[Federal Register Volume 77, Number 18 (Friday, January 27, 2012)]
[Rules and Regulations]
[Pages 4228-4238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-1150]
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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.
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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
[[Page 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 Sec. 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 17[alpha]-methyl-
[Delta]1-dihydrotestosterone;
In Sec. 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 Sec. 1303.11(c), correcting the spelling
of ``nnt'' to be ``not'';
In the second sentence of Sec. 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 Sec. 1305.03(d), updating the reference to reflect the new
organization of Sec. 1300.01;
In the heading for Sec. 1306.24, correcting the spelling of
``filing'' to be ``filling'';
In Sec. 1308.11(d)(8), correcting the spelling of
``mdthylenedioxy'' to be``methylenedioxy'';
In Sec. 1308.12(b)(4), correcting the spelling of ``whhch'' to be
``which'';
In Sec. 1308.13(b), correcting the spelling of ``sxstem'' to be
``system'' and correcting the term ``position'' to be ``positional'';
In Sec. Sec. 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 Sec. 1300.02;
In the second sentence of Sec. 1309.62(a), correcting the spelling
of ``cases'' to be ``ceases'';
In the heading of Sec. 1310.10, adding ``Federal'' at the
beginning of ``Food, Drug, and Cosmetic Act'';
In Sec. 1312.18(d), correcting the citation from ``paragraph (a)''
to ``paragraph (b)'';
In Sec. 1312.21(c), correcting the spelling of ``repuest'' to be
``request'';
In Sec. Sec. 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 Sec. 1313.14(c), correcting the spelling of ``Sevice'' to be
``Service'';
In Sec. 1313.31(b)(5), correcting the word ``new'' to be ``net'';
In Sec. 1314.45, correcting the citation from ``1314.15'' to
``1314.30'';
In Sec. 1316.03(d), correcting and updating the reference from
``DEA Form 84'' to ``DEA Form 400''; and
In Sec. 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
[[Page 4230]]
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 foreign-based 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
0
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).
0
2. In Sec. 1300.01, paragraph (b) is revised to read as follows:
Sec. 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) 3[beta],17-dihydroxy-5a-androstane
(2) 3[alpha],17[beta]-dihydroxy-5a-androstane
(3) 5[alpha]-androstan-3,17-dione
(4) 1-androstenediol (3[beta],17[beta]-dihydroxy-5[alpha]-androst-1-
ene)
(5) 1-androstenediol (3[alpha],17[beta]-dihydroxy-5[alpha]-androst-1-
ene)
(6) 4-androstenediol (3[beta],17[beta]-dihydroxy-androst-4-ene)
(7) 5-androstenediol (3[beta],17[beta]-dihydroxy-androst-5-ene)
(8) 1-androstenedione ([5[alpha]]-androst-1-en-3,17-dione)
(9) 4-androstenedione (androst-4-en-3,17-dione)
(10) 5-androstenedione (androst-5-en-3,17-dione)
(11) bolasterone (7[alpha],17[alpha]-dimethyl-17[beta]-hydroxyandrost-
4-en-3-one)
(12) boldenone (17[beta]-hydroxyandrost-1,4-diene-3-one)
(13) boldione (androsta-1,4-diene-3,17-dione)
(14) calusterone (7[beta],17[alpha]-dimethyl-17[beta]-hydroxyandrost-4-
en-3-one)
(15) clostebol (4-chloro-17[beta]-hydroxyandrost-4-en-3-one)
(16) dehydrochloromethyltestosterone (4-chloro-17[beta]-hydroxy-
17[alpha]-methyl-androst-1,4-dien-3-one)
(17) desoxymethyltestosterone (17[alpha]-methyl-5[alpha]-androst-2-en-
