2011 11 01 usp pending monographs v2 7

							USP Pending Monographs Guideline, Version 2.7
Effective November 1, 2011


USP Pending Monographs

Karen A. Russo, Ph.D.
Vice President, Small Molecules
kar@usp.org    301-816-8379
USP Pending Monographs: Objective



   Enables monograph development and publication before
    FDA approval has been granted to a generic
    manufacturer
   Ultimate purpose is to have an official USP-NF
    monograph ready as soon as possible after FDA
    approval of an application (i.e., ANDA, BLA)
   USP Pending Monographs web site is
    www.usp.org/standards/pending/
USP Pending Monographs: Requirements


   Sponsors
     – Who have filed or intend to file with FDA an Abbreviated
       New Drug Application (ANDA) or Abbreviated New Animal
       Drug Application (ANADA) within six months; or
     – Who have filed or intend to file with FDA a Biosimilar or
       Interchangeable Biologics License Application (a Public
       Health Service Act 351(k) BLA) within six months; or
     – Who have submitted a Drug Master File (DMF) for an
       article to FDA; or
     – Whose substance is or will be the subject of a Time and
       Extent Application or citizen petition to amend an FDA
       OTC drug monograph.
USP Pending Monographs: Requirements



   Documentation
     – Statement of intent to file an ANDA, ANADA or BLA
       within six months
     – Copy of the DMF filing letter
   Confidentiality
     – Sponsor may request that all or part of Request for
       Revision be viewed only by USP and FDA for a
       specified time before the Draft Pending Monograph is
       posted
       USP Pending Monographs: Process


                        Monograph development begins

                    Draft Pending Monograph is posted for
                          90-day public review period

                     Relevant Expert Committee(s) ballots
                     If not approved           If approved

                   Authorized Pending Monograph is posted
Determine
next steps      FDA approves Sponsor’s ANDA, ANADA or BLA

                     Relevant Expert Committee(s) ballots
                     If not approved          If approved
             Pending Monograph becomes official via Revision Bulletin
             (official date is not less than six months after the posting)

             Official monograph is published in the USP-NF or Supplement
What if there is an existing official USP or NF monograph?



 If there is an existing official USP or NF monograph, then
  information from the Authorized Pending Monograph will
  be merged with the existing monograph, as appropriate,
  to create a monograph that reflects all FDA-approved
  articles (see the Guideline for Submitting Requests for
  Revision to USP–NF).
 This revision to the existing monograph will advance to
  official status in the USP-NF via a Revision Bulletin and
  will be official immediately upon posting consistent with
  USP’s Guideline on Use of Accelerated Processes for
  Revisions to the USP-NF.
USP Reference Standards



   Unless USP determines otherwise, if the proposed
    monograph includes the use of a new USP Reference
    Standard then USP will not publish the proposed
    monograph on its Web site until it has received the
    necessary reference material bulk candidate(s)

   Any USP Reference Standard developed in support of a
    Pending Monograph may be available for sale at any
    time before or after Web site publication of the Draft or
    Authorized Pending monograph