Food and Drug Administration, HHS § 310.201
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Food and Drug Administration, HHS § 310.201 (d) Prescription legend not allowed on (v) The preparation is labeled with exempted drugs. The use of the prescrip- adequate directions for use in minor tion caution statement quoted in sec- conditions as a simple analgesic. tion 503(b) (4) of the act, in the labeling (vi) The dosages of N-acetyl-p-amino- of a drug exempted under the provi- phenol recommended or suggested in sions of this section, constitutes mis- the labeling do not exceed: For adults, branding. Any other statement or sug- 0.65 gram (10 grains) per dose or 2.6 gestion in the labeling of a drug ex- grams (40 grains) per 24-hour period: for empted under this section, that such children 6 to 12 years of age, one-half of drug is limited to prescription use, the maximum adult dose or dosage; for may constitute misbranding. children 3 to 6 years of age, one-fifth of (e) Prescription-exemption procedure of the maximum adult dose or dosage. OTC drug review. A drug limited to pre- (vii) The labeling bears, in juxtaposi- scription use under section 503(b)(1)(B) tion with the dosage recommendations, of the act may also be exempted from a clear warning statement against ad- prescription-dispensing requirements ministration of the drug to children by the procedure set forth in § 330.13 of under 3 years of age and against use of this chapter. the drug for more than 10 days, unless such uses are directed by a physician. [39 FR 11680, Mar. 29, 1974, as amended at 41 FR 32582, Aug. 4, 1976; 42 FR 4714, Jan. 25, (viii) If the article is offered for use 1977; 42 FR 15674, Mar. 22, 1977; 72 FR 15043, in arthritis or rheumatism, the label- Mar. 30, 2007] ing prominently bears a statement that the beneficial effects claimed are § 310.201 Exemption for certain drugs limited to the temporary relief of limited by new-drug applications to minor aches and pains of arthritis and prescription sale. rheumatism and, in juxtaposition with (a) The prescription-dispensing re- directions for use in such conditions, a quirements of section503(b)(1)(B) of the conspicuous warning statement, such Federal Food, Drug, and Cosmetic Act as ‘‘Caution: If pain persists for more are not necessary for the protection of than 10 days, or redness is present, or the public health with respect to the in conditions affecting children under following drugs subject to new drug ap- 12 years of age, consult a physician im- plications: mediately’’. (1) N-Acetyl-p-aminophenol (acetami- (2) Sodium gentisate (sodium-2, 5-di- nophen, p-hydroxy-acetanilid) prepara- hydroxybenzoate) preparations meet- tions meeting all the following condi- ing all the following conditions: tions: (i) The sodium gentisate is prepared, (i) The N-acetyl-p-aminophenol is with or without other drugs, in tablet prepared, with or without other drugs, or other dosage form suitable for oral in tablet or other dosage form suitable use in self-medication, and containing for oral use in self-medication, and no drug limited to prescription sale containing no drug limited to prescrip- under the provisions of section 503(b)(1) tion sale under the provisions of sec- of the act. tion 503(b)(1) of the act. (ii) The sodium gentisate and all (ii) The N-acetyl-p-aminophenol and other components of the preparation all other components of the prepara- meet their professed standards of iden- tion meet their professed standards of tity, strength, quality, and purity. identity, strength, quality, and purity. (iii) If the preparation is a new drug, (iii) If the preparation is a new drug, an application pursuant to section an application pursuant to section 505 505(b) of the act is approved for it. (b) of the act is approved for it. (iv) The preparation contains not (iv) The preparation contains not more than 0.5 gram (7.7 grains) of anhy- more than 0.325 gram (5 grains) of N- drous sodium gentisate per dosage acetyl-p-aminophenol per dosage unit, unit. or if it is in liquid form not more than (v) The preparation is labeled with 100 milligrams of N-acetyl-p-amino- adequate directions for use in minor phenol per milliliter. conditions as a simple analgesic. 