[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1308.21]

[Page 99]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1308_SCHEDULES OF CONTROLLED SUBSTANCES--Table of Contents
 
Sec. 1308.21  Application for exclusion of a nonnarcotic substance.

    (a) Any person seeking to have any nonnarcotic substance which may, 
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301), be 
lawfully sold over the counter without a prescription, excluded from any 
schedule, pursuant to section 201(g) (1) of the Act (21 U.S.C. 811 (g) 
(1)), may apply to the Administrator, Drug Enforcement Administration, 
Department of Justice, Washington, DC 20537.
    (b) An application for an exclusion under this section shall contain 
the following information:
    (1) The name and address of the applicant;
    (2) The name of the substance for which exclusion is sought; and
    (3) The complete quantitative composition of the substance.
    (c) Within a reasonable period of time after the receipt of an 
application for an exclusion under this section, the Administrator shall 
notify the applicant of his acceptance or nonacceptance of his 
application, and if not accepted, the reason therefore. The 
Administrator need not accept an application for filing if any of the 
requirements prescribed in paragraph (b) of this section is lacking or 
is not set forth as to be readily understood. If the applicant desires, 
he may amend the application to meet the requirements of paragraph (b) 
of this section. If the application is accepted for filing, the 
Administrator shall issue and publish in the Federal Register his order 
on the application, which shall include a reference to the legal 
authority under which the order is issued and the findings of fact and 
conclusions of law upon which the order is based. This order shall 
specify the date on which it shall take effect. The Administrator shall 
permit any interested person to file written comments on or objections 
to the order within 60 days of the date of publication of his order in 
the Federal Register. If any such comments or objections raise 
significant issues regarding any finding of fact or conclusion 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. Thereafter, 
the Administrator shall reinstate, revoke, or amend his original order 
as he determines appropriate.
    (d) The Administrator may at any time revoke any exclusion granted 
pursuant to section 201(g) of the Act (21 U.S.C. 811(g)) by following 
the procedures set forth in paragraph (c) of this section for handling 
an application for an exclusion which has been accepted for filing.