[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1307.11]

[Page 89-90]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1307_MISCELLANEOUS--Table of Contents
 
Sec. 1307.11  Distribution by dispenser to another practitioner
or reverse distributor.

    (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;

[[Page 90]]

    (ii) The distribution is recorded by the distributing practitioner 
in accordance with Sec. 1304.22(c) of this chapter and by the receiving 
practitioner in accordance with Sec. 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 Sec. 
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) A reverse distributor who is registered to receive such 
controlled substances.
    (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 
Sec. 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.

[68 FR 41229, July 11, 2003, as amended at 70 FR 25466, May 13, 2005]