21 U.S.C. § 154a
Special licenses for special circumstances; expedited procedure; conditions; exemptions; criteria
United States · Title 21 — FOOD AND DRUGS · Status: effective
Cite this
- Citation
- 21 U.S.C. § 154a, Special licenses for special circumstances; expedited procedure; conditions; exemptions; criteria, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/454138
- Permanent ID
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Full text
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—
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—
Legislative history
The public laws that enacted or amended this section. Tallies are for the whole bill as it passed each chamber — often an omnibus covering far more than this provision — not a vote on this section alone.
- Food Security Act of 1985House: no recorded tallySenate: no recorded tally