21 C.F.R. Subpart A—General Provisions


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 328—OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL

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Subpart A—General Provisions

§ 328.1   Scope.

Reference in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.

§ 328.3   Definitions.

As used in this part:

(a) Alcohol means the substance known as ethanol, ethyl alcohol, or Alcohol, USP.

(b) Inactive ingredient means any component of a product other than an active ingredient as defined in §210.3(b)(7) of this chapter.

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