Pharmacopeial monograph, adoption

Specifications in pharmacopeial monographs and product licences require intravenous immunoglobulin products to be free from significant amounts of anti-A and anti-B antibodies (132). It has been advised that a specification be adopted that will prevent the use of batches of intravenous immunoglobulin with abnormally high anti-D titers (over 1 64) (132). 

Efforts are under way to make the USP-NF more useful worldwide. Incorporation of monographs for multi-vitamin products, biotechnology-derived products, veterinary drugs, and botanicals and other dietary supplements help. The US AN and USP Dictionary of Drug Names has wide international applicability, thereby making it a repository of International Names Nomenclature (INN) and British Adopted Names (BAN), as well as U.S. Adopted Names (USAN). Pharmacopeial Forum now contains announcements of proposals from the Japanese Pharmacopeia and European Pharmacopeia for revision of standards for international harmonization. 

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. 

Once the company has compiled the necessary information, they submit the proposed monograph to USP so it may be adopted as an official standard. The appropriate USP expert committee reviews the information, to assess its completeness and scientific merit, and subsequently approves it for publication in Pharmacopeial Forum (PF), USP s bimonthly journal of scientific review and compendial revision. Once a monograph has been published in PF, any interested person, company, or regulatory authority, including USP Expert Committee members, may comment on the contents of the proposal. The USP may chose to accept the comments and revise the original proposal, or reject the comments and proceed to adopt the original submission as initially published. 

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