yourstate.us
21 CFR 1307.11

§ 1307.11 Distribution by dispenser to another practitioner.

United States · 21 CFR — Food and Drugs · Status: effective

Get this as JSONEmbed this
Cite this
Citation
21 CFR 1307.11, § 1307.11 Distribution by dispenser to another practitioner, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91970
Permanent ID
ys:prov:91970@1
SHA-256
fb7652a74374052b19f1835a96033f10e25e33b09817fd5974b7a37bb60206cd

The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.

Full text

(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; (ii) The distribution is recorded by the distributing practitioner in accordance with § 1304.22(c) of this chapter and by the receiving practitioner in accordance with § 1304.22(c) of this chapter; (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. (2) [Reserved] (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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.