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Title 21
Food and Drugs
Part 1300 to End
Revised as of April 1, 2014
Containing a codification of documents
of general applicability and future effect
As of April 1, 2014
Published by the Office of the Federal Register
National Archives and Records Administration
as a Special Edition of the Federal Register
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U.S. GOVERNMENT OFFICIAL EDITION NOTICE
Legal Status and Use of Seals and Logos
The seal of the National Archives and Records Administration
(NARA) authenticates the Code of Federal Regulations (CFR)
as
the official codification of Federal regulations established
under
the Federal Register Act. Under the provisions of 44 U.S.C.
1507, the
contents of the CFR, a special edition of the Federal Register,
shall
be judicially noticed. The CFR is prima facie evidence of the
origi-
nal documents published in the Federal Register (44 U.S.C.
1510).
It is prohibited to use NARAs official seal and the stylized
Code
of Federal Regulations logo on any republication of this
material
without the express, written permission of the Archivist of
the
United States or the Archivists designee. Any person using
NARAs official seals and logos in a manner inconsistent with
the
provisions of 36 CFR part 1200 is subject to the penalties
specified
in 18 U.S.C. 506, 701, and 1017.
Use of ISBN Prefix
This is the Official U.S. Government edition of this
publication
and is herein identified to certify its authenticity. Use of the
016
ISBN prefix is for U.S. Government Printing Office Official
Edi-
tions only. The Superintendent of Documents of the U.S.
Govern-
ment Printing Office requests that any reprinted edition clearly
be
labeled as a copy of the authentic work with a new ISBN.
U . S. G O VE R NM E NT P R IN T IN G O F FI C E
U.S. Superintendent of Documents Washington, DC 204020001
http://bookstore.gpo.gov
Phone: toll-free (866) 512-1800; DC area (202) 512-1800
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iii
Table of ContentsPage
Explanation
................................................................................................
v
Title 21:
Chapter IIDrug Enforcement Administration, Department of
Justice
.........................................................................................
3
Chapter IIIOffice of National Drug Control Policy
...................... 245
Finding Aids:
Table of CFR Titles and Chapters
....................................................... 317
Alphabetical List of Agencies Appearing in the CFR
......................... 337
List of CFR Sections Affected
.............................................................
347
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Cite this Code: CFR
To cite the regulations in
this volume use title,part and section num-
ber. Thus, 21 CFR1300.01 refers to title 21,part 1300, section
01.
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Explanation
The Code of Federal Regulations is a codification of the general
and permanent
rules published in the Federal Register by the Executive
departments and agen-
cies of the Federal Government. The Code is divided into 50
titles which represent
broad areas subject to Federal regulation. Each title is divided
into chapters
which usually bear the name of the issuing agency. Each chapter
is further sub-divided into parts covering specific regulatory
areas.
Each volume of the Code is revised at least once each calendar
year and issued
on a quarterly basis approximately as follows:
Title 1 through Title
16..............................................................as
of January 1
Title 17 through Title 27
.................................................................as
of April 1
Title 28 through Title 41
..................................................................as
of July 1
Title 42 through Title 50
.............................................................as of
October 1
The appropriate revision date is printed on the cover of each
volume.
LEGAL STATUS
The contents of the Federal Register are required to be
judicially noticed (44
U.S.C. 1507). The Code of Federal Regulations is prima facie
evidence of the text
of the original documents (44 U.S.C. 1510).
HOW TO USE THE CODE OF FEDERAL REGULATIONS
The Code of Federal Regulations is kept up to date by the
individual issues
of the Federal Register. These two publications must be used
together to deter-
mine the latest version of any given rule.
To determine whether a Code volume has been amended since its
revision date
(in this case, April 1, 2014), consult the List of CFR Sections
Affected (LSA),
which is issued monthly, and the Cumulative List of Parts
Affected, which
appears in the Reader Aids section of the daily Federal
Register. These two lists
will identify the Federal Register page number of the latest
amendment of any
given rule.
EFFECTIVE AND EXPIRATION DATES
Each volume of the Code contains amendments published in the
Federal Reg-
ister since the last revision of that volume of the Code. Source
citations for
the regulations are referred to by volume number and page number
of the Federal
Register and date of publication. Publication dates and
effective dates are usu-
ally not the same and care must be exercised by the user in
determining the
actual effective date. In instances where the effective date is
beyond the cut-
off date for the Code a note has been inserted to reflect the
future effective
date. In those instances where a regulation published in the
Federal Register
states a date certain for expiration, an appropriate note will
be inserted following
the text.
OMB CONTROL NUMBERS
The Paperwork Reduction Act of 1980 (Pub. L. 96511) requires
Federal agencies
to display an OMB control number with their information
collection request.
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Many agencies have begun publishing numerous OMB control numbers
as amend-
ments to existing regulations in the CFR. These OMB numbers are
placed as
close as possible to the applicable recordkeeping or reporting
requirements.
PAST PROVISIONS OF THE CODE
Provisions of the Code that are no longer in force and effect as
of the revision
date stated on the cover of each volume are not carried. Code
users may find
the text of provisions in effect on any given date in the past
by using the appro-
priate List of CFR Sections Affected (LSA). For the convenience
of the reader,
a List of CFR Sections Affected is published at the end of each
CFR volume.
For changes to the Code prior to the LSA listings at the end of
the volume,
consult previous annual editions of the LSA. For changes to the
Code prior to
2001, consult the List of CFR Sections Affected compilations,
published for 1949-
1963, 1964-1972, 1973-1985, and 1986-2000.
[RESERVED] TERMINOLOGY
The term [Reserved] is used as a place holder within the Code of
Federal
Regulations. An agency may add regulatory information at a
[Reserved] loca-
tion at any time. Occasionally [Reserved] is used editorially to
indicate that
a portion of the CFR was left vacant and not accidentally
dropped due to a print-
ing or computer error.
INCORPORATION BY REFERENCE
What is incorporation by reference? Incorporation by reference
was established
by statute and allows Federal agencies to meet the requirement
to publish regu-
lations in the Federal Register by referring to materials
already published else-
where. For an incorporation to be valid, the Director of the
Federal Register
must approve it. The legal effect of incorporation by reference
is that the mate-
rial is treated as if it were published in full in the Federal
Register (5 U.S.C.
552(a)). This material, like any other properly issued
regulation, has the force
of law.
What is a proper incorporation by reference? The Director of the
Federal Register
will approve an incorporation by reference only when the
requirements of 1 CFR
part 51 are met. Some of the elements on which approval is based
are:
(a) The incorporation will substantially reduce the volume of
material pub-
lished in the Federal Register.
(b) The matter incorporated is in fact available to the extent
necessary to
afford fairness and uniformity in the administrative
process.
(c) The incorporating document is drafted and submitted for
publication in
accordance with 1 CFR part 51.
What if the material incorporated by reference cannot be found?
If you have any
problem locating or obtaining a copy of material listed as an
approved incorpora-
tion by reference, please contact the agency that issued the
regulation containing
that incorporation. If, after contacting the agency, you find
the material is not
available, please notify the Director of the Federal Register,
National Archives
and Records Administration, 8601 Adelphi Road, College Park, MD
20740-6001, or
call 202-741-6010.
CFR INDEXES AND TABULAR GUIDES
A subject index to the Code of Federal Regulations is contained
in a separate
volume, revised annually as of January 1, entitled CFR I NDEX
AND FINDING AIDS.
This volume contains the Parallel Table of Authorities and
Rules. A list of CFR
titles, chapters, subchapters, and parts and an alphabetical
list of agencies pub-
lishing in the CFR are also included in this volume.
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THIS TITLE
Title 21FOOD AND DRUGS is composed of nine volumes. The parts in
these
volumes are arranged in the following order: Parts 199, 100169,
170199, 200299,
300499, 500599, 600799, 8001299 and 1300 to end. The first eight
volumes, con-
taining parts 11299, comprise Chapter IFood and Drug
Administration, Depart-
ment of Health and Human Services. The ninth volume, containing
part 1300 toend, includes Chapter IIDrug Enforcement
Administration, Department of Jus-
tice, and Chapter IIIOffice of National Drug Control Policy. The
contents of
these volumes represent all current regulations codified under
this title of the
CFR as of April 1, 2014.
For this volume, Michele Bugenhagen was Chief Editor. The Code
of Federal
Regulations publication program is under the direction of the
Managing Editor,
assisted by Ann Worley.
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Title 21Food and Drugs(This book contains part 1300 to End)
Part
CHAPTER IIDrug Enforcement Administration, Depart-ment of
Justice
..................................................................
1301
CHAPTER IIIOffice of National Drug Control Policy ............
1401
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CHAPTER IIDRUG ENFORCEMENT
ADMINISTRATION, DEPARTMENT OF JUSTICE
Part Page
1300 Definitions
..............................................................
51301 Registration of manufacturers, distributors, and
dispensers of controlled substances ..................... 211302
Labeling and packaging requirements for con-
trolled substances
................................................ 541303 Quotas
.....................................................................
