Pub. L. 112-144, tit. VII, sec. 707 (as amended)
PROHIBITION AGAINST DELAYING, DENYING, LIMITING, OR REFUSING INSPECTION.
SEC. 707. PROHIBITION AGAINST DELAYING, DENYING, LIMITING, OR REFUSING INSPECTION.
(a) In General.—Section 501 (21 U.S.C. 351) is amended by adding at the end the following:
“(j) If it is a drug and it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.”
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(b) [21 U.S.C. 351 note] Guidance.—Not later than 1 year after the date of enactment of this section, the Secretary of Health and Human Services shall issue guidance that defines the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection, for purposes of section 501(j) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)).
- Cross-references to the US Code
- 21 U.S.C. 351 note