This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

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REGISTER issue of each week.

Rules and Regulations Federal Register

4973 

Vol. 75, No. 20 

Monday, February 1, 2010 

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 nonVerDate Nov<24>2008 16:55 Jan 29, 2010 Jkt 220001 PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 E:\FR\FM\01FER1.SGM 01FER1

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4974 Federal Register / Vol. 75, No. 20 / Monday, February 1, 2010 / Rules and Regulations 

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, 


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Federal Register / Vol. 75, No. 20 / Monday, February 1, 2010 / Rules and Regulations 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 chemicals must register unless all of the 

chemical produced is consumed internally and is not available for 

use in products.

No change. 

Manufacturers of scheduled listed chemical products must register if 

they also distribute.

All manufacturers of drug products containing List I chemicals * must 

register. 

Manufacturers of prescription products ** containing List I chemicals do 

not register 

Chemical Distributors 

Distributors of List I chemicals and scheduled listed chemical products 

must register.

No change. 

Distributors of prescription products ** containing List I chemicals do 

not register 

Chemical Importers and Exporters 

Importers of List I chemicals and scheduled listed chemical products 

must register.

Importers of List I chemicals and all drug products 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 scheduled listed chemical products 

must register.

No change. 

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 substances and drug products containing List I chemicals may register as only controlled substance 

manufacturers.

No change. 

Manufacturers of drug products containing any List I chemical * who 

distribute or dispense controlled substances may register for only 

their controlled substance activity. A separate registration for the 

chemical activity is permissible.

Manufacturers of controlled substances and drug products containing 

any List I chemical * must register as controlled substances manufacturers. If they manufacture drug products containing any List I chemical * and only distribute or dispense controlled substances at the 

same location, they must register separately for each activity. 

Distributors of both controlled substances and drug products containing 

List I chemicals may register as only controlled substance distributors.

No change. 

Importers/Exporters of Controlled Substances and Drug Products Containing List I Chemicals 

Importers of both controlled substances and drug products containing 

List I chemicals must register as controlled substance importers.

No change. 

Exporters of both controlled substances and drug products containing 

List I chemicals must register as controlled substance exporters.

No change. 

Manufacturers, Distributors, Importers, and Exporters of Bulk List I Chemicals 

Manufacturers, distributors, importers, and exporters of bulk List I 

chemicals must register, regardless of whether they handle controlled substances.

No change. 

*‘‘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 


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4976 Federal Register / Vol. 75, No. 20 / Monday, February 1, 2010 / Rules and Regulations 

1Prior to the proposed revision, 21 CFR 

1309.24(c) stated: ‘‘The requirement of registration 

is waived for any person who imports or exports a 

product containing a List I chemical that is 

regulated pursuant to § 1300.02(b)(28)(i)(D), if that 

person is registered with the Administration to 

engage in the same activity with a controlled 

substance.’’ The revision DEA proposed sought 

merely to provide specificity regarding those 

products regulated pursuant to 21 CFR 

1300.02(b)(28)(i)(D) and did not change the 

requirements regarding to whom the waiver of the 

requirement of registration applied. 

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 

§ 1300.02(b)(28)(i)(D), if that person is 

registered with the Administration to engage 

in the same activity with a controlled 

substance.1

The definition of ‘‘regulated 

transaction’’ describes the following: 

‘‘Any transaction in a listed chemical 

that is contained in a drug other than a 

scheduled listed chemical product that 

may be marketed or distributed lawfully 

in the United States under the Federal 

Food, Drug, and Cosmetic Act, * * *’’ 

(21 U.S.C. 802(39)(A)(iv), 21 CFR 

1300.02(b)(28)(i)(D)). 

A scheduled listed chemical product 

is defined as a product that contains 

ephedrine, pseudoephedrine, or 

phenylpropanolamine that may be 

marketed or distributed lawfully in the 

United States under the FFD&CA as a 

nonprescription drug (21 U.S.C. 

802(45)(A), 21 CFR 1300.02(b)(34)(i))). 