561304 Records and reports of registrants
.......................... 641305 Orders for schedule I and II
controlled substances 821306 Prescriptions
........................................................... 901307
Miscellaneous
.......................................................... 1021308
Schedules of controlled substances .........................
1051309 Registration of manufacturers, distributors, im-
porters and exporters of list I chemicals .............. 1291310
Records and reports of listed chemicals and certainmachines
..............................................................
140
1311 Requirements for electronic orders and prescrip-tions
.....................................................................
164
1312 Importation and exportation of controlled sub-stances
.................................................................
185
1313 Importation and exportation of list I and list IIchemicals
.............................................................
199
1314 Retail sale of scheduled listed chemical products ...
2101315 Importation and production quotas for ephedrine,
pseudoephedrine, and phenylpropanolamine ........ 2181316
Administrative functions, practices, and proce-
dures
.....................................................................
228
1321 DEA Mailing addresses
............................................ 24113221399
[Reserved]
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PART 1300DEFINITIONS
Sec.1300.01 Definitions relating to controlled
substances.1300.02 Definitions relating to listed chemi-
cals.1300.03 Definitions relating to electronic or-
ders for controlled substances and elec-tronic prescriptions for
controlled sub-stances.
1300.04 Definitions relating to the dis-pensing of controlled
substances bymeans of the Internet.
AUTHORITY: 21 U.S.C. 802, 821, 829, 871(b),
951, 958(f).
SOURCE: 62 FR 13941, Mar. 24, 1997, unlessotherwise noted.
1300.01 Definitions relating to con-trolled substances.
(a) Any term not defined in this partshall have the definition
set forth insection 102 of the Act (21 U.S.C. 802),except that
certain terms used in part1316 of this chapter are defined at
thebeginning of each subpart of that part.
(b) As used in parts 1301 through 1308and part 1312 of this
chapter, the fol-lowing terms shall have the meaningsspecified:
Act means the Controlled Substances
Act, as amended (84 Stat. 1242; 21 U.S.C.801) and/or the
Controlled SubstancesImport and Export Act, as amended (84Stat.
1285; 21 U.S.C. 951).
Administration means the Drug En-forcement Administration.
Administrator means the Adminis-trator of the Drug Enforcement
Admin-istration. The Administrator has beendelegated authority
under the Act bythe Attorney General (28 CFR 0.100).
Anabolic steroid means any drug orhormonal substance, chemically
andpharmacologically related to testos-terone (other than
estrogens,progestins, corticosteroids, anddehydroepiandrosterone),
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-dihydroxy-
5a-androst-1-ene)(5) 1-androstenediol (3a,17b-dihydroxy-
5a-androst-1-ene)(6) 4-androstenediol (3b,17b-dihydroxy-
androst-4-ene)(7) 5-androstenediol (3b,17b-dihydroxy-
androst-5-ene)
(8) 1-androstenedione ([5a]-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
(7a,17a-dimethyl-17b-hydroxyandrost-4-en-3-one)
(12) boldenone (17b-hydroxyandrost-1,4-diene-3-one)
(13) boldione (androsta-1,4-diene-3,17-dione)
(14) calusterone
(7b,17a-dimethyl-17b-hydroxyandrost-4-en-3-one)
(15) clostebol (4-chloro-17b-hydroxyandrost-4-en-3-one)
(16)
dehydrochloromethyltestosterone(4-chloro-17b-hydroxy-17a-methyl-androst-1,4-dien-3-one)
(17) desoxymethyltestosterone
(17a-methyl-5a-androst-2-en-17b-ol)(a.k.a. madol)
(18) D1-dihydrotestosterone (a.k.a.1-testosterone)
(17b-hydroxy-5a-androst-1-en-3-one)
(19) 4-dihydrotestosterone (17b-hy-droxy-androstan-3-one)
(20) drostanolone (17b-hydroxy-2a-methyl-5a-androstan-3-one)
(21) ethylestrenol (17a-ethyl-17b-hydroxyestr-4-ene)
(22) fluoxymesterone
(9-fluoro-17a-methyl-11b,17b-dihydroxyandrost-4-en-3-one)
(23) formebolone
(2-formyl-17a-methyl-11a,17b-dihydroxyandrost-1,4-dien-3-one)
(24) furazabol
(17a-methyl-17b-hydroxyandrostano[2,3-c]-furazan)
(25) 13b-ethyl-17b-hydroxygon-4-en-3-one
(26) 4-hydroxytestosterone
(4,17b-dihydroxy-androst-4-en-3-one)
(27)
4-hydroxy-19-nortestosterone(4,17b-dihydroxy-estr-4-en-3-one)
(28) mestanolone (17a-methyl-17b-hy-droxy-5-androstan-3-one)
(29) mesterolone (1a-methyl-17b-hy-
droxy-[5a]-androstan-3-one)(30) methandienone
(17a-methyl-17b-
hydroxyandrost-1,4-dien-3-one)(31) methandriol
(17a-methyl-3b,17b-
dihydroxyandrost-5-ene)(32) Methasterone
(2a,17a-dimethyl-5a-
androstan-17b-ol-3-one)(33) methenolone (1-methyl-17b-hy-
droxy-5a-androst-1-en-3-one)(34)
17a-methyl-3b,17b-dihydroxy-5a-an-
drostane
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21 CFR Ch. II (4114 Edition) 1300.01
(35) 17a-methyl-3a,17b-dihydroxy-5a-an-drostane
(36) 17a-methyl-3b,17b-dihydroxyandrost-4-ene
(37)
17a-methyl-4-hydroxynandrolone(17a-methyl-4-hydroxy-17b-hydroxyestr-4-en-3-one)
(38) methyldienolone
(17a-methyl-17b-hydroxyestra-4,9(10)-dien-3-one)
(39) methyltrienolone
(17a-methyl-17b-hydroxyestra-4,9,11-trien-3-one)
(40) methyltestosterone
(17a-methyl-17b-hydroxyandrost-4-en-3-one)
(41) mibolerone (7a,17a-dimethyl-17b-hydroxyestr-4-en-3-one)(42)
17a-methyl-D1-dihydrotestosterone
(17b-hydroxy-17a-methyl-5a-androst-1-en-3-one) (a.k.a.
17-a-methyl-1-testosterone)
(43) nandrolone (17b-hydroxyestr-4-en-3-one)
(44) 19-nor-4-androstenediol (3b, 17b-dihydroxyestr-4-ene)
(45) 19-nor-4-androstenediol (3a, 17b-dihydroxyestr-4-ene)
(46) 19-nor-5-androstenediol (3b, 17b-dihydroxyestr-5-ene)
(47) 19-nor-5-androstenediol (3a, 17b-dihydroxyestr-5-ene)
(48) 19-nor-4,9(10)-androstadienedione
(estra-4,9(10)-diene-3,17-dione)(49) 19-nor-4-androstenedione
(estr-4-en-
3,17-dione)
(50) 19-nor-5-androstenedione (estr-5-en-3,17-dione)
(51) norbolethone (13b,
17a-diethyl-17b-hydroxygon-4-en-3-one)
(52) norclostebol (4-chloro-17b-hydroxyestr-4-en-3-one)
(53) norethandrolone (17a-ethyl-17b-hydroxyestr-4-en-3-one)
(54) normethandrolone
(17a-methyl-17b-hydroxyestr-4-en-3-one)
(55) oxandrolone
(17a-methyl-17b-hy-droxy-2-oxa-[5a]-androstan-3-one)
(56) oxymesterone (17a-methyl-4,17b-
dihydroxyandrost-4-en-3-one)(57) oxymetholone (17a-methyl-2-
hydroxymethylene-17b-hydroxy-[5a]-androstan-3-one)
(58) Prostanozol (17b-hydroxy-5a-androstano[3,2-c]pyrazole)
(59) stanozolol
(17a-methyl-17b-hy-droxy-[5a]-androst-2-eno[3,2-c]-pyr-azole)
(60) stenbolone
(17b-hydroxy-2-methyl-[5a]-androst-1-en-3-one)
(61) testolactone
(13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oicacid
lactone)
(62) testosterone (17b-hydroxyandrost-4-en-3-one)
(63) tetrahydrogestrinone (13b,
17a-diethyl-17b-hydroxygon-4,9,11-trien-3-one)
(64) trenbolone (17b-hydroxyestr-4,9,11-trien-3-one)
(65) Any salt, ester, or ether of a drugor substance described
in this para-graph. Except such term does notinclude an anabolic
steroid that is
expressly intended for administra-tion through implants to
cattle orother nonhuman species and thathas been approved by the
Secretaryof Health and Human Services forsuch administration. If
any personprescribes, dispenses, or distributessuch steroid for
human use, theperson shall be considered to haveprescribed,
dispensed, or distrib-uted an anabolic steroid within themeaning of
this paragraph.
Automated dispensing system means amechanical system that
performs oper-ations or activities, other thancompounding or
administration, rel-ative to the storage, packaging, count-
ing, labeling, and dispensing of medica-tions, and which
collects, controls, andmaintains all transaction information.
