C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 330—OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED › Subpart A—General Provisions

21 C.F.R. § 330.5

Drug categories

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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).

Notes of Decisions
Cited in 2 cases, 1969–1984 · leading case: Jaekel v. United States, 304 F. Supp. 993 (S.D.N.Y. 1969).
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Jaekel v. United States, 304 F. Supp. 993 (S.D.N.Y. 1969). · cites it 2× “4 3 (now 21 C.F.R. § 330.5 ), the District Supervisor of the *996 Bureau of Narcotics placed an advertisement in the New York Post on November 22, 29, and December 6, 1966, which stated: “TREASURY DEPARTMENT, BUREAU OF NARCOTICS Notice is hereby given that on 11/9/66, one 1964…”
United States v. Articles of Drug ... Promise Toothpaste for Sensitive Teeth, 594 F. Supp. 211 (N.D. Ill. 1984). “at 89; 21 C.F.R. § 330.5 (1983). Shortly thereafter, the public was invited to submit data relevant to this portion of the OTC review.”
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