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Publishing of 21 CFR Part - Current Good Manufacturing Practice for Finished Pharmaceuticals established requirements concerning the expiration date on a drug product and stability testing to assure the appropriateness of that date. Each drug product may be a unique article because of, for instance, differences in 1 chemical and physical properties of the active ingredients or the excipients, 2 manufacturing procedures, 3 formulations, 4 containers and closures, 5 proposed storage conditions, and 6 the stability of the article to maintain its quality or purity through the use of antioxidants or preservatives. Because of the uniqueness of each drug product, it is virtually impossible to provide one set of rules that can apply to all situations. The CGMPs were purposely written broadly to allow for such unique differences. The absence of an expiration date on any drug product packaged after September 29, , except for those drugs specifically exempt by
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Related to Freshness dating: expiration date. Medspeak A term borrowed from the food industry for the length of time that a blood product, therapeutic agent or other product may be stored under appropriate conditions before it must be discarded by law. Segen's Medical Dictionary. All rights reserved. Stability of a product during storage; the maximum time during which it can be kept without undergoing change in chemical structure and properties. Stability of a product after it is prepared or manufactured; length of time any substance may be stored before changes occur that alter its chemical structure or make-up and degeneration ensues. Mentioned in?
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Last Updated: February 19, References. This article was co-authored by our trained team of editors and researchers who validated it for accuracy and comprehensiveness. This article has been viewed , times. Learn more
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