GroundRules
21 CFR 333.303: Definitions.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER D—DRUGS FOR HUMAN USE
- PART 333—TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
- Subpart D—Topical Acne Drug Products
As used in this subpart:
(a) Acne. A disease involving the oil glands and hair follicles of the skin which is manifested by blackheads, whiteheads, acne pimples, and acne blemishes.
(b) Acne blemish. A flaw in the skin resulting from acne.
(c) Acne drug product. A drug product used to reduce the number of acne blemishes, acne pimples, blackheads, and whiteheads.
(d) Acne pimple. A small, prominent, inflamed elevation of the skin resulting from acne.
(e) Blackhead. A condition of the skin that occurs in acne and is characterized by a black tip.
(f) Whitehead. A condition of the skin that occurs in acne and is characterized by a small, firm, whitish elevation of the skin.
Collected 2026-08-27T02:24:47Z. Source file · JSON