[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: 21CFR1308.24]

[Page 102-103]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1308_SCHEDULES OF CONTROLLED SUBSTANCES--Table of Contents
 
Sec. 1308.24  Exempt chemical preparations.

    (a) The chemical preparations and mixtures approved pursuant to 
Sec. 1308.23 are exempt from application of sections 302, 303, 305, 
306, 307, 308, 309, 1002, 1003 and 1004 of the Act (21 U.S.C. 822-823, 
825-829, 952-954) and Sec. 1301.74 of this chapter, to the extent 
described in paragraphs (b) to (h) of this section. Substances set forth 
in paragraph (j) of this section shall be exempt from the application of 
sections 305, 306, 307, 308, 309, 1002, 1003 and 1004 of the Act (21 
U.S.C. 825-829, 952-954) and Sec. Sec. 1301.71-1301.73 and 1301.74 (a), 
(b), (d), (e) and (f) of this chapter to the extent as hereinafter may 
be provided.
    (b) Registration and security: Any person who manufactures an exempt 
chemical preparation or mixture must be registered under the Act and 
comply with all relevant security requirements regarding controlled 
substances being used in the manufacturing process until the preparation 
or mixture is in the form described in paragraph (i) of this section. 
Any other person who handles an exempt chemical preparation after it is 
in the form described in paragraph (i) of this section is not required 
to be registered under the Act to handle that preparation, and the 
preparation is not required to be stored in accordance with security 
requirements regarding controlled substances.
    (c) Labeling: In lieu of the requirements set forth in part 1302 of 
this chapter, the label and the labeling of an exempt chemical 
preparation must be prominently marked with its full trade name or other 
description and the name of the manufacturer or supplier as set forth in 
paragraph (i) of this section, in such a way that the product can be 
readily identified as an exempt chemical preparation. The label and 
labeling must also include in a prominent manner the statement ``For 
industrial use only'' or ``For chemical use only'' or ``For in vitro use 
only--not for human or animal use'' or ``Diagnostic reagent--for 
professional use only'' or a comparable statement warning the person 
reading it that human or animal use is not intended. The symbol 
designating the schedule of the controlled substance is not required on 
either the label or the labeling of the exempt chemical preparation, nor 
is it necessary to list all ingredients of the preparation.
    (d) Records and reports: Any person who manufactures an exempt 
chemical preparation or mixture must keep complete and accurate records 
and file all reports required under part 1304 of this chapter regarding 
all controlled substances being used in the manufacturing process until 
the preparation or mixture is in the form described in paragraph (i) of 
this section. In lieu of records and reports required under part 1304 of 
this chapter regarding exempt chemical preparations, the manufacturer 
need only record the name, address, and registration number, if any, of 
each person to whom the manufacturer distributes any exempt chemical 
preparation. Each importer or exporter of an exempt narcotic chemical 
preparation must submit a semiannual report of the total quantity of 
each substance imported or exported in each calendar half-year within 30 
days of the close of the period to the Drug and Chemical Evaluation 
Section, Drug Enforcement Administration, Department

[[Page 103]]

of Justice, Washington, DC 20537. Any other person who handles an exempt 
chemical preparation after it is in the form described in paragraph (i) 
of this section is not required to maintain records or file reports.
    (e) Quotas, order forms, prescriptions, import, export, and 
transshipment requirements: Once an exempt chemical preparation is in 
the form described in paragraph (i) of this section, the requirements 
regarding quotas, order forms, prescriptions, import permits and 
declarations, export permit and declarations, and transshipment and 
intransit permits and declarations do not apply. These requirements do 
apply, however, to any controlled substances used in manufacturing the 
exempt chemical preparation before it is in the form described in 
paragraph (i) of this section.
    (f) Criminal penalties: No exemption granted pursuant to Sec. 
1308.23 affects the criminal liability for illegal manufacture, 
distribution, or possession of controlled substances contained in the 
exempt chemical preparation. Distribution, possession, and use of an 
exempt chemical preparation are lawful for registrants and 
nonregistrants only as long as such distribution, possession, or use is 
intended for laboratory, industrial, or educational purposes and not for 
immediate or subsequent administration to a human being or other animal.
    (g) Bulk materials: For materials exempted in bulk quantities, the 
Administrator may prescribe requirements other than those set forth in 
paragraphs (b) through (e) of this section on a case-by-case basis.
    (h) Changes in chemical preparations: Any change in the quantitative 
or qualitative composition of the preparation or mixture after the date 
of application, or change in the trade name or other designation of the 
preparation or mixture, set forth in paragraph (i) of this section, 
requires a new application for exemption.
    (i) A listing of exempt chemical preparations may be obtained by 
submitting a written request to the Drug and Chemical Evaluation 
Section, Drug Enforcement Administration, Washington, DC 20537.
    (j) The following substances are designated as exempt chemical 
preparations for the purposes set forth in this section.
    (1) Chloral. When packaged in a sealed, oxygen-free environment, 
under nitrogen pressure, safeguarded against exposure to the air.
    (2) Emit\R\ Phenobarbital Enzyme Reagent B. In one liter quantities 
each with a 5 ml. retention sample for repackaging as an exempt chemical 
preparation only.

[38 FR 8255, Mar. 30, 1973]

    Editorial Note: For Federal Register citations affecting Sec. 
1308.24, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.

          Excluded Veterinary Anabolic Steroid Implant Products