CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 5]

[CITE: 21CFR328]

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D - DRUGS FOR HUMAN USE

PART 328 OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL

Subpart A - General Provisions

Sec. 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.

Sec. 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.

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 371.
Source: 60 FR 13595, Mar. 13, 1995, unless otherwise noted.