Expiration dating and stability testing for human drug products

As a point of information, USP monographs for active ingredients used in drug products generally focus on single synthetic compounds.By contrast, Botanicals generally consist of complex mixtures of active ingredients that work in synergy.Where new drug products for investigational use are to be reconstituted at the time of dispensing, their labeling shall bear expiration information for the reconstituted drug product.of September 29, 1978, the requirements in this section shall not be enforced for human OTC drug products if their labeling does not bear dosage limitations and they are stable for at least 3 years as supported by appropriate stability data.Tokyo, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, 1990.Pharmaceutical Inspection Convention Stability of pharmaceutical products: collected papers given at a seminar, Salzburg, 9-11 June 1976 (available from the Secretariat to the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products, c/o EFTA Secretariat, 9-11 rue de Varembé, 1202 Geneva, Switzerland).This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

Japan Draft policy to deal with stability data required in applying for approval to manufacture (import) drugs and draft guidelines for stability studies.(For original reference, see: First regulations of 1 December 1986 for the implementation of the Medicaments Law.Testing, authorization, and labelling of medicaments intended for use in human medicine.Paul Motise, Center for Drug Evaluation and Research Are there CGMP regulations or guidances specific to Botanicals? Reference: FDA Guidance "Guideline For Submitting Supporting Documentation in Drug Applications For The Manufacture of Drug Substances," 2/87; FDA draft guidance, "Guidance For Industry, Botanical Drug Products," 8/98 There are no regulations specific to Botanicals, per se, but there are some applicable guidance documents.Botanicals are generally either starting materials for the production of active pharmaceutical ingredients or drug substances for use as ingredients in dosage forms.

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