17[beta]-ol) (a.k.a. `madol')
(18) [Delta]1-dihydrotestosterone (a.k.a.`1-testosterone') (17[beta]-
hydroxy-5[alpha]-androst-1-en-3-one)
(19) 4-dihydrotestosterone (17[beta]-hydroxy-androstan-3-one)
(20) drostanolone (17[beta]-hydroxy-2[alpha]-methyl-5[alpha]-androstan-
3-one)
(21) ethylestrenol (17[alpha]-ethyl-17[beta]-hydroxyestr-4-ene)
(22) fluoxymesterone (9-fluoro-17[alpha]-methyl-11[beta],17[beta]-
dihydroxyandrost-4-en-3-one)
(23) formebolone (2-formyl-17[alpha]-methyl-11[alpha],17[beta]-
dihydroxyandrost-1,4-dien-3-one)
(24) furazabol (17[alpha]-methyl-17[beta]-hydroxyandrostano[2,3-c]-
furazan)
(25) 13[beta]-ethyl-17[beta]-hydroxygon-4-en-3-one
(26) 4-hydroxytestosterone (4,17[beta]-dihydroxy-androst-4-en-3-one)
(27) 4-hydroxy-19-nortestosterone (4,17[beta]-dihydroxy-estr-4-en-3-
one)
(28) mestanolone (17[alpha]-methyl-17[beta]-hydroxy-5-androstan-3-one)
(29) mesterolone (1[alpha]-methyl-17[beta]-hydroxy-[5[alpha]]-
androstan-3-one)
(30) methandienone (17[alpha]-methyl-17[beta]-hydroxyandrost-1,4-dien-
3-one)
(31) methandriol (17[alpha]-methyl-3[beta],17[beta]-dihydroxyandrost-5-
ene)
(32) methenolone (1-methyl-17[beta]-hydroxy-5[alpha]-androst-1-en-3-
one)
(33) 17[alpha]-methyl-3[beta],17[beta]-dihydroxy-5a-androstane
(34) 17[alpha]-methyl-3[alpha],17[beta]-dihydroxy-5a-androstane
(35) 17[alpha]-methyl-3[beta],17[beta]-dihydroxyandrost-4-ene
(36) 17[alpha]-methyl-4-hydroxynandrolone (17[alpha]-methyl-4-hydroxy-
17[beta]-hydroxyestr-4-en-3-one)
(37) methyldienolone (17[alpha]-methyl-17[beta]-hydroxyestra-4,9(10)-
dien-3-one)
(38) methyltrienolone (17[alpha]-methyl-17[beta]-hydroxyestra-4,9,11-
trien-3-one)
(39) methyltestosterone (17[alpha]-methyl-17[beta]-hydroxyandrost-4-en-
3-one)
(40) mibolerone (7[alpha],17[alpha]-dimethyl-17[beta]-hydroxyestr-4-en-
3-one)
(41) 17[alpha]-methyl-[Delta]1-dihydrotestosterone (17[beta]-hydroxy-
17[alpha]-methyl-5[alpha]-androst-1-en-3-one) (a.k.a. `17-[alpha]-
methyl-1-testosterone')
[[Page 4231]]
(42) nandrolone (17[beta]-hydroxyestr-4-en-3-one)
(43) 19-nor-4-androstenediol (3[beta], 17[beta]-dihydroxyestr-4-ene)
(44) 19-nor-4-androstenediol (3[alpha], 17[beta]-dihydroxyestr-4-ene)
(45) 19-nor-5-androstenediol (3[beta], 17[beta]-dihydroxyestr-5-ene)
(46) 19-nor-5-androstenediol (3[alpha], 17[beta]-dihydroxyestr-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 (13[beta], 17[alpha]-diethyl-17[beta]-hydroxygon-4-
en-3-one)
(51) norclostebol (4-chloro-17[beta]-hydroxyestr-4-en-3-one)
(52) norethandrolone (17[alpha]-ethyl-17[beta]-hydroxyestr-4-en-3-one)
(53) normethandrolone (17[alpha]-methyl-17[beta]-hydroxyestr-4-en-3-
one)
(54) oxandrolone (17[alpha]-methyl-17[beta]-hydroxy-2-oxa-[5[alpha]]-
androstan-3-one)
(55) oxymesterone (17[alpha]-methyl-4,17[beta]-dihydroxyandrost-4-en-3-
one)
(56) oxymetholone (17[alpha]-methyl-2-hydroxymethylene-17[beta]-
hydroxy-[5[alpha]]-androstan-3-one)
(57) stanozolol (17[alpha]-methyl-17[beta]-hydroxy-[5[alpha]]-androst-
2-eno[3,2-c]-pyrazole)
(58) stenbolone (17[beta]-hydroxy-2-methyl-[5[alpha]]-androst-1-en-3-
one)
(59) testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic
acid lactone)
(60) testosterone (17[beta]-hydroxyandrost-4-en-3-one)
(61) tetrahydrogestrinone (13[beta], 17[alpha]-diethyl-17[beta]-
hydroxygon-4,9,11-trien-3-one)
(62) trenbolone (17[beta]-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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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
Sec. 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.
