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Regulations &
Codified CSA > CFR > Section 1304 > Section 1304.22
Section 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 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.
In addition to the requirements
of this paragraph, practitioners dispensing gamma-hydroxybutyric acid under a
prescription must also comply with Sec. 1304.26.
(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]
NOTICE: This is an
unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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