CFR Subpart A

CFR Subpart A
in effect

21 C.F.R. § 1316.01 Scope of subpart A.

Procedures regarding administrative inspections and warrants pursuant to sections 302(f), 510, 1008(d), and 1015 of the Act (21 U.S.C. 822(f), 880, 958(d), and 965) are governed generally by those sections and specifically by the sections of this subpart.

21 C.F.R. § 1316.02 Definitions.

As used in this subpart, the following terms shall have the meanings specified: (a) The term Act means the Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import and Export Act (84 Stat. 1285; 21 U.S.C. 951). (b) The term Administration means the Drug Enforcement Administration. (c) The term controlled premises means— (1) Places where original or other records or documents required under the Act are kept or required to be kept, and (2) Places, including factories, warehouses, or other establishments and conveyances, where persons registered under the Act or exempted from registration under the Act, or regulated persons may lawfully hold, manufacture, or distribute, dispense, administer, or otherwise dispose of controlled substances or listed chemicals or where records relating to those activities are maintained. (d) The term Administrator means the Administrator of the Administration. The Administrator has been delegated authority under the Act by the Attorney General (28 CFR 0.100). (e) The term inspector means an officer or employee of the Administration authorized by the Administrator to make inspections under the Act. (f) The term register and registration refer to registration required and permitted by sections 303 and 1008 of the Act (21 U.S.C. 823 and 958). (g) Any term not defined 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.

21 C.F.R. § 1316.03 Authority to make inspections.

In carrying out his functions under the Act, the Administrator, through his inspectors, is authorized in accordance with sections 510 and 1015 of the Act (21 U.S.C. 880 and 965) to enter controlled premises and conduct administrative inspections thereof, for the purpose of: (a) Inspecting, copying, and verifying the correctness of records, reports, or other documents required to be kept or made under the Act and regulations promulgated under the Act, including, but not limited to, inventory and other records required to be kept pursuant to part 1304 of this chapter, order form records required to be kept pursuant to part 1305 of this chapter, prescription and distribution records required to be kept pursuant to part 1306 of this chapter, records of listed chemicals, tableting machines, and encapsulating machines required to be kept pursuant to part 1310 of this chapter, import/export records of listed chemicals required to be kept pursuant to part 1313 of this chapter, shipping records identifying the name of each carrier used and the date and quantity of each shipment, and storage records identifying the name of each warehouse used and the date and quantity of each storage. (b) Inspecting within reasonable limits and to a reasonable manner all pertinent equipment, finished and unfinished controlled substances, listed chemicals, and other substances or materials, containers, and labeling found at the controlled premises relating to this Act; (c) Making a physical inventory of all controlled substances and listed chemicals on-hand at the premises; (d) Collecting samples of controlled substances or listed chemicals (in the event any samples are collected during an inspection, the inspector shall issue a receipt for such samples on DEA Form 400 to the owner, operator, or agent in charge of the premises); (e) Checking of records and information on distribution of controlled substances or listed chemicals by the registrant or regulated person (i.e., has the distribution of controlled substances or listed chemicals increased markedly within the past year, and if so why); (f) Except as provided in § 1316.04, all other things therein (including records, files, papers, processes, controls and facilities) appropriate for verification of the records, reports, documents referred to above or otherwise bearing on the provisions of the Act and the regulations thereunder.

21 C.F.R. § 1316.04 Exclusion from inspection.

(a) Unless the owner, operator or agent in charge of the controlled premises so consents in writing, no inspection authorized by these regulations shall extend to: (1) Financial data: (2) Sales data other than shipping data; or (3) Pricing data. (b) [Reserved]

21 C.F.R. § 1316.05 Entry.

An inspection shall be carried out by an inspector. Any such inspector, upon (a) stating his purpose and (b) presenting to the owner, operator or agent in charge of the premises to be inspected (1) appropriate credentials, and (2) written notice of his inspection authority under § 1316.06 of this chapter, and (c) receiving informed consent under § 1316.08 or through the use of administrative warrant issued under §§ 1316.09-1316.13, shall have the right to enter such premises and conduct inspections at reasonable times and in a reasonable manner.

21 C.F.R. § 1316.06 Notice of inspection.

The notice of inspection (DEA (or DNB) Form 82) shall contain: (a) The name and title of the owner, operator, or agent in charge of the controlled premises; (b) The controlled premises name; (c) The address of the controlled premises to be inspected; (d) The date and time of the inspection; (e) A statement that a notice of inspection is given pursuant to section 510 of the Act (21 U.S.C. 880); (f) A reproduction of the pertinent parts of section 510 of the Act; and (g) The signature of the inspector.

