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U.S. Code as of:
01/19/04
Section 154a. Special licenses for special circumstances; expedited procedure; conditions; exemptions; criteria
In order to meet an emergency condition, limited market or local
situation, or other special circumstance (including production
solely for intrastate use under a State-operated program), the
Secretary may issue a special license under an expedited procedure
on such conditions as are necessary to assure purity, safety, and a
reasonable expectation of efficacy. The Secretary shall exempt by
regulation from the requirement of preparation pursuant to an
unsuspended and unrevoked license any virus, serum, toxin, or
analogous product prepared by any person, firm, or corporation -
(1) solely for administration to animals of such person, firm,
or corporation;
(2) solely for administration to animals under a
veterinarian-client-patient relationship in the course of the
State licensed professional practice of veterinary medicine by
such person, firm, or corporation; or
(3) solely for distribution within the State of production
pursuant to a license granted by such State under a program
determined by the Secretary to meet criteria under which the
State -
(A) may license virus, serum, toxin, and analogous products
and establishments that produce such products;
(B) may review the purity, safety, potency, and efficacy of
such products prior to licensure;
(C) may review product test results to assure compliance with
applicable standards for purity, safety, and potency, prior to
release to the market;
(D) may deal effectively with violations of State law
regulating virus, serum, toxin, and analogous products; and
(E) exercises the authority referred to in subclauses (A)
through (D) consistent with the intent of this chapter of
prohibiting the preparation, sale, barter, exchange, or
shipment of worthless, contaminated, dangerous, or harmful
virus, serum, toxin, or analogous products.
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