Food and Drug Administration, HHS § 310.532

§ 310.531 Drug products containing ac- methyl salicylate, oxyguinoline sul- tive ingredients offered over-the- fate, petrolatum, phenol, pine tar, counter (OTC) for the treatment of rosin, rosin cerate, sassafras oil, thy- boils. mol, or zinc oxide initially introduced (a) Aminacrine hydrochloride, benzo- or initially delivered for introduction caine, bismuth subnitrate, calomel, into interstate commerce that is not in camphor, cholesterol, ergot fluid ex- compliance with this section is subject tract, hexachlorophene, ichthammol, to regulatory action. isobutamben, juniper tar (oil of cade), (e) After May 16, 1994, any such OTC lanolin, magnesium sulfate, menthol, drug product that contains benzocaine, methyl salicylate, oxyguinoline sul- ichthammol, sulfur, or triclosan ini- fate, petrolatum, phenol, pine tar, tially introduced or initially delivered rosin, rosin cerate, sassafras oil, sulfur, for introduction into interstate com- thymol, triclosan, and zinc oxide have merce that is not in compliance with been present in OTC boil treatment this section is subject to regulatory ac- drug products. There is a lack of ade- tion. quate data to establish general rec- (f) This section does not apply to ognition of the safety and effectiveness drug products that contain benzocaine of these or any other ingredient for labeled, represented, or promoted for OTC use for the treatment of boils. OTC topical use in accordance with Treatment is defined as reducing the part 348 of this chapter. size of a boil or reducing an infection related to a boil. Treatment has in- [58 FR 60336, Nov. 15, 1993] volved the use of ‘‘drawing salves’’ for these purposes. These ‘‘drawing salves’’ § 310.532 Drug products containing ac- contained various ingredients. Based tive ingredients offered over-the- on evidence currently available, any counter (OTC) to relieve the symp- toms of benign prostatic hyper- OTC drug product offered for the treat- trophy. ment of boils cannot be considered gen- erally recognized as safe and effective. (a) The amino acids glycine, alanine, (b) Any OTC drug product that is la- and glutamic acid (alone or in com- beled, represented, or promoted for the bination) and the ingredient sabal have treatment of boils is regarded as a new been present in over-the-counter (OTC) drug within the meaning of section drug products to relieve the symptoms 201(p) of the Federal Food, Drug, and of benign prostatic hypertrophy, e.g., Cosmetic Act (the act), for which an urinary urgency and frequency, exces- approved application or abbreviated sive urinating at night, and delayed application under section 505 of the act urination. There is a lack of adequate and part 314 of this chapter is required data to establish general recognition of for marketing. In the absence of an ap- the safety and effectiveness of these or proved new drug application or abbre- any other ingredients for OTC use in viated new drug application, such prod- relieving the symptoms of benign pros- uct is also misbranded under section tatic hypertrophy. In addition, there is 502 of the act. no definitive evidence that any drug (c) Clinical investigations designed product offered for the relief of the to obtain evidence that any OTC boil symptoms of benign prostatic hyper- treatment drug product is safe and ef- trophy would alter the obstructive or fective for the purpose intended must inflammatory signs and symptoms of comply with the requirements and pro- this condition. Therefore, self-medica- cedures governing the use of investiga- tion with OTC drug products might un- tional new drugs set forth in part 312 of necessarily delay diagnosis and treat- this chapter. ment of progressive obstruction and (d) After May 7, 1991, any such OTC secondary infections. Based on evi- drug product that contains aminacrine dence currently available, any OTC hydrochloride, bismuth subnitrate, cal- drug product containing ingredients of- omel, camphor, cholesterol, ergot fluid fered for use in relieving the symptoms extract, hexachlorophene, isobu- of benign prostatic hypertrophy cannot tamben, juniper tar (oil of cade), lan- be generally recognized as safe and ef- olin, magnesium sulfate, menthol, fective.

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