As discussed previously, for a drug to 

be ‘‘marketed or distributed lawfully in 

the United States under the Federal 

Food, Drug, and Cosmetic Act,’’ such 

drug product must be in packaged/ 

labeled form as required under the 

FFD&CA. Thus, regardless of whether 

the product being imported or exported 

is a scheduled listed chemical product 

or another drug product containing a 

List I chemical, for a person to use the 

waiver granted in 21 CFR 1309.24(c) to 

import a drug containing a List I 

chemical, that drug must be in a 

packaged/labeled form in compliance 

with the marketing and distribution 

requirements of the FFD&CA. 

Thus, the waiver pertains only to 

those products which are fully 

formulated and packaged pursuant to 

the FFD&CA, not to the importation of 

bulk chemical, which would include 

any product not fully formulated, 

packaged, and labeled as required to 

meet the terms of the waiver, as well as 

any chemical in an unfinished form 

(e.g., bulk powder, bulk liquid). DEA 

questions whether any person 

conducting research or chemical 

analysis involving a List I chemical or 

a product containing a List I chemical 

would choose to import a product 

meeting the marketing/distribution 

requirements of the FFD&CA. As has 

been discussed previously, if a person 

were to import a List I chemical, or a 

product containing a List I chemical, 

which did not meet the criteria for 

lawful distribution or marketing under 

the FFD&CA, then that person would be 

required to obtain a separate registration 

as a chemical importer to conduct the 

importation. 

The commenter appears to believe 

that controlled substances research and 

chemical analysis registrants are 

permitted to import List I chemicals 

based on their controlled substance 

research or chemical analysis 

registration. For Schedule I researchers, 

the regulations provide the following 

regarding coincident activities: ‘‘A 

researcher may manufacture or import 

the basic class of substance or 

substances for which registration was 

issued, provided that such manufacture 

or import is set forth in the protocol 

required in § 1301.18 * * *’’ (21 CFR 

1301.13(e)(1)(v)). That coincident 

activity clearly limits the importation 

authority only to those controlled 

substances set forth in the researcher 

protocol, and does not grant any 

authority related to importation of List 

I chemicals for any purpose, including 

research. Thus, a Schedule I researcher 

would be required to obtain a separate 

chemical importer registration to import 

any List I chemical for any purpose, 

regardless of whether that chemical was 

lawfully marketed or distributed under 

the FFD&CA. 

For Schedule II–V researchers, the 

regulations provide the following 

regarding coincident activities: ‘‘May 


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Federal Register / Vol. 75, No. 20 / Monday, February 1, 2010 / Rules and Regulations 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 

§ 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 

§ 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 


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chemical to produce drug products. 

Existing standard industry reports 

containing the required information are 

acceptable, provided the information is 

readily retrievable from the report. 

Under 21 CFR 1310.05, regulated 

persons are required to report to DEA 

any regulated transaction involving an 

extraordinary quantity, an uncommon 

method of payment or delivery, or any 

other circumstance that the regulated 

person believes may indicate that the 

listed chemical will be used in violation 

of the CSA. Regulated persons are also 

required to report to DEA any proposed 

regulated transaction with a person 

whose description or other identifying 

information has been furnished to the 

regulated person. Finally, regulated 

persons are required to report any 

unusual or excessive loss or 

disappearance of a listed chemical. 

Security. All applicants and 

registrants must provide effective 

controls against theft and diversion of 

chemicals as described in 21 CFR 

1309.71. 

Administrative Inspection. Places, 

including factories, warehouses, or 

other establishments and conveyances, 

where regulated persons may lawfully 

hold, manufacture, distribute, dispense, 

administer, or otherwise dispose of 

ephedrine, pseudoephedrine, or 

phenylpropanolamine, or products 

containing ephedrine, pseudoephedrine, 

or phenylpropanolamine, or where 

records relating to those activities are 

maintained, are controlled premises as 

defined in 21 CFR 1316.02(c). The CSA 

(21 U.S.C. 880) allows for administrative 

inspections of these controlled premises 

as provided in 21 CFR Part 1316, 

Subpart A. 

Section by Section Description of Final 

Rule Changes 

DEA is revising the authority citation 

for 21 CFR part 1309 to add 21 U.S.C. 

802, definitions, and 21 U.S.C. 952, 

importation of controlled substances, to 

the authority for that part. 