Basic class means, as to controlledsubstances listed in
Schedules I and II:
(1) Each of the opiates, including itsisomers, esters, ethers,
salts, and saltsof isomers, esters, and ethers wheneverthe
existence of such isomers, esters,ethers, and salts is possible
within thespecific chemical designation, listed in 1308.11(b) of
this chapter;
(2) Each of the opium derivatives, in-cluding its salts,
isomers, and salts ofisomers whenever the existence of suchsalts,
isomers, and salts of isomers ispossible within the specific
chemical
designation, listed in 1308.11(c) of thischapter;
(3) Each of the hallucinogenic sub-stances, including its salts,
isomers,and salts of isomers whenever the ex-istence of such salts,
isomers, and saltsof isomers is possible within the spe-cific
chemical designation, listed in 1308.11(d) of this chapter;
(4) Each of the following substances,whether produced directly
or indirectly
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21 CFR Ch. II (4114 Edition) 1300.01
such article from the jurisdiction ofthe United States (whether
or not suchtaking out or removal constitutes anexportation within
the meaning of thecustoms and related laws of the
UnitedStates).
Exporter includes every person whoexports, or who acts as an
exportbroker for exportation of, controlledsubstances listed in any
schedule.
Freight forwarding facility means aseparate facility operated by
a distrib-uting registrant through which sealed,packaged controlled
substances in un-
marked shipping containers (i.e., thecontainers do not indicate
that thecontents include controlled substances)are, in the course
of delivery to, or re-turn from, customers, transferred inless than
24 hours. A distributing reg-istrant who operates a freight
for-warding facility may use the facility totransfer controlled
substances fromany location the distributing reg-istrant operates
that is registered withthe Administration to
manufacture,distribute, or import controlled sub-stances, or, with
respect to returns,registered to dispense controlled sub-stances,
provided that the notice re-quired by 1301.12(b)(4) of Part 1301
of
this chapter has been submitted andapproved. For purposes of
this defini-tion, a distributing registrant is aperson who is
registered with the Ad-ministration as a manufacturer,
dis-tributor, and/or importer.
Hearing means:(1) In part 1301 of this chapter, any
hearing held for the granting, denial,revocation, or suspension
of a registra-tion pursuant to sections 303, 304, and1008 of the
Act (21 U.S.C. 823, 824 and958).
(2) In part 1303 of this chapter, anyhearing held regarding the
determina-tion of aggregate production quota orthe issuance,
adjustment, suspension,
or denial of a procurement quota or anindividual manufacturing
quota.
(3) In part 1308 of this chapter, anyhearing held for the
issuance, amend-ment, or repeal of any rule issuablepursuant to
section 201 of the Act (21U.S.C. 811).
Import means, with respect to any ar-ticle, any bringing in or
introductionof such article into either the jurisdic-tion of the
United States or the cus-
toms territory of the United States,and from the jurisdiction of
the UnitedStates into the customs territory ofthe United States
(whether or not suchbringing in or introduction constitutesan
importation within the meaning ofthe tariff laws of the United
States).
Importer includes every person whoimports, or who acts as an
importbroker for importation of, controlledsubstances listed in any
schedule.
Individual practitioner means a physi-cian, dentist,
veterinarian, or other in-dividual licensed, registered, or
other-
wise permitted, by the United States orthe jurisdiction in which
he/she prac-tices, to dispense a controlled sub-stance in the
course of professionalpractice, but does not include a phar-macist,
a pharmacy, or an institutionalpractitioner.
Institutional practitioner means a hos-pital or other person
(other than an in-dividual) licensed, registered, or other-wise
permitted, by the United States orthe jurisdiction in which it
practices,to dispense a controlled substance inthe course of
professional practice, butdoes not include a pharmacy.
Interested person means any personadversely affected or
aggrieved by any
rule or proposed rule issuable pursuantto section 201 of the Act
(21 U.S.C. 811).
Inventory means all factory andbranch stocks in finished form of
abasic class of controlled substancemanufactured or otherwise
acquired bya registrant, whether in bulk, commer-cial containers,
or contained in phar-maceutical preparations in the posses-sion of
the registrant (including stocksheld by the registrant under
separateregistration as a manufacturer, im-porter, exporter, or
distributor).
Isomer means:(1) The optical isomer, except as used
in 1308.11(d) and 1308.12(b)(4) of thischapter. As used in
1308.11(d) of this
chapter, the term isomer means anyoptical, positional, or
geometric iso-mer. As used in 1308.12(b)(4) of thischapter, the
term isomer means anyoptical or geometric isomer;
(2) As used in 1308.11(d) of this chap-ter, the term positional
isomermeans any substance possessing thesame molecular formula and
corestructure and having the same func-tional group(s) and/or
substituent(s) as
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those found in the respective ScheduleI hallucinogen, attached
at any posi-tion(s) on the core structure, but insuch manner that
no new chemicalfunctionalities are created and no ex-isting
chemical functionalities are de-stroyed relative to the
respectiveSchedule I hallucinogen. Rearrange-ments of alkyl
moieties within or be-tween functional group(s) or substit-uent(s),
or divisions or combinations ofalkyl moieties, that do not create
newchemical functionalities or destroy ex-isting chemical
functionalities, are al-
lowed i.e., result in compounds whichare positional isomers. For
purposes ofthis definition, the core structure isthe parent
molecule that is the com-mon basis for the class; for
example,tryptamine, phenethylamine, orergoline. Examples of
rearrangementsresulting in creation and/or destructionof chemical
functionalities (and there-fore resulting in compounds which arenot
positional isomers) include, but arenot limited to: Ethoxy to
alpha-hy-droxyethyl, hydroxy and methyl tomethoxy, or the
repositioning of a phe-nolic or alcoholic hydroxy group tocreate a
hydroxyamine. Examples ofrearrangements resulting in com-pounds
which would be positional iso-mers 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 meansthe customs territory of
the UnitedStates, the Virgin Islands, the CanalZone, Guam, American
Samoa, and theTrust Territories of the Pacific Islands.
Label means any display of written,printed, or graphic matter
placed uponthe commercial container of any con-trolled substance by
any manufacturerof such substance.
Labeling means all labels and other
written, printed, or graphic matter:(1) Upon any controlled
substance or
any of its commercial containers orwrappers, or
(2) Accompanying such controlledsubstance.
Long Term Care Facility (LTCF) meansa nursing home, retirement
care, men-tal care or other facility or institutionwhich provides
extended health care toresident patients.
Maintenance treatment means the dis-pensing for a period in
excess of twen-ty-one days, of a narcotic drug or nar-cotic drugs
in the treatment of an indi-vidual for dependence upon heroin
orother morphine-like drug.
Manufacture means the producing,preparation,
propagation,compounding, or processing of a drugor other substance
or the packaging orrepackaging of such substance, or thelabeling or
relabeling of the commer-cial container of such substance, butdoes
not include the activities of a
practitioner who, as an incident to his/her administration or
dispensing suchsubstance in the course of his/her pro-fessional
practice, prepares, com-pounds, packages or labels such
sub-stance.
Manufacturer means a person whomanufactures a drug or other
sub-stance, whether under a registration asa manufacturer or under
authority ofregistration as a researcher or chem-ical analyst.
Mid-level practitioner means an indi-vidual practitioner, other
than a physi-cian, dentist, veterinarian, or podia-trist, who is
licensed, registered, orotherwise permitted by the United
States or the jurisdiction in which he/she practices, to
dispense a controlledsubstance in the course of
professionalpractice. Examples of mid-level practi-tioners include,
but are not limited to,health care providers such as
nursepractitioners, nurse midwives, nurseanesthetists, clinical
nurse specialistsand physician assistants who are au-thorized to
dispense controlled sub-stances by the State in which
theypractice.
Name means the official name, com-mon or usual name, chemical
name, orbrand name of a substance.
Narcotic drug means any of the fol-lowing whether produced
directly or in-
directly by extraction from substancesof vegetable origin or
independently bymeans of chemical synthesis or by acombination of
extraction and chem-ical synthesis:
(1) Opium, opiates, derivatives ofopium and opiates, including
their iso-mers, esters, ethers, salts, and salts ofisomers, esters,
and ethers wheneverthe existence of such isomers, esters,ethers and
salts is possible within the
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specific chemical designation. Suchterm does not include the
isoquinolinealkaloids of opium.
(2) Poppy straw and concentrate ofpoppy straw.
(3) Coca leaves, except coca leavesand extracts of coca leaves
from whichcocaine, ecgonine and derivatives of ec-gonine or their
salts have been re-moved.
(4) Cocaine, its salts, optical and geo-metric isomers, and
salts of isomers.
(5) Ecgonine, its derivatives, their
salts, isomers and salts of isomers.(6) Any compound, mixture,
or prepa-ration which contains any quantity ofany of the substances
referred to inparagraphs (1) through (5) of this defi-nition.
Narcotic treatment program means aprogram engaged in maintenance
and/or detoxification treatment with nar-cotic drugs.
