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Section 1308 > Section 1308.21
EXCLUDED NONNARCOTIC SUBSTANCES
Section 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 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]
NOTICE: This is an
unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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