 to 1399. These regulations are designed to ensure that there is a 
sufficient supply of controlled substances for legitimate medical, 
scientific, 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. Those classified as List II 
chemicals may be used to manufacture controlled substances.
    On March 9, 2006, the President signed the Combat Methamphetamine 
Epidemic Act of 2005 (CMEA), which is Title VII of the USA PATRIOT 
Improvement and Reauthorization Act of 2005 (Pub. L. 109-177). 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 section 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.
    Controlled substances are subject to a closed system of controls 
that ensures that no person may manufacture, distribute, import, 
export, or dispense unless that person is a DEA registrant, or exempted 
from the requirement of registration. Production of Schedule I and II 
controlled substances is limited to the quantity that DEA has 
determined is required to meet the legitimate medical, scientific, 
research, and industrial needs of the United States; for

[[Page 3434]]

lawful export requirements; and for establishment and maintenance of 
reserve stocks (21 U.S.C. 826(a)). After DEA establishes the total 
annual need, DEA issues individual manufacturing and procurement quotas 
to manufacturers; under section 826, quotas may be issued only to 
registered manufacturers. Manufacturers may not produce or purchase 
more of a substance than is available under their individual quotas. 
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.
    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 the ability to suspend a proposed import under 21 U.S.C. 971 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, although at least one company in the United 
States manufactures the chemicals in bulk. The three chemicals 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 under the FFD&CA). 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. DEA has regulated the distribution, import, and 
export of scheduled listed chemical products.
    DEA, in 1995, first imposed registration requirements on firms that 
manufacture, distribute, import, and export List I chemicals. Although 
section 822 of the CSA states that any person who manufactures or 
distributes a controlled substance or List I chemical must register 
with DEA, DEA limited chemical registration for manufacturers to firms 
that manufacture to distribute List I chemicals. Some manufacturers 
were not required to register under the ``manufacture for 
distribution'' policy. Those that manufactured and chemically consumed 
and transformed all of the chemical in their own processes; those that 
purchased List I chemicals in bulk and manufactured prescription drug 
products that contain a List I chemical; and those that repackaged or 
relabeled prescription drug products that contain a List I chemical 
were not required to obtain a DEA chemical registration. Firms that 
manufacture a List I chemical in bulk and distribute to wholesalers or 
to other manufacturers were already required to register and file 
reports with DEA. Firms that manufacture scheduled listed chemical 
products (nonprescription/OTC drug products containing ephedrine, 
pseudoephedrine, or phenylpropanolamine) also distribute those 
products, were already required to obtain a DEA chemical registration.
    As a consequence of the ``manufacture for distribution'' policy, 
firms that manufactured prescription drugs containing ephedrine, 
pseudoephedrine, and phenylpropanolamine were not required to register 
because distributions of the prescription drug products were not 
regulated. DEA, in Sec.  1309.22, listed only four activities involving 
List I chemicals that required registration: Retail distributing, non-
retail distributing, importing, and exporting. On the application for 
registration form, firms were required to indicate whether they were 
seeking to be registered as manufacturers or distributors (e.g., 
wholesalers), but the regulation did not distinguish between those who 
manufacture to distribute and those who simply distribute. In addition, 
in Sec.  1309.24, DEA waived the chemical distribution registration 
requirement for firms that manufacture or distribute drug products 
lawfully marketed under the FFD&CA containing the three chemicals for 
any firm that is registered to manufacture, distribute, or dispense a 
controlled substance. Note that this waiver (from the requirement to 
obtain a separate DEA chemical registration) was only provided for drug 
products containing a listed chemical which is in final packaged/
labeled form which is lawfully marketed under the FFD&CA. Drug products 
not in final packaged/labeled form were not provided this waiver. For 
example, an importer of bulk tablets containing a listed chemical, 
intended for a drug product marketed in the United States, would still 
have to obtain a chemical importer registration, and would not be able 
to use their controlled substance registration for such activity.
    The waiver does not apply in the reverse; a firm that handles 
controlled substances must register for the applicable controlled 
substance activity even if it is already registered to conduct the same 
activity with List I chemicals.
    As a consequence of these decisions, 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 they do not handle controlled substances and the 
only products they 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 they are registered as controlled substance 
distributors or dispensers, they 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.
    Because of the new CMEA mandates for importation, import quotas, 
and production quotas for these chemicals, DEA is proposing to revise 
its registration provisions. 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 the CSA section 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 manufacturers 
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

