§154a — Title 21 Food and Drugs | U.S. Code

Summary

The Secretary can quickly give a special license when there is an emergency, a small or local market, or another special situation (including when products are made only for use inside one State under a State program). These fast licenses can include conditions needed to keep the product pure, safe, and likely to work. The Secretary must make rules that let some virus, serum, toxin, or similar product be made without a federal license when it is: (1) made only for the maker’s own animals; (2) made only for animals treated by a licensed veterinarian under a vet-client-patient relationship; or (3) made only for sale inside one State under a State licensing program that meets five tests: it can license products and makers; it checks purity, safety, potency, and effectiveness before licensure; it reviews test results before release; it can enforce State rules; and it acts in line with the law’s goal to stop worthless, contaminated, or dangerous products.

Title 21, §154a

Food and Drugs — Source: USLM XML via OLRC

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.

Notes & Related Subsidiaries

Editorial Notes

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.

Statutory Notes and Related Subsidiaries

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 section 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

Summary

Title 21, §154a

Notes & Related Subsidiaries

Editorial Notes

Statutory Notes and Related Subsidiaries

Effective Date

Effective Date

Transfer of Functions

Transfer of Functions

Citations & Metadata