21 C.F.R. § 1316.07 Requirement for administrative inspection warrant; exceptions.

In all cases where an inspection is contemplated, an administrative inspection warrant is required pursuant to section 510 of the Act (21 U.S.C. 880), except that such warrant shall not be required for establishments applying for initial registration under the Act, for the inspection of books and records pursuant to an administrative subpoena issued in accordance with section 506 of the Act (21 U.S.C. 876) nor for entries in administrative inspections (including seizures of property): (a) With the consent of the owner, operator, or agent in charge of the controlled premises as set forth in § 1316.08; (b) In situations presenting imminent danger to health or safety; (c) In situations involving inspection of conveyances where there is reasonable cause to obtain a warrant; (d) In any other exceptional or emergency circumstance or time or opportunity to apply for a warrant is lacking; or (e) In any other situations where a warrant is not constitutionally required.

21 C.F.R. § 1316.08 Consent to inspection.

(a) An administrative inspection warrant shall not be required if informed consent is obtained from the owner, operator, or agent in charge of the controlled premises to be inspected. (b) Wherever possible, informed consent shall consist of a written statement signed by the owner, operator, or agent in charge of the premises to be inspected and witnessed by two persons. The written consent shall contain the following information: (1) That he (the owner, operator, or agent in charge of the premises) has been informed of his constitutional right not to have an administrative inspection made without an administrative inspection warrant; (2) That he has right to refuse to consent to such an inspection; (3) That anything of an incriminating nature which may be found may be seized and used against him in a criminal prosecution; (4) That he has been presented with a notice of inspection as set forth in § 1316.06; (5) That the consent is given by him is voluntary and without threats of any kind; and (6) That he may withdraw his consent at any time during the course of inspection. (c) The written consent shall be produced in duplicate and be distributed as follows: (1) The original will be retained by the inspector; and (2) The duplicate will be given to the person inspected.

21 C.F.R. § 1316.09 Application for administrative inspection warrant.

(a) An administrative inspection warrant application shall be submitted to any judge of the United States or of a State court of record, or any United States magistrate and shall contain the following information: (1) The name and address of the controlled premises to be inspected; (2) A statement of statutory authority for the administrative inspection warrant, and that the fact that the particular inspection in question is designed to insure compliance with the Act and the regulations promulgated thereunder; (3) A statement relating to the nature and extent of the administrative inspection, including, where necessary, a request to seize specified items and/or to collect samples of finished or unfinished controlled substances or listed chemicals; (4) A statement that the establishment either: (i) Has not been previously inspected, or (ii) Was last inspected on a particular date. (b) The application shall be submitted under oath to an appropriate judge or magistrate.

21 C.F.R. § 1316.10 Administrative probable cause.

If the judge or magistrate is satisfied that “administrative probable cause,” as defined in section 510(d)(1) of the Act (21 U.S.C. 880(d)(1)) exists, he shall issue an administrative warrant. Administrative probable cause shall not mean criminal probable cause as defined by Federal statute or case law.

21 C.F.R. § 1316.11 Execution of warrants.

An administrative inspection warrant shall be executed and returned as required by, and any inventory or seizure made shall comply with the requirements of, section 510(d)(3) of the Act (21 U.S.C. 880(d)(3)). The inspection shall begin as soon as is practicable after the issuance of the administrative inspection warrant and shall be completed with reasonable promptness. The inspection shall be conducted during regular business hours and shall be completed in a reasonable manner.

21 C.F.R. § 1316.12 Refusal to allow inspection with an administrative warrant.

If a registrant or any person subject to the Act refuses to permit execution of an administrative warrant or impedes the inspector in the execution of that warrant, he shall be advised that such refusal or action constitutes a violation of section 402(a)(6) of the Act (21 U.S.C. 842(a)(6)). If he persists and the circumstances warrant, he shall be arrested and the inspection shall commence or continue.

21 C.F.R. § 1316.13 Frequency of administrative inspections.

Except where circumstances otherwise dictate, it is the intent of the Administration to inspect all manufacturers of controlled substances listed in Schedules I and II and distributors of controlled substances listed in Schedule I once each year. Distributors of controlled substances listed in Schedules II through V and manufacturers of controlled substances listed in Schedules III through V shall be inspected as circumstances may require, based in part on the registrant's history of compliance with the requirements of this chapter and maintenance of effective controls and procedures to guard against the diversion of controlled substances.

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