
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC154a]

 
                        TITLE 21--FOOD AND DRUGS
 
 CHAPTER 5--VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS
 
Sec. 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.

(Mar. 4, 1913, ch. 145, Sec. 1 [part], as added Pub. L. 99-198, title 
XVII, Sec. 1768(c), Dec. 23, 1985, 99 Stat. 1654.)

                          Codification

    See note set out under section 151 of this title.
    Another section 1768 of Pub. L. 99-198, cited as a credit to this 
section, amended section 136y of Title 7, Agriculture.


                             Effective Date

    Section effective Dec. 23, 1985, except as otherwise provided, see 
section 1768(f) of Pub. L. 99-198, set out as an Effective Date of 1985 
Amendment note under section 151 of this title.
