21 U.S. Code § 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.

Source

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

See note set out under section 151 of this title.
Another section 1768 ofPub. 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) ofPub. 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.

The table below lists the classification updates, since Jan. 3, 2012, for this section. Updates to a broader range of sections may be found at the update page for containing chapter, title, etc.

The most recent Classification Table update that we have noticed was Tuesday, August 13, 2013

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21 USCDescription of ChangeSession YearPublic LawStatutes at Large

This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


9 CFR - Animals and Animal Products

9 CFR Part 101 - DEFINITIONS

9 CFR Part 102 - LICENSES FOR BIOLOGICAL PRODUCTS

9 CFR Part 103 - EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND EVALUATION OF BIOLOGICAL PRODUCTS PRIOR TO LICENSING

9 CFR Part 104 - PERMITS FOR BIOLOGICAL PRODUCTS

9 CFR Part 105 - SUSPENSION, REVOCATION, OR TERMINATION OF BIOLOGICAL LICENSES OR PERMITS

9 CFR Part 106 - EXEMPTION FOR BIOLOGICAL PRODUCTS USED IN DEPARTMENT PROGRAMS OR UNDER DEPARTMENT CONTROL OR SUPERVISION

9 CFR Part 107 - EXEMPTIONS FROM PREPARATION PURSUANT TO AN UNSUSPENDED AND UNREVOKED LICENSE

9 CFR Part 108 - FACILITY REQUIREMENTS FOR LICENSED ESTABLISHMENTS

9 CFR Part 109 - STERILIZATION AND PASTEURIZATION AT LICENSED ESTABLISHMENTS

9 CFR Part 112 - PACKAGING AND LABELING

9 CFR Part 113 - STANDARD REQUIREMENTS

9 CFR Part 114 - PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS

9 CFR Part 115 - INSPECTIONS

9 CFR Part 116 - RECORDS AND REPORTS

9 CFR Part 117 - ANIMALS AT LICENSED ESTABLISHMENTS

9 CFR Part 118 - DETENTION; SEIZURE AND CONDEMNATION

9 CFR Part 122 - ORGANISMS AND VECTORS

9 CFR Part 123 - RULES OF PRACTICE GOVERNING PROCEEDINGS UNDER THE VIRUS-SERUM-TOXIN ACT

32 CFR - National Defense

 

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