Rules & Procedures of the 2010–2015 Council of Experts

8. Other Documentary Standards

8.01 Food Chemicals Codex

  1. Requests for Revision. Proposals to create new standards or to revise standards in the Food Chemicals Codex (FCC) shall be submitted in accordance with any applicable guidelines developed by USP. The Scientific Liaison shall evaluate the relevancy, supportability, and urgency of the request in accordance with the established policies and procedures and determine whether to proceed with the requested revision. The Scientific Liaison may notify the Food Ingredients Expert Committee (FI EC) of a pending FCC request for revision, and may also provide the request to other relevant Expert Committees or Expert Panels.
  2. Notice and Comment Period. Except as provided in subsections (e) and (f) below, all proposals to revise the FCC shall be published in the FCC Forum on the USP website for public review and comment. Unless otherwise determined by USP, a proposal that includes the use of a new USP Reference Standard shall not be scheduled for publication in the FCC Forum until a suitable reference standard bulk candidate has been received by USP. A period