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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

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

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 5]
[CITE: 21CFR328.3]



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. 328.3 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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