Net disposal means, for a stated pe-riod, the quantity of a
basic class ofcontrolled substance distributed by theregistrant to
another person, plus thequantity of that basic class used by
theregistrant in the production of (or con-verted by the registrant
into) another
basic class of controlled substance or anoncontrolled substance,
plus thequantity of that basic class otherwisedisposed of by the
registrant, less thequantity of that basic class returned tothe
registrant by any purchaser, andless the quantity of that basic
classdistributed by the registrant to an-other registered
manufacturer of thatbasic class for purposes other than usein the
production of, or conversioninto, another basic class of
controlledsubstance or a noncontrolled substanceor in the
manufacture of dosage formsof that basic class.
Person includes any individual, cor-poration, government or
governmental
subdivision or agency, business trust,partnership, association,
or other legalentity.
Pharmacist means any pharmacist li-censed by a State to dispense
con-trolled substances, and shall includeany other person (e.g.,
pharmacist in-tern) authorized by a State to dispensecontrolled
substances under the super-vision of a pharmacist licensed by
suchState.
Prescription means an order for medi-
cation 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 dis-
pense a drug to a bed patient for imme-
diate 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), com-
mencing with the publication by theAdministrator of the proposed
rule,
amended rule, or repeal in the FEDERAL
REGISTER.
Purchaser means any registered per-
son 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 sep-
arated 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 vis-ually 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 ac-
quired from another DEA registrant for
the purpose of
(1) Returning unwanted, unusable, or
outdated controlled substances to the
manufacturer or the manufacturers
agent; or
(2) Where necessary, processing such
substances or arranging for processing
such substances for disposal.
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Supplier means any registered personentitled to fill order forms
pursuant to 1305.06 of this chapter.
[62 FR 13941, Mar. 24, 1997, as amended at 65FR 44678, July 19,
2000; 68 FR 37409, June 24,2003; 68 FR 41228, July 11, 2003; 70 FR
25465,May 13, 2005; 70 FR 74656, Dec. 16, 2005; 71 FR60427, Oct.
13, 2006; 72 FR 67852, Dec. 3, 2007;74 FR 63609, Dec. 4, 2009; 77
FR 4230, Jan. 27,2012; 77 FR 44461, July 30, 2012]
1300.02 Definitions relating to listedchemicals.
(a) Any term not defined in this part
shall have the definition set forth insection 102 of the Act (21
U.S.C. 802),except that certain terms used in part1316 of this
chapter are defined at thebeginning of each subpart of that
part.
(b) As used in parts 1309, 1310, and1313 of this chapter, the
followingterms shall have the meaning specified:
Act means the Controlled SubstancesAct, as amended (84 Stat.
1242; 21 U.S.C.801) and/or the Controlled SubstancesImport and
Export Act, as amended (84Stat. 1285; 21 U.S.C. 951).
Administration means the Drug En-forcement Administration.
Administrator means the Adminis-trator of the Drug Enforcement
Admin-
istration. The Administrator has beendelegated authority under
the Act bythe Attorney General (28 CFR 0.100).
At retail, with respect to the sale orpurchase of a scheduled
listed chemicalproduct, means a sale or purchase forpersonal use,
respectively.
Broker and trader mean any indi-vidual, corporation, corporate
division,partnership, association, or other legalentity which
assists in arranging aninternational transaction in a
listedchemical by
(1) Negotiating contracts;(2) Serving as an agent or inter-
mediary; or(3) Fulfilling a formal obligation to
complete the transaction by bringingtogether a buyer and seller,
a buyerand transporter, or a seller and trans-porter, or by
receiving any form ofcompensation for so doing.
Chemical export means transferringownership or control, or the
sending ortaking of threshold quantities of listedchemicals out of
the United States(whether or not such sending or takingout
constitutes an exportation within
the meaning of the customs and relatedlaws of the United
States).
Chemical exporter is a regulated per-son who, as the principal
party in in-terest in the export transaction, hasthe power and
responsibility for deter-mining and controlling the sending ofthe
listed chemical out of the UnitedStates.
Chemical import means with respectto a listed chemical, any
bringing in orintroduction of such listed chemicalinto either the
jurisdiction of theUnited States or into the customs ter-
ritory of the United States (whether ornot such bringing in or
introductionconstitutes an importation within themeaning of the
tariff laws of theUnited States).
Chemical importer is a regulated per-son who, as the principal
party in in-terest in the import transaction, hasthe power and
responsibility for deter-mining and controlling the bringing inor
introduction of the listed chemicalinto the United States.
Chemical mixture means a combina-tion of two or more chemical
sub-stances, at least one of which is not alisted chemical, except
that such termdoes not include any combination of a
listed chemical with another chemicalthat is present solely as
an impurity orwhich has been created to evade the re-quirements of
the Act.
Combination ephedrine product meansa drug product containing
ephedrine orits salts, optical isomers, or salts of op-tical
isomers, and therapeutically sig-nificant quantities of another
activemedicinal ingredient.
Customs territory of the United Statesmeans the several States,
the Districtof Columbia, and Puerto Rico.
Drug product means an active ingre-dient in dosage form that has
been ap-proved or otherwise may be lawfullymarketed under the
Federal Food,
Drug, and Cosmetic Act for distribu-tion in the United
States.
Encapsulating machine means anymanual, semi-automatic, or fully
auto-matic equipment which may be used tofill shells or capsules
with any pow-dered, granular, semi-solid, or liquidmaterial.
Established business relationship meansthe regulated person has
imported orexported a listed chemical at least
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21 CFR Ch. II (4114 Edition) 1300.02
once within the past six months, ortwice within the past twelve
monthsfrom or to a foreign manufacturer, dis-tributor, or end user
of the chemicalthat has an established business with afixed street
address. A person or busi-ness that functions as a broker
orintermediary is not a customer for pur-poses of this
definition.
Established record as an importermeans that the regulated person
hasimported a listed chemical at leastonce within the past six
months, ortwice within the past twelve monthsfrom a foreign
supplier.
Hearing means any hearing held forthe granting, denial,
revocation, orsuspension of a registration pursuantto sections 303,
304, and 1008 of the Act(21 U.S.C. 823, 824 and 958).
International transaction means atransaction involving the
shipment ofa listed chemical across an inter-national border (other
than a UnitedStates border) in which a broker ortrader located in
the United Statesparticipates.
Jurisdiction of the United States meansthe customs territory of
the UnitedStates, the Virgin Islands, the Canal
Zone, Guam, American Samoa, and theTrust Territories of the
Pacific Islands.
Listed chemical means any List Ichemical or List II
chemical.
List I chemical means a chemical spe-cifically designated by the
Adminis-trator in 1310.02(a) of this chapterthat, in addition to
legitimate uses, isused in manufacturing a controlledsubstance in
violation of the Act and isimportant to the manufacture of a
con-trolled substance.
List II chemical means a chemical,other than a List I chemical,
specifi-cally designated by the Administratorin 1310.02(b) of this
chapter that, inaddition to legitimate uses, is used in
manufacturing a controlled substancein violation of the Act.
Mobile retail vendor means a person orentity that makes sales at
retail froma stand that is intended to be tem-porary or is capable
of being movedfrom one location to another, whetherthe stand is
located within or on thepremises of a fixed facility (such as
akiosk at a shopping center or an air-port) or whether the stand is
located
on unimproved real estate (such as alot or field leased for
retail purposes).
Name means the official name, com-mon or usual name, chemical
name, orbrand name of a substance.
Person includes any individual, cor-poration, government or
governmentalsubdivision or agency, business trust,partnership,
association, or other legalentity.
Readily retrievable means that certainrecords are kept by
automatic dataprocessing systems or other electronicor mechanized
recordkeeping systems
in such a manner that they can be sep-arated out from all other
records in areasonable time and/or records are kepton which certain
items are asterisked,redlined, or in some other manner vis-ually
identifiable apart from otheritems appearing on the records.
Register and registration refer only toregistration required and
permitted bysections 303 or 1007 of the Act (21 U.S.C.823 or
957).
Registrant means any person who isregistered pursuant to either
section303 or section 1008 of the Act (21 U.S.C.823 or 958).
Regular customer means a person withwhom the regulated person
has an es-
tablished business relationship for aspecified listed chemical
or chemicalsthat has been reported to the Adminis-tration subject
to the criteria estab-lished in part 1313 of this chapter.
Regular importer means, with respectto a listed chemical, a
person that hasan established record as an importer ofthat listed
chemical that is reported tothe Administrator.
Regulated person means any indi-vidual, corporation,
partnership, asso-ciation, or other legal entity who man-ufactures,
distributes, imports, or ex-ports a listed chemical, a tableting
ma-chine, or an encapsulating machine, orwho acts as a broker or
trader for an
international transaction involving alisted chemical, tableting
machine, orencapsulating machine.
Regulated seller means a retail dis-tributor (including a
pharmacy or amobile retail vendor), except that theterm does not
include an employee oragent of the distributor.
