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Regulation of Topical Antimicrobials: History, Status and Future Perspective

  • Mary K. Bruch (a1) and Elaine Larson (a2)

Abstract

Antimicrobial agents used as disinfectants and antiseptics are increasing in epidemiologic importance. The regulation of topical antiseptics has ranged from nonexistent, lax and confusing to inclusion in the Food and Drug Administration (FDA) over-the-counter (OTC) review of drug ingredients. This article simplifies the complex history, current status and future possibilities for the hospital use of topical antiseptic products.

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Dexide, Inc., P.O. Box 185789, Fort Worth, TX 76181-5789

References

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1. Code of Federal Regulations (CFR 21). General and Administrative Procedures. 1972;330:10330.13.
2. OTC topical antimicrobial products and drug and cosmetic products (OTC panel report). Federal Register. September 13, 1974;39(Part II):3310233141.
3. OTC topical antimicrobial products (tentative final monograph). Federal Register. January 6, 1978;43(Part 11): 12101249.
4. Baumgartner, KC. A historical examination of the FDA's review of the safety and effectiveness of over-the-counter drugs. Food Drug Cosmetic Law Journal. 1988;43:463494.
5. Ayliffe, CAJ. Standardization of disinfectant testing. J Hosp Infect. 1989;13:211216.

Regulation of Topical Antimicrobials: History, Status and Future Perspective

  • Mary K. Bruch (a1) and Elaine Larson (a2)

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