Eye on excipients: Excipients in the regulatory environme

Eye on excipients: Excipients in the regulatory environment
July 2005
John A. McCarty
A discussion of how regulatory agencies, national pharmacopoeias, and trade groups influence the acceptance and use of pharmaceutical and nutritional excipients. The article describes the challenges of harmonizing the regulations that govern the acceptance and use of excipients.
Over the last 30 years, the number of excipients in use and the regulatory environment governing their acceptance in marketed drug products have changed significantly. It was not until the 1970s, for example, that the first synthetic polymers were acceptable for use. Until that time, most excipients were food additives, and the pharmaceutical industry considered them to be inert and inactive ingredients. That?s no longer true, and today excipients play a much bigger role.
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