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Chemical Handler's Manual

SECTION II – DEFINITIONS

The official language for most definitions presented in this section may be found at 21 U.S.C. § 802 or 21 C.F.R. § 1300.02.

At Retail
A sale or purchase for personal use of a scheduled listed chemical product.

Broker and Trader
Any individual, corporation, corporate division, partnership, association, or other legal entity which assists in arranging an international transaction in a listed chemical by:

  • Negotiating contracts;
  • Serving as an agent or intermediary; or
  • Fulfilling a formal obligation to complete the transaction by bringing together a buyer and seller, a buyer and transporter, or a seller and transporter, or by receiving any form of compensation for so doing.

Chemical Exporter
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.

Chemical Importer
A regulated person who, as the principal party in interest in the import transaction, has the power and responsibility for determining and controlling the bringing in or  introduction of the listed chemical into the United States.

Chemical Mixture
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.

Encapsulating Machine
Any manual, semi-automatic, or fully automatic equipment which may be used to fill shells or capsules with any powdered, granular, semi-solid, or liquid material.

Established Business Relationship
The regulated person has imported or exported a listed chemical at least once within the past six months, or twice within the past twelve months from or to a foreign manufacturer, distributor, or end user of the chemical that has an established business with a fixed street address. A person or business that functions as a broker or intermediary is not a customer for purposes of this definition.

Established Record as an Importer
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.

Excluded Transactions
Pursuant to 21 U.S.C. § 802(39)(A)(iii), certain transactions have been excluded from the definition of regulated transactions (see Appendix E).

Exempt Chemical Mixtures
A mixture containing a listed chemical in concentrations equal to or less than those specified in the "Table of Concentration Limits" detailed in 21 C.F.R. § 1310.12 is exempt from CSA chemical regulatory provisions such as registration, recordkeeping, and import/export notification requirements (see Appendix F). ¬†Appendix G provides four categories of chemical mixtures that are automatically exempt.

International Transaction
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.

Listed Chemical
Any List I or List II chemical. A complete list can be found at 21 C.F.R. § 1310.02.

List I Chemical
A chemical specified by regulation that, in addition to legitimate uses, is used in manufacturing a controlled substance in violation of the Act and is important to the manufacture of a controlled substance.

List II Chemical
A chemical, other than a List I chemical, specified by regulation that, in addition to legitimate uses, is used in manufacturing a controlled substance in violation of the Act.

Mail-Order Sale
A retail sale of scheduled listed chemical products for personal use where a regulated person uses or attempts to use the U.S. Postal Service or any private or commercial carrier to deliver the product to the customer. This includes purchase orders submitted by phone, mail, fax, Internet, or any method other than face-to-face transaction.

Manufacture
The production, preparation, propagation, compounding, or processing of a drug or other substance, either directly or indirectly or by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of such substance or labeling or relabeling of its container; except that such term does not include the preparation, compounding, packaging, or labeling of a drug or other substance in conformity with applicable State or local law by a practitioner as an incident to his administration or dispensing of such drug or substance in the course of his professional practice.

Mobile Retail Vendor
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).

Net Disposal
A complete definition can be found at 21 C.F.R. § 1315.02.

Person
Any individual, corporation, government or governmental subdivision or agency, business trust, partnership, association, or other legal entity.

Readily Retrievable
Means that certain records are kept by automatic data processing systems or other electronic or mechanized recordkeeping systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records.

Registrant
Any person registered with the DEA.

Regular Customer
A person with whom the regulated person has an established business relationship for a specified listed chemical(s) that has been reported to the DEA.

Regular Importer
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 DEA.

Regulated Person
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, a tableting machine, or encapsulating machine.

Regulated Seller
A retail distributor, including a pharmacy or a mobile retail vendor. This term does not include an employee or agent of such distributor.

Regulated Transaction
1. A distribution, receipt, sale, importation or exportation of a listed chemical, or an international transaction involving shipment of a listed chemical, or if the DEA establishes a threshold amount for a specific listed chemical, a threshold amount as determined by the DEA which includes a cumulative threshold amount for multiple transactions of a listed chemical.

A regulated transaction does not include:

  1. 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.
  2. 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 21 C.F.R. Parts 1309, 1310, 1313, and 1315.
  3. 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;
  4. 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 (v) of the definition of regulated transaction found at 21 C.F.R. § 1300.02(b), unless –
    1. The DEA has determined pursuant to the criteria in 21 C.F.R. § 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 the listed chemical contained in the drug included in the transaction or multiple transactions equals or exceeds the threshold established for that chemical;
  5. 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 21 C.F.R. § 1310.03(c); or
  6. Any transaction in a chemical mixture designated in 21 C.F.R. §§ 1310.12 and 1310.13 that the DEA has exempted from regulation.

2. A distribution, importation, or exportation of a tableting machine or encapsulating machine except that such term does not include a domestic lawful distribution in the usual course of business between agents and employees of a single regulated person; in this context, agents or employees means individuals under the direct management and control of the regulated person.

Retail Distributor
A grocery store, general merchandise store, drug store, or other entity or person whose activities as a distributor relating to ephedrine, pseudoephedrine, or phenylpropanolamine products 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.

Scheduled Listed Chemical Product (SLCP)
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.

Tableting Machine
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 cohesive solid tablets.

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