§1304.04. Maintenance of records and inventories. — Inbound Citations
21 C.F.R. § 1304.04
Statutory Authority
Cited by 7 regulations in release Current.
Citations to 21 C.F.R. § 1304.04 as a whole
-
(b) A registered individual practitioner is required to keep records, as described in § 1304.04, of controlled substances in Schedules II, III, IV, and V which are dispensed, other than by prescribing or administering in the lawful course of professional practice.
-
(e) A bound record book for dispensing of controlled substances under this section is maintained by the pharmacist, which book shall contain the name and address of the purchaser, the name and quantity of controlled substance purchased, the date of each purchase, and the name or initials of the pharmacist who dispensed the substance to the purchaser (the book shall be maintained in accordance with the recordkeeping requirement of § 1304.04 of this chapter); and
Citations to §1304.04(a)
-
(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.
-
(2) The NTP must retain all records for the NTP as well as any mobile component two years from the date of execution, in accordance with § 1304.04(a). However, if the State in which the NTP is located requires that records be retained longer than two years, the NTP should contact its State opioid treatment authority for information about State requirements.
Citations to §1304.04(h)
-
(a) A pharmacist may dispense directly a controlled substance listed in Schedule II that is a prescription drug as determined under section 503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) only pursuant to a written prescription signed by the practitioner, except as provided in paragraph (d) of this section. A paper prescription for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner's agent to a pharmacy via facsimile equipment, provided that the original manually signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance, except as noted in paragraph (e), (f), or (g) of this section. The original prescription shall be maintained in accordance with § 1304.04(h) of this chapter.
-
(d) All written prescriptions and written records of emergency oral prescriptions shall be kept in accordance with requirements of § 1304.04(h) of this chapter.
-
(d) All prescriptions for controlled substances listed in Schedules III, IV, and V shall be kept in accordance with § 1304.04(h) of this chapter.