§ 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—
(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;
(C)
may review product test results to assure compliance with applicable standards for purity, safety, and potency, prior to release to the market;