USP Updates Guideline for Pending Monographs

The US Pharmacopeial (USP) Convention (Rockville, MD) has announced updates to the guideline for its pending monographs approach. The revised guideline can streamline a drug’s entry into the US market by allowing manufacturers to submit information supporting a monograph before the Food and Drug Administration (FDA) grants full approval. After FDA approval, a pending monograph becomes official and moves into the US Pharmacopeia. The approach is similar to the FDA’s tentative approval, which has been used since 2004 to make available in overseas markets crucial drugs that are still on patent in the US (e.g., some medications for HIV/AIDS).

The pending standards approach helps drug manufacturers seeking FDA approval by creating an authorized pending monograph for a drug. This meets an FDA requirement that drugs be the subject of a compendial monograph. Drug manufacturers begin the pending standards process by submitting monograph information and materials to the USP for public comment. When the monograph is approved by the USP’s Council of Experts, the authorized pending monograph is made available on the USP’s web site.

The USP first implemented the pending monograph approach in early 2007. Comments received since then have lead to changes, including:

• Clarification of what constitutes intent to file an application with the FDA.

• Sponsors must promptly inform the USP of any changes resulting from the regulatory review and approval process so the pending standards monograph can be updated accordingly.

• USP will use its revision bulletin process to move a pending standards monograph to official status on product approval.

• USP must receive the bulk material necessary to develop any accompanying USP reference standards before posting a proposed pending standards monograph on its public web site.

Details of the policy and explanations of recent revisions are available on the USP web site.