Revised processes and new approaches
The July–August 2006 PF Policies and Announcements column included "Recent Modifications to the USP Standards-Setting Process," a notice that USP's Council of Experts approved
changes to its Rules and Procedures to expedite the monograph approval process and to expand the scope of the monographs that USP publishes (6). These changes
were effective Sept. 1, 2006.
New authority to evaluate comments. One provision in particular is designed to reinforce the ability of an Expert Committee to finalize and approve revisions
to USP–NF without republication in PF. Previously, any change made to a proposed revision published in PF automatically triggered republication of the monograph in PF, frequently necessitating multiple publication cycles. In some cases, second-entry manufacturers complained that the system
was being exploited to delay approval of their monograph and, thus, entry of their product into the US marketplace.
Under the new provision, an Expert Committee will be given authority to evaluate comments on their scientific merits, to modify
the submitted monograph if supporting scientific and validation information so warrant, and to move the monograph to official
status in the next Interim Revision Announcement, Supplement, or USP–NF. The Expert Committee would be required to summarize and respond to public comments about the revision, much like the comment
and response section at the beginning of Federal Register notices. In other words, the current Briefings that introduce monograph revisions in PF would be greatly expanded and would be more informational.
An essential point is that the Expert Committee will be allowed to decide whether it has sufficient information to modify
the draft monograph if necessary and make it official or to send it back to PF for another round of public review and comments. In either case, the Expert Committee, as always, will make its decisions
based on sound scientific principles.
Communicating changes. Expert Committees also will use the USP Web site and other vehicles more extensively to communicate proposed revisions. In
addition, the revised Rules and Procedures allow a new group, FDA Observers, to more fully participate in USP Expert Committee meetings. Once confidentiality issues
have been resolved, FDA Observers can contribute their compendial and scientific knowledge to the monograph review process.
These changes will expedite monograph development and approvals, but USP again emphasizes that Expert Committees always have
the option to republish monographs in PF for further public review when the circumstances warrant. USP believes that speeding up approvals should not impose a compliance
burden on industry, and, thus, the implementation period between publication of new monographs and revisions and the date
on which they become official generally is being expanded to six months. Each issue of PF contains a chart indicating the dates on which comments are due, the targeted official publication, the latter's date of
publication, and the official date.
New ways to develop monographs. In addition to revising its processes, USP is expanding the approaches used to acquire and develop monographs. For example,
USP is developing procedures to identify monographs that are published in other major pharmacopeias of the world but not in
USP–NF. Some of these candidate monographs may be submitted to the Council of Experts for review and possible adoption as alternative-source
monographs. USP's Monograph and Reference Standards Development Department will work with partners whenever possible to conduct
inter- and intra-laboratory collaborative tests using sound metrological procedures to evaluate candidate reference standard
materials as appropriate. USP's new office in India will collaborate and may help provide candidate reference standards for
articles approved as generics in the United States.
USP also is undertaking the development of monographs for medicines pending approval at FDA (Standards for Articles Pending
FDA Approval or SAPFA) so that such monographs can be made available and official upon FDA approval. Before FDA approval,
a SAPFA monograph will be posted on USP's Web site, but once approval is granted (and FDA is allowed an opportunity to comment
on the monograph), it will be moved to USP–NF and have official status.