The laws governing the U.S. Food and Drug Administration (FDA) do not provide for the approval of stand-alone excipients. Current regulations do not permit the use of excipients, but allow their use. The acceptance process for excipients is slow and only recently did the FDA propose draft guidance for nonclinical studies for pharmaceutical excipients. The FDA has made four suggestions to the U.S. Pharmacopoeia concerning including excipient monographs in the National Formulary for excipients not yet allowed. This article reviews these four proposals to identify the proposal that is most appropriate.
FDA.2002. Guidance for Industry, Nonclinical Studies for Development of Pharmaceutical Excipients, draft.U.S. Department of Health and Human Services, FDA, CDER and CBER, September 2002.
2.
Food, Drug and Cosmetic Act. 1938.
3.
Proceeding of the USP/IPEC Joint Conference on Pharmaceutical Excipients. 2001. Fort Myers, FL.
4.
Steinberg, M., J. F. Borzelleca, E. K. Enter, F. K. Kinoshita, A. Loper, D. B. Mitchell, C. B. Tamulinas, and M. L. Weiner. 1996. A new approach to the safety assessment of pharmaceutical excipients. Regul. Toxicol. Pharmacol.24:149–154.
5.
U.S. Code of Federal Regulations. 1978. Title 21 Part 210 3(8).
6.
U.S. Federal Food, Drug and Cosmetic Act. 1990. United States Code of Federal Regulations. Title 21.
7.
U.S. Pharmacopoeia, Excipient Biological Safety Evaluation Guidelines. 24, (1074) 2037–2040.
8.
Uchiyama, M.1999. Regulatory status of excipients in Japan. Drug Information J.33:27–33.