11 VerDate Mar<15>2010 13:06 May 27, 2010 Jkt 220069 PO 00000 Frm 00021 Fmt 8010 Sfmt 8010 Y:\SGML\220069.XXX 220069 wwoods2 on DSK1DXX6B1PROD with CFR § 310.201 21 CFR Ch. I (4–1–10 Edition) (vi) The dosages of sodium gentisate case of rectal bleeding, as this may in- recommended or suggested in the label- dicate serious disease. ing do not exceed: For adults, 0.5 gram (4) Phenyltoloxamine dihydrogen cit- (7.7 grains) per dose of 2.0 grams (31 rate (N,N-dimethyl-(a-phenyl-O-toloxy) grains) per 24-hour period; for children ethylamine dihydrogen citrate), prep- 6 to 12 years of age, one-half of the arations meeting all the following con- maximum adult dose or dosage. ditions: (vii) The labeling bears, in juxtaposi- (i) The phenyltoloxamine dihydrogen tion with the dosage recommendations, citrate is prepared, with or without a clear warning statement against ad- other drugs, in tablet or other dosage ministration of the drug to children form suitable for oral use in self-medi- under 6 years of age and against use of cation, and containing no drug limited the drug for a prolonged period, except to prescription sale under the provi- as such uses may be directed by a phy- sions of section 503(b)(1) of the act. sician. (ii) The phenyltoloxamine dihydro- (3) Isoamylhydrocupreine and zola- gen citrate and all other components of mine hydrochloride (N, N-dimethyl-N′- the preparation meet their professed 2-thiazolyl-N′-p-methoxybenzyl-ethyl- standards of identity, strength, qual- enediamine hydrochloride) prepara- ity, and purity. tions meeting all the following condi- (iii) If the preparation is a new drug, tions: an application pursuant to section (i) The isoamylhydrocupreine and zo- 505(b) of the act is approved for it. lamine hydrochloride are prepared in (iv) The preparation contains not dosage form suitable for self-medica- more than 88 milligrams of phenyl- tion as rectal suppositories or as an toloxamine dihydrogen citrate (equiva- ointment and containing no drug lim- lent to 50 milligrams of phenyltolox- ited to prescription sale under the pro- amine) per dosage unit. visions of section 503(b)(1) of the act. (v) The preparation is labeled with adequate directions for use in the tem- (ii) The isoamylhydrocupreine, zola- porary relief of the symptoms of hay amine hydrochloride, and all other fever and/or the symptoms of other components of the preparation meet minor conditions in which it is indi- their professed standards of identity, cated. strength, quality, and purity. (vi) The dosages recommended or (iii) If the preparation is a new drug, suggested in the labeling do not exceed: an application pursuant to section For adults, 88 milligrams of phenyl- 505(b) of the act is approved for it. toloxamine dihydrogen citrate (equiva- (iv) The preparation contains not lent to 50 milligrams of phenyltolox- more than 0.25 percent of isoamyl- amine) per dose or 264 milligrams of hydrocupreine and 1.0 percent of zola- phenyltoloxamine dihydrogen citrate mine hydrochloride. (equivalent to 150 milligrams of phen- (v) If the preparation is in supposi- yltoloxamine) per 24-hour period; for tory form, it contains not more than children 6 to 12 years of age, one-half of 5.0 milligrams of isoamylhydrocupreine the maximum adult dose or dosage. and not more than 20.0 milligrams of (vii) The labeling bears, in juxtaposi- zolamine hydrochloride per supposi- tion with the dosage recommendations: tory. (a) Clear warning statements against (vi) The preparation is labeled with administration of the drug to children adequate directions for use in the tem- under 6 years of age, except as directed porary relief of local pain and itching by a physician, and against driving a associated with hemorrhoids. car or operating machinery while using (vii) The directions provide for the the drug, since it may cause drowsi- use of not more than two suppositories ness. or two applications of ointment in a 24- (b) If the article is offered for tem- hour period. porary relief of the symptoms of colds, (viii) The labeling bears, in jux- a statement that continued adminis- taposition with the dosage rec- tration for such use should not exceed ommendations, a clear warning state- 3 days, except as directed by a physi- ment against use of the preparation in cian. 12 VerDate Mar<15>2010 13:06 May 27, 2010 Jkt 220069 PO 00000 Frm 00022 Fmt 8010 Sfmt 8010 Y:\SGML\220069.XXX 220069 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 310.201 (5)–(7) [Reserved] suitable for self-medication by external (8) Dicyclomine hydrochloride (1- application to the skin as a spray, and cyclohexylhexahydrobenzoic acid. b-di- containing no drug limited to prescrip- ethylaminoethyl ester hydrochloride; tion sale under the provisions of sec- diethylaminocarbethoxy-bicyclohexyl tion 503(b)(1) of the act. hydrochloride) preparations meeting (ii) The hexadenol and all other com- all the following conditions: ponents of the preparation meet their (i) The dicyclomine hydrochloride is professed standards of identity, prepared with suitable antacid and strength, quality, and purity. other components, in tablet or other (iii) If the preparation is a new drug, dosage form for oral use in self-medica- an application pursuant to section tion, and containing no drug limited to 505(b) of the act is approved for it.