Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024
§ 330.5 - Drug categories.

Monographs promulgated pursuant to the provisions of this part shall be established in this part 330 and following parts and shall cover the following designated categories:

(a) Antacids.

(b) Laxatives.

(c) Antidiarrheal products.

(d) Emetics.

(e) Antiemetics.

(f) Antiperspirants.

(g) Sunburn prevention and treatment products.

(h) Vitamin-mineral products.

(i) Antimicrobial products.

(j) Dandruff products.

(k) Oral hygiene aids.

(l) Hemorrhoidal products.

(m) Hematinics.

(n) Bronchodilator and antiasthmatic products.

(o) Analgesics.

(p) Sedatives and sleep aids.

(q) Stimulants.

(r) Antitussives.

(s) Allergy treatment products.

(t) Cold remedies.

(u) Antirheumatic products.

(v) Ophthalmic products.

(w) Contraceptive products.

(x) Miscellaneous dermatologic products.

(y) Dentifrices and dental products such as analgesics, antiseptics, etc.

(z) Miscellaneous (all other OTC drugs not falling within one of the above therapeutic categories).

authority: 21 U.S.C. 321,351,352,353,355,360,360fff-6,371
source: 39 FR 11741, Mar. 29, 1974, unless otherwise noted.
cite as: 21 CFR 330.5