[Title 21 CFR 1300.02]
[Code of Federal Regulations (annual edition) - April 1, 2002 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter II - DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE]
[Part 1300 - DEFINITIONS]
[Sec. 1300.02 - Definitions relating to listed chemicals.]
[From the U.S. Government Printing Office]
21FOOD AND DRUGS92002-04-012002-04-01falseDefinitions relating to listed chemicals.1300.02Sec. 1300.02FOOD AND DRUGSDRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICEDEFINITIONS
Sec. 1300.02 Definitions relating to listed chemicals.
(a) Any term not defined in this part shall have the definition set
forth in section 102 of the Act (21 U.S.C. 802), except that certain
terms used in part 1316 of this chapter are defined at the beginning of
each subpart of that part.
(b) As used in parts 1309, 1310, and 1313 of this chapter, the
following terms shall have the meaning specified:
(1) The term 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) as amended.
(2) The term Administration means the Drug Enforcement
Administration.
(3) The term 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).
(4) The terms 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--
(i) Negotiating contracts;
(ii) Serving as an agent or intermediary; or
(iii) 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.
(5) The term 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).
(6) The term chemical exporter is a regulated person who, as the
principal party in 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.
(7) The term chemical import means with respect to a listed
chemical, any
[[Page 10]]
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).
(8) The term 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.
(9) The term 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.
(10) The term customs territory of the United States means the
several States, the District of Columbia, and Puerto Rico.
(11) The term 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.
(12) The term established business relationship with a foreign
customer means the regulated person has exported a listed chemical at
least once within the past six months, or twice within the past twelve
months to a foreign manufacturer, distributor, or end user of the
chemical that has an established business in the foreign country with a
fixed street address. A person or business which functions as a broker
or intermediary is not a customer for purposes of this definition. The
term also means that the regulated person has provided the
Administration with the following information in accordance with the
waiver of 15-day advance notice requirements of Sec. 1313.24 of this
chapter:
(i) The name and street address of the chemical exporter and of each
regular customer;
(ii) The telephone number, telex number, contact person, and where
available, the facsimile number for the chemical exporter and for each
regular customer;
(iii) The nature of the regular customer's business (i.e., importer,
exporter, distributor, manufacturer, etc.), and if known, the use to
which the listed chemical or chemicals will be applied;
(iv) The duration of the business relationship;
(v) The frequency and number of transactions occurring during the
preceding 12-month period;
(vi) the amounts and the listed chemical or chemicals involved in
regulated transactions between the chemical exporter and regular
customer;
(vii) The method of delivery (direct shipment or through a broker or
forwarding agent); and
(viii) Other information that the chemical exporter considers
relevant for determining whether a customer is a regular customer.
(13) The term 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. The term also means that the regulated person has provided the
Administration with the following information in accordance with the
waiver of the 15-day advance notice requirements of Sec. 1313.15 of this
chapter:
(i) The name, DEA registration number (where applicable), street
address, telephone number, telex number, and, where available, the
facsimile number of the regulated person and of each foreign supplier;
and
(ii) The frequency and number of transactions occurring during the
preceding 12 month period.
(14) The term 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).
(15) The term 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.
[[Page 11]]
(16) The term 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.
(17) The term listed chemical means any List I chemical or List II
chemical.
(18) The term 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.
(19) The term 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.
(20) The term name means the official name, common or usual name,
chemical name, or brand name of a substance.
(21) The term person includes any individual, corporation,
government or governmental subdivision or agency, business trust,
partnership, association, or other legal entity.
(22) The term 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.
(23) The terms 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).
(24) The term 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).
(25) The term 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
Sec. 1300.02(b)(12).
(26) The term 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.
(27) The term 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.
(28) The term regulated transaction means:
(i) 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:
(A) 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;
(B) 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, and 1313 of this
chapter;
(C) Any category of transaction or any category of transaction for a
specific listed chemical or chemicals specified by regulation of the
Administrator as excluded from this definition as unnecessary for
enforcement of the Act;
[[Page 12]]
(D) Any transaction in a listed chemical that is contained in a drug
that may be marketed or distributed lawfully in the United States under
the Federal Food, Drug, and Cosmetic Act unless--
(1)(i) The drug contains ephedrine or its salts, optical isomers, or
salts of optical isomers; or
(ii) The Administrator has determined pursuant to the criteria in
1310.10 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
(2) The quantity of ephedrine or other listed chemical contained in
the drug included in the transaction or multiple transactions equals or
exceeds the threshold established for that chemical.
(E) Any transaction in a chemical mixture listed in Sec. 1310.13 of
this chapter.
(ii) 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.
(29) The term 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, phenylpropanolamine, or ephedrine 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. For the purposes of this paragraph, sale
for personal use means the distribution of below-threshold quantities in
a single transaction to an individual for legitimate medical use. 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.
(30) The term 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.
[62 FR 13941, Mar. 24, 1997; 62 FR 15392, Apr. 1, 1997]
Effective Date Note: At 67 FR 14859, Mar. 28, 2002, Sec. 1300.02 was
amended by revising paragraph (b)(28)(i)(D), and adding paragraphs
(b)(31) and (32), effective Apr. 29, 2002. For the convenience of the
user, the revised and added text follows:
Sec. 1300.02 Definitions relating to listed chemicals.
* * * * *
(b) * * *
(28) * * *
(i) * * *
(D) * * *
(1)(i) the drug contains ephedrine or its salts, optical isomers, or
salts of optical isomers, pseudoephedrine or its salts, optical isomers,
or salts of optical isomers, or phenylpropanolamine or its salts,
optical isomers, or salts of optical isomers unless otherwise exempted
under Sec. 1310.11 of this chapter, except that any sale of ordinary
over-the-counter pseudoephedrine or phenylpropanolamine products by
retail distributors shall not be a regulated transaction; or
(ii) 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
(2) The quantity of ephedrine, pseudoephedrine, phenylpropanolamine,
or other listed chemical contained in the drug included in the
transaction or multiple transactions equals or exceeds the threshold
established for that chemical, except that the threshold for any sale of
products containing pseudoephedrine or phenylpropanolamine by retail
distributors or by distributors required to submit reports by
Sec. 1310.03(c) shall be 24 grams of pseudoephedrine or 24 grams of
phenylpropanolamine in a single transaction. For combination ephedrine
products the threshold for any sale by retail distributors or by
distributors required to submit reports by Sec. 1310.03(c) shall be 24
grams of ephedrine in a single transaction.
* * * * *
(31) The term ordinary over-the-counter pseudoephedrine or
phenylpropanolamine product means any product containing pseudoephedrine
or phenylpropanolamine that is--
[[Page 13]]
(i) Regulated pursuant to the Act; and
(ii)(A) Except for liquids, sold in package sizes of not more than
3.0 grams of pseudoephedrine base or 3.0 grams of phenylpropanolamine
base, and that is packaged in blister packs, each blister containing not
more than two dosage units, or where the use of blister packs is
technically infeasible, that is packaged in unit dose packets or
pouches, and
(B) For liquids, sold in package sizes of not more than 3.0 grams of
pseudoephedrine base or 3.0 grams of phenylpropanolamine base.
(32) The term 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.