21 CFR 1307.11 - Distribution by dispenser to another practitioner.
(a) A practitioner who is registered to dispense a controlled substance may distribute (without being registered to distribute) a quantity of such substance to -
(1) Another practitioner for the purpose of general dispensing by the practitioner to patients, provided that -
(i) The practitioner to whom the controlled substance is to be distributed is registered under the Act to dispense that controlled substance;
(iii) If the substance is listed in Schedule I or II, an order form is used as required in part 1305 of this chapter; and
(iv) The total number of dosage units of all controlled substances distributed by the practitioner pursuant to this section and § 1301.25 of this chapter during each calendar year in which the practitioner is registered to dispense does not exceed 5 percent of the total number of dosage units of all controlled substances distributed and dispensed by the practitioner during the same calendar year.
(b) If, during any calendar year in which the practitioner is registered to dispense, the practitioner has reason to believe that the total number of dosage units of all controlled substances which will be distributed by him pursuant to paragraph (a)(1) of this section and § 1301.25 of this chapter will exceed 5 percent of this total number of dosage units of all controlled substances distributed and dispensed by him during that calendar year, the practitioner shall obtain a registration to distribute controlled substances.
(c) The distributions that a registered retail pharmacy makes to automated dispensing systems at long term care facilities for which the retail pharmacy also holds registrations do not count toward the 5 percent limit in paragraphs (a)(1)(iv) and (b) of this section.
- 21 CFR 1304.11 — Inventory Requirements.
- 21 CFR 1304.22 — Records for Manufacturers, Distributors, Dispensers, Researchers, Importers, Exporters, Registrants That Reverse Distribute, and Collectors.
- 21 CFR 1301.25 — Registration Regarding Ocean Vessels, Aircraft, and Other Entities.
- 21 CFR 1305.06 — Persons Entitled to Fill Orders for Schedule I and II Controlled Substances.
- 21 CFR 1301.76 — Other Security Controls for Practitioners.
- 21 CFR 1304.03 — Persons Required to Keep Records and File Reports.
Title 21 published on 2015-12-03.
No entries appear in the Federal Register after this date, for 21 CFR Part 1307.