4228 Federal Register / Vol. 77, No. 18 / Friday, January 27, 2012 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

[Docket No. FDA–2011–N–0003] 

New Animal Drugs for Use in Animal 

Feeds; Monensin 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of a supplemental new animal 

drug application (NADA) filed by 

Elanco Animal Health, A Division of Eli 

Lilly & Co. The supplemental NADA 

provides for approval of free-choice 

feeds for growing cattle on pasture or in 

dry lot (stocker and feeder cattle and 

dairy and beef replacement heifers). 

DATES: This rule is effective January 27, 

2012. 

FOR FURTHER INFORMATION CONTACT: 

Suzanne Sechen, Center for Veterinary 

Medicine (HFV–126), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, (240) 276–8105, 

email: suzanne.sechen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Elanco 

Animal Health, A Division of Eli Lilly 

& Co., Lilly Corporate Center, 

Indianapolis, IN 46285, filed a 

supplement to NADA 95–735 that 

provides for use of RUMENSIN 90 

(monensin) Type A medicated article in 

free-choice feeds for growing cattle on 

pasture or in dry lot (stocker and feeder 

cattle and dairy and beef replacement 

heifers) for increased rate of weight gain 

and for prevention and control of 

coccidiosis. The supplemental NADA is 

approved as of November 18, 2011, and 

the regulations in 21 CFR 558.355 are 

amended to reflect the approval. 

A summary of safety and effectiveness 

data and information submitted to 

support approval of this application 

may be seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852, between 9 

a.m. and 4 p.m., Monday through 

Friday. 

The Agency has determined under 21 

CFR 25.33 that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects in 21 CFR Part 558 

Animal drugs, Animal feeds. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 558 is amended as follows: 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 1. The authority citation for 21 CFR 

part 558 continues to read as follows: 

Authority: 21 U.S.C. 360b, 371. 

■ 2. In § 558.355, add paragraph 

(f)(3)(iv); and in paragraph (f)(3)(x)(c), 

remove the last sentence. 

The addition reads as follows: 

§ 558.355 Monensin. 

* * * * * 

(f) * * * 

(3) * * * 

(iv) Amount. Monensin at 

concentrations in free-choice Type C 

medicated feeds to provide 50 to 200 mg 

per head per day. 

(a) Indications for use. Growing cattle 

on pasture or in dry lot (stocker and 

feeder cattle and dairy and beef 

replacement heifers): For increased rate 

of weight gain; for prevention and 

control of coccidiosis due to Eimeria 

bovis and E. zuernii. 

(b) Limitations. During the first 5 days 

of feeding, cattle should receive no more 

than 100 milligrams per day. Do not 

feed additional salt or minerals. Do not 

mix with grain or other feeds. Monensin 

is toxic to cattle when consumed at 

higher than approved levels. Stressed 

and/or feed- and/or water-deprived 

cattle should be adapted to the pasture 

and to unmedicated supplement before 

using the monensin medicated 

supplement. The product’s effectiveness 

in cull cows and bulls has not been 

established. See paragraph (d) of this 

section for other required label 

warnings. 

* * * * * 

Dated: January 23, 2012. 

William T. Flynn, 

Acting Director, Center for Veterinary 

Medicine. 

[FR Doc. 2012–1755 Filed 1–26–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Parts 1300, 1303, 1304, 1305, 

1306, 1308, 1309, 1310, 1312, 1313, 

1314, 1316 

[Docket No. DEA–356] 

Technical Amendments and 

Corrections to DEA Regulations 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice. 

ACTION: Final rule. 

SUMMARY: This final rule updates the 

Code of Federal Regulations pertaining 

to DEA by alphabetizing definitions and 

eliminating the numeric listings in those 

definitions in order to simplify future 

rulemakings where additional 

definitions are added or deleted. This 

rule also corrects typographic errors, 

reflects organizational changes, and 

updates cross-reference listings in the 

CFR. This action makes no substantive 

changes to the affected rules. 

DATES: The effective date of this rule is 

January 27, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Rhea D. Moore, Office of Diversion 

Control, Drug Enforcement 

Administration, 8701 Morrissette Drive, 

Springfield, Virginia 22152; Telephone 

(202) 307–7165. 

SUPPLEMENTARY INFORMATION: 

Background 

DEA implements and enforces Titles 

II and III of 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 

through 1321. 

The Administrative Procedure Act (5 

U.S.C. 553) does not require notice and 

the opportunity for public comment 

where the agency for good cause finds 

that notice and public comment are 

unnecessary, impracticable, or contrary 

to the public interest under 5 U.S.C. 

553(b)(B) or on rules affecting agency 

organization, procedure, or practice 

under 5 U.S.C. 553(b)(A). This rule 

contains technical corrections and 

updates organizational changes in 

agency regulations; it imposes no new 

or substantive requirement on the 

public or DEA registrants. As such, DEA 

has determined that notice and 


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Federal Register / Vol. 77, No. 18 / Friday, January 27, 2012 / Rules and Regulations 4229 

opportunity for public comment on this 

rule are unnecessary. This rule is also 

exempt from notice and comment 

because these changes involve rules of 

agency organization, procedure, or 

practice. Because this is not a 

substantive rule and as DEA finds good 

cause under 5 U.S.C. 553(d)(3) for the 

above reasons, this final rule shall take 

effect upon date of publication in the 

Federal Register. 

Technical Amendments and 

Corrections 

This rule removes the numbers for 

each definition in 21 CFR 1300.01 and 

21 CFR 1300.02 and alphabetizes the 

definitions of each section so they can 

be easily referenced and so that 

additions and deletions can be made in 

future rulemakings without 

renumbering or causing confusion by 

placing definitions out of alphabetical 

order. 

This rule also clarifies the regulations 

by correcting typographical errors and 

updating citation listings and 

organizational changes previously 

overlooked. Specifically, the changes 

are: 

In § 1300.01(b), alphabetizing the 

definitions, italicization of defined 

terms, removing the numbered 

designations, standardization of 

subordinate definitions by placement in 

quotation marks, separating the term 

‘‘manufacturer,’’ correcting the citation 

in ‘‘supplier’’ from 1305.08 to 1305.06, 

standardization of ‘‘a.k.a.’’ names for 

substances listed under ‘‘anabolic 

steroids,’’ and correcting the spelling of 

four of the chemical names for 

substances listed under ‘‘anabolic 

steroid’’: boldenone, mesterolone, 

methyltrienolone, and 17a-methyl-D1- 

dihydrotestosterone; 

In § 1300.02(b), alphabetizing the 

definitions, italicization of defined 

terms, removing the numbered 

designations, standardization of 

subordinate definitions by placement in 

quotation marks, and adding ‘‘Federal’’ 

at the beginning of ‘‘Food, Drug, and 

Cosmetic Act’’ in the definition of ‘‘Drug 

product’’; 

In the fifth sentence of § 1303.11(c), 

correcting the spelling of ‘‘nnt’’ to be 

‘‘not’’; 

In the second sentence of § 1304.03(a), 

correcting the citation to be 1307.13 

instead of 1307.15, and in the fifth 

sentence correcting the word ‘‘acquire’’ 

to be ‘‘require’’; 

In § 1305.03(d), updating the 

reference to reflect the new organization 

of § 1300.01; 

In the heading for § 1306.24, 

correcting the spelling of ‘‘filing’’ to be 

‘‘filling’’; 

In § 1308.11(d)(8), correcting the 

spelling of ‘‘mdthylenedioxy’’ to 

be‘‘methylenedioxy’’; 

In § 1308.12(b)(4), correcting the 

spelling of ‘‘whhch’’ to be ‘‘which’’; 

In § 1308.13(b), correcting the spelling 

of ‘‘sxstem’’ to be ‘‘system’’ and 

correcting the term ‘‘position’’ to be 

‘‘positional’’; 

In §§ 1309.21(a)(2), 1309.24(b)–(d), 

1310.04(f)(1)(ii) and (g), 1310.05(d) and 

(f)(2), 1310.06(h)(5), 1310.09(b), 

1310.10(a), 1310.14, 1313.21(c)(1), 

1313.24(a), and 1314.115(a)(2), updating 

the references to reflect the new 

organization of § 1300.02; 

In the second sentence of § 1309.62(a), 

correcting the spelling of ‘‘cases’’ to be 

‘‘ceases’’; 

In the heading of § 1310.10, adding 

‘‘Federal’’ at the beginning of ‘‘Food, 

Drug, and Cosmetic Act’’; 

In § 1312.18(d), correcting the citation 

from ‘‘paragraph (a)’’ to ‘‘paragraph (b)’’; 

In § 1312.21(c), correcting the spelling 

of ‘‘repuest’’ to be ‘‘request’’; 

In §§ 1312.25, 1312.28(c), 1313.12(d), 

and 1313.32(b)(2), updating the 

organizational listings of ‘‘Drug 

Operations Section,’’ ‘‘Drug Control 

Section,’’ and ‘‘Chemical Operations 

Section’’ to the correct ‘‘Import/Export 

Unit’’; 

In § 1313.14(c), correcting the spelling 

of ‘‘Sevice’’ to be ‘‘Service’’; 

In § 1313.31(b)(5), correcting the word 

‘‘new’’ to be ‘‘net’’; 

In § 1314.45, correcting the citation 

from ‘‘1314.15’’ to ‘‘1314.30’’; 

In § 1316.03(d), correcting and 

updating the reference from ‘‘DEA Form 

84’’ to ‘‘DEA Form 400’’; and 

In § 1316.42(g), correcting the spelling 

of ‘‘colmencing’’ to be ‘‘commencing.’’ 