Regulated transaction means:(1) A distribution, receipt, sale,
im-
portation, or exportation of a listed
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chemical, or an international trans-action involving shipment of
a listedchemical, or if the Administrator es-tablishes a threshold
amount for a spe-cific listed chemical, a thresholdamount as
determined by the Adminis-trator, which includes a
cumulativethreshold amount for multiple trans-actions, of a listed
chemical, exceptthat such term does not include:
(i) A domestic lawful distribution inthe usual course of
business betweenagents or employees of a single regu-lated person;
in this context, agents or
employees means individuals under thedirect management and
control of theregulated person;
(ii) A delivery of a listed chemical toor by a common or
contract carrier forcarriage in the lawful and usual courseof the
business of the common or con-tract carrier, or to or by a
warehouse-man for storage in the lawful and usualcourse of the
business of the ware-houseman, except that if the carriageor
storage is in connection with thedistribution, importation, or
expor-tation of a listed chemical to a thirdperson, this paragraph
does not relievea distributor, importer, or exporterfrom compliance
with parts 1309, 1310,
1313, and 1315 of this chapter;(iii) Any category of transaction
or
any category of transaction for a spe-cific listed chemical or
chemicals spec-ified by regulation of the Adminis-trator as
excluded from this definitionas unnecessary for enforcement of
theAct;
(iv) Any transaction in a listed chem-ical that is contained in
a drug otherthan a scheduled listed chemical prod-uct that may be
marketed or distrib-uted lawfully in the United Statesunder the
Federal Food, Drug, and Cos-metic Act, subject to paragraph
(1)(v)of this definition, unless
(A) The Administrator has deter-
mined pursuant to the criteria in 1310.10 of this chapter that
the drug orgroup of drugs is being diverted to ob-tain the listed
chemical for use in theillicit production of a controlled
sub-stance; and
(B) The quantity of the listed chem-ical contained in the drug
included inthe transaction or multiple trans-actions equals or
exceeds the thresholdestablished for that chemical;
(v) Any transaction in a scheduledlisted chemical product that
is a saleat retail by a regulated seller or a dis-tributor required
to submit reportsunder 1310.03(c) of this chapter; or
(vi) Any transaction in a chemicalmixture designated in 1310.12
and1310.13 of this chapter that the Admin-istrator has exempted
from regulation.
(2) A distribution, importation, or ex-portation of a tableting
machine or en-capsulating machine except that suchterm does not
include a domestic law-ful distribution in the usual course
ofbusiness between agents and employeesof a single regulated
person; in thiscontext, agents or employees means in-dividuals
under the direct managementand control of the regulated person.
Retail distributor means a grocerystore, general merchandise
store, drugstore, or other entity or person whoseactivities as a
distributor relating todrug products containingpseudoephedrine or
phenylpropanola-mine are limited almost exclusively tosales for
personal use, both in numberof sales and volume of sales, either
di-rectly 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 withinStandard Industrial Classification(SIC) code 5411, a
general merchandisestore is an entity within SIC codes5300 through
5399 and 5499, and a drugstore is an entity within SIC
code5912.
Scheduled listed chemical productmeans:
(1) A product that contains ephed-rine, pseudoephedrine, or
phenyl-propanolamine and may be marketedor distributed lawfully in
the UnitedStates under the Federal Food, Drug,and Cosmetic Act as a
nonprescriptiondrug. Ephedrine, pseudoephedrine, and
phenylpropanolamine include theirsalts, optical isomers, and
salts of opti-cal isomers.
(2) Scheduled listed chemical productdoes not include any
product that is acontrolled substance under part 1308 ofthis
chapter. In the absence of suchscheduling by the Attorney General,
achemical specified in paragraph (1) ofthis definition may not be
consideredto be a controlled substance.
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(3) Contains a public key that cor-responds to a private key
under thesole control of the certificate holder;
(4) Identifies the operational period;and
(5) Contains a serial number and isdigitally signed by the
certification au-thority issuing it.
Digital signature means a record cre-ated when a file is
algorithmicallytransformed into a fixed length digestthat is then
encrypted using an asym-metric cryptographic private key
asso-ciated with a digital certificate. The
combination of the encryption and al-gorithm transformation
ensure thatthe signers identity and the integrityof the file can be
confirmed.
Digitally sign means to affix a digitalsignature to a data
file.
Electronic prescription means a pre-scription that is generated
on an elec-tronic application and transmitted asan electronic data
file.
Electronic prescription application pro-vider means an entity
that develops ormarkets electronic prescription soft-ware either as
a stand-alone applica-tion or as a module in an electronichealth
record application.
Electronic signature means a method
of signing an electronic message thatidentifies a particular
person as thesource of the message and indicates thepersons
approval of the informationcontained in the message.
False match rate means the rate atwhich an impostors biometric
is false-ly accepted as being that of an author-ized user. It is
one of the statisticsused to measure biometric performancewhen
operating in the verification orauthentication task. The false
matchrate is similar to the false accept (oracceptance) rate.
False non-match rate means the rateat which a genuine users
biometric isfalsely rejected when the users bio-
metric data fail to match the enrolleddata for the user. It is
one of the statis-tics used to measure biometric per-formance when
operating in theverification or authentication task.The false match
rate is similar to thefalse reject (or rejection) rate, exceptthat
it does not include the rate atwhich a biometric system fails to
ac-quire a biometric sample from a gen-uine user.
FIPS means Federal InformationProcessing Standards. These
Federalstandards, as incorporated by referencein 1311.08 of this
chapter, prescribespecific performance requirements,practices,
formats, communicationsprotocols, etc., for hardware,
software,data, etc.
FIPS 1402, as incorporated by ref-erence in 1311.08 of this
chapter,means the National Institute of Stand-ards and Technology
publication enti-tled Security Requirements for Cryp-tographic
Modules, a Federal stand-
ard for security requirements for cryp-tographic modules.
FIPS 1802, as incorporated by ref-erence in 1311.08 of this
chapter,means the National Institute of Stand-ards and Technology
publication enti-tled Secure Hash Standard, a Fed-eral secure hash
standard.
FIPS 1803, as incorporated by ref-erence in 1311.08 of this
chapter,means the National Institute of Stand-ards and Technology
publication enti-tled Secure Hash Standard (SHS), aFederal secure
hash standard.
FIPS 1862, as incorporated by ref-erence in 1311.08 of this
chapter,means the National Institute of Stand-
ards and Technology publication enti-tled Digital Signature
Standard, aFederal standard for applications usedto generate and
rely upon digital signa-tures.
FIPS 1863, as incorporated by ref-erence in 1311.08 of this
chapter,means the National Institute of Stand-ards and Technology
publication enti-tled Digital Signature Standard(DSS), a Federal
standard for applica-tions used to generate and rely upondigital
signatures.
Hard token means a cryptographickey stored on a special hardware
device(e.g., a PDA, cell phone, smart card,USB drive, one-time
password device)
rather than on a general purpose com-puter.
Identity proofing means the process bywhich a credential service
provider orcertification authority validates suffi-cient
information to uniquely identifya person.
Installed electronic prescription applica-tion means software
that is used to cre-ate electronic prescriptions and that
isinstalled on a practitioners computers
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21 CFR Ch. II (4114 Edition) 1300.03
and servers, where access and recordsare controlled by the
practitioner.
Installed pharmacy application meanssoftware that is used to
process pre-scription information and that is in-stalled on a
pharmacys computers orservers and is controlled by the
phar-macy.
Intermediary means any technologysystem that receives and
transmits anelectronic prescription between thepractitioner and
pharmacy.
Key pair means two mathematically
related keys having the propertiesthat:
(1) One key can be used to encrypt amessage that can only be
decryptedusing the other key; and
(2) Even knowing one key, it iscomputationally infeasible to
discoverthe other key.
NIST means the National Institute ofStandards and
Technology.
NIST SP 800631, as incorporated byreference in 1311.08 of this
chapter,means the National Institute of Stand-ards and Technology
publication enti-tled Electronic Authentication Guide-line, a
Federal standard for electronicauthentication.
NIST SP 800761, as incorporated byreference in 1311.08 of this
chapter,means the National Institute of Stand-ards and Technology
publication enti-tled Biometric Data Specification forPersonal
Identity Verification, a Fed-eral standard for biometric data
speci-fications for personal identityverification.
Operating point means a point chosenon a receiver operating
characteristic(ROC) curve for a specific algorithm atwhich the
biometric system is set tofunction. It is defined by its
cor-responding coordinatesa false matchrate and a false non-match
rate. AnROC curve shows graphically the trade-
off between the principal two types oferrors (false match rate
and false non-match rate) of a biometric system byplotting the
performance of a specificalgorithm on a specific set of data.
Paper prescription means a prescrip-tion created on paper or
computer gen-erated to be printed or transmitted viafacsimile that
meets the requirementsof part 1306 of this chapter including
amanual signature.
Password means a secret, typically acharacter string (letters,
numbers, andother symbols), that a person memo-rizes and uses to
authenticate his iden-tity.
PDA means a Personal Digital Assist-ant, a handheld computer
used to man-age contacts, appointments, and tasks.
