Big Changes for USP

The United States Pharmacopeia (USP) is in the process of completely rewriting the General Notices and Requirements sections of the USP and National Formulary (NF), to become effective in 2009. The General Notices provide a framework for interpreting and applying requirements for the USP-NF, so these revisions affect every monograph, general test, and requirement.

Neil Schwarzwalder

Because of the potential impacts on testing and compliance, these revisions require careful evaluation by pharmaceutical manufacturers, their suppliers, and contractors. Timely industry review of the proposal is needed to meet the ambitious timeline planned by USP for review and implementation.

The most visible changes to the General Notices are a completely revised format and a new numbering system intended to improve clarity and user-friendliness. This restructuring will make it easier to find information on alternative methods, controlling impurities, quality of water for testing and manufacturing, labeling, and other topics crucial for appropriate application of the USP and NF. Although there is little intentional change in meaning for most of these topics, changes in context and unintended alterations in meaning are possible.

Significant changes in content are also proposed, including a plan to share the same General Notices for five different publications. In addition to the USP and NF, USP now publishes the Food Chemicals Codex (FCC) and two online publications:

• Standards for Articles Legally Marketed Outside of the US (SALMOUS or S-USP), intended for international pharmaceuticals

• Pending Standards, intended for pharmaceuticals pending approval by the US Food and Drug Administration.

Adopting the same General Notices for all of these publications requires careful consideration to ensure their appropriate use.

Another major change concerns a new definition of official, which may affect the regulatory status of articles and interpretation of requirements. Because the term official compendium is defined in the Food, Drug and Cosmetic (FD&C) Act to include the USP and NF, but not the other publications, care is needed to avoid confusion. In a related initiative, USP is also considering changing the status of some general chapters, so that some non-mandatory sections might be made mandatory, and vice versa.

The URL (www.usp.org/USPNF/generalNotices.html) links to the revisions of both the USP-NF and the FCCGeneral Notices and describes the timeline for review and comment.

Industry participation urged

Industry members are encouraged to review the revised USP General Notices with experts in their organizations to identify areas of concern and provide comments to USP. In addition, a project team sponsored by the USP invites feedback from affected parties to formulate a detailed user response to the proposed revisions.

The General Notices Project Team was established "to open a dialogue between stakeholders and USP and to review the USP-NF General Notices related to content and considerations for rearranging its presentation." The project team (see box) brings together considerable expertise. The team welcomes constructive feedback and alternative proposals from other stakeholders.

General Notices Project Team .

The General Notices Project Team requests feedback by Oct. 31, 2007. Comments should be sent to Neil Schwarzwalder, nas@lilly.com, Lynn Best, lynn_best@baxter.com, or the team member representing your organization.

Neil Schwarzwalder is a global compendial consultant for Global Quality Laboratories, Eli Lilly and Company, tel. 317.276.9787 fax 317.433.0268 nas@lilly.com

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