[[Page 4232]]
(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
Sec. 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 Sec. 1308.11(d) and
Sec. 1308.12(b)(4) of this chapter. As used in Sec. 1308.11(d) of
this chapter, the term ``isomer'' means any optical, positional, or
geometric isomer. As used in Sec. 1308.12(b)(4) of this chapter, the
term ``isomer'' means any optical or geometric isomer;
(2) As used in Sec. 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,N-diethyl to N-
methyl-N-propyl, or alpha-methylamino 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
[[Page 4233]]
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 Sec. Sec. 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 Sec. 1305.06 of this chapter.
0
3. In Sec. 1300.02, paragraph (b) is revised to read as follows:
Sec. 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
[[Page 4234]]
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 Sec. 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 Sec. 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
[[Page 4235]]
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
Sec. 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 Sec. 1310.03(c) of this chapter; or
(vi) Any transaction in a chemical mixture designated in Sec. Sec.
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 semi-solid 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
0
4. The authority citation for Part 1303 continues to read as follows:
Authority: 21 U.S.C. 821, 826, 871(b).
0
5. In Sec. 1303.11, the fifth sentence of paragraph (c) is revised to
read as follows:
Sec. 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
0
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.
0
7. In Sec. 1304.03, the second and fifth sentences of paragraph (a)
are revised to read as follows:
Sec. 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 Sec. 1301.22(b) of this chapter or pursuant to Sec. Sec.
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
0
8. The authority citation for Part 1305 continues to read as follows:
Authority: 21 U.S.C. 821, 828, 871(b), unless otherwise noted.
0
9. In Sec. 1305.03, paragraph (d) is revised to read as follows:
Sec. 1305.03 Distributions requiring a Form 222 or a digitally signed
electronic order.
* * * * *
(d) Delivery from a central fill pharmacy, as defined in Sec.
1300.01 of this chapter, to a retail pharmacy.
PART 1306--PRESCRIPTIONS
0
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.
0
11. In Sec. 1306.24, the section heading is revised to read as
follows:
Sec. 1306.24 Labeling of substances and filling of prescriptions.
* * * * *
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
12. The authority citation for Part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.
0
13. In Sec. 1308.11, paragraph (d)(8) is revised to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(d) * * *
(8) 5-methoxy-3,4-methylenedioxy-amphetamine 7401
* * * * *
0
14. In Sec. 1308.12, paragraph (b)(4) is revised to read as follows:
Sec. 1308.12 Schedule II.
* * * * *
(b) * * *
(4) Coca leaves (9040) and any salt, compound, derivative or
preparation of coca leaves (including cocaine (9041)
[[Page 4236]]
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.
* * * * *
0
15. In Sec. 1308.13, paragraph (b) introductory text is revised to
read as follows:
Sec. 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
0
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.
0
17. In Sec. 1309.21, paragraph (a)(2) is revised to read as follows:
Sec. 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 Sec. 1300.02 of this
chapter.
* * * * *
0
18. In Sec. 1309.24, paragraphs (b), (c), and (d) are revised to read
as follows:
Sec. 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 Sec. 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 Sec.
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 Sec. 1300.02 of this chapter.
* * * * *
0
19. In Sec. 1309.62, the second sentence of paragraph (a) is revised
to read as follows:
Sec. 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
0
20. The authority citation for Part 1310 continues to read as follows:
Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890.
0
21. In Sec. 1310.04, paragraph (f)(1)(ii) and the first sentence of
paragraph (g) are revised to read as follows:
Sec. 1310.04 Maintenance of records.
* * * * *
(f) * * *
(1) * * *
(ii) For List I chemicals that are contained in scheduled listed
chemical products as defined in Sec. 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 Sec. 1300.02 of this chapter. * * *
* * * * *
0
22. In Sec. 1310.05, the fifth sentence of paragraph (d) and paragraph
(f)(2) are revised to read as follows:
Sec. 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 Sec. 1300.02 of this
chapter except as set forth in Sec. 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 Sec. 1300.02 of this chapter, except
that this paragraph does not apply to sales of scheduled listed
chemical products at retail.