Pharmacy application provider meansan entity that develops or
marketssoftware that manages the receipt andprocessing of
electronic prescriptions.
Private key means the key of a key
pair that is used to create a digital sig-nature.
Public key means the key of a keypair that is used to verify a
digital sig-nature. The public key is made avail-able to anyone who
will receivedigitally signed messages from theholder of the key
pair.
Public Key Infrastructure (PKI) meansa structure under which a
certificationauthority verifies the identity of appli-cants;
issues, renews, and revokes dig-ital certificates; maintains a
registryof public keys; and maintains an up-to-date certificate
revocation list.
Readily retrievable means that certainrecords are kept by
automatic data
processing applications or other elec-tronic or mechanized
recordkeepingsystems in such a manner that theycan be separated out
from all otherrecords in a reasonable time and/orrecords are kept
on which certainitems are asterisked, redlined, or insome other
manner visually identifi-able apart from other items appearingon
the records.
SAS 70 Audit means a third-partyaudit of a technology provider
thatmeets the American Institute of Cer-tified Public Accountants
(AICPA)Statement of Auditing Standards(SAS) 70 criteria.
Signing function means any keystroke
or other action used to indicate thatthe practitioner has
authorized fortransmission and dispensing a con-trolled substance
prescription. Thesigning function may occur simulta-neously with or
after the completion ofthe two-factor authentication protocolthat
meets the requirements of part1311 of this chapter. The signing
func-tion may have different names (e.g.,approve, sign, transmit),
but it serves
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Drug Enforcement Administration, Justice 1300.04
as the practitioners final authoriza-tion that he intends to
issue the pre-scription for a legitimate medical rea-son in the
normal course of his profes-sional practice.
SysTrust means a professional serviceperformed by a qualified
certified pub-lic accountant to evaluate one or moreaspects of
electronic systems.
Third-party audit means an inde-pendent review and examination
ofrecords and activities to assess the ade-quacy of system
controls, to ensurecompliance with established policies
and operational procedures, and to rec-ommend necessary changes
in controls,policies, or procedures.
Token means something a person pos-sesses and controls
(typically a key orpassword) used to authenticate the per-sons
identity.
Trusted agent means an entity au-thorized to act as a
representative of acertification authority or credentialservice
provider in confirming practi-tioner identification during the
enroll-ment process.
Valid prescription means a prescrip-tion that is issued for a
legitimatemedical purpose by an individual prac-titioner licensed
by law to administerand prescribe the drugs concerned andacting in
the usual course of the prac-titioners professional practice.
WebTrust means a professional serv-ice performed by a qualified
certifiedpublic accountant to evaluate one ormore aspects of Web
sites.
[75 FR 16304, Mar. 31, 2010]
1300.04 Definitions relating to thedispensing of controlled
substancesby means of the Internet.
(a) Any term not defined in this partor elsewhere in this
chapter shall havethe definition set forth in sections 102and 309
of the Act (21 U.S.C. 802, 829).
(b) The term covering practitionermeans, with respect to a
patient, apractitioner who conducts a medicalevaluation (other than
an in-personmedical evaluation) at the request of apractitioner
who:
(1) Has conducted at least one in-per-son medical evaluation of
the patientor an evaluation of the patient throughthe practice of
telemedicine, withinthe previous 24 months; and
(2) Is temporarily unavailable to con-duct the evaluation of the
patient.
(c) The term deliver, distribute, or dis-pense by means of the
Internet refers, re-spectively, to any delivery, distribu-tion, or
dispensing of a controlled sub-stance that is caused or facilitated
bymeans of the Internet.
(d) The term filling new prescriptionsfor controlled substances
in Schedule III,IV, or V means filling a prescription foran
individual for a controlled sub-stance in Schedule III, IV, or V,
if:
(1) The pharmacy dispensing thatprescription has previously
dispensedto the patient a controlled substanceother than by means
of the Internetand pursuant to the valid prescriptionof a
practitioner that meets the appli-cable requirements of subsections
(b)and (c) of section 309 of the Act (21U.S.C. 829) and 1306.21 and
1306.22 ofthis chapter (for purposes of this defi-nition, such a
prescription shall be re-ferred to as the original
prescrip-tion);
(2) The pharmacy contacts the prac-titioner who issued the
original pre-scription at the request of that indi-vidual to
determine whether the prac-
titioner will authorize the issuance of anew prescription for
that individual forthe controlled substance described inparagraph
(d)(1) of this section (i.e., thesame controlled substance as
describedin paragraph (d)(1)); and
(3) The practitioner, acting in theusual course of professional
practice,determines there is a legitimate med-ical purpose for the
issuance of the newprescription.
(e) The term homepage means theopening or main page or screen of
theWeb site of an online pharmacy that isviewable on the
Internet.
(f) The term in-person medical evalua-tion means a medical
evaluation that is
conducted with the patient in the phys-ical presence of the
practitioner, with-out regard to whether portions of theevaluation
are conducted by otherhealth professionals. Nothing in
thisparagraph shall be construed to implythat one in-person medical
evaluationdemonstrates that a prescription hasbeen issued for a
legitimate medicalpurpose within the usual course of pro-fessional
practice.
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21 CFR Ch. II (4114 Edition) 1300.04
(g) The term Internet means collec-tively the myriad of computer
andtelecommunications facilities, includ-ing equipment and
operating software,which comprise the interconnectedworldwide
network of networks thatemploy the Transmission Control
Pro-tocol/Internet Protocol, or any prede-cessor or successor
protocol to suchprotocol, to communicate informationof all kinds by
wire or radio.
(h) The term online pharmacy means aperson, entity, or Internet
site, wheth-er in the United States or abroad, that
knowingly or intentionally delivers,distributes, or dispenses,
or offers orattempts to deliver, distribute, or dis-pense, a
controlled substance by meansof the Internet. The term includes,
butis not limited to, a pharmacy that hasobtained a modification of
its registra-tion pursuant to 1301.13 and 1301.19 ofthis chapter
that currently authorizesit to dispense controlled substances
bymeans of the Internet, regardless ofwhether the pharmacy is
currently dis-pensing controlled substances bymeans of the
Internet. The term doesnot include:
(1) Manufacturers or distributors reg-istered under subsection
(a), (b), (d), or
(e) of section 303 of the Act (21 U.S.C.823(a), (b), (d), or
(e)) (1301.13 of thischapter) who do not dispense con-trolled
substances to an unregisteredindividual or entity;
(2) Nonpharmacy practitioners whoare registered under section
303(f) ofthe Act (21 U.S.C. 823(f)) (1301.13 ofthis chapter) and
whose activities areauthorized by that registration;
(3) Any hospital or other medical fa-cility that is operated by
an agency ofthe United States (including the ArmedForces), provided
such hospital orother facility is registered under sec-tion 303(f)
of the Act (21 U.S.C. 823(f))( 1301.13 of this chapter);
(4) A health care facility owned oroperated by an Indian tribe
or tribalorganization, only to the extent suchfacility is carrying
out a contract orcompact under the Indian Self-Deter-mination and
Education AssistanceAct;
(5) Any agent or employee of any hos-pital or facility referred
to in para-graph (h)(3) or (h)(4) of this section,provided such
agent or employee is
lawfully acting in the usual course ofbusiness or employment,
and withinthe scope of the official duties of suchagent or
employee, with such hospitalor facility, and, with respect to
agentsor employees of health care facilitiesspecified in paragraph
(h)(4) of this sec-tion, only to the extent such individ-uals are
furnishing services pursuantto the contracts or compacts
describedin such paragraph;
(6) Mere advertisements that do notattempt to facilitate an
actual trans-action involving a controlled sub-
stance;(7) A person, entity, or Internet site
that is not in the United States anddoes not facilitate the
delivery, dis-tribution, or dispensing of a controlledsubstance by
means of the Internet toany person in the United States;
(8) A pharmacy registered under sec-tion 303(f) of the Act (21
U.S.C. 823(f))( 1301.13 of this chapter) whose dis-pensing of
controlled substances viathe Internet consists solely of:
(i) Refilling prescriptions for con-trolled substances in
Schedule III, IV,or V, as defined in paragraph (k) of thissection;
or
(ii) Filling new prescriptions for con-
trolled substances in Schedule III, IV,or V, as defined in
paragraph (d) of thissection;
(9)(i) Any registered pharmacy whosedelivery, distribution, or
dispensing ofcontrolled substances by means of theInternet consists
solely of filling pre-scriptions that were electronically
pre-scribed in a manner authorized by thischapter and otherwise in
compliancewith the Act.
(ii) A registered pharmacy will bedeemed to meet this exception
if, inview of all of its activities other thanthose referred to in
paragraph (h)(9)(i)of this section, it would fall outside
thedefinition of an online pharmacy; or
(10)(i) Any registered pharmacywhose delivery, distribution, or
dis-pensing of controlled substances bymeans of the Internet
consists solely ofthe transmission of prescription infor-mation
between a pharmacy and anautomated dispensing system locatedin a
long term care facility when theregistration of the automated
dis-pensing system is held by that phar-macy as described in
1301.17 and
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Drug Enforcement Administration, Justice 1300.04
1301.27 and the pharmacy is otherwisecomplying with this
chapter.
