§ 154a. — Special licenses for special circumstances; expedited procedure; conditions; exemptions; criteria.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 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.
Transfer of Functions
For transfer of functions of the Secretary of Agriculture relating
to agricultural import and entry inspection activities under this
chapter to the Secretary of Homeland Security, and for treatment of
related references, see sections 231, 551(d), 552(d), and 557 of Title
6, Domestic Security, and the Department of Homeland Security
Reorganization Plan of November 25, 2002, as modified, set out as a note
under section 542 of Title 6.
