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Title 21 CFR reference

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United States • Title 21 CFR • Part 1313

Part 1313PART 1313—IMPORTATION AND EXPORTATION OF LIST I AND LIST II CHEMICALS

This part of Title 21 of the CFR outlines the procedures for the importation and exportation of List I and List II chemicals, as governed by section 1018 of the Act (21 U.S.C. 971). It details definitions, applicable forms, and requirements for establishing business relationships and records for importers.

What this part covers

  • Governs importation, exportation, transshipment, and in-transit shipment of listed chemicals.
  • Defines terms based on section 102 of the Act and part 1300 of this chapter.
  • Specifies the use of DEA Form 486 and DEA Form 486A for declarations.
  • Outlines requirements for documenting an established business relationship with customers.
  • Details information needed to establish a record as an importer, including supplier details.

Sections in Part 1313

§ 1313.01

Scope.

Procedures governing the importation, exportation, transshipment and in-transit shipment of listed chemicals pursuant to section 1018 of the Act (21 U.S.C. 971) are governed generally by that section and specifically by the sections of this part. [54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32465, June 22, 1995]

§ 1313.02

Definitions.

Any term used in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter. [62 FR 13969, Mar. 24, 1997]

§ 1313.03

Forms applicable to this part.

Table | Form | Access/submission | | --- | --- | | DEA Form 486, Import/Export Declaration for List I and List II Chemicals | electronic. | | DEA Form 486A Import Declaration for ephedrine, pseudoephedrine, and phenylpropanolamine (including drug products containing these chemicals) | electronic. | [81 FR 97036, Dec. 30, 2016]

§ 1313.05

Requirements for an established business relationship.

To document that an importer or exporter has an established business relationship with a customer, the importer or exporter must provide the Administrator with the following information in accordance with the waiver of 15-day advance notice requirements of § 1313.15 or § 1313.24: (a) The name and street address of the chemical importer or exporter and of each regular customer; (b) The telephone number, contact person, and where available, the facsimile number for the chemical importer or exporter and for each regular customer; i.e.(c) The nature of the regular customer's business (, importer, exporter, distributor, manufacturer, etc.), and if known, the use to which the listed chemical or chemicals will be applied; (d) The duration of the business relationship; (e) The frequency and number of transactions occurring during the preceding 12-month period; (f) The amounts and the listed chemical or chemicals involved in regulated transactions between the chemical importer or exporter and regular customer; (g) The method of delivery (direct shipment or through a broker or forwarding agent); and (h) Other information that the chemical importer or exporter considers relevant for…

§ 1313.08

Requirements for establishing a record as an importer.

To establish a record as an importer, the regulated person must provide the Administrator with the following information in accordance with the waiver of the 15-day advance notice requirements of § 1313.15: (a) The name, DEA registration number (where applicable), street address, telephone number, and, where available, the facsimile number of the regulated person and of each foreign supplier; and (b) The frequency and number of transactions occurring during the preceding 12 month period. [72 FR 17407, Apr. 9, 2007]

Regulatory Context

This document sits within United States CFR and is most useful when linked to operational submission, quality, and inspection workflows.

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