§320.1. Definitions. — Inbound Citations
21 C.F.R. § 320.1
Statutory Authority
Cited by 1 regulation in release Current.
Citations to 21 C.F.R. § 320.1 as a whole
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(a) A drug or drug product (as defined in § 320.1 of this chapter) in finished package form is misbranded under section 502 (a) and (b)(1) of the act if its label does not bear conspicuously the name and place of business of the manufacturer, packer, or distributor. This paragraph does not apply to any drug or drug product dispensed in accordance with section 503(b)(1) of the act.