21 C.F.R. § 330.5

Current through September 30, 2024

Section 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).

21 C.F.R. § 330.5