USP's Work Plan and New Revision Approaches - Pharmaceutical Technology

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USP's Work Plan and New Revision Approaches
Following its 2005 Convention, USP is adopting new approaches to develop monographs and products and to carry out the organization's ambitious work plans.


Pharmaceutical Technology


The United States Pharmacopeia's (USP) mission statement notes that USP "promotes the public health and benefits practitioners and patients by disseminating authoritative standards and information developed by its volunteers for medicines, other health care technologies, and related practices used to maintain and improve health and promote optimal health care" (1). Since the publication of the first United States Pharmacopeia (USP) in 1820, one of USP's abiding strategies for advancing this mission has been the continuous revision and improvement of USP and, since 1975, USP–NF.

The growth of the compendia has been remarkable: the 1820 edition of USP contained 621 monographs, but USP 29 includes more than 4000 ingredient and drug, dietary supplement, and other product monographs for therapeutic articles legally marketed in the United States, and NF 24 now includes more than 355 excipient monographs.

USP cannot compel pharmaceutical manufacturers to submit a monograph, technically known as a request for revision to USP–NF. Because of confidentiality agreements between a new drug application (NDA) sponsor and the US Food and Drug Administration, the agency also cannot publicly release information about the private specification that it concludes with the sponsor during the approval of the sponsor's NDA (2). Many companies understand and support public standards for pharmaceutical articles (e.g., the availability of compendial standards for identity, strength, purity, and quality of articles in public commerce; public standards for labeling, shipping, and storage; and many more). USP has worked diligently to gain the cooperation of these pharmaceutical manufacturers who understand and support public quality standards (3). USP has posted a guideline on its Web site to help sponsors submit a request for revision for a new monograph or a revision of an existing one (4).

Nonetheless, these efforts to solicit new monographs have fallen behind the rate of NDA approvals. At the same time, analytical techniques such as thin-layer chromatography in many older monographs have become outdated because of advances in analytical technologies, including high-performance liquid chromatography and mass spectrometry. Before USP convened its most recent five-year convention in 2005, it was clear that USP–NF was missing monographs: approximately 2000 new monographs were needed, and approximately 800 existing monographs required updating.

Taking stock

As part of an organized plan to reduce the number of missing monographs in USP–NF, each Expert Committee was asked to review the monographs within its purview at the end of the 2000–2005 revision cycle and to develop a list of those that were in need of revision and new monographs that should be developed during the 2005–2010 cycle. In some cases, revision could include extensive rewrites or even subdivision into several distinct chapters (e.g., the possible division of Chromatography ‹621› into several smaller, possibly easier to use, chapters). USP soon will publish an article about the revision of General Chapters and other initiatives and has posted a table showing the status of existing and proposed General Chapters and revisions ( http://www.usp.org/USPNF/submitMonograph/generalChapterWorkplans.html) (5).

In a parallel activity, USP staff consulted numerous databases and identified a list of high-priority monographs, defined as drug substances and products, as well as excipients that are or soon will be off patent. These have been organized into lists that are posted on USP's Web site at http://www.usp.org/USPNF/submitMonograph/newMon.html. The Web site indicates when a monograph proposal has been received. When the request for revision has been published in USP's bimonthly journal of standards development and pharmacopeial review, Pharmacopeial Forum (PF), the monograph name is removed from the list. The list of high-priority monographs also is published in PF.


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