Pharmaceutical product

Pharmaceutical product means any of the following materials, excluding any material that is a nonreactive solvent, excipient, binder, or filler, or any material that is produced in a chemical manufacturing process unit that is subject to the requirements of subparts F and G of this part 63:
(1) Any material described by the standard industrial classification (SIC) code 2833 or 2834; or
(2) Any material whose manufacturing process is described by North American Industrial Classification System (NAICS) code 325411 or 325412; or
(3) A finished dosage form of a drug, for example, a tablet, capsule, solution, etc.; or
(4) Any active ingredient or precursor that is produced at a facility whose primary manufacturing operations are described by SIC code 2833 or 2834; or
(5) At a facility whose primary operations are not described by SIC code 2833 or 2834, any material whose primary use is as an active ingredient or precursor.


40 CFR § 63.1251

Scoping language

Terms used in this subpart are defined in the Act, in subpart A of this part, or in this section. If the same term is defined in subpart A of this part and in this section, it shall have the meaning given in this section for the purposes of this subpart.

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