Finally, this rule would update 

sections of Parts 1310 and 1313 to 

accurately reflect how information is 

submitted to DEA by removing 

references to ‘‘telex number,’’ an 

outdated form of technology. This 

would occur by removing ‘‘telex’’ or 

‘‘telex number’’ from 21 CFR 

1310.06(e)(1), (e)(4), (f)(1) and (f)(4), 

1313.13(c)(1), 1313.31(b)(11), and 

1313.33(c)(1) and (c)(4). 

Regulatory Analyses 

Administrative Procedure Act 

The Administrative Procedure Act (5 

U.S.C. 553) does not require notice and 

the opportunity for public comment 

where the agency for good cause finds 

that notice and public procedure 

thereon is unnecessary, impracticable, 

or contrary to the public interest under 

5 U.S.C. 553(b)(B) or on rules affecting 

agency organization, procedure, or 

practice under 5 U.S.C. 553(b)(A). This 

rule contains technical corrections and 

updates organizational changes in 

agency regulations; it imposes no new 

or substantive requirement on the 

public or DEA registrants. As such, DEA 

finds good cause that notice and 

opportunity for public comment on this 

rule are unnecessary pursuant to 5 

U.S.C. 553(b)(B). This rule is also 

exempt from notice and comment 

pursuant to 5 U.S.C. 553(b)(A) as these 

changes involve rules of agency 

organization, procedure, or practice. 

Because this is not a substantive rule 

and as DEA finds good cause under 5 

U.S.C. 553(d)(3) for the above reasons, 

this final rule is effective upon date of 

publication in the Federal Register. 

Regulatory Flexibility Act 

This rule has been reviewed in 

accordance with the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Deputy Assistant Administrator 

certifies that this regulation will have no 

economic impact on a substantial 

number of small entities. This 

rulemaking only makes technical 

amendments and imposes no new 

requirements. 

Executive Orders 12866 and 13563 

The Deputy Assistant Administrator 

certifies that this is not a significant 

regulatory action within the meaning of 

Executive Order 12866 and the 

principles reaffirmed in Executive Order 

13563, as it makes only technical 

amendments to the current regulations. 

Executive Order 12988 

This proposed regulation meets the 

applicable standards set forth in 

Sections 3(a) and 3(b)(2) of Executive 

Order 12988 Civil Justice Reform to 

eliminate ambiguity, minimize 

litigation, establish clear legal standards 

and reduce burden. 

Executive Order 13132 

This rulemaking does not preempt or 

modify any provision of State law, 

impose enforcement responsibilities on 

any State, or 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 $136,000,000 or more 

(adjusted for inflation) in any one year, 

and will not significantly or uniquely 

affect small governments. Therefore, no 


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4230 Federal Register / Vol. 77, No. 18 / Friday, January 27, 2012 / Rules and Regulations 

actions were deemed necessary under 

the provisions of the Unfunded 

Mandates Reform Act of 1995, 2 U.S.C 

1532. 

Paperwork Reduction Act of 1995 

This action does not impose a 

collection of information requirement 

under the Paperwork Reduction Act of 

1995, 44 U.S.C. 3501–3521. 

Executive Order 13175 

This proposed rule will not have 

tribal implications and will not impose 

substantial direct compliance costs on 

Indian tribal governments. 

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 

21 CFR Part 1300 

Chemicals, Drug traffic control. 

21 CFR Part 1303 

Administrative practice and 

procedure, Drug traffic control. 

21 CFR Part 1304 

Drug traffic control, Reporting and 

recordkeeping requirements. 

21 CFR Part 1305 

Drug traffic control. 

21 CFR Part 1306 

Drug traffic control, Prescription 

drugs. 

21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

21 CFR Part 1309 

Administrative practice and 

procedure, Drug traffic control, Exports, 

Imports, Security measures. 

21 CFR Part 1310 

Drug traffic control, Exports, Imports, 

Security measures. 

21 CFR Parts 1312 and 1313 

Administrative practice and 

procedure, Drug traffic control, Exports, 

Imports, Reporting and recordkeeping 

requirements. 

21 CFR Part 1314 

Drug traffic control, Reporting and 

recordkeeping requirements. 

21 CFR Part 1316 

Administrative practice and 

procedure, Authority delegations 

(Government agencies), Drug traffic 

control, Research, Seizures and 

forfeitures. 

For the reasons set out above, 21 CFR 

Parts 1300, 1303, 1304, 1305, 1306, 

1308, 1309, 1310, 1312, 1313, 1314, and 

1316 are amended to read as follows: 

PART 1300—DEFINITIONS 

■ 1. The authority citation for Part 1300 

continues to read as follows: 

Authority: 21 U.S.C. 802, 821, 829, 871(b), 

951, 958(f). 

■ 2. In § 1300.01, paragraph (b) is 

revised to read as follows: 

§ 1300.01 Definitions relating to controlled 

substances. 

* * * * * 

(b) As used in parts 1301 through 

1308 and part 1312 of this chapter, the 

following terms shall have the meanings 

specified: 

Act means the Controlled Substances 

Act, as amended (84 Stat. 1242; 21 

U.S.C. 801) and/or the Controlled 

Substances Import and Export Act, as 

amended (84 Stat. 1285; 21 U.S.C. 951). 

Administration means the Drug 

Enforcement Administration. 

Administrator means the 

Administrator of the Drug Enforcement 

Administration. The Administrator has 

been delegated authority under the Act 

by the Attorney General (28 CFR 0.100). 

Anabolic steroid means any drug or 

hormonal substance, chemically and 

pharmacologically related to 

testosterone (other than estrogens, 

progestins, corticosteroids, and 

dehydroepiandrosterone), and includes: 

(1) 3b,17-dihydroxy-5a-androstane 

(2) 3a,17b-dihydroxy-5a-androstane 

(3) 5a-androstan-3,17-dione 

(4) 1-androstenediol (3b,17b-dihydroxy5a-androst-1-ene) 

(5) 1-androstenediol (3a,17b-dihydroxy5a-androst-1-ene) 

(6) 4-androstenediol (3b,17b-dihydroxyandrost-4-ene) 

(7) 5-androstenediol (3b,17b-dihydroxyandrost-5-ene) 

(8) 1-androstenedione ([5a]-androst-1- 

en-3,17-dione) 

(9) 4-androstenedione (androst-4-en3,17-dione) 

(10) 5-androstenedione (androst-5-en3,17-dione) 

(11) bolasterone (7a,17a-dimethyl-17bhydroxyandrost-4-en-3-one) 

(12) boldenone (17b-hydroxyandrost1,4-diene-3-one) 

(13) boldione (androsta-1,4-diene-3,17- 

dione) 

(14) calusterone (7b,17a-dimethyl-17bhydroxyandrost-4-en-3-one) 

(15) clostebol (4-chloro-17bhydroxyandrost-4-en-3-one) 

(16) dehydrochloromethyltestosterone 

(4-chloro-17b-hydroxy-17a-methylandrost-1,4-dien-3-one) 

(17) desoxymethyltestosterone (17amethyl-5a-androst-2-en-17b-ol) 

(a.k.a. ‘madol’) 

(18) D1-dihydrotestosterone (a.k.a.‘1- 

testosterone’) (17b-hydroxy-5aandrost-1-en-3-one) 

(19) 4-dihydrotestosterone (17bhydroxy-androstan-3-one) 

(20) drostanolone (17b-hydroxy-2amethyl-5a-androstan-3-one) 

(21) ethylestrenol (17a-ethyl-17bhydroxyestr-4-ene) 

(22) fluoxymesterone (9-fluoro-17amethyl-11b,17b-dihydroxyandrost4-en-3-one) 

(23) formebolone (2-formyl-17a-methyl11a,17b-dihydroxyandrost-1,4- 

dien-3-one) 

(24) furazabol (17a-methyl-17bhydroxyandrostano[2,3-c]-furazan) 

