CPG Sec. 480.300 Lack of Expiration Date of Stability Data March 1995
*The CGMP regulations (21 CFR 211.137) have required that drug products packaged since September 29, 1979, bear an expiration date which is supported by appropriate stability data, with limited exceptions. OTC drug products which have no dosage limitation and which are stable for at least three years as demonstrated by appropriate data are exempt from the requirement to bear an expiration date. Homeopathic drugs, while required to have a limited evaluation of stability, are also exempt from the requirement to bear an expiration date. Additionally, allergenic extracts that are labeled "No U.S. Standard of Potency" are exempt from the requirements to be labeled with an expiration date and the performance of stability studies.*
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
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