C.F.R. » Title 21 » CHAPTER II—DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE › PART 1304—RECORDS AND REPORTS OF REGISTRANTS

21 C.F.R. § 1304.21

General requirements for continuing records

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(a) Every registrant required to keep records pursuant to § 1304.03 shall maintain, on a current basis, a complete and accurate record of each substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of by him/her, and each inner liner, sealed inner liner, and unused and returned mail-back package, except that no registrant shall be required to maintain a perpetual inventory.

(b) Separate records shall be maintained by a registrant for each registered location except as provided in § 1304.04 (a). In the event controlled substances are in the possession or under the control of a registrant at a location for which he is not registered, the substances shall be included in the records of the registered location to which they are subject to control or to which the person possessing the substance is responsible.

(c) Separate records shall be maintained by a registrant for each independent activity and collection activity for which he/she is registered or authorized, except as provided in § 1304.22(d).

(d) In recording dates of receipt, distribution, other transfers, or destruction, the date on which the controlled substances are actually received, distributed, otherwise transferred, or destroyed will be used as the date of receipt, distribution, transfer, or destruction (e.g., invoices or packing slips, or DEA Form 41). In maintaining records concerning imports and exports, the registrant must record the anticipated date of release by a customs official for permit applications and declarations and the date on which the controlled substances are released by a customs officer at the port of entry or port of export for return information.

(e) Record of destruction. In addition to any other recordkeeping requirements, any registered person that destroys a controlled substance pursuant to § 1317.95(d), or causes the destruction of a controlled substance pursuant to § 1317.95(c), shall maintain a record of destruction on a DEA Form 41. The records shall be complete and accurate, and include the name and signature of the two employees who witnessed the destruction. Except, destruction of a controlled substance dispensed by a practitioner for immediate administration at the practitioner's registered location, when the substance is not fully exhausted (e.g., some of the substance remains in a vial, tube, or syringe after administration but cannot or may not be further utilized), shall be properly recorded in accordance with § 1304.22(c), and such record need not be maintained on a DEA Form 41.

[36 FR 7792, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13960, Mar. 24, 1997; 79 FR 53563, Sept. 9, 2014; 81 FR 97020, Dec. 30, 2016]
Notes of Decisions
Cited in 6 cases, 1976–2008 · leading case: Norman Bridge Drug Co. v. Michael Banner, John R. Bartels, Jr., Adm'r, Drug Enf't Admin., 529 F.2d 822 (5th Cir. 1976).
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Norman Bridge Drug Co. v. Michael Banner, John R. Bartels, Jr., Adm'r, Drug Enf't Admin., 529 F.2d 822 (5th Cir. 1976). “05(a); (6) That Norman Bridge Drug Company had failed to keep complete and accurate records of receipts of controlled substances in Schedules III, IV and V in that it did not record the date of receipt on its invoices, in violation of 21 CFR 1304.21(a); (7) That Norman Bridge…”
United States v. Poulin, 926 F. Supp. 246 (D. Mass. 1996). · cites it 3× “§ 842 (a)(5) and 21 C.F.R. § 1304.21 , he provided no record of when the drugs were last present in the pharmacy.”
Easy Returns Worldwide, Inc. v. United States, 266 F. Supp. 2d 1014 (E.D. Mo. 2003). “22; 21 C.F.R. § 1304.21 (d). An inventory of all stocks of controlled substances on hand is required at least every two years.”
Med. Shoppe-Jonesborough v. Drug Enf't Admin., 300 F. App'x 409 (6th Cir. 2008). “§ 827 (a)(1), (3); see also 21 C.F.R. § 1304.21 . These records must “includ[e] the name and address of the person to whom [a drug] was dispensed, the date of dispensing, the number of units or volume dispensed, and the written or typewritten name or initials of the individual…”
United States v. Stidham, 938 F. Supp. 808 (S.D. Ala. 1996). “§ 842 in violation of 21 C.F.R. § 1304.21 in that they could not account for 56,000 milligrams or approximately 560 dosage units of methadone.”
White v. North Carolina Bd. of Pharmacy, 241 S.E.2d 730 (N.C. Ct. App. 1978). “grain, and atropine one one-fiftieth (l/150th) grain tablets, the principal ingredient of which is morphine, a Schedule II Controlled Substance, which tablets were received, sold, delivered, dispensed, distributed, possessed and otherwise disposed of at and by Mebane Drug…”
— 21 C.F.R. § 1304.21(a) — 1 case
Norman Bridge Drug Co. v. Michael Banner, John R. Bartels, Jr., Adm'r, Drug Enf't Admin., 529 F.2d 822 (5th Cir. 1976). “05(a); (6) That Norman Bridge Drug Company had failed to keep complete and accurate records of receipts of controlled substances in Schedules III, IV and V in that it did not record the date of receipt on its invoices, in violation of 21 CFR 1304.21(a); (7) That Norman Bridge…”
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