* * * * *
0
23. In Sec. 1310.06, paragraphs (e)(1), (e)(4), (f)(1), (f)(4), and
(h)(5) are revised to read as follows:
Sec. 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
[[Page 4237]]
becomes a component of a product exempted from paragraphs (1)(iv) or
(1)(v) of the definition of regulated transaction in Sec. 1300.02 of
this chapter during the preceding calendar year.
* * * * *
0
24. In Sec. 1310.09, the first sentence of paragraph (b) is revised to
read as follows:
Sec. 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 Sec. 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. * *
*
* * * * *
0
25. In Sec. 1310.10, the section heading and first sentence of
paragraph (a) is revised to read as follows:
Sec. 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 Sec. 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.* * *
* * * * *
0
26. In Sec. 1310.14, the introductory paragraph is revised to read as
follows:
Sec. 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 Sec. 1300.02 of this chapter pursuant to the
criteria listed in Sec. 1310.10 of this part:
* * * * *
PART 1312--IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES
0
27. The authority citation for Part 1312 continues to read as follows:
Authority: 21 U.S.C. 952, 953, 954, 957, 958.
0
28. In Sec. 1312.18, paragraph (d) is revised to read as follows:
Sec. 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.
0
29. In Sec. 1312.21, paragraph (c) is revised to read as follows:
Sec. 1312.21 Requirement of authorization to export.
* * * * *
(c) A separate authorization request is obtained for each
consignment of such controlled substances to be exported.
0
30. In Sec. 1312.25, the second sentence is revised to read as
follows:
Sec. 1312.25 Expiration date.
* * * Any unused export permit shall be returned by the permittee
to the Import/Export Unit for cancellation.
0
31. In Sec. 1312.28, paragraph (c) is revised to read as follows:
Sec. 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
0
32. The authority citation for Part 1313 continues to read as follows:
Authority: 21 U.S.C. 802, 830, 871(b), 971.
0
33. In Sec. 1313.12, paragraph (d) is revised to read as follows:
Sec. 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
Sec. 1313.12(b) or through use of electronic facsimile media.
* * * * *
0
34. In Sec. 1313.13, paragraph (c)(1) is revised to read as follows:
Sec. 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
* * * * *
0
35. In Sec. 1313.14, paragraph (c) is revised to read as follows:
Sec. 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.
0
36. In Sec. 1313.21, paragraph (c)(1) is revised to read as follows:
Sec. 1313.21 Requirement of authorization to export.
* * * * *
(c) * * *
(1) Any regulated person who has satisfied the requirements of
Sec. 1313.24 for reporting to the Administration an established
business relationship, as defined in Sec. 1300.02 of this chapter,
with a foreign customer.
* * * * *
0
37. In Sec. 1313.24, paragraph (a) is revised to read as follows:
Sec. 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 Sec. 1300.02 of this chapter for an
established business relationship with a foreign customer not later
than August 31, 1989.
* * * * *
0
38. In Sec. 1313.31, paragraphs (b)(5) and (b)(11) are revised to read
as follows:
Sec. 1313.31 Advance notice of importation for transshipment or
transfer.
* * * * *
(b) * * *
[[Page 4238]]
(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;
* * * * *
0
39. In Sec. 1313.32, paragraph (b)(2) is revised to read as follows:
Sec. 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.
* * * * *
0
40. In Sec. 1313.33, paragraphs (c)(1) and (c)(4) are revised to read
as follows:
Sec. 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
0
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.
0
42. In Sec. 1314.45, the introductory paragraph is revised to read as
follows:
Sec. 1314.45 Privacy protections.
To protect the privacy of individuals who purchase scheduled listed
chemical products, the disclosure of information in logbooks under
Sec. 1314.30 is restricted as follows:
* * * * *
0
43. In Sec. 1314.115, paragraph (a)(2) is revised to read as follows:
Sec. 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 Sec. 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
0
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.
0
45. In Sec. 1316.03, paragraph (d) is revised to read as follows:
Sec. 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);
* * * * *
0
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.
0
47. In Sec. 1316.42, paragraph (g) is revised to read as follows:
Sec. 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