[Federal Register Volume 75, Number 20 (Monday, February 1, 2010)]
[Rules and Regulations]
[Pages 4973-4982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-1968]



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  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
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
    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 
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 
Sec. Sec.  1309.71 through 1309.73 and the recordkeeping and reporting 
requirements set forth under Parts 1310, 1313, 1314, and 1315 of this 
chapter.

[[Page 4982]]


0
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 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