[[Page 3435]]

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 they manufacture scheduled listed chemical 
products or other products containing a List I chemical that is 
described and included in the definition of ``regulated transaction'' 
in Sec.  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.) This provision must also be 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 will require some manufacturers and 
locations to register that had not previously been subject to DEA 
regulations; other registrants will be required to obtain separate 
registrations for chemicals and controlled substances. The proposed 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

    As noted above, 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)).
    If this rule is finalized as proposed, 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, would 
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 handled. If a person 
manufactures controlled substances at one location and drug products 
containing ephedrine, pseudoephedrine, or phenylpropanolamine at 
another location, the person would be required to obtain a separate 
registration for each location. Under the waiver previously described 
in this rulemaking, persons who are currently registered as controlled 
substances manufacturers at a location where drug products containing 
these List I chemicals are also manufactured would 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 would cover both the manufacturing of controlled 
substances and drug products containing ephedrine, pseudoephedrine, or 
phenylpropanolamine, at that location. Controlled substances 
manufacturers would, 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, 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 
would need to obtain a List I chemical manufacturing registration for 
the location. The following table indicates the changes in registration 
requirements being proposed for various business activities.

------------------------------------------------------------------------
                Current                              Proposed
------------------------------------------------------------------------
            Chemical Manufacturers (No Controlled Substances)
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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 register if            products containing List I
 distribute.                              chemicals * would 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
 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
 register.                                containing List I chemicals *
Importers of prescription products **     would register.
 containing List I chemicals do not
 register..

[[Page 3436]]

 
Exporters of List I chemicals and        No change.
 scheduled listed chemical products
 register.
Exporters of prescription products **
 containing List I chemicals do not
 register..
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    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 drug products
 containing any List I chemical * who     containing any List I chemical
 distribute or dispense controlled        * would register as
 substances may register for only their   manufacturers. If they
 controlled substance activity. A         distribute or dispense
 separate registration for the chemical   controlled substances they
 activity is permissible.                 would register separately for
                                          those activities.
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 register as controlled
 substance importers.
Exporters of both controlled substances  No change.
 and drug products containing List I
 chemicals 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
 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 Sec.   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 chart, 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 Federal Food, Drug, and Cosmetic Act for
  prescription drugs, such drugs must be packaged and labeled in
  accordance with the Federal Food, Drug and Cosmetic Act as
  prescription drugs.

Proposed Requirements of This Rule

    DEA is proposing that a person who manufactures or imports a 
prescription drug product containing ephedrine, pseudoephedrine, or 
phenylpropanolamine would be required to comply with the following:
    Registration. Any person who manufactures or imports a drug product 
containing ephedrine, pseudoephedrine, or phenylpropanolamine, or 
proposes to engage in the manufacture or importation of a drug product 
containing ephedrine, pseudoephedrine, or phenylpropanolamine, would be 
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, 
distribution, 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 would become subject to the registration 
requirement under the CSA. DEA recognizes, however, that it is not 
possible for persons who would be 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 proposing to 
establish in Sec.  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 30 days 
from the date of publication of a Final Rule in the Federal Register. 
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.
    Importation. All persons importing ephedrine, pseudoephedrine, or 
phenylpropanolamine, or drug products containing ephedrine, 
pseudoephedrine, or phenylpropanolamine would be 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

[[Page 3437]]

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 
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 
causes the regulated person to believe 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 Analysis of Proposed Rule Changes

    DEA is proposing to amend Sec. Sec.  1309.11 and 1309.12 to replace 
``manufacture for distribution'' with ``manufacture.'' In addition, in 
both sections, DEA is proposing to remove 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 Controlled Substances 
Act. To avoid confusion, DEA decided to address all registration 
revisions related to CMEA implementation in this rulemaking.
    Section 1309.21 is proposed to be 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 
would require 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 proposing to add a table to the section, similar 
to the table in Sec.  1301.13 on controlled substance registration 
requirements, to summarize the requirements for each business activity. 
As discussed above, this revision would not alter the registration 
requirements for bulk manufacturers of List I chemicals and for 
manufacturers of scheduled listed chemical products.
    Section 1309.22 is proposed to be 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 proposing to add 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 Sec.  1309.24 paragraph (b) is proposed to be 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 Sec.  1300.02(b)(28)(i)(D) is exempted from registration only if 
registered to conduct the same activity with controlled substances. 
Paragraph (c) is proposed to be 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 Sec.  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 proposed to be removed because CMEA 
statutorily does not require them to register. The remaining paragraphs 
(f) through (l) would be redesignated (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). The Combat 
Methamphetamine Epidemic Act of 2005 amended the Controlled Substances 
Act 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 Controlled Substances Act 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 proposes to codify 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, would 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 and diversion of List I chemicals. Any

