Pending Monographs

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–NF 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.

A Pending Monograph request will be accepted from a sponsor awaiting FDA approval even if there is an official USP–NF monograph. Following FDA approval of the application supporting the Pending Monograph, the Pending and the official monographs will be merged and presented to the Expert Committee for approval. If approved, the resulting flexible monograph will accommodate the 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.

No. A company is not permitted to label their article as "USP", "NF" or "USP–NF" on the basis of adherence to a Draft or Authorized Pending Monograph. Use of the "USP", "NF" or "USP–NF" labeling is permitted only in reference to official USP–NF monographs.

Yes. Pending Monographs may be revised based on comments received from interested parties, provided that adequate supporting data are submitted to USP. For Draft monographs, minor comments may be incorporated into the monograph during the balloting step in which the Draft proposal advances to Authorized status and this can happen without the need for another 90-day public comment period. In cases where there are more substantive revisions needed to a Draft monograph, or if there is a request to revise an Authorized Pending Monograph, a revised Draft is prepared and posted for a 90-day public comment period.

Pending Monographs have two main statuses: Draft or Authorized. Draft Pending Monographs indicate “Draft” and a version number (e.g., Draft 1, etc) while Authorized Pending Monographs indicate “Authorized” along with a version number and date (e.g., Authorized Version 1, March 1, 2011).