DEA is amending 21 CFR 1309.11 and 

1309.12 to replace ‘‘manufacture for 

distribution’’ with ‘‘manufacture.’’ In 

addition, in both sections, DEA is 

removing references to retail 

distributors. In amendments to 21 

U.S.C. 823(h) the CMEA expressly 

stated that distributors of scheduled 

listed chemical products at retail are not 

required to register under the CSA. To 

avoid confusion, DEA decided to 

address all registration revisions related 

to CMEA implementation in this 

rulemaking. 

Section 1309.21 is revised to state that 

every person who manufactures or 

proposes to manufacture a List I 

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 


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Federal Register / Vol. 75, No. 20 / Monday, February 1, 2010 / Rules and Regulations 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 

§ 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 


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4980 Federal Register / Vol. 75, No. 20 / Monday, February 1, 2010 / Rules and Regulations 

minutes for an average respondent to 

respond when completing the 

application on paper, and 15 minutes 

for an average respondent to respond 

when completing an application 

electronically. This application is 

submitted annually. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: DEA estimates that this 

collection has a public burden of 612 

hours annually. 

Respondents Burden (hours) Total hour burden 

DEA–510 (paper) ................................................................................................... 60 0 .5 30 

DEA–510 (electronic) ............................................................................................. 325 0 .25 81 .25 

DEA–510a (paper) ................................................................................................. 580 0 .5 290 

DEA–510a (electronic) ........................................................................................... 840 0 .25 210 

Total ................................................................................................................ 1,805 ................................ 611 .25 

Executive Order 12988 

This regulation meets the applicable 

standards set forth in 3(a) and 3(b)(2) of 

Executive Order 12988 Civil Justice 

Reform. 

Executive Order 13132 

This rulemaking does not impose 

enforcement responsibilities on any 

State; nor does it diminish the power of 

any State to enforce its own laws. 

Accordingly, this rulemaking does not 

have federalism implications warranting 

the application of Executive Order 

13132. 

Unfunded Mandates Reform Act of 1995 

This rule will not result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $120,000,000 or more 

(adjusted for inflation) in any one year, 

and will not significantly or uniquely 

affect small governments. Therefore, no 

actions were deemed necessary under 

the provisions of the Unfunded 

Mandates Reform Act of 1995. 

Congressional Review Act 

This rule is not a major rule as 

defined by section 804 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Congressional 

Review Act). This rule will not result in 

an annual effect on the economy of 

$100,000,000 or more; a major increase 

in costs or prices; or significant adverse 

effects on competition, employment, 

investment, productivity, innovation, or 

on the ability of United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. 

List of Subjects in 21 CFR Part 1309 

Administrative practice and 

procedure; Drug traffic control; Exports; 

Imports; Security measures. 

■ For the reasons set out above, 21 CFR 

part 1309 is amended as follows: 

PART 1309—REGISTRATION OF 

MANUFACTURERS, DISTRIBUTORS, 

IMPORTERS AND EXPORTERS OF 

LIST I CHEMICALS 

■ 1. The authority citation for part 1309 

is revised to read as follows: 

Authority: 21 U.S.C. 802, 821, 822, 823, 

824, 830, 871(b), 875, 877, 886a, 952, 958. 

■ 2. Section 1309.11 is revised to read 

as follows: 

§ 1309.11 Fee amounts. 

(a) For each application for 

registration or reregistration to 

manufacture the applicant shall pay an 

annual fee of $2,293. 

(b) For each application for 

registration or reregistration to 

distribute, import, or export a List I 

chemical, the applicant shall pay an 

annual fee of $1,147. 

■ 3. Section 1309.12 is revised to read 

as follows: 

§ 1309.12 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: 

§ 1309.21 Persons required to register. 

(a) Unless exempted by law or under 

§§ 1309.24 through 1309.26 or 

§§ 1310.12 through 1310.13 of this 

chapter, the following persons must 

annually obtain a registration specific to 

the List I chemicals to be handled: 

(1) Every person who manufactures or 

imports or proposes to manufacture or 

import a List I chemical or a drug 

product containing ephedrine, 

pseudoephedrine, or 

phenylpropanolamine. 

(2) Every person who distributes or 

exports or proposes to distribute or 

export any List I chemical, other than 

those List I chemicals contained in a 

product exempted under 

§ 1300.02(b)(28)(i)(D) of this chapter. 

