§ 310.508 - Use of certain halogenated salicylanilides as an inactive ingredient in drug products.

(a) Halogenated salicylanilides (tribromsalan (TBS, 3,4′,5-tribromosalicylanilide), dibromsalan (DBS, 4′, 5-dibromosalicylanilide), metabromsalan (MBS, 3, 5-dibromosalicylanilide), and 3,3′, 4,5′-tetrachlorosalicylanilide (TC-SA)) have been used as active or inactive ingredients in a number of over-the-counter (OTC) drug products, largely antibacterial soaps, for antimicrobial, preservative, and other purposes. These halogenated salicylanilides are potent photosensitizers and can cause disabling skin disorders. In some instances the photosensitization may persist for prolonged periods as a severe reaction without further exposure to these chemicals. Safer alternative antimicrobial agents are available.

(b) These halogenated salicylanilides are not generally recognized as safe and effective for use as active or inactive ingredients in any drug products. Therefore, any drug product containing such a halogenated salicylanilide as an ingredient at any level for any purpose is a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act for which an approved new drug application pursuant to section 505 of the act and part 314 of this chapter is required for marketing.

(c) Clinical investigations designed to obtain evidence that any drug product containing a halogenated salicylanilide as an ingredient at any level for any purpose is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter.

(d) Any such drug product initially introduced into interstate commerce after December 1, 1975, that is not in compliance with this section is subject to regulatory action.