Regulations &
Codified CSA > CFR > Section 1310 > Section 1310.14
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:
- The name and address of the applicant.
- The
exact trade name of the scheduled listed chemical product for which exemption
is sought.
- The complete quantitative and qualitative composition of the
drug product.
- A brief statement of the facts that the applicant believes
justify the granting of an exemption under this section.
- Certification by
the applicant that the product may be lawfully marketed or distributed under
the Federal, Food, Drug, and Cosmetic Act.
- 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. Thereafter, the Administrator shall reinstate, revoke, or amend the
original order as deemed appropriate.
[71 FR 56024, Sept. 26, 2006]
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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