(b) Only persons actually engaged in 

the activities are required to obtain a 

registration; related or affiliated persons 

who are not engaged in the activities are 

not required to be registered. (For 

example, a stockholder or parent 

corporation of a corporation distributing 

List I chemicals is not required to obtain 

a registration.) 

(c) The registration requirements are 

summarized in the following table: 

SUMMARY OF REGISTRATION REQUIREMENTS AND LIMITATIONS

Business activity Chemicals DEA forms Application fee 

Registration 

period 

(years) 

Coincident activities allowed 

Manufacturing ... List I, Drug products containing 

ephedrine, pseudoephedrine, 

phenylpropanolamine.

New—510 .........

Renewal—510a 

$2,293 

2,293 

1 May distribute that chemical for 

which registration was issued; 

may not distribute any chemical for which not registered. 


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Federal Register / Vol. 75, No. 20 / Monday, February 1, 2010 / Rules and Regulations 4981 

SUMMARY OF REGISTRATION REQUIREMENTS AND LIMITATIONS—Continued 

Business activity Chemicals DEA forms Application fee 

Registration 

period 

(years) 

Coincident activities allowed 

Distributing ........ List I, Scheduled listed chemical 

products.

New—510 .........

Renewal—510a 

1,147 

1,147 

1 

Importing ........... List I, Drug Products containing 

ephedrine, pseudoephedrine, 

phenylpropanolamine.

New—510 .........

Renewal—510a 

1,147 

1,147 

1 May distribute that chemical for 

which registration was issued; 

may not distribute any chemical for which not registered. 

Exporting ........... List I, Scheduled listed chemical 

products.

New—510 .........

Renewal—510a 

1,147 

1,147 

1 

■ 5. Section 1309.22 is revised to read 

as follows: 

§ 1309.22 Separate registration for 

independent activities. 

(a) The following groups of activities 

are deemed to be independent of each 

other: 

(1) Manufacturing of List I chemicals 

or drug products containing ephedrine, 

pseudoephedrine, or 

phenylpropanolamine. 

(2) Distributing of List I chemicals and 

scheduled listed chemical products. 

(3) Importing List I chemicals or drug 

products containing ephedrine, 

pseudoephedrine, or 

phenylpropanolamine. 

(4) Exporting List I chemicals and 

scheduled listed chemical products. 

(b) Except as provided in paragraphs 

(c) and (d) of this section, every person 

who engages in more than one group of 

independent activities must obtain a 

separate registration for each group of 

activities, unless otherwise exempted by 

the Act or §§ 1309.24 through 1309.26. 

(c) A person registered to import any 

List I chemical shall be authorized to 

distribute that List I chemical after 

importation, but no other chemical that 

the person is not registered to import. 

(d) A person registered to 

manufacture any List I chemical shall be 

authorized to distribute that List I 

chemical after manufacture, but no 

other chemical that the person is not 

registered to manufacture. 

■ 6. In § 1309.23, paragraph (a) is 

revised to read as follows: 

§ 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: 

§ 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 

§ 1300.02(b)(28)(i)(D) of this chapter, if 

that person is registered with the 

Administration to engage in the same 

activity with a controlled substance. 

(c) The requirement of registration is 

waived for any person who imports or 

exports a scheduled listed chemical 

product or other product containing a 

List I chemical that is described and 

included in the definition of ‘‘regulated 

transaction’’ in § 1300.02(b)(28)(i)(D) of 

this chapter, if that person is registered 

with the Administration to engage in the 

same activity with a controlled 

substance. 

(d) The requirement of registration is 

waived for any person who only 

distributes a prescription drug product 

containing a List I chemical that is 

regulated pursuant to 

§ 1300.02(b)(28)(i)(D) of this chapter. 

(e) The requirement of registration is 

waived for any person whose activities 

with respect to List I chemicals are 

limited to the distribution of red 

phosphorus, white phosphorus, or 

hypophosphorous acid (and its salts) to 

another location operated by the same 

firm solely for internal end-use, or an 

EPA or State licensed waste treatment or 

disposal firm for the purpose of waste 

disposal. 