(ii) A registered pharmacy will bedeemed to meet this exception
if, inview of all of its activities other thanthose referred to in
paragraph (h)(10)(i)of this section, it would fall outside
thedefinition of an online pharmacy.
(i) Effective January 15, 2010, theterm practice of telemedicine
means thepractice of medicine in accordancewith applicable Federal
and State lawsby a practitioner (other than a phar-macist) who is
at a location remote
from the patient and is communicatingwith the patient, or health
care profes-sional who is treating the patient,using a
telecommunications system re-ferred to in section 1834(m) of the
So-cial Security Act (42 U.S.C. 1395m(m)),which practice falls
within a categorylisted in the following paragraphs (i)(1)through
(7):
(1) Treatment in a hospital or clinic.The practice of
telemedicine is beingconducted while the patient is beingtreated
by, and physically located in, ahospital or clinic registered under
sec-tion 303(f) of the Act (21 U.S.C. 823(f))by a practitioner
acting in the usualcourse of professional practice, who is
acting in accordance with applicableState law, and who is
registered undersection 303(f) of the Act (21 U.S.C.823(f)) in the
State in which the patientis located, unless the practitioner:
(i) Is exempted from such registra-tion in all States under
section 302(d)of the Act (21 U.S.C. 822(d); or
(ii) Is an employee or contractor ofthe Department of Veterans
Affairswho is acting in the scope of such em-ployment or contract,
and registeredunder section 303(f) of the Act (21U.S.C. 823(f)) in
any State or is uti-lizing the registration of a hospital orclinic
operated by the Department ofVeterans Affairs registered under
sec-
tion 303(f);(2) Treatment in the physical presence
of a practitioner. The practice of tele-medicine is being
conducted while thepatient is being treated by, and in thephysical
presence of, a practitioneracting in the usual course of
profes-sional practice, who is acting in ac-cordance with
applicable State law,and who is registered under section303(f) of
the Act (21 U.S.C. 823(f)) in the
State in which the patient is located,unless the
practitioner:
(i) Is exempted from such registra-tion in all States under
section 302(d)of the Act (21 U.S.C. 822(d)); or
(ii) Is an employee or contractor ofthe Department of Veterans
Affairswho is acting in the scope of such em-ployment or contract,
and registeredunder section 303(f) of the Act (21U.S.C. 823(f)) in
any State or is usingthe registration of a hospital or
clinicoperated by the Department of Vet-erans Affairs registered
under section
303(f);(3) Indian Health Service or tribal orga-
nization. The practice of telemedicineis being conducted by a
practitionerwho is an employee or contractor ofthe Indian Health
Service, or is work-ing for an Indian tribe or tribal organi-zation
under its contract or compactwith the Indian Health Service
underthe Indian Self-Determination andEducation Assistance Act; who
is act-ing within the scope of the employ-ment, contract, or
compact; and who isdesignated as an Internet Eligible Con-trolled
Substances Provider by the Sec-retary of Health and Human
Servicesunder section 311(g)(2) of the Act (21
U.S.C. 831(g)(2));(4) Public health emergency declared by
the Secretary of Health and Human Serv-ices. The practice of
telemedicine isbeing conducted during a public healthemergency
declared by the Secretaryof Health and Human Services undersection
319 of the Public Health ServiceAct (42 U.S.C. 247d), and involves
pa-tients located in such areas, and suchcontrolled substances, as
the Secretaryof Health and Human Services, withthe concurrence of
the Administrator,designates, provided that such designa-tion shall
not be subject to the proce-dures prescribed by the
AdministrativeProcedure Act (5 U.S.C. 551559 and 701
706);(5) Special registration. The practice of
telemedicine is being conducted by apractitioner who has
obtained from theAdministrator a special registrationunder section
311(h) of the Act (21U.S.C. 831(h));
(6) Department of Veterans Affairs med-ical emergency. The
practice of tele-medicine is being conducted:
(i) In a medical emergency situation:
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21 CFR Ch. II (4114 Edition) 1300.04
(A) That prevents the patient frombeing in the physical presence
of apractitioner registered under section303(f) of the Act (21
U.S.C. 823(f)) who isan employee or contractor of the Vet-erans
Health Administration acting inthe usual course of business and
em-ployment and within the scope of theofficial duties or contract
of that em-ployee or contractor;
(B) That prevents the patient frombeing physically present at a
hospitalor clinic operated by the Departmentof Veterans Affairs
registered under
section 303(f) of the Act (21 U.S.C.823(f));
(C) During which the primary carepractitioner of the patient or
a practi-tioner otherwise practicing telemedi-cine within the
meaning of this para-graph is unable to provide care or
con-sultation; and
(D) That requires immediate inter-vention by a health care
practitionerusing controlled substances to preventwhat the
practitioner reasonably be-lieves in good faith will be imminentand
serious clinical consequences, suchas further injury or death;
and
(ii) By a practitioner that:(A) Is an employee or contractor
of
the Veterans Health Administrationacting within the scope of
that employ-ment or contract;
(B) Is registered under section 303(f)of the Act (21 U.S.C.
823(f)) in any Stateor is utilizing the registration of a hos-pital
or clinic operated by the Depart-ment of Veterans Affairs
registeredunder section 303(f); and
(C) Issues a controlled substance pre-scription in this
emergency contextthat is limited to a maximum of a five-day supply
which may not be extendedor refilled; or
(7) Other circumstances specified by reg-ulation. The practice
of telemedicine isbeing conducted under any other cir-
cumstances that the Administratorand the Secretary of Health
andHuman Services have jointly, by regu-lation, determined to be
consistentwith effective controls against diver-sion and otherwise
consistent with thepublic health and safety.
(j) Temporary definition of practice oftelemedicine. Prior to
January 15, 2010,or as otherwise specified by regulationprior to
that date, instead of the defini-
tion in paragraph (i), the term practice
of telemedicine means the practice of
medicine in accordance with applicable
Federal and State laws by a practi-
tioner (as that term is defined in sec-
tion 102 of the Act (21 U.S.C. 802))
(other than a pharmacist) who is at a
location remote from the patient and is
communicating with the patient, or
health care professional who is treat-
ing the patient, using a telecommuni-
cations system referred to in section
1834(m) of the Social Security Act (42
U.S.C. 1395m(m)), if the practitioner isusing an interactive
telecommuni-
cations system that satisfies the re-
quirements of section 410.78(a)(3) of
title 42, Code of Federal Regulations.
(k) The term refilling prescriptions for
controlled substances in Schedule III, IV,
or V:
(1) Means the dispensing of a con-
trolled substance in Schedule III, IV, or
V in accordance with refill instructions
issued by a practitioner as part of a
valid prescription that meets the re-
quirements of subsections (b) and (c) of
section 309 of the Act (21 U.S.C. 829)
and 1306.21 and 1306.22 of this chapter,
as appropriate; and(2) Does not include the issuance of a
new prescription to an individual for a
controlled substance that individual
was previously prescribed.
(l)(1) The term valid prescription
means a prescription that is issued for
a legitimate medical purpose in the
usual course of professional practice
by:
(i) A practitioner who has conducted
at least one in-person medical evalua-
tion of the patient; or
(ii) A covering practitioner.
(2) Nothing in this paragraph (l) shall
be construed to imply that one in-per-
son medical evaluation demonstrates
that a prescription has been issued for
a legitimate medical purpose within
the usual course of professional prac-
tice.
[74 FR 15619, Apr. 6, 2009]
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21 CFR Ch. II (4114 Edition) 1301.01
GENERAL INFORMATION
1301.01 Scope of this part 1301.
Procedures governing the registra-tion of manufacturers,
distributors,dispensers, importers, and exporters ofcontrolled
substances pursuant to sec-tions 301304 and 10071008 of the Act
(21U.S.C. 821824 and 957958) are set forthgenerally by those
sections and specifi-cally by the sections of this part.
[62 FR 13945, Mar. 24, 1997]
1301.02 Definitions.
Any term used in this part shall havethe definition set forth in
section 102 ofthe Act (21 U.S.C. 802) or part 1300 ofthis
chapter.
[62 FR 13945, Mar. 24, 1997]
1301.03 Information; special instruc-tions.
Information regarding proceduresunder these rules and
instructionssupplementing these rules will be fur-nished upon
request by writing to theRegistration Section, Drug Enforce-ment
Administration. See the Table ofDEA Mailing Addresses in 1321.01
ofthis chapter for the current mailing ad-
dress.
[75 FR 10676, Mar. 9, 2010]
REGISTRATION
1301.11 Persons required to register;requirement of modification
of reg-istration authorizing activity as anonline pharmacy.
