[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: 21CFR1310.16]

[Page 138-139]
 
                         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. 1310.16  Exemptions for certain scheduled listed chemical products.

    (a) Upon the application of a manufacturer of a scheduled listed 
chemical product, the Administrator may by regulation provide that the 
product is exempt from part 1314 of this chapter if the Administrator 
determines that the product cannot be used in the illicit manufacture of 
a controlled substance.
    (b) An application for an exemption under this section must contain 
all of the following information:
    (1) The name and address of the applicant.
    (2) The exact trade name of the scheduled listed chemical product 
for which exemption is sought.
    (3) The complete quantitative and qualitative composition of the 
drug product.
    (4) A brief statement of the facts that the applicant believes 
justify the granting of an exemption under this section.
    (5) Certification by the applicant that the product may be lawfully 
marketed or distributed under the Federal, Food, Drug, and Cosmetic Act.
    (6) The identification of any information on the application that is 
considered by the applicant to be a trade secret or confidential and 
entitled to protection under U.S. laws restricting the public disclosure 
of such information by government employees.
    (c) The Administrator may require the applicant to submit additional 
documents or written statements of fact relevant to the application that 
he deems necessary for determining if the application should be granted.
    (d) Within a reasonable period of time after the receipt of a 
completed application for an exemption under this section, the 
Administrator shall notify the applicant of acceptance or non-acceptance 
of the application. If the application is not accepted, an explanation 
will be provided. The Administrator is not required to accept an 
application if any of the information required in paragraph (b) of this 
section or requested under paragraph (c) of this section is lacking or 
not readily understood. The applicant may, however, amend the 
application to meet the requirements of paragraphs (b) and (c) of this 
section.
    (e) If the application is accepted for filing, the Administrator 
shall issue and publish in the Federal Register an order on the 
application, which shall include a reference to the legal authority 
under which the order is based. This order shall specify the date on 
which it shall take effect.
    (f) The Administrator shall permit any interested person to file 
written comments on or objections to the order. If any comments or 
objections raise significant issues regarding any findings of fact or 
conclusions of law upon which the order is based, the Administrator 
shall immediately suspend the effectiveness of the order until he may 
reconsider the application in light of the comments and objections 
filed.

[[Page 139]]

Thereafter, the Administrator shall reinstate, revoke, or amend the 
original order as deemed appropriate.

[71 FR 56024, Sept. 26, 2006]