[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1304.25]

[Page 60-62]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1304--RECORDS AND REPORTS OF REGISTRANTS--Table of Contents
 
Sec. 1304.25  Records for treatment programs which compound narcotics for treatment programs and other locations.

    Each person registered or authorized by Sec. 1301.22 of this chapter 
to compound narcotic drugs for off-site use in a narcotic treatment 
program shall maintain records which include the following information 
for each narcotic drug:
    (a) For each narcotic controlled substance in bulk form to be used 
in, or capable of use in, or being used in, the compounding of the same 
or other noncontrolled substances in finished form:
    (1) The name of the substance;
    (2) The quantity compounded in bulk form by the registrant, 
including the date, quantity and batch or other identifying number of 
each batch compounded;
    (3) The quantity received from other persons, including the date and 
quantity of each receipt and the name, address and registration number 
of the

[[Page 61]]

other person from whom the substance was received;
    (4) The quantity imported directly by the registrant (under a 
registration as an importer) for use in compounding by him, including 
the date, quantity and import permit or declaration number of each 
importation;
    (5) The quantity used to compound the same substance in finished 
form, including:
    (i) The date and batch or other identifying number of each 
compounding;
    (ii) The quantity used in the compound;
    (iii) The finished form (e.g., 10-milligram tablets or 10-milligram 
concentration per fluid ounce or milliliter;
    (iv) The number of units of finished form compounded;
    (v) The quantity used in quality control;
    (vi) The quantity lost during compounding and the causes therefore, 
if known;
    (vii) The total quantity of the substance contained in the finished 
form;
    (viii) The theoretical and actual yields; and
    (ix) Such other information as is necessary to account for all 
controlled substances used in the compounding process;
    (6) The quantity used to manufacture other controlled and non-
controlled substances; including the name of each substance manufactured 
and the information required in paragraph (a)(5) of this section;
    (7) The quantity distributed in bulk form to other programs, 
including the date and quantity of each distribution and the name, 
address and registration number of each program to whom a distribution 
was made;
    (8) The quantity exported directly by the registrant (under a 
registration as an exporter), including the date, quantity, and export 
permit or declaration number of each exploration; and
    (9) The quantity disposed of by destruction, including the reason, 
date and manner of destruction. All other destruction of narcotic 
controlled substances will comply with Sec. 1307.22.
    (b) For each narcotic controlled substance in finished form:
    (1) The name of the substance;
    (2) Each finished form (e.g., 10-milligram tablet or 10 milligram 
concentration per fluid ounce or milliliter) and the number of units or 
volume or finished form in each commercial container (e.g., 100-tablet 
bottle or 3-milliliter vial);
    (3) The number of containers of each such commercial finished form 
compounded from bulk form by the registrant, including the information 
required pursuant to paragraph (a)(5) of this section;
    (4) The number of units of finished forms and/or commercial 
containers received from other persons, including the date of and number 
of units and/or commercial containers in each receipt and the name, 
address and registration number of the person from whom the units were 
received;
    (5) The number of units of finished forms and/or commercial 
containers imported directly by the person (under a registration or 
authorization to import), including the date of, the number of units 
and/or commercial containers in, and the import permit or declaration 
number for, each importation;
    (6) The number of units and/or commercial containers compounded by 
the registrant from units in finished form received from others or 
imported, including:
    (i) The date and batch or other identifying number of each 
compounding;
    (ii) The operation performed (e.g., repackaging or relabeling);
    (iii) The number of units of finished form used in the compound, the 
number compounded and the number lost during compounding, with the 
causes for such losses, if known; and
    (iv) Such other information as is necessary to account for all 
controlled substances used in the compounding process;
    (7) The number of containers distributed to other programs, 
including the date, the number of containers in each distribution, and 
the name, address and registration number of the program to whom the 
containers were distributed;
    (8) The number of commercial containers exported directly by the 
registrant (under a registration as an exporter), including the date, 
number of

[[Page 62]]

containers and export permit or declaration number for each exportation; 
and
    (9) The number of units of finished forms and/or commercial 
containers destroyed in any manner by the registrant, including the 
reason, the date and manner of destruction. All other destruction of 
narcotic controlled substances will comply with Sec. 1307.22.

[39 FR 37985, Oct. 25, 1974. Redesignated at 62 FR 13961, Mar. 24, 1997]

                                 Reports