[[Page 3438]]

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 fee would 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 section 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 discussed throughout 
this rulemaking, the Controlled Substances Act 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 Notice of Proposed Rulemaking would require 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 
would be 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 would be 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 may have to obtain a new DEA registration. DEA 
assumes that these firms 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 proposing to revise 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 proposing to amend 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 would be 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 proposing to revise the collection itself, but 
rather is proposing to make changes only to the application forms 
themselves.
    The Department of Justice, Drug Enforcement Administration, has 
submitted the following 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 is published to obtain comments from the public 
and affected agencies.
    All comments and suggestions, or questions regarding additional 
information, to include obtaining a copy of the proposed information 
collection instrument with instructions, should be directed to Mark W. 
Caverly, Chief, Liaison and Policy Section, Office of Diversion 
Control, Drug Enforcement Administration, Washington, DC 20537.
    Written comments and suggestions from the public and affected 
agencies concerning the information collection-related aspects of this 
rule are encouraged. Your comments should address one or more of the 
following four points:
    (1) Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information,

[[Page 3439]]

including the validity of the methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submission of responses.

Overview of 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 2,776 persons respond to this collection annually. DEA estimates 
that it takes 30 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 927 hours annually.

------------------------------------------------------------------------
                                                Number of   Total burden
                     Form                      respondents      hours
------------------------------------------------------------------------
DEA-510 (paper)..............................          286         143
DEA-510 (electronic).........................          478         119.5
DEA-510a (paper).............................          644         322
DEA-510a (electronic)........................        1,368         342
                                              --------------------------
    Total....................................        2,776         926.5
------------------------------------------------------------------------

    If additional information is required, contact: Lynn Bryant, 
Department Clearance Officer, Information Management and Security 
Staff, Justice Management Division, Department of Justice, Patrick 
Henry Building, Suite 1600, 601 D Street, NW., Washington, DC 20530.

Executive Order 12988

    This regulation meets the applicable standards set forth in 
Sec. Sec.  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.

    For the reasons set out above, 21 CFR part 1309 is proposed to be 
amended as follows:

PART 1309--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS 
AND EXPORTERS OF LIST I CHEMICALS

    1. The authority citation for part 1309 continues to read as 
follows:

    Authority: 21 U.S.C. 821, 822, 823, 824, 830, 871(b), 875, 877, 
886a, 958.

    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.
    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.
    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, 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

[[Page 3440]]

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    Registration      activities
                                                                       fee       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
                                pseudoephedrin                                                    was issued;
                                e,                                                                may not
                                phenylpropanol                                                    distribute any
                                amine.                                                            chemical for
                                                                                                  which not
                                                                                                  registered.
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
                                pseudoephedrin                                                    was issued;
                                e,                                                                may not
                                phenylpropanol                                                    distribute any
                                amine.                                                            chemical for
                                                                                                  which not
                                                                                                  registered.
Exporting....................  List I,          New--510.......           1,147               1
                                Scheduled       Renewal--510a..           1,147
                                listed
                                chemical
                                products.
----------------------------------------------------------------------------------------------------------------

    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.
    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.
* * * * *
    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), 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), 
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 of this part.

[[Page 3441]]

    (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 of this part. 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 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 
Sec. Sec.  1309.71 through 1309.73 of this part and the recordkeeping 
and reporting requirements set forth under parts 1310 and 1313 of this 
chapter.
    8. Section 1309.25 is amended by adding a new paragraph (c) to read 
as follows:


Sec.  1309.25  Temporary exemption from registration for chemical 
registration applicants.

* * * * *
    (c) Each person required by section 302 of the Act (21 U.S.C. 822) 
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 [DATE 30 DAYS AFTER PUBLICATION OF A FINAL RULE IN THE Federal 
Register]. The exemption will remain in effect for each person who has 
made such application until DEA 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 11, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. E8-774 Filed 1-17-08; 8:45 am]
BILLING CODE 4410-09-P