21 U.S.C. § 154a — Special licenses for special circumstances; expedited procedure; conditions; exemptions; criteria

To handle an emergency, a small or local market, or another special situation, including making a product only for use within one state under a state-run program, the Secretary can issue a special license through a faster process. This special license comes with whatever conditions are needed to ensure the product is pure, safe, and reasonably likely to work. The Secretary must also write a regulation exempting certain products from needing a normal, active license. This exemption covers any virus, serum, toxin, or similar product made by a person, firm, or corporation for: (1) giving only to that same person's, firm's, or corporation's own animals; (2) giving only to animals under a state-licensed veterinarian's care, as part of a proper veterinarian-client-patient relationship; or (3) distributing only within the state where it was made, under a license granted by a state program, but only if the Secretary decides that state's program meets certain standards. The state's program must (A) be able to license these products and the places that make them; (B) be able to check the products' purity, safety, potency, and effectiveness before licensing; (C) be able to check test results for compliance before the product reaches the market; (D) be able to effectively deal with violations of state law on these products; and (E) actually use these powers (A) through (D) in a way consistent with this chapter's goal, which is stopping the sale of worthless, contaminated, dangerous, or harmful products.