(f) The requirement of registration is 

waived for any person whose 

distribution of red phosphorus or white 

phosphorus is limited solely to residual 

quantities of chemical returned to the 

producer, in reusable rail cars and 

intermodal tank containers which 

conform to International Standards 

Organization specifications (with 

capacities greater than or equal to 2,500 

gallons in a single container). 

(g) The requirement of registration is 

waived for any person whose activities 

with respect to List I chemicals are 

limited solely to the distribution of 

Lugol’s Solution (consisting of 5 percent 

iodine and 10 percent potassium iodide 

in an aqueous solution) in original 

manufacturer’s packaging of one fluid 

ounce (30 ml) or less. 

(h) The requirement of registration is 

waived for any manufacturer of a List I 

chemical, if that chemical is produced 

solely for internal consumption by the 

manufacturer and there is no 

subsequent distribution or exportation 

of the List I chemical. 

(i) If any person exempted under 

paragraph (b), (c), (d), (e), or (f) of this 

section also engages in the distribution, 

importation, or exportation of a List I 

chemical, other than as described in 

such paragraph, the person shall obtain 

a registration for the activities, as 

required by § 1309.21. 

(j) The Administrator may, upon 

finding that continuation of the waiver 

would not be in the public interest, 

suspend or revoke a waiver granted 

under paragraph (b), (c), (d), (e), or (f) of 

this section pursuant to the procedures 

set forth in §§ 1309.43 through 1309.46 

and §§ 1309.51 through 1309.55. In 

considering the revocation or 

suspension of a person’s waiver granted 

pursuant to paragraph (b) or (c) of this 

section, the Administrator shall also 

consider whether action to revoke or 

suspend the person’s controlled 

substance registration pursuant to 

section 304 of the Act (21 U.S.C. 824) 

is warranted. 

(k) Any person exempted from the 

registration requirement under this 

section must comply with the security 

requirements set forth in §§ 1309.71 

through 1309.73 and the recordkeeping 

and reporting requirements set forth 

under Parts 1310, 1313, 1314, and 1315 

of this chapter. 


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■ 8. Section 1309.25 is amended by 

adding a new paragraph (c) to read as 

follows: 

§ 1309.25 Temporary exemption from 

registration for chemical registration 

applicants. 

* * * * * 

(c) Each person required by sections 

302 or 1007 of the Act (21 U.S.C. 822 

or 957) to obtain a registration to 

manufacture or import prescription drug 

products containing ephedrine, 

pseudoephedrine, or 

phenylpropanolamine is temporarily 

exempted from the registration 

requirement, provided that the person 

submits a proper application for 

registration on or before March 3, 2010. 

The exemption will remain in effect for 

each person who has made such 

application until the Administration has 

approved or denied the application. 

This exemption applies only to 

registration; all other chemical control 

requirements set forth in this part and 

parts 1310, 1313, and 1315 of this 

chapter remain in full force and effect. 

Dated: January 22, 2010. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control. 

[FR Doc. 2010–1968 Filed 1–29–10; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

28 CFR Part 0 

[Docket No. DEA–315F] 

Redelegation of Functions; Delegation 

of Authority to Drug Enforcement 

Administration Official 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice. 

ACTION: Final rule. 

SUMMARY: Under delegated authority, 

the Administrator of the Drug 

Enforcement Administration (DEA), 

Department of Justice, is amending the 

appendix to the Justice Department 

regulations to redelegate certain 

functions and authority which were 

vested in the Attorney General by the 

Controlled Substances Act and 

subsequently delegated to the 

Administrator of DEA. 

DATES: Effective Dates: This Final Rule 

is effective February 1, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Mark W. Caverly, Chief, Liaison and 

Policy Section, Office of Diversion 

Control, Drug Enforcement 

Administration, 8701 Morrissette Drive, 

Springfield, VA 22152, Telephone (202) 

307–7297. 