(25) 13b-ethyl-17b-hydroxygon-4-en-3- 

one 

(26) 4-hydroxytestosterone (4,17bdihydroxy-androst-4-en-3-one) 

(27) 4-hydroxy-19-nortestosterone 

(4,17b-dihydroxy-estr-4-en-3-one) 

(28) mestanolone (17a-methyl-17bhydroxy-5-androstan-3-one) 

(29) mesterolone (1a-methyl-17bhydroxy-[5a]-androstan-3-one) 

(30) methandienone (17a-methyl-17bhydroxyandrost-1,4-dien-3-one) 

(31) methandriol (17a-methyl-3b,17bdihydroxyandrost-5-ene) 

(32) methenolone (1-methyl-17bhydroxy-5a-androst-1-en-3-one) 

(33) 17a-methyl-3b,17b-dihydroxy-5aandrostane 

(34) 17a-methyl-3a,17b-dihydroxy-5aandrostane 

(35) 17a-methyl-3b,17bdihydroxyandrost-4-ene 

(36) 17a-methyl-4-hydroxynandrolone 

(17a-methyl-4-hydroxy-17bhydroxyestr-4-en-3-one) 

(37) methyldienolone (17a-methyl-17bhydroxyestra-4,9(10)-dien-3-one) 

(38) methyltrienolone (17a-methyl-17bhydroxyestra-4,9,11-trien-3-one) 

(39) methyltestosterone (17a-methyl17b-hydroxyandrost-4-en-3-one) 

(40) mibolerone (7a,17a-dimethyl-17bhydroxyestr-4-en-3-one) 

(41) 17a-methyl-D1-dihydrotestosterone 

(17b-hydroxy-17a-methyl-5aandrost-1-en-3-one) (a.k.a. ‘17-amethyl-1-testosterone’) 


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Federal Register / Vol. 77, No. 18 / Friday, January 27, 2012 / Rules and Regulations 4231 

(42) nandrolone (17b-hydroxyestr-4-en3-one) 

(43) 19-nor-4-androstenediol (3b, 17bdihydroxyestr-4-ene) 

(44) 19-nor-4-androstenediol (3a, 17bdihydroxyestr-4-ene) 

(45) 19-nor-5-androstenediol (3b, 17bdihydroxyestr-5-ene) 

(46) 19-nor-5-androstenediol (3a, 17bdihydroxyestr-5-ene) 

(47) 19-nor-4,9(10)-androstadienedione 

(estra-4,9(10)-diene-3,17-dione) 

(48) 19-nor-4-androstenedione (estr-4- 

en-3,17-dione) 

(49) 19-nor-5-androstenedione (estr-5- 

en-3,17-dione) 

(50) norbolethone (13b, 17a-diethyl-17bhydroxygon-4-en-3-one) 

(51) norclostebol (4-chloro-17bhydroxyestr-4-en-3-one) 

(52) norethandrolone (17a-ethyl-17bhydroxyestr-4-en-3-one) 

(53) normethandrolone (17a-methyl17b-hydroxyestr-4-en-3-one) 

(54) oxandrolone (17a-methyl-17bhydroxy-2-oxa-[5a]-androstan-3- 

one) 

(55) oxymesterone (17a-methyl-4,17bdihydroxyandrost-4-en-3-one) 

(56) oxymetholone (17a-methyl-2- 

hydroxymethylene-17b-hydroxy- 

[5a]-androstan-3-one) 

(57) stanozolol (17a-methyl-17bhydroxy-[5a]-androst-2-eno[3,2-c]- 

pyrazole) 

(58) stenbolone (17b-hydroxy-2-methyl- 

[5a]-androst-1-en-3-one) 

(59) testolactone (13-hydroxy-3-oxo13,17-secoandrosta-1,4-dien-17-oic 

acid lactone) 

(60) testosterone (17b-hydroxyandrost-4- 

en-3-one) 

(61) tetrahydrogestrinone (13b, 17adiethyl-17b-hydroxygon-4,9,11- 

trien-3-one) 

(62) trenbolone (17b-hydroxyestr-4,9,11- 

trien-3-one) 

(63) Any salt, ester, or ether of a drug 

or substance described in this 

paragraph. Except such term does 

not include an anabolic steroid that 

is expressly intended for 

administration through implants to 

cattle or other nonhuman species 

and that has been approved by the 

Secretary of Health and Human 

Services for such administration. If 

any person prescribes, dispenses, or 

distributes such steroid for human 

use, the person shall be considered 

to have prescribed, dispensed, or 

distributed an anabolic steroid 

within the meaning of this 

paragraph. 

Automated dispensing system means 

a mechanical system that performs 

operations or activities, other than 

compounding or administration, relative 

to the storage, packaging, counting, 

labeling, and dispensing of medications, 

and which collects, controls, and 

maintains all transaction information. 

Basic class means, as to controlled 

substances listed in Schedules I and II: 

(1) Each of the opiates, including its 

isomers, esters, ethers, salts, and salts of 

isomers, esters, and ethers whenever the 

existence of such isomers, esters, ethers, 

and salts is possible within the specific 

chemical designation, listed in 

§ 1308.11(b) of this chapter; 

(2) Each of the opium derivatives, 

including its salts, isomers, and salts of 

isomers whenever the existence of such 

salts, isomers, and salts of isomers is 

possible within the specific chemical 

designation, listed in § 1308.11(c) of this 

chapter; 

(3) Each of the hallucinogenic 

substances, including its salts, isomers, 

and salts of isomers whenever the 

existence of such salts, isomers, and 

salts of isomers is possible within the 

specific chemical designation, listed in 

§ 1308.11(d) of this chapter; 

(4) Each of the following substances, 

whether produced directly or indirectly 

by extraction from substances of 

vegetable origin, or independently by 

means of chemical synthesis, or by a 

combination of extraction and chemical 

synthesis: 

(i) Opium, including raw opium, 

opium extracts, opium fluid extracts, 

powdered opium, granulated opium, 

deodorized opium and tincture of 

opium; 

(ii) Apomorphine; 

(iii) Codeine; 

(iv) Etorphine hydrochloride; 

(v) Ethylmorphine; 

(vi) Hydrocodone; 

(vii) Hydromorphone; 

(viii) Metopon; 

(ix) Morphine; 

(x) Oxycodone; 

(xi) Oxymorphone; 

(xii) Thebaine; 

(xiii) Mixed alkaloids of opium listed 

in § 1308.12(b)(2) of this chapter; 

(xiv) Cocaine; and 

(xv) Ecgonine; 

(5) Each of the opiates, including its 

isomers, esters, ethers, salts, and salts of 

isomers, esters, and ethers whenever the 

existence of such isomers, esters, ethers, 

and salts is possible within the specific 

chemical designation, listed in 

§ 1308.12(c) of this chapter; and 

(6) Methamphetamine, its salts, 

isomers, and salts of its isomers; 

(7) Amphetamine, its salts, optical 

isomers, and salts of its optical isomers; 

(8) Phenmetrazine and its salts; 

(9) Methylphenidate; 

(10) Each of the substances having a 

depressant effect on the central nervous 

system, including its salts, isomers, and 

salts of isomers whenever the existence 

of such salts, isomers, and salts of 

isomers is possible within the specific 

chemical designation, listed in 

§ 1308.12(e) of this chapter. 

Central fill pharmacy means a 

pharmacy which is permitted by the 

state in which it is located to prepare 

controlled substances orders for 

dispensing pursuant to a valid 

prescription transmitted to it by a 

registered retail pharmacy and to return 

the labeled and filled prescriptions to 

the retail pharmacy for delivery to the 

ultimate user. Such central fill 

pharmacy shall be deemed ‘‘authorized’’ 

to fill prescriptions on behalf of a retail 

pharmacy only if the retail pharmacy 

and central fill pharmacy have a 

contractual relationship providing for 

such activities or share a common 

owner. 

Commercial container means any 

bottle, jar, tube, ampule, or other 

receptacle in which a substance is held 

for distribution or dispensing to an 

ultimate user, and in addition, any box 

or package in which the receptacle is 

held for distribution or dispensing to an 

ultimate user. The term commercial 

container does not include any package 

liner, package insert or other material 

kept with or within a commercial 

container, nor any carton, crate, drum, 

or other package in which commercial 

containers are stored or are used for 

shipment of controlled substances. 

Compounder means any person 

engaging in maintenance or 

detoxification treatment who also 

mixes, prepares, packages or changes 

the dosage form of a narcotic drug listed 

in Schedules II, III, IV or V for use in 

maintenance or detoxification treatment 

by another narcotic treatment program. 

Controlled substance has the meaning 

given in section 802(6) of Title 21, 

United States Code (U.S.C.). 

Customs territory of the United States 

means the several States, the District of 

Columbia, and Puerto Rico. 

