US Pharmacopeia Pending Monographs Guideline

Frequently Asked Questions


Version 1.0, Effective May 14, 2008
  1. What is the objective of the pending monographs approach?

    2. The United States Pharmacopeia (USP) Pending Monographs approach enable Web-based publication of monographs for drugs based on information that has not yet received FDA approval (i.e., applications pending FDA approval). It is important to note that Pending Monographs are not official. The ultimate purpose of Pending Monographs is to have an official USP monograph ready as soon as possible after FDA grants final product approval to the sponsor. To this end, the Pending Monographs approach lets monograph development begin before FDA's approval process is complete, resulting in an official USP monograph in a shorter time frame than would be possible if monograph development started only after final FDA approval.

    This approach is intended especially for generic manufacturers and drug master file (DMF) holders and will enable the monograph development to begin prior to FDA approval of their generic products. This approach is consistent with USP's goal of promoting public health by making monographs publicly available.

    The Pending Monograph approach also addresses the development process for any associated USP Reference Standards, which generally must be available before or at the same time that the monograph becomes official.

  2. How was the Pending Monographs Guideline modified?

    3. In response to questions and comments received by USP, the Pending Monographs Guideline was modified in several ways. The revised Guideline:

    • Clarifies what constitutes intent to file an application with FDA;
    • Indicates that sponsors must promptly inform USP of any changes resulting from the regulatory review and approval process so the Pending Monograph can be updated accordingly;
    • Indicates that USP will use its Revision Bulletin process to move a Pending Monograph to official status upon product approval rather than using an Interim Revision Announcement; and
    • Indicates that USP must receive the bulk material necessary to develop any accompanying USP Reference Standards before posting a proposed Pending Monograph on its public Web site.
  3. What if there is an official monograph?

    4. A Pending Monograph request will be accepted from a sponsor awaiting FDA approval even if there is an official monograph. Following FDA approval of the application supporting the Pending Monograph, the Pending and the official monographs will be merged. The resulting flexible monograph will accommodate approved manufacturers by providing test–specific requirements as appropriate. This same approach applies to cases in which there is a Pending Monograph and a monograph from an FDA–approved sponsor in development at the same time.