The Pending Monograph Process (PMP) enables publication of monographs for qualified articles based on monograph sponsor-provided information from applications filed with FDA. The purpose of the PMP is to have an official USP or NF monograph that reflects attributes of approved products published as soon as possible after FDA grants final product approvals. The PMP enables monograph development or revision to begin before FDA’s approval process is complete, resulting in an official USP or NF monograph more rapidly than would be possible if monograph development or revision started only after final FDA approval. These new or revised monographs do not become official text until approved by a USP Expert Committee and an application matching those attributes has been approved by FDA.
The Pending Monograph Process (PMP) was developed through a collaboration between USP and FDA as a practical way to expedite the monograph development and revision based on new applicants’ specifications provided in applications submitted to the FDA. The resulting PMP also was informed by feedback from stakeholders on USP’s former process.
After potential sponsors notify USP of their application with FDA, USP staff will collaborate on development of a draft monograph. The proposed monograph will be published in Pharmacopeial Forum for comment, if necessary. If the proposal is a revision to an existing monograph, then it will be placed on the USP website as part of a Notice of Intent to Revise as a notification of an expected change. The monograph will be made official after the sponsor’s application is approved by FDA. For details, see the Pending Monograph Guideline at http://www.uspnf.com/pending-monographs or email pendingrevisions@usp.org.
The Notice of Intent to Revise step will be omitted and the revision will be published as a Revision Bulletin as quickly as possible, contingent on approval by the Expert Committee.
If the revision proposal already appeared in PF for 90 days, then the revision proposal will be converted to a Revision Bulletin and posted as quickly as possible, contingent on the nature of the comments received and approval by the Expert Committee. The revision may have a delayed official date.
If publication in PF is required but the revision proposal has not appeared in PF or is in PF at the time of approval, then the revision proposal will undergo the full notice-and-comment period, and then be converted to a Revision Bulletin and posted as quickly as possible, contingent on approval by the Expert Committee. The revision may have a delayed official date.
If the updates to the monograph specifications are to widen them (e.g., the acceptance criteria for a specific test are widened), the NITR will either be revised and reposted (if the monograph sponsor’s application has not yet been approved by FDA) or the updated revisions will be made official per the process specified in the guideline. If the monograph specifications are tightened and there are known compliance implications to stakeholders, the updated monograph will be republished in PF. In either case, the final version of the monograph will need to be approved by the EC.
Yes. All stakeholders are encouraged to comment on new monograph proposals and revision proposals appearing in PF regardless of the process used. This consistent approach is a benefit of the current PMP.
No. Revisions to a monograph made outside of the Pending Monograph Process (PMP) typically will not be reflected in the posted Notice of Intent to Revise (NITR). The posted text will bear a statement that it may not reflect the full and accurate contents of the currently official monograph, and that it may change prior to becoming official (e.g., if the monograph sponsor’s final FDA approved specifications differ from those in the NITR). Users should always refer to the official version of the USP–NF standard.
The Notice of Intent to Revise (NITR) will be revised to indicate that the revision was canceled, and then will be archived.
No. Because such monographs never attained official status, they should not be used for demonstration of compliance. In addition, such monographs have not been maintained through USP’s normal revision process and may not reflect appropriate requirements.