Source: http://www.law.cornell.edu/cfr/text/21/1307.11
Timestamp: 2014-11-26 07:11:09
Document Index: 107383330

Matched Legal Cases: ['art 1307', '§ 1304', '§ 1304', 'art 1305', '§ 1301', '§ 1301']

21 CFR 1307.11 - Distribution by dispenser to another practitioner or reverse distributor. | LII / Legal Information Institute
CFR › Title 21 › Chapter II › Part 1307 › Section 1307.11 21 CFR 1307.11 - Distribution by dispenser to another practitioner or reverse distributor.
A practitioner who is registered to dispense a controlled substance may distribute (without being registered to distribute) a quantity of such substance to—
Another practitioner for the purpose of general dispensing by the practitioner to patients, provided that—
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;
If the substance is listed in Schedule I or II, an order form is used as required in part 1305 of this chapter; and
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.
A reverse distributor who is registered to receive such controlled substances.
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.
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.