(1) the term “drug”— (A) means a drug (as defined in section 321(g) of this title ) that is intended for human use and that is subject to section 353(b)(1) of this title ; and (B) does not include biological products (as defined in section 262 of title 42 ), unless otherwise provided by the Secretary in the regulations promulgated under subsection (i);


21 USC § 356c(h)(1)

Scoping language

For purposes of this section
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