Detoxification treatment means the 

dispensing, for a period of time as 

specified below, of a narcotic drug or 

narcotic drugs in decreasing doses to an 

individual to alleviate adverse 

physiological or psychological effects 

incident to withdrawal from the 

continuous or sustained use of a 

narcotic drug and as a method of 

bringing the individual to a narcotic 

drug-free state within such period of 

time. There are two types of 

detoxification treatment: Short-term 

detoxification treatment and long-term 

detoxification treatment. 


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(1) Short-term detoxification 

treatment is for a period not in excess 

of 30 days. 

(2) Long-term detoxification treatment 

is for a period more than 30 days but not 

in excess of 180 days. 

Dispenser means an individual 

practitioner, institutional practitioner, 

pharmacy or pharmacist who dispenses 

a controlled substance. 

Export means, with respect to any 

article, any taking out or removal of 

such article from the jurisdiction of the 

United States (whether or not such 

taking out or removal constitutes an 

exportation within the meaning of the 

customs and related laws of the United 

States). 

Exporter includes every person who 

exports, or who acts as an export broker 

for exportation of, controlled substances 

listed in any schedule. 

Freight forwarding facility means a 

separate facility operated by a 

distributing registrant through which 

sealed, packaged controlled substances 

in unmarked shipping containers (i.e., 

the containers do not indicate that the 

contents include controlled substances) 

are, in the course of delivery to, or 

return from, customers, transferred in 

less than 24 hours. A distributing 

registrant who operates a freight 

forwarding facility may use the facility 

to transfer controlled substances from 

any location the distributing registrant 

operates that is registered with the 

Administration to manufacture, 

distribute, or import controlled 

substances, or, with respect to returns, 

registered to dispense controlled 

substances, provided that the notice 

required by § 1301.12(b)(4) of Part 1301 

of this chapter has been submitted and 

approved. For purposes of this 

definition, a ‘‘distributing registrant’’ is 

a person who is registered with the 

Administration as a manufacturer, 

distributor, and/or importer. 

Hearing means: 

(1) In part 1301 of this chapter, any 

hearing held for the granting, denial, 

revocation, or suspension of a 

registration pursuant to sections 303, 

304, and 1008 of the Act (21 U.S.C. 823, 

824 and 958). 

(2) In part 1303 of this chapter, any 

hearing held regarding the 

determination of aggregate production 

quota or the issuance, adjustment, 

suspension, or denial of a procurement 

quota or an individual manufacturing 

quota. 

(3) In part 1308 of this chapter, any 

hearing held for the issuance, 

amendment, or repeal of any rule 

issuable pursuant to section 201 of the 

Act (21 U.S.C. 811). 

Import means, with respect to any 

article, any bringing in or introduction 

of such article into either the 

jurisdiction of the United States or the 

customs territory of the United States, 

and from the jurisdiction of the United 

States into the customs territory of the 

United States (whether or not such 

bringing in or introduction constitutes 

an importation within the meaning of 

the tariff laws of the United States). 

Importer includes every person who 

imports, or who acts as an import broker 

for importation of, controlled substances 

listed in any schedule. 

Individual practitioner means a 

physician, dentist, veterinarian, or other 

individual licensed, registered, or 

otherwise permitted, by the United 

States or the jurisdiction in which he/ 

she practices, to dispense a controlled 

substance in the course of professional 

practice, but does not include a 

pharmacist, a pharmacy, or an 

institutional practitioner. 

Institutional practitioner means a 

hospital or other person (other than an 

individual) licensed, registered, or 

otherwise permitted, by the United 

States or the jurisdiction in which it 

practices, to dispense a controlled 

substance in the course of professional 

practice, but does not include a 

pharmacy. 

Interested person means any person 

adversely affected or aggrieved by any 

rule or proposed rule issuable pursuant 

to section 201 of the Act (21 U.S.C. 811). 

Inventory means all factory and 

branch stocks in finished form of a basic 

class of controlled substance 

manufactured or otherwise acquired by 

a registrant, whether in bulk, 

commercial containers, or contained in 

pharmaceutical preparations in the 

possession of the registrant (including 

stocks held by the registrant under 

separate registration as a manufacturer, 

importer, exporter, or distributor). 

Isomer means: 

(1) The optical isomer, except as used 

in § 1308.11(d) and § 1308.12(b)(4) of 

this chapter. As used in § 1308.11(d) of 

this chapter, the term ‘‘isomer’’ means 

any optical, positional, or geometric 

isomer. As used in § 1308.12(b)(4) of 

this chapter, the term ‘‘isomer’’ means 

any optical or geometric isomer; 

(2) As used in § 1308.11(d) of this 

chapter, the term ‘‘positional isomer’’ 

means any substance possessing the 

same molecular formula and core 

structure and having the same 

functional group(s) and/or substituent(s) 

as those found in the respective 

Schedule I hallucinogen, attached at any 

position(s) on the core structure, but in 

such manner that no new chemical 

functionalities are created and no 

existing chemical functionalities are 

destroyed relative to the respective 

Schedule I hallucinogen. 

Rearrangements of alkyl moieties within 

or between functional group(s) or 

substituent(s), or divisions or 

combinations of alkyl moieties, that do 

not create new chemical functionalities 

or destroy existing chemical 

functionalities, are allowed i.e., result in 

compounds which are positional 

isomers. For purposes of this definition, 

the ‘‘core structure’’ is the parent 

molecule that is the common basis for 

the class; for example, tryptamine, 

phenethylamine, or ergoline. Examples 

of rearrangements resulting in creation 

and/or destruction of chemical 

functionalities (and therefore resulting 

in compounds which are not positional 

isomers) include, but are not limited to: 

Ethoxy to alpha-hydroxyethyl, hydroxy 

and methyl to methoxy, or the 

repositioning of a phenolic or alcoholic 

hydroxy group to create a 

hydroxyamine. Examples of 

rearrangements resulting in compounds 

which would be positional isomers 

include: Tert-butyl to sec-butyl, 

methoxy and ethyl to isopropoxy, N,Ndiethyl to N-methyl-N-propyl, or alphamethylamino to N-methylamino. 

Jurisdiction of the United States 

means the customs territory of the 

United States, the Virgin Islands, the 

Canal Zone, Guam, American Samoa, 

and the Trust Territories of the Pacific 

Islands. 

Label means any display of written, 

printed, or graphic matter placed upon 

the commercial container of any 

controlled substance by any 

manufacturer of such substance. 

Labeling means all labels and other 

written, printed, or graphic matter: 

(1) Upon any controlled substance or 

any of its commercial containers or 

wrappers, or 

(2) Accompanying such controlled 

substance. 

Long Term Care Facility (LTCF) 

means a nursing home, retirement care, 

mental care or other facility or 

institution which provides extended 

health care to resident patients. 

Maintenance treatment means the 

dispensing for a period in excess of 

twenty-one days, of a narcotic drug or 

narcotic drugs in the treatment of an 

individual for dependence upon heroin 

or other morphine-like drug. 

Manufacture means the producing, 

preparation, propagation, compounding, 

or processing of a drug or other 

substance or the packaging or 

repackaging of such substance, or the 

labeling or relabeling of the commercial 

container of such substance, but does 

not include the activities of a 


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practitioner who, as an incident to his/ 

her administration or dispensing such 

substance in the course of his/her 

professional practice, prepares, 

compounds, packages or labels such 

substance. 

Manufacturer means a person who 

manufactures a drug or other substance, 

whether under a registration as a 

manufacturer or under authority of 

registration as a researcher or chemical 

analyst. 

Mid-level practitioner means an 

individual practitioner, other than a 

physician, dentist, veterinarian, or 

podiatrist, who is licensed, registered, 

or otherwise permitted by the United 

States or the jurisdiction in which he/ 

she practices, to dispense a controlled 

substance in the course of professional 

practice. Examples of mid-level 

practitioners include, but are not 

limited to, health care providers such as 

nurse practitioners, nurse midwives, 

nurse anesthetists, clinical nurse 

specialists and physician assistants who 

are authorized to dispense controlled 

substances by the State in which they 

practice. 

Name means the official name, 

common or usual name, chemical name, 

or brand name of a substance. 

Narcotic drug means any of the 

following whether produced directly or 

indirectly by extraction from substances 

of vegetable origin or independently by 

means of chemical synthesis or by a 

combination of extraction and chemical 

synthesis: 

(1) Opium, opiates, derivatives of 

opium and opiates, including their 

isomers, esters, ethers, salts, and salts of 

isomers, esters, and ethers whenever the 

existence of such isomers, esters, ethers 

and salts is possible within the specific 

chemical designation. Such term does 

not include the isoquinoline alkaloids of 

opium. 

(2) Poppy straw and concentrate of 

poppy straw. 

