[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: 21CFR1310.15]

[Page 125-126]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES--Table of Contents
 
Sec. 1310.15  Exempt drug products containing ephedrine and 
therapeutically significant quantities of another active medicinal 
ingredient.

    (a) The drug products containing ephedrine and therapeutically 
significant quantities of another active medicinal ingredient listed in 
paragraph (e) of this section have been exempted by the Administrator 
from application of sections 302, 303, 310, 1007, and 1008 of the Act 
(21 U.S.C. 822-3, 830, and 957-8) to the extent described in paragraphs 
(b), (c), and (d) of this section.
    (b) No exemption granted pursuant to 1310.14 affects the criminal 
liability for illegal possession or distribution of listed chemicals 
contained in the exempt drug product.
    (c) Changes in drug product compositions: Any change in the 
quantitative or qualitative composition of an exempt drug product listed 
in paragraph (d) requires a new application for exemption.
    (d) In addition to the drug products listed in the compendium set 
forth in Sec. 1310.01(b)(28)(i)(D)(1), the following drug products, in 
the form and quantity listed in the application submitted (indicated as 
the ``date'') are designated as exempt drug products for the purposes 
set forth in this section:

Exempt Drug Products Containing Ephedrine and Therapeutically Significant Quantities of Another Active Medicinal
                                                   Ingredient
----------------------------------------------------------------------------------------------------------------
               Supplier                      Product name                 Form                     Date
----------------------------------------------------------------------------------------------------------------
[Reserved]...........................  .......................  .......................  .......................
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[[Page 126]]


[60 FR 32463, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997]

                          PARTS 1311 [RESERVED]