[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: 21CFR1304.22]

[Page 58-59]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1304--RECORDS AND REPORTS OF REGISTRANTS--Table of Contents
 
Sec. 1304.22  Records for manufacturers, distributors, dispensers, researchers, importers and exporters.

    Each person registered or authorized (by Sec. 1301.13(e) or 
Secs. 1307.11-1307.13 of this chapter) to manufacture, distribute, 
dispense, import, export or conduct research with controlled substances 
shall maintain records with the information listed below.
    (a) Records for manufacturers. Each person registered or authorized 
to manufacture controlled substances shall maintain records with the 
following information:
    (1) For each controlled substance in bulk form to be used in, or 
capable of use in, or being used in, the manufacture of the same or 
other controlled or noncontrolled substances in finished form,
    (i) The name of the substance;
    (ii) The quantity manufactured in bulk form by the registrant, 
including the date, quantity and batch or other identifying number of 
each batch manufactured;
    (iii) The quantity received from other persons, including the date 
and quantity of each receipt and the name, address, and registration 
number of the other person from whom the substance was received;
    (iv) The quantity imported directly by the registrant (under a 
registration as an importer) for use in manufacture by him/her, 
including the date, quantity, and import permit or declaration number 
for each importation;
    (v) The quantity used to manufacture the same substance in finished 
form, including:
    (A) The date and batch or other identifying number of each 
manufacture;
    (B) The quantity used in the manufacture;
    (C) The finished form (e.g., 10-milligram tablets or 10-milligram 
concentration per fluid ounce or milliliter);
    (D) The number of units of finished form manufactured;
    (E) The quantity used in quality control;
    (F) The quantity lost during manufacturing and the causes therefore, 
if known;
    (G) The total quantity of the substance contained in the finished 
form;
    (H) The theoretical and actual yields; and
    (I) Such other information as is necessary to account for all 
controlled substances used in the manufacturing process;
    (vi) The quantity used to manufacture other controlled and 
noncontrolled substances, including the name of each substance 
manufactured and the information required in paragraph (a)(1)(v) of this 
section;
    (vii) The quantity distributed in bulk form to other persons, 
including the date and quantity of each distribution and the name, 
address, and registration number of each person to whom a distribution 
was made;
    (viii) 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 exportation;
    (ix) The quantity distributed or disposed of in any other manner by 
the registrant (e.g., by distribution of complimentary samples or by 
destruction), including the date and manner of distribution or disposal, 
the name, address, and registration number of the person to whom 
distributed, and the quantity distributed or disposed; and
    (x) The originals of all written certifications of available 
procurement quotas submitted by other persons (as required by 
Sec. 1303.12(f) of this chapter) relating to each order requiring the 
distribution of a basic class of controlled substance listed in Schedule 
I or II.
    (2) For each controlled substance in finished form,
    (i) The name of the substance;
    (ii) Each finished form (e.g., 10-milligram tablet or 10-milligram 
concentration per fluid ounce or milliliter) and the number of units or 
volume of finished form in each commercial container (e.g., 100-tablet 
bottle or 3-milliliter vial);
    (iii) The number of containers of each such commercial finished form 
manufactured from bulk form by the registrant, including the information 
required pursuant to paragraph (a)(1)(v) of this section;
    (iv) The number of units of finished forms and/or commercial 
containers acquired from other persons, including

[[Page 59]]

the date of and number of units and/or commercial containers in each 
acquisition to inventory and the name, address, and registration number 
of the person from whom the units were acquired;
    (v) 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;
    (vi) The number of units and/or commercial containers manufactured 
by the registrant from units in finished form received from others or 
imported, including:
    (A) The date and batch or other identifying number of each 
manufacture;
    (B) The operation performed (e.g., repackaging or relabeling);
    (C) The number of units of finished form used in the manufacture, 
the number manufactured and the number lost during manufacture, with the 
causes for such losses, if known; and
    (D) Such other information as is necessary to account for all 
controlled substances used in the manufacturing process;
    (vii) The number of commercial containers distributed to other 
persons, including the date of and number of containers in each 
reduction from inventory, and the name, address, and registration number 
of the person to whom the containers were distributed; (viii) The number 
of commercial containers exported directly by the registrant (under a 
registration as an exporter), including the date, number of containers 
and export permit or declaration number for each exportation; and
    (ix) The number of units of finished forms and/or commercial 
containers distributed or disposed of in any other manner by the 
registrant (e.g., by distribution of complimentary samples or by 
destruction), including the date and manner of distribution or disposal, 
the name, address, and registration number of the person to whom 
distributed, and the quantity in finished form distributed or disposed.
    (b) Records for distributors. Each person registered or authorized 
to distribute controlled substances shall maintain records with the same 
information required of manufacturers pursuant to paragraphs (a)(2) (i), 
(ii), (iv), (v), (vii), (viii) and (ix) of this section.
    (c) Records for dispensers and researchers. Each person registered 
or authorized to dispense or conduct research with controlled substances 
shall maintain records with the same information required of 
manufacturers pursuant to paragraph (a)(2) (i), (ii), (iv), (vii), and 
(ix) of this section. In addition, records shall be maintained of the 
number of units or volume of such finished form dispensed, including the 
name and address of the person to whom it was dispensed, the date of 
dispensing, the number of units or volume dispensed, and the written or 
typewritten name or initials of the individual who dispensed or 
administered the substance on behalf of the dispenser.
    (d) Records for importers and exporters. Each person registered or 
authorized to import or export controlled substances shall maintain 
records with the same information required of manufacturers pursuant to 
paragraphs (a)(2) (i), (iv), (v) and (vii) of this section. In addition, 
the quantity disposed of in any other manner by the registrant (except 
quantities used in manufacturing by an importer under a registration as 
a manufacturer), which quantities are to be recorded pursuant to 
paragraphs (a)(1) (iv) and (v) of this section; and the quantity (or 
number of units or volume in finished form) exported, including the 
date, quantity (or number of units or volume), and the export permit or 
declaration number for each exportation, but excluding all quantities 
(and number of units and volumes) manufactured by an exporter under a 
registration as a manufacturer, which quantities (and numbers of units 
and volumes) are to be recorded pursuant to paragraphs (a)(1)(xiii) or 
(a)(2)(xiii) of this section.

[62 FR 13960, Mar. 24, 1997]