(3) Coca leaves, except coca leaves 

and extracts of coca leaves from which 

cocaine, ecgonine and derivatives of 

ecgonine or their salts have been 

removed. 

(4) Cocaine, its salts, optical and 

geometric isomers, and salts of isomers. 

(5) Ecgonine, its derivatives, their 

salts, isomers and salts of isomers. 

(6) Any compound, mixture, or 

preparation which contains any 

quantity of any of the substances 

referred to in paragraphs (1) through (5) 

of this definition. 

Narcotic treatment program means a 

program engaged in maintenance and/or 

detoxification treatment with narcotic 

drugs. 

Net disposal means, for a stated 

period, the quantity of a basic class of 

controlled substance distributed by the 

registrant to another person, plus the 

quantity of that basic class used by the 

registrant in the production of (or 

converted by the registrant into) another 

basic class of controlled substance or a 

noncontrolled substance, plus the 

quantity of that basic class otherwise 

disposed of by the registrant, less the 

quantity of that basic class returned to 

the registrant by any purchaser, and less 

the quantity of that basic class 

distributed by the registrant to another 

registered manufacturer of that basic 

class for purposes other than use in the 

production of, or conversion into, 

another basic class of controlled 

substance or a noncontrolled substance 

or in the manufacture of dosage forms 

of that basic class. 

Person includes any individual, 

corporation, government or 

governmental subdivision or agency, 

business trust, partnership, association, 

or other legal entity. 

Pharmacist means any pharmacist 

licensed by a State to dispense 

controlled substances, and shall include 

any other person (e.g., pharmacist 

intern) authorized by a State to dispense 

controlled substances under the 

supervision of a pharmacist licensed by 

such State. 

Prescription means an order for 

medication which is dispensed to or for 

an ultimate user but does not include an 

order for medication which is dispensed 

for immediate administration to the 

ultimate user (e.g., an order to dispense 

a drug to a bed patient for immediate 

administration in a hospital is not a 

prescription). 

Proceeding means all actions taken for 

the issuance, amendment, or repeal of 

any rule issued pursuant to section 201 

of the Act (21 U.S.C. 811), commencing 

with the publication by the 

Administrator of the proposed rule, 

amended rule, or repeal in the Federal 

Register. 

Purchaser means any registered 

person entitled to obtain and execute 

order forms pursuant to §§ 1305.04 and 

1305.06. 

Readily retrievable means that certain 

records are kept by automatic data 

processing systems or other electronic 

or mechanized recordkeeping systems 

in such a manner that they can be 

separated out from all other records in 

a reasonable time and/or records are 

kept on which certain items are 

asterisked, redlined, or in some other 

manner visually identifiable apart from 

other items appearing on the records. 

Register and registration refer only to 

registration required and permitted by 

sections 303 or 1007 of the Act (21 

U.S.C. 823 or 957). 

Registrant means any person who is 

registered pursuant to either section 303 

or section 1008 of the Act (21 U.S.C. 823 

or 958). 

Reverse distributor means a registrant 

who receives controlled substances 

acquired from another DEA registrant 

for the purpose of— 

(1) Returning unwanted, unusable, or 

outdated controlled substances to the 

manufacturer or the manufacturer’s 

agent; or 

(2) Where necessary, processing such 

substances or arranging for processing 

such substances for disposal. 

Supplier means any registered person 

entitled to fill order forms pursuant to 

§ 1305.06 of this chapter. 

■ 3. In § 1300.02, paragraph (b) is 

revised to read as follows: 

§ 1300.02 Definitions relating to listed 

chemicals. 

* * * * * 

(b) As used in parts 1309, 1310, and 

1313 of this chapter, the following terms 

shall have the meaning specified: 

Act means the Controlled Substances 

Act, as amended (84 Stat. 1242; 21 

U.S.C. 801) and/or the Controlled 

Substances Import and Export Act, as 

amended (84 Stat. 1285; 21 U.S.C. 951). 

Administration means the Drug 

Enforcement Administration. 

Administrator means the 

Administrator of the Drug Enforcement 

Administration. The Administrator has 

been delegated authority under the Act 

by the Attorney General (28 CFR 0.100). 

At retail, with respect to the sale or 

purchase of a scheduled listed chemical 

product, means a sale or purchase for 

personal use, respectively. 

Broker and trader mean any 

individual, corporation, corporate 

division, partnership, association, or 

other legal entity which assists in 

arranging an international transaction in 

a listed chemical by— 

(1) Negotiating contracts; 

(2) Serving as an agent or 

intermediary; or 

(3) Fulfilling a formal obligation to 

complete the transaction by bringing 

together a buyer and seller, a buyer and 

transporter, or a seller and transporter, 

or by receiving any form of 

compensation for so doing. 

Chemical export means transferring 

ownership or control, or the sending or 

taking of threshold quantities of listed 

chemicals out of the United States 

(whether or not such sending or taking 

out constitutes an exportation within 

the meaning of the customs and related 

laws of the United States). 

Chemical exporter is a regulated 

person who, as the principal party in 


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interest in the export transaction, has 

the power and responsibility for 

determining and controlling the sending 

of the listed chemical out of the United 

States. 

Chemical import means with respect 

to a listed chemical, any bringing in or 

introduction of such listed chemical 

into either the jurisdiction of the United 

States or into the customs territory of 

the United States (whether or not such 

bringing in or introduction constitutes 

an importation within the meaning of 

the tariff laws of the United States). 

Chemical importer is a regulated 

person who, as the principal party in 

interest in the import transaction, has 

the power and responsibility for 

determining and controlling the 

bringing in or introduction of the listed 

chemical into the United States. 

Chemical mixture means a 

combination of two or more chemical 

substances, at least one of which is not 

a listed chemical, except that such term 

does not include any combination of a 

listed chemical with another chemical 

that is present solely as an impurity or 

which has been created to evade the 

requirements of the Act. 

Combination ephedrine product 

means a drug product containing 

ephedrine or its salts, optical isomers, or 

salts of optical isomers, and 

therapeutically significant quantities of 

another active medicinal ingredient. 

Customs territory of the United States 

means the several States, the District of 

Columbia, and Puerto Rico. 

Drug product means an active 

ingredient in dosage form that has been 

approved or otherwise may be lawfully 

marketed under the Federal Food, Drug, 

and Cosmetic Act for distribution in the 

United States. 

Encapsulating machine means any 

manual, semi-automatic, or fully 

automatic equipment which may be 

used to fill shells or capsules with any 

powdered, granular, semi-solid, or 

liquid material. 

Established business relationship 

means the regulated person has 

imported or exported a listed chemical 

at least once within the past six months, 

or twice within the past twelve months 

from or to a foreign manufacturer, 

distributor, or end user of the chemical 

that has an established business with a 

fixed street address. A person or 

business that functions as a broker or 

intermediary is not a customer for 

purposes of this definition. 

Established record as an importer 

means that the regulated person has 

imported a listed chemical at least once 

within the past six months, or twice 

within the past twelve months from a 

foreign supplier. 

Hearing means any hearing held for 

the granting, denial, revocation, or 

suspension of a registration pursuant to 

sections 303, 304, and 1008 of the Act 

(21 U.S.C. 823, 824 and 958). 

International transaction means a 

transaction involving the shipment of a 

listed chemical across an international 

border (other than a United States 

border) in which a broker or trader 

located in the United States participates. 

Jurisdiction of the United States 

means the customs territory of the 

United States, the Virgin Islands, the 

Canal Zone, Guam, American Samoa, 

and the Trust Territories of the Pacific 

Islands. 

Listed chemical means any List I 

chemical or List II chemical. 

List I chemical means a chemical 

specifically designated by the 

Administrator in § 1310.02(a) of this 

chapter that, in addition to legitimate 

uses, is used in manufacturing a 

controlled substance in violation of the 

Act and is important to the manufacture 

of a controlled substance. 

List II chemical means a chemical, 

other than a List I chemical, specifically 

designated by the Administrator in 

§ 1310.02(b) of this chapter that, in 

addition to legitimate uses, is used in 

manufacturing a controlled substance in 

violation of the Act. 

Mobile retail vendor means a person 

or entity that makes sales at retail from 

a stand that is intended to be temporary 

or is capable of being moved from one 

location to another, whether the stand is 

located within or on the premises of a 

fixed facility (such as a kiosk at a 

shopping center or an airport) or 

whether the stand is located on 

unimproved real estate (such as a lot or 

field leased for retail purposes). 

Name means the official name, 

common or usual name, chemical name, 

or brand name of a substance. 

Person includes any individual, 

corporation, government or 

governmental subdivision or agency, 

business trust, partnership, association, 

or other legal entity. 

