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Section
1300 > Section 1300.02
Section 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 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 means the regulated
person has imported or exported a listed chemical at least once within the
past six months, or twice within the past twelve months from or to a foreign
manufacturer, distributor, or end user of the chemical that has an established
business with a fixed street address. A person or business that functions as a
broker or intermediary is not a customer for purposes of this definition.
(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.
(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.
(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 part 1313 of this chapter.
(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 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;
- A delivery of a listed chemical to or by a common or contract carrier for
carriage in the lawful and usual course of the business of the common or
contract carrier, or to or by a warehouseman for storage in the lawful and
usual course of the business of the warehouseman, except that if the carriage
or storage is in connection with the distribution, importation, or exportation
of a listed chemical to a third person, this paragraph does not relieve a
distributor, importer, or exporter from compliance with parts 1309, 1310, 1313 and
1315 of this chapter;
- 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;
- Any transaction in a listed
chemical that is contained in a drug other than a scheduled listed chemical
product that may be marketed or distributed lawfully in the United States
under the Federal Food, Drug, and Cosmetic Act, subject to paragraph (b)(28)(i)(E)
of this section, unless-- (1) 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 the listed chemical
contained in the drug included in the transaction or multiple transactions
equals or exceeds the threshold established for that chemical;
- Any
transaction in a scheduled listed chemical product that is a sale at retail by
a regulated seller or a distributor required to submit reports under Sec.
1310.03(c) of this chapter; or
- Any transaction in a chemical mixture
designated in Sec. Sec. 1310.12 and 1310.13 of this chapter that the
Administrator has exempted from regulation.
(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 or phenylpropanolamine are limited almost exclusively to sales
for personal use, both in number of sales and volume of sales, either directly
to walk-in customers or in face-to-face transactions by direct sales. Also for
the purposes of this paragraph, a grocery store is an entity within Standard
Industrial Classification (SIC) code 5411, a general merchandise store is an
entity within SIC codes 5300 through 5399 and 5499, and a drug store is an
entity within SIC code 5912.
(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.
(31) 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.
(32) The term drug product means an active ingredient in dosage form
that has been approved or otherwise may be lawfully marketed under the
Food, Drug, and Cosmetic Act for distribution in the United States.
(33)
The term valid prescription means a prescription that is issued for a
legitimate medical purpose by an individual practitioner licensed by law
to administer and prescribe the drugs concerned and acting in the usual
course of the practitioner's professional practice.
(34)(i) The term scheduled listed
chemical product means a product that contains ephedrine, pseudoephedrine, or
phenylpropanolamine and may be marketed or distributed lawfully in the United
States under the Federal, Food, Drug, and Cosmetic Act as a nonprescription
drug. Ephedrine, pseudoephedrine, and phenylpropanolamine include their salts,
optical isomers, and salts of optical isomers.
(ii) Scheduled listed chemical
product does not include any product that is a controlled substance under part
1308 of this chapter. In the absence of such scheduling by the Attorney
General, a chemical specified in paragraph (b)(34)(i) of this section may not
be considered to be a controlled substance.
(35) The term regulated seller
means a retail distributor (including a pharmacy or a mobile retail vendor),
except that the term does not include an employee or agent of the distributor.
(36) The term mobile retail vendor means a person or entity that makes sales
at retail from a stand that is intended to be temporary or is capable of being
moved from one location to another, whether the stand is located within or on
the premises of a fixed facility (such as a kiosk at a shopping center or an
airport) or whether the stand is located on unimproved real estate (such as a
lot or field leased for retail purposes).
(37) The term at retail, with
respect to the sale or purchase of a scheduled listed chemical product, means
a sale or purchase for personal use, respectively.
[62 FR 13941, Mar. 24, 1997; 62 FR 15392, Apr. 1, 1997: 67 FR 14859, Mar. 28,
2002, as amended at 68 FR 23203, May 1, 2003; 68 FR 57803, Oct. 7, 2003; 71 FR
56023, Sept 26, 2006; Apr. 9, 2007; 72 FR 37448, July 10, 2007]
NOTICE: This is an
unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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