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21 U.S.C. § 154a — Special licenses for special circumstances; expedited procedure; conditions; exemptions; criteria
Federal law — U.S. Code and appendices · legal_authorities
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 analog
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 154a
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Stable record: federal_law:legal_authorities:record_usc_0b3e4527e60dfbb9ea84bc05
Source file: Laws/federal/codes/united-states-code/title-21/section-154a-special-licenses-for-special-circumstances-expedited-procedure-condition--0058b4335e.md
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Source location: Title 21, Chapter 5, § 154a; chapter-005-viruses-serums-toxins-antitoxins-and-analogous-products.md
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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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Federal law — U.S. Code and appendices · legal_authorities
(1) **Sense of Congress** — It is the sense of Congress that the Federal air marshal program is critical to aviation security.
(2) **Limitation on statutory construction** — Nothing in this chapter, including any amendment made by this chapter, shall be construed as preventing the Under Secretary of Transportation for Security from implementing and training Federal air marshals.
Source: Supplied U.S. Code snapshot — release unconfirmed · 6 U.S.C. § 542
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Federal law — U.S. Code and appendices · legal_authorities
It shall be unlawful for any person, firm, or corporation to prepare, sell, barter, or exchange in the District of Columbia, or in the Territories, or in any place under the jurisdiction of the United States, or to ship or deliver for shipment in or from the United States, the District of Columbia, any territory of the United States, or any place under the jurisdiction of the United States, any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product intended for use in the treatment of domestic animals, and no person, firm, or corporation shall prepare, sell, barter, exchange, or ship as aforesaid any virus, serum, toxin, or analogous product manufactured within the United States and intended for use in the treatment of domestic animals, unless and until the said virus, serum, toxin, or analogous product shall have been prepared, under and in compliance with regulations prescribed by the Secretary of Agriculture, at an establishment holding an unsuspended and unrevoked license issued by the Secretary of Agriculture as hereinafter authorized.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 151
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Federal law — U.S. Code and appendices · legal_authorities
There is authorized to be appropriated to carry out this subchapter (other than [section 136u(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title7-section136u/a&num=0&edition=prelim))—
(1) $83,000,000 for fiscal year 1989, of which not more than $13,735,500 shall be available for research under this subchapter;
(2) $95,000,000 for fiscal year 1990, of which not more than $14,343,600 shall be available for research under this subchapter; and
(3) $95,000,000 for fiscal year 1991, of which not more than $14,978,200 shall be available for research under this subchapter.
Source: Supplied U.S. Code snapshot — release unconfirmed · 7 U.S.C. § 136y
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Federal law — U.S. Code and appendices · legal_authorities
Page 18
TITLE 21—FOOD AND DRUGS
§ 154a
L. 99–198, set out as a note under section 151 of this
title.
TRANSFER OF FUNCTIONS
For transfer of functions of the Secretary of Agri-
culture relating to agricultural import and entry in-
spection activities under this chapter to the Secretary
of Homeland Security, and for treatment of related ref-
erences, 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.
§ 154a. Special licenses for special circumstances;
expedited procedure; conditions; exemptions;
criteria
In order to meet an emergency condition, lim-
ited 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 reason-
able 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 relation-
ship in the course of the State licensed profes-
sional 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, t
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 154a
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