Readily retrievable means that certain 

records are kept by automatic data 

processing systems or other electronic 

or mechanized recordkeeping systems 

in such a manner that they can be 

separated out from all other records in 

a reasonable time and/or records are 

kept on which certain items are 

asterisked, redlined, or in some other 

manner visually identifiable apart from 

other items appearing on the records. 

Register and registration refer only to 

registration required and permitted by 

sections 303 or 1007 of the Act (21 

U.S.C. 823 or 957). 

Registrant means any person who is 

registered pursuant to either section 303 

or section 1008 of the Act (21 U.S.C. 823 

or 958). 

Regular customer means a person 

with whom the regulated person has an 

established business relationship for a 

specified listed chemical or chemicals 

that has been reported to the 

Administration subject to the criteria 

established in part 1313 of this chapter. 

Regular importer means, with respect 

to a listed chemical, a person that has 

an established record as an importer of 

that listed chemical that is reported to 

the Administrator. 

Regulated person means any 

individual, corporation, partnership, 

association, or other legal entity who 

manufactures, distributes, imports, or 

exports a listed chemical, a tableting 

machine, or an encapsulating machine, 

or who acts as a broker or trader for an 

international transaction involving a 

listed chemical, tableting machine, or 

encapsulating machine. 

Regulated seller means a retail 

distributor (including a pharmacy or a 

mobile retail vendor), except that the 

term does not include an employee or 

agent of the distributor. 

Regulated transaction means: 

(1) A distribution, receipt, sale, 

importation, or exportation of a listed 

chemical, or an international transaction 

involving shipment of a listed chemical, 

or if the Administrator establishes a 

threshold amount for a specific listed 

chemical, a threshold amount as 

determined by the Administrator, which 

includes a cumulative threshold amount 

for multiple transactions, of a listed 

chemical, except that such term does 

not include: 

(i) A domestic lawful distribution in 

the usual course of business between 

agents or employees of a single 

regulated person; in this context, agents 

or employees means individuals under 

the direct management and control of 

the regulated person; 

(ii) A delivery of a listed chemical to 

or by a common or contract carrier for 

carriage in the lawful and usual course 

of the business of the common or 

contract carrier, or to or by a 

warehouseman for storage in the lawful 

and usual course of the business of the 

warehouseman, except that if the 

carriage or storage is in connection with 

the distribution, importation, or 

exportation of a listed chemical to a 

third person, this paragraph does not 

relieve a distributor, importer, or 

exporter from compliance with parts 

1309, 1310, 1313, and 1315 of this 

chapter; 

(iii) Any category of transaction or 

any category of transaction for a specific 


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listed chemical or chemicals specified 

by regulation of the Administrator as 

excluded from this definition as 

unnecessary for enforcement of the Act; 

(iv) Any transaction in a listed 

chemical that is contained in a drug 

other than a scheduled listed chemical 

product that may be marketed or 

distributed lawfully in the United States 

under the Federal Food, Drug, and 

Cosmetic Act, subject to paragraph (1)(v) 

of this definition, unless— 

(A) The Administrator has determined 

pursuant to the criteria in § 1310.10 of 

this chapter that the drug or group of 

drugs is being diverted to obtain the 

listed chemical for use in the illicit 

production of a controlled substance; 

and 

(B) The quantity of the listed chemical 

contained in the drug included in the 

transaction or multiple transactions 

equals or exceeds the threshold 

established for that chemical; 

(v) Any transaction in a scheduled 

listed chemical product that is a sale at 

retail by a regulated seller or a 

distributor required to submit reports 

under § 1310.03(c) of this chapter; or 

(vi) Any transaction in a chemical 

mixture designated in §§ 1310.12 and 

1310.13 of this chapter that the 

Administrator has exempted from 

regulation. 

(2) A distribution, importation, or 

exportation of a tableting machine or 

encapsulating machine except that such 

term does not include a domestic lawful 

distribution in the usual course of 

business between agents and employees 

of a single regulated person; in this 

context, agents or employees means 

individuals under the direct 

management and control of the 

regulated person. 

Retail distributor means a grocery 

store, general merchandise store, drug 

store, or other entity or person whose 

activities as a distributor relating to drug 

products containing pseudoephedrine 

or phenylpropanolamine are limited 

almost exclusively to sales for personal 

use, both in number of sales and volume 

of sales, either directly to walk-in 

customers or in face-to-face transactions 

by direct sales. Also for the purposes of 

this paragraph, a ‘‘grocery store’’ is an 

entity within Standard Industrial 

Classification (SIC) code 5411, a 

‘‘general merchandise store’’ is an entity 

within SIC codes 5300 through 5399 

and 5499, and a ‘‘drug store’’ is an entity 

within SIC code 5912. 

Scheduled listed chemical product 

means: 

(1) A product that contains ephedrine, 

pseudoephedrine, or 

phenylpropanolamine and may be 

marketed or distributed lawfully in the 

United States under the Federal Food, 

Drug, and Cosmetic Act as a 

nonprescription drug. Ephedrine, 

pseudoephedrine, and 

phenylpropanolamine include their 

salts, optical isomers, and salts of 

optical isomers. 

(2) Scheduled listed chemical product 

does not include any product that is a 

controlled substance under part 1308 of 

this chapter. In the absence of such 

scheduling by the Attorney General, a 

chemical specified in paragraph (1) of 

this definition may not be considered to 

be a controlled substance. 

Tableting machine means any 

manual, semi-automatic, or fully 

automatic equipment which may be 

used for the compaction or molding of 

powdered or granular solids, or semisolid material, to produce coherent solid 

tablets. 

Valid prescription means a 

prescription that is issued for a 

legitimate medical purpose by an 

individual practitioner licensed by law 

to administer and prescribe the drugs 

concerned and acting in the usual 

course of the practitioner’s professional 

practice. 

PART 1303—QUOTAS 

■ 4. The authority citation for Part 1303 

continues to read as follows: 

Authority: 21 U.S.C. 821, 826, 871(b). 

■ 5. In § 1303.11, the fifth sentence of 

paragraph (c) is revised to read as 

follows: 

§ 1303.11 Aggregate production quotas. 

* * * * * 

(c) * * * In the event the 

Administrator decides to hold such a 

hearing, he shall publish notice of the 

hearing in the Federal Register, which 

notice shall summarize the issue s to be 

heard and shall set the time for the 

hearing which shall not be less than 30 

days after the date of publication of the 

notice. * * * 

PART 1304—RECORDS AND 

REPORTS OF REGISTRANTS 

■ 6. The authority citation for Part 1304 

continues to read as follows: 

Authority: 21 U.S.C. 821, 827, 831, 871(b), 

958(e), 965, unless otherwise noted. 

■ 7. In § 1304.03, the second and fifth 

sentences of paragraph (a) are revised to 

read as follows: 

§ 1304.03 Persons required to keep 

records and file reports. 

(a) * * * Any registrant who is 

authorized to conduct other activities 

without being registered to conduct 

those activities, either pursuant to 

§ 1301.22(b) of this chapter or pursuant 

to §§ 1307.11–1307.13 of this chapter, 

shall maintain the records and 

inventories and shall file the reports 

required by this part for persons 

registered to conduct such activities. 

* * * Also, the Administration does not 

wish to require separate stocks of the 

same substance to be purchased and 

stored for separate activities. * * * 

* * * * * 

PART 1305—ORDERS FOR SCHEDULE 

I AND II CONTROLLED SUBSTANCES 

■ 8. The authority citation for Part 1305 

continues to read as follows: 

Authority: 21 U.S.C. 821, 828, 871(b), 

unless otherwise noted. 

■ 9. In § 1305.03, paragraph (d) is 

revised to read as follows: 

§ 1305.03 Distributions requiring a Form 

222 or a digitally signed electronic order. 

* * * * * 

(d) Delivery from a central fill 

pharmacy, as defined in § 1300.01 of 

this chapter, to a retail pharmacy. 

PART 1306—PRESCRIPTIONS 

■ 10. The authority citation for Part 

1306 continues to read as follows: 

Authority: 21 U.S.C. 821, 829, 831, 871(b), 

unless otherwise noted. 

■ 11. In § 1306.24, the section heading 

is revised to read as follows: 

§ 1306.24 Labeling of substances and 

filling of prescriptions. 

* * * * * 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 12. The authority citation for Part 

1308 continues to read as follows: 

Authority: 21 U.S.C. 811, 812, 871(b), 

unless otherwise noted. 

■ 13. In § 1308.11, paragraph (d)(8) is 

revised to read as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(d) * * * 

(8) 5-methoxy-3,4-methylenedioxyamphetamine 7401 

* * * * * 

■ 14. In § 1308.12, paragraph (b)(4) is 

revised to read as follows: 

§ 1308.12 Schedule II. 