SUPPLEMENTARY INFORMATION: DEA 

implements the Comprehensive Drug 

Abuse Prevention and Control Act of 

1970, often referred to as the Controlled 

Substances Act (CSA) and the 

Controlled Substances Import and 

Export Act (21 U.S.C. 801–971), as 

amended. DEA publishes the 

implementing regulations for these 

statutes in Title 21 of the Code of 

Federal Regulations (CFR), parts 1300 to 

1399. These regulations are designed to 

ensure that there is a sufficient supply 

of controlled substances for legitimate 

medical, scientific, research, and 

industrial purposes and to deter the 

diversion of controlled substances to 

illegal purposes. The CSA mandates that 

DEA establish a closed system of control 

for manufacturing, distributing, and 

dispensing controlled substances. Any 

person who manufactures, distributes, 

dispenses, imports, exports, or conducts 

research or chemical analysis with 

controlled substances must register with 

DEA (unless exempt) and comply with 

the applicable requirements for the 

activity. The CSA, as amended, also 

requires DEA to regulate the 

manufacture and distribution of 

chemicals that may be used to 

manufacture controlled substances 

illegally. Listed chemicals that are 

classified as List I chemicals are 

important to the manufacture of 

controlled substances. Those classified 

as List II chemicals may be used to 

manufacture controlled substances. 

Retail Sales Provisions of the Combat 

Methamphetamine Epidemic Act of 

2005 

On March 9, 2006, the President 

signed the Combat Methamphetamine 

Epidemic Act of 2005 (CMEA), which is 

Title VII of the USA PATRIOT 

Improvement and Reauthorization Act 

of 2005 (Pub. L. 109–177). Among other 

things, the CMEA amended the CSA to 

change the regulations for selling 

nonprescription products that contain 

ephedrine, pseudoephedrine, and 

phenylpropanolamine, their salts, 

optical isomers, and salts of optical 

isomers. CMEA created a new category 

of products called scheduled listed 

chemical products. A scheduled listed 

chemical product is defined as a 

product that contains ephedrine, 

pseudoephedrine, or 

phenylpropanolamine that may be 

marketed or distributed lawfully in the 

United States under the Federal Food, 

Drug, and Cosmetic Act as a 

nonprescription drug (21 U.S.C. 

802(45)(A), 21 CFR 1300.02(b)(34)(i))). 

CMEA established provisions 

regarding the retail sale of these 

scheduled listed chemical products by 

regulated sellers (i.e., retail distributors 

including mobile retail vendors) and 

distributors required to submit reports 

under 21 U.S.C. 830(b)(3) (i.e., mail 

order distributors). These requirements, 

which were promulgated in 21 CFR, 

part 1314, include, but are not limited 

to: 

• Packaging requirements for 

nonliquid forms of scheduled listed 

chemical products (i.e., blister packs, 

with each blister containing no more 

than two dosage units or, if blister packs 

are technically infeasible, in unit dose 

packets or pouches) (21 CFR 1314.05). 

• Daily sales limits (21 CFR 1314.20). 

• Product placement (i.e., placing the 

product so that customers do not have 

direct access before the sale is made, 

referred to as ‘‘behind the counter’’ 

placement, including circumstances in 

which the product is stored in a locked 

cabinet located in an area of the facility 

where customers do have direct access) 

(21 CFR 1314.25(b)). 

• Recordkeeping (i.e., logbook 

provisions) (21 CFR 1314.30). 

• Employee training (21 CFR 

1314.35). 

• Self-certification (21 CFR 1314.40). 

Redelegation of Authority 

The Attorney General has delegated 

his functions under the CSA to the 

Administrator of the Drug Enforcement 

Administration (21 U.S.C. 871(a) and 28 

CFR 0.100(b)). The Attorney General has 

also authorized the Administrator to 

redelegate any of his functions under 

the CSA to any subordinates (28 CFR 

0.104). To further enhance the 

administration of the CSA and its 

regulations, the Administrator is 

redelegating to the Deputy Assistant 

Administrator, Office of Diversion 

Control, Drug Enforcement 

Administration, and the authority to 

exercise all necessary functions with 

respect to the promulgation and 

implementation of regulations in 21 

CFR, part 1314. This redelegation will 

empower the Deputy Assistant 

Administrator, among other things, to 

exercise signing authority for any rules, 

regulations, or procedures which he 

may deem necessary for the efficient 

execution of the retail sales provisions 

contained in part 1314. Final orders in 

connection with the suspension or 

revocation of a regulated seller’s or mail 

order distributor’s right to sell 

scheduled listed chemical products 

shall continue to be made by the Deputy 


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