The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (b)(2), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see Tables.

In subsecs. (b)(1), (c), “October 1, 1988” was substituted for “the effective date of this subpart” on authority of section 323 of Pub. L. 99–660, as amended, set out as an Effective Date note under section 300aa–1 of this title.

1987—Subsecs. (b)(1), (c). Pub. L. 100–203 substituted “effective date of this subpart” for “effective date of this part”.