* * * * * 

(b) * * * 

(4) Coca leaves (9040) and any salt, 

compound, derivative or preparation of 

coca leaves (including cocaine (9041) 


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and ecgonine (9180) and their salts, 

isomers, derivatives and salts of isomers 

and derivatives), and any salt, 

compound, derivative, or preparation 

thereof which is chemically equivalent 

or identical with any of these 

substances, except that the substances 

shall not include decocainized coca 

leaves or extraction of coca leaves, 

which extractions do not contain 

cocaine or ecgonine. 

* * * * * 

■ 15. In § 1308.13, paragraph (b) 

introductory text is revised to read as 

follows: 

§ 1308.13 Schedule III. 

* * * * * 

(b) Stimulants. Unless specifically 

excepted or unless listed in another 

schedule, any material, compound, 

mixture, or preparation which contains 

any quantity of the following substances 

having a stimulant effect on the central 

nervous system, including its salts, 

isomers (whether optical, positional, or 

geometric), and salts of such isomers 

whenever the existence of such salts, 

isomers, and salts of isomers is possible 

within the specific chemical 

designation: 

* * * * * 

PART 1309—REGISTRATION OF 

MANUFACTURERS, DISTRIBUTORS, 

IMPORTERS AND EXPORTERS OF 

LIST I CHEMICALS 

■ 16. The authority citation for Part 

1309 continues to read as follows: 

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

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

■ 17. In § 1309.21, paragraph (a)(2) is 

revised to read as follows: 

§ 1309.21 Persons required to register. 

(a) * * * 

(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 paragraph 

(1)(iv) of the definition of regulated 

transaction in § 1300.02 of this chapter. 

* * * * * 

■ 18. In § 1309.24, paragraphs (b), (c), 

and (d) are revised to read as follows: 

§ 1309.24 Waiver of registration 

requirement for certain activities. 

* * * * * 

(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 paragraph 

(1)(iv) of the definition of regulated 

transaction in § 1300.02 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 paragraph (1)(iv) of the 

definition of regulated transaction in 

§ 1300.02 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 paragraph (1)(iv) 

of the definition of regulated transaction 

in § 1300.02 of this chapter. 

* * * * * 

■ 19. In § 1309.62, the second sentence 

of paragraph (a) is revised to read as 

follows: 

§ 1309.62 Termination of registration. 

(a) * * * Any registrant who ceases 

legal existence or discontinues business 

or professional practice shall promptly 

notify the Special Agent in Charge of the 

Administration in the area in which the 

person is located of such fact and seek 

authority and instructions to dispose of 

any List I chemicals obtained under the 

authority of that registration. 

* * * * * 

PART 1310—RECORDS AND 

REPORTS OF LISTED CHEMICALS 

AND CERTAIN MACHINES 

■ 20. The authority citation for Part 

1310 continues to read as follows: 

Authority: 21 U.S.C. 802, 827(h), 830, 

871(b), 890. 

■ 21. In § 1310.04, paragraph (f)(1)(ii) 

and the first sentence of paragraph (g) 

are revised to read as follows: 

§ 1310.04 Maintenance of records. 

* * * * * 

(f) * * * 

(1) * * * 

(ii) For List I chemicals that are 

contained in scheduled listed chemical 

products as defined in § 1300.02 of this 

chapter, the thresholds established in 

paragraph (g) of this section apply only 

to non-retail distribution, import, and 

export. Sales of these products at retail 

are subject to the requirements of part 

1314 of this chapter. 

* * * * * 

(g) For listed chemicals for which no 

thresholds have been established, the 

size of the transaction is not a factor in 

determining whether the transaction 

meets the definition of a regulated 

transaction as set forth in § 1300.02 of 

this chapter. * * * 

* * * * * 

■ 22. In § 1310.05, the fifth sentence of 

paragraph (d) and paragraph (f)(2) are 

revised to read as follows: 

§ 1310.05 Reports. 

* * * * * 

(d) * * * This reporting requirement 

does not apply to drug or other products 

which are exempted under paragraphs 

(1)(iv) or (1)(v) of the definition of 

regulated transaction in § 1300.02 of this 

chapter except as set forth in 

§ 1310.06(h)(5). * * * 

* * * * * 

(f) * * * 

(2) Distributions of drug products by 

retail distributors that may not include 

face-to-face transactions to the extent 

that such distributions are consistent 

with the activities authorized for a retail 

distributor as defined in § 1300.02 of 

this chapter, except that this paragraph 

does not apply to sales of scheduled 

listed chemical products at retail. 

* * * * * 

■ 23. In § 1310.06, paragraphs (e)(1), 

(e)(4), (f)(1), (f)(4), and (h)(5) are revised 

to read as follows: 

§ 1310.06 Content of records and reports. 

* * * * * 

(e) * * * 

(1) The name, address, telephone 

number, and, where available, the 

facsimile number of the regulated 

person; the name, address, telephone 

number, and, where available, the 

facsimile number of the import broker 

or forwarding agent, if any: 

* * * * * 

(4) The name, address, telephone 

number, and, where available, the 

facsimile number of the consignor in the 

foreign country of exportation. 

(f) * * * 

(1) The name, address, telephone 

number, and, where available, the 

facsimile number of the regulated 

person; the name, address, telephone 

number, and, where available, the 

facsimile number of the export broker, 

if any: 

* * * * * 

(4) The name, address, telephone 

number, and, where available, the 

facsimile number of the consignee in the 

country where the shipment is destined; 

the name(s) and address(es) of any 

intermediate consignee(s). 

* * * * * 

(h) * * * 

(5) The aggregate quantity of each 

listed chemical manufactured which 


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becomes a component of a product 

exempted from paragraphs (1)(iv) or 

(1)(v) of the definition of regulated 

transaction in § 1300.02 of this chapter 

during the preceding calendar year. 

* * * * * 

■ 24. In § 1310.09, the first sentence of 

paragraph (b) is revised to read as 

follows: 

§ 1310.09 Temporary exemption from 

registration. 

* * * * * 

(b) Each person required by section 

302 of the Act (21 U.S.C. 822) to obtain 

a registration to distribute, import, or 

export a drug product that contains 

pseudoephedrine or 

phenylpropanolamine that is regulated 

pursuant to paragraph (1)(iv) of the 

definition of regulated transaction in 

§ 1300.02 of this chapter is temporarily 

exempted from the registration 

requirement, provided that the person 

submits a proper application for 

registration on or before December 3, 

1997. * * * 

* * * * * 

■ 25. In § 1310.10, the section heading 

and first sentence of paragraph (a) is 

revised to read as follows: 

§ 1310.10 Removal of the exemption of 

drugs distributed under the Federal Food, 

Drug and Cosmetic Act. 

(a) The Administrator may remove 

from exemption under paragraph (1)(iv) 

of the definition of regulated transaction 

in § 1300.02 of this chapter any drug or 

group of drugs that the Administrator 

finds is being diverted to obtain a listed 

chemical for use in the illicit production 

of a controlled substance.* * * 

* * * * * 

■ 26. In § 1310.14, the introductory 

paragraph is revised to read as follows: 

§ 1310.14 Removal of exemption from 

definition of regulated transaction. 

The Administrator finds that the 

following drugs or groups of drugs are 

being diverted to obtain a listed 

chemical for use in the illicit production 

of a controlled substance and removes 

the drugs or groups of drugs from 

exemption under paragraph (1)(iv) of 

the definition of regulated transaction in 

§ 1300.02 of this chapter pursuant to the 

criteria listed in § 1310.10 of this part: 

* * * * * 

PART 1312—IMPORTATION AND 

EXPORTATION OF CONTROLLED 

SUBSTANCES 

■ 27. The authority citation for Part 

1312 continues to read as follows: 

Authority: 21 U.S.C. 952, 953, 954, 957, 

958. 

■ 28. In § 1312.18, paragraph (d) is 

revised to read as follows: 

§ 1312.18 Contents of import declaration. 

* * * * * 

(d) Notwithstanding the time 

limitations included in paragraph (b) of 

this section, an applicant may obtain a 

special waiver of these time limitations 

in emergency or unusual instances, 

provided that a specific confirmation is 

received from the Administrator or his 

delegate advising the registrant to 

proceed pursuant to the special waiver. 

■ 29. In § 1312.21, paragraph (c) is 

revised to read as follows: 

§ 1312.21 Requirement of authorization to 

export. 

* * * * * 

(c) A separate authorization request is 

obtained for each consignment of such 

controlled substances to be exported. 

■ 30. In § 1312.25, the second sentence 

is revised to read as follows: 

§ 1312.25 Expiration date. 

* * * Any unused export permit 

shall be returned by the permittee to the 

Import/Export Unit for cancellation. 

■ 31. In § 1312.28, paragraph (c) is 

revised to read as follows: 

§ 1312.28 Distribution of special controlled 

substances invoice. 

