[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: 21CFR1308.21]

[Page 99-100]
 
                         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 drug that 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

[[Page 100]]

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.

[38 FR 8254, Mar. 30, 1973, as amended at 70 FR 74657, Dec. 16, 2005]