United States Pharmacopeia pharmacopeial forum

A guideline for evaluation of the photostability of new drug substances and dosage forms was published in 1997 [39]. Subsequently, a joint study was undertaken by the U.S. Food and Drug Administration (FDA) and Pharmaceutical Research and Manufacturers of America to evaluate the ICF1 guideline. A draft chapter for the United States Pharmacopeia, based on the guideline and the joint study, has been published in Pharmacopeial Forum [40]. 

The United States Pharmacopeia-National Formulary (USP-NF), USP34-NF29 SI. General Requirements/< > JSP Reference Standards, pp 38-40. Pharmacopeial Forum 35(6) 1507... 

Opalchenova, G.A. Comparison of the microbial limit tests in the british, european, and united states pharmacopeias and recommendation for harmonization. Pharmacopeial Forum 1994, 20 (4), 7872-7877. 

Several years after the successful launch of a new product, it is typical for North American pharmaceutical firms to become involved in the United States Pharmacopeia-National Formulary (USP-NF) revision process to allow inclusion of their API and formulations in the USP-NF. The USP-NF and their supplements are a compilation of monographs prepared under the authority of the Pharmacopeial Convention. The purpose of the USP-NF and supplements is to provide authoritative standards and specifications for materials and substances and their preparations that are used in health care or for the improvement or maintenance of health.16 The revision process— as outlined in the USP-NF—begins with inquiries, comments and suggestions for revision in the USP-NF text mailed directly to the USP.17 Participation in this process ensures consideration of the innovator s methods, specifications, and reference standards for inclusion in the USP-NF. Approval for inclusion in the USP-NF is gained after consideration by an Expert Committee of the USP Council of Experts. If the Expert Committee so recommends, the proposed revision is published in the Pharmacopeial Forum (PF) for review and comments by interested readers of the PF. The comments and data submitted by interested readers are reviewed and addressed, and the Expert Committee then decides whether to recommend to the USP Council of Experts that the proposed revision should be adopted in the USP-NF. 

Stage 3 Publication of the draft text in the forum of each pharmacopoeia Pharmeuropa (Ph Eur), Japanese Pharmacopoeial Forum (Japanese Pharmacopoeia) and Pharmacopeial Forum (United States Pharmacopeia) Comments received and consolidated Preparation of a second draft text ( Stage 4 draft )... 

United States Pharmacopeia, Near-Infrared Spectrophotometry, Pharmacopeial Forum, 24 1998. 

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