* * * * * 

(c) Copy 3 shall accompany the 

shipment and will be detached by the 

District Director of the U.S. Customs 

Service at the port of exportation, who 

shall sign and date the certification of 

customs on such Copy 3, noting any 

changes from the entries made by the 

exporter, and shall then promptly 

forward Copy 3 to the Import/Export 

Unit of the Administration. 

* * * * * 

PART 1313—IMPORTATION AND 

EXPORTATION OF LIST I AND LIST II 

CHEMICALS 

■ 32. The authority citation for Part 

1313 continues to read as follows: 

Authority: 21 U.S.C. 802, 830, 871(b), 971. 

■ 33. In § 1313.12, paragraph (d) is 

revised to read as follows: 

§ 1313.12 Requirement of authorization to 

import. 

* * * * * 

(d) For imports where advance 

notification is waived pursuant to 

paragraph (c)(1) of this section, the DEA 

Form 486 must be received by the Drug 

Enforcement Administration, Import/ 

Export Unit, on or before the date of 

importation through use of the mailing 

address listed in § 1313.12(b) or through 

use of electronic facsimile media. 

* * * * * 

■ 34. In § 1313.13, paragraph (c)(1) is 

revised to read as follows: 

§ 1313.13 Contents of import declaration. 

* * * * * 

(c) * * * 

(1) The name, address, telephone 

number, and, where available, the 

facsimile number of the chemical 

importer; the name, address, telephone 

number, and, where available, the 

facsimile number of the broker or 

forwarding agent (if any); and 

* * * * * 

■ 35. In § 1313.14, paragraph (c) is 

revised to read as follows: 

§ 1313.14 Distribution of import 

declaration. 

* * * * * 

(c) Copy 3 shall be presented to the 

U.S. Customs Service along with the 

customs entry. If the import is a 

regulated transaction for which the 15- 

day advance notice requirement has 

been waived, the regulated person shall 

declare this information to the U.S. 

Customs Service Official by checking 

the block on the DEA Form 486 

designated for this purpose. 

■ 36. In § 1313.21, paragraph (c)(1) is 

revised to read as follows: 

§ 1313.21 Requirement of authorization to 

export. 

* * * * * 

(c) * * * 

(1) Any regulated person who has 

satisfied the requirements of § 1313.24 

for reporting to the Administration an 

established business relationship, as 

defined in § 1300.02 of this chapter, 

with a foreign customer. 

* * * * * 

■ 37. In § 1313.24, paragraph (a) is 

revised to read as follows: 

§ 1313.24 Waiver of 15-day advance notice 

for chemical exporters. 

(a) Each regulated person shall 

provide to the Administration the 

identity and information listed in the 

definition of established business 

relationship in § 1300.02 of this chapter 

for an established business relationship 

with a foreign customer not later than 

August 31, 1989. 

* * * * * 

■ 38. In § 1313.31, paragraphs (b)(5) and 

(b)(11) are revised to read as follows: 

§ 1313.31 Advance notice of importation 

for transshipment or transfer. 

* * * * * 

(b) * * * 


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4238 Federal Register / Vol. 77, No. 18 / Friday, January 27, 2012 / Rules and Regulations 

(5) The net weight of each listed 

chemical given in kilograms or parts 

thereof; 

* * * * * 

(11) The name, address, business, 

telephone number, and, where 

available, the facsimile number of the 

importer, transferor, or transshipper; 

* * * * * 

■ 39. In § 1313.32, paragraph (b)(2) is 

revised to read as follows: 

§ 1313.32 Requirement of authorization for 

international transactions. 

* * * * * 

(b) * * * 

(2) A copy of the DEA Form 486 may 

be transmitted directly to the Drug 

Enforcement Administration, Import/ 

Export Unit, through electronic 

facsimile media not later than 15 days 

prior to the exportation. 

* * * * * 

■ 40. In § 1313.33, paragraphs (c)(1) and 

(c)(4) are revised to read as follows: 

§ 1313.33 Contents of an international 

transaction declaration. 

* * * * * 

(c) * * * 

(1) The name, address, telephone 

number, and, where available, the 

facsimile number of the chemical 

exporter; the name, address, telephone 

number, and, where available, the 

facsimile number of the chemical 

importer; 

* * * * * 

(4) The name, address, telephone 

number, and, where available, the 

facsimile number of the consignee in the 

country where the chemical shipment is 

destined; the name(s) and address(es) of 

any intermediate consignee(s). 

PART 1314—RETAIL SALE OF 

SCHEDULED LISTED CHEMICAL 

PRODUCTS 

■ 41. The authority citation for Part 

1314 continues to read as follows: 

Authority: 21 U.S.C. 802, 830, 842, 871(b), 

875, 877, 886a. 

■ 42. In § 1314.45, the introductory 

paragraph is revised to read as follows: 

§ 1314.45 Privacy protections. 

To protect the privacy of individuals 

who purchase scheduled listed 

chemical products, the disclosure of 

information in logbooks under § 1314.30 

is restricted as follows: 

* * * * * 

■ 43. In § 1314.115, paragraph (a)(2) is 

revised to read as follows: 

§ 1314.115 Distributions not subject to 

reporting requirements. 

(a) * * * 

(2) Distributions by retail distributors 

that may not include face-to-face 

transactions to the extent that such 

distributions are consistent with the 

activities authorized for a retail 

distributor as specified in the definition 

of retail distributor in § 1300.02 of this 

chapter, except that this paragraph (a)(2) 

does not apply to sales of scheduled 

listed chemical products at retail. 

* * * * * 

PART 1316—ADMINISTRATIVE 

FUNCTIONS, PRACTICES, AND 

PROCEDURES 

■ 44. The authority citation for Subpart 

A of Part 1316 continues to read as 

follows: 

Authority: 21 U.S.C. 822(f), 830(a), 871(b), 

880, 958(f), 965. 

■ 45. In § 1316.03, paragraph (d) is 

revised to read as follows: 

§ 1316.03 Authority to make inspections. 

* * * * * 

(d) Collecting samples of controlled 

substances or listed chemicals (in the 

event any samples are collected during 

an inspection, the inspector shall issue 

a receipt for such samples on DEA Form 

400 to the owner, operator, or agent in 

charge of the premises); 

* * * * * 

■ 46. The authority citation for Subpart 

D of Part 1316 continues to read as 

follows: 

Authority: 21 U.S.C. 811, 812, 871(b), 875, 

958(d), 965. 

■ 47. In § 1316.42, paragraph (g) is 

revised to read as follows: 

§ 1316.42 Definitions. 

* * * * * 

(g) The term proceeding means all 

actions involving a hearing, 

commencing with the publication by the 

Administrator of the notice of proposed 

rulemaking or the issuance of an order 

to show cause. 

* * * * * 

Dated: January 13, 2012. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control. 

[FR Doc. 2012–1150 Filed 1–26–12; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF STATE 

22 CFR Part 8 

RIN 1400–AC64 

[Public Notice 7773] 

Advisory Committee Management 

AGENCY: Department of State. 

ACTION: Final rule. 

SUMMARY: This final rule removes 

regulations which implement the 

Federal Advisory Committee Act 

(FACA) for the Department of State. The 

Department of State implementation of 

FACA is now governed by the rules 

promulgated by GSA and internal policy 

guidance in the Foreign Affairs Manual. 

DATES: Effective Date: This rule is 

effective on February 27, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Alice Kottmyer, Office of the Legal 

Adviser, who may be reached at (202) 

647–2318. 

SUPPLEMENTARY INFORMATION: Pursuant 

to Section 8(a) of the Federal Advisory 

Committee Act (FACA), 5 U.S.C. 

Appendix, agency heads are required to 

establish uniform administrative 

guidelines and management controls for 

advisory committees established by that 

agency. 

The Department of State first finalized 

its rules, codified at 22 CFR Part 8, in 

1975. Since then, GSA has promulgated 

comprehensive guidance at 41 CFR Part 

102–3, and the Department recently 

published updated internal guidance 

that implements FACA and the GSA 

regulations. The Department guidance is 

in Volume 11 of the Foreign Affairs 

Manual, and can be found at: http:// 

www.state.gov/documents/organization/ 

176811.pdf. The provisions of Part 8 are 

obsolete and are hereby removed. 

Regulatory Analyses 

Administrative Procedure Act 

Removing 22 CFR part 8 is a decision 

regarding the Department’s 

organization, procedure, or practice and 

is not subject to the notice-andcomment procedures of 5 U.S.C. 553(b). 

Regulatory Flexibility Act/Executive 

Order 13272: Small Business 

The Department certifies that this 

rulemaking is not expected to have a 

significant impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act, 

5 U.S.C. 601–612, and Executive Order 

13272, section 3(b). 


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