(a) Every person who manufactures,distributes, dispenses,
imports, or ex-ports any controlled substance or whoproposes to
engage in the manufacture,distribution, dispensing, importationor
exportation of any controlled sub-stance shall obtain a
registration un-less exempted by law or pursuant to
1301.22 through 1301.26. Except as pro-vided in paragraph (b) of
this section,only persons actually engaged in suchactivities are
required to obtain a reg-istration; related or affiliated
personswho are not engaged in such activitiesare not required to be
registered. (Forexample, a stockholder or parent cor-poration of a
corporation manufac-turing controlled substances is not re-quired
to obtain a registration.)
(b) As provided in sections 303(f) and401(h) of the Act (21
U.S.C. 823(f) and841(h)), it is unlawful for any personwho falls
within the definition of on-line pharmacy (as set forth in
section102(52) of the Act (21 U.S.C. 802(52)) and 1300.04(h) of
this chapter) to deliver,distribute, or dispense a controlled
sub-stance by means of the Internet if suchperson is not validly
registered with amodification of such registration au-thorizing
such activity (unless suchperson is exempt from such
modifiedregistration requirement under the Act
or this chapter). The Act further pro-vides that the
Administrator may onlyissue such modification of registrationto a
person who is registered as a phar-macy under section 303(f) of the
Act (21U.S.C. 823(f)). Accordingly, any phar-macy registered
pursuant to 1301.13 ofthis part that falls within the defini-tion
of an online pharmacy and pro-poses to dispense controlled
substancesby means of the Internet must obtain amodification of its
registration author-izing such activity following the sub-mission
of an application in accordancewith 1301.19 of this part. This
require-ment does not apply to a registeredpharmacy that does not
fall within thedefinition of an online pharmacy setforth in
1300.04(h). Under the Act, per-sons other than registered
pharmaciesare not eligible to obtain such a modi-fication of
registration but remain lia-ble under section 401(h) of the Act
(21U.S.C. 841(h)) if they deliver, dis-tribute, or dispense a
controlled sub-stance while acting as an online phar-macy without
being validly registeredwith a modification authorizing
suchactivity.
[74 FR 15621, Apr. 6, 2009]
1301.12 Separate registrations forseparate locations.
(a) A separate registration is re-quired for each principal
place of busi-ness or professional practice at onegeneral physical
location where con-trolled substances are manufactured,distributed,
imported, exported, or dis-pensed by a person.
(b) The following locations shall bedeemed not to be places
where con-trolled substances are manufactured,distributed, or
dispensed:
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Drug Enforcement Administration, Justice 1301.13
(1) A warehouse where controlledsubstances are stored by or on
behalf ofa registered person, unless such sub-stances are
distributed directly fromsuch warehouse to registered
locationsother than the registered location fromwhich the
substances were delivered orto persons not required to register
byvirtue of subsection 302(c)(2) or sub-section 1007(b)(1)(B) of
the Act (21U.S.C. 822(c)(2) or 957(b)(1)(B));
(2) An office used by agents of a reg-istrant where sales of
controlled sub-stances are solicited, made, or super-
vised but which neither contains suchsubstances (other than
substances fordisplay purposes or lawful distributionas samples
only) nor serves as a dis-tribution point for filling sales
orders;and
(3) An office used by a practitioner(who is registered at
another locationin the same State or jurisdiction of theUnited
States) where controlled sub-stances are prescribed but neither
ad-ministered nor otherwise dispensed asa regular part of the
professional prac-tice of the practitioner at such office,and where
no supplies of controlledsubstances are maintained.
(4) A freight forwarding facility, as
defined in 1300.01 of this part, providedthat the distributing
registrant oper-ating the facility has submitted writ-ten notice of
intent to operate the fa-cility by registered mail, return re-ceipt
requested (or other suitablemeans of documented delivery) andsuch
notice has been approved. The no-tice shall be submitted to the
SpecialAgent in Charge of the Administra-tions offices in both the
area in whichthe facility is located and each area inwhich the
distributing registrant main-tains a registered location that
willtransfer controlled substances throughthe facility. The notice
shall detail theregistered locations that will utilize
the facility, the location of the facil-ity, the hours of
operation, the indi-vidual(s) responsible for the
controlledsubstances, the security and record-keeping procedures
that will be em-ployed, and whether controlled sub-stances returns
will be processedthrough the facility. The notice mustalso detail
what state licensing re-quirements apply to the facility andthe
registrants actions to comply with
any such requirements. The SpecialAgent in Charge of the DEA
Office inthe area where the freight forwardingfacility will be
operated will providewritten notice of approval or dis-approval to
the person within thirtydays after confirmed receipt of the
no-tice. Registrants that are currently op-erating freight
forwarding facilitiesunder a memorandum of understandingwith the
Administration must providenotice as required by this section
nolater than September 18, 2000 and re-ceive written approval from
the Spe-
cial Agent in Charge of the DEA Officein the area in which the
freight for-warding facility is operated in order tocontinue
operation of the facility.
[62 FR 13945, Mar. 24, 1997, as amended at 65FR 44678, July 19,
2000; 65 FR 45829, July 25,2000; 71 FR 69480, Dec. 1, 2006]
1301.13 Application for registration;time for application;
expirationdate; registration for independentactivities; application
forms, fees,contents and signature; coincidentactivities.
(a) Any person who is required to beregistered and who is not so
registeredmay apply for registration at any time.
No person required to be registeredshall engage in any activity
for whichregistration is required until the appli-cation for
registration is granted and aCertificate of Registration is issued
bythe Administrator to such person.
(b) Any person who is registered mayapply to be reregistered not
more than60 days before the expiration date ofhis/her registration,
except that a bulkmanufacturer of Schedule I or II con-trolled
substances or an importer ofSchedule I or II controlled
substancesmay apply to be reregistered no morethan 120 days before
the expirationdate of their registration.
(c) At the time a manufacturer, dis-
tributor, reverse distributor, re-searcher, analytical lab,
importer, ex-porter or narcotic treatment programis first
registered, that business activ-ity shall be assigned to one of
twelvegroups, which shall correspond to themonths of the year. The
expirationdate of the registrations of all reg-istrants within any
group will be thelast date of the month designated forthat group.
In assigning any of these
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21 CFR Ch. II (4114 Edition) 1301.13
business activities to a group, the Ad-ministration may select a
group theexpiration date of which is less thanone year from the
date such businessactivity was registered. If the businessactivity
is assigned to a group whichhas an expiration date less than
threemonths from the date of which thebusiness activity is
registered, the reg-istration shall not expire until oneyear from
that expiration date; in allother cases, the registration shall
ex-pire on the expiration date followingthe date on which the
business activity
is registered.(d) At the time a retail pharmacy,
hospital/clinic, practitioner or teach-ing institution is first
registered, thatbusiness activity shall be assigned toone of twelve
groups, which shall cor-respond to the months of the year.
Theexpiration date of the registrations ofall registrants within
any group will bethe last day of the month designatedfor that
group. In assigning any of theabove business activities to a
group,the Administration may select a groupthe expiration date of
which is not lessthan 28 months nor more than 39months from the
date such business ac-tivity was registered. After the initial
registration period, the registrationshall expire 36 months from
the initialexpiration date.
(e) Any person who is required to beregistered and who is not so
registered,shall make application for registrationfor one of the
following groups of con-trolled substances activities, which
are
deemed to be independent of eachother. Application for each
registrationshall be made on the indicated form,and shall be
accompanied by the indi-cated fee. Fee payments shall be madein the
form of a personal, certified, orcashiers check or money order
madepayable to the Drug Enforcement Ad-ministration. The
application fees arenot refundable. Any person, when reg-istered to
engage in the activities de-scribed in each subparagraph in
thisparagraph, shall be authorized to en-gage in the coincident
activities de-
scribed without obtaining a registra-tion to engage in such
coincident ac-tivities, provided that, unless specifi-cally
exempted, he/she complies withall requirements and duties
prescribedby law for persons registered to engagein such coincident
activities. Any per-son who engages in more than onegroup of
independent activities shallobtain a separate registration for
eachgroup of activities, except as providedin this paragraph under
coincident ac-tivities. A single registration to engagein any group
of independent activitieslisted below may include one or
morecontrolled substances listed in theschedules authorized in that
group of
independent activities. A person reg-istered to conduct research
with con-trolled substances listed in Schedule Imay conduct
research with any sub-stances listed in Schedule I for whichhe/she
has filed and had approved a re-search protocol.
(1)
Business activityControlled sub-
stancesDEA Application
forms
Applicationfee($)
Registrationperiod(years)
Coincident activities allowed
(i) Manufacturing Schedules IV ... New225 Re-newal225a.
$3,047 1 Schedules IV: May distribute that sub-stance or class
for which registrationwas issued; may not distribute ordispose of
any substance or classfor which not registered. SchedulesIIV:
Except a person registered todispose of any controlled
substance
may conduct chemical analysis andpreclinical research (including
qualitycontrol analysis) with substances list-ed in those schedules
for which au-thorization as a mfg. was issued.
(ii) Distributing .... Schedules IV ... New225 Re-newal225a.
1,523 1
(iii) Reverse dis-tributing.
Schedules IV ... New225 Re-newal225a.
1,523 1
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8/11/2019 CFR 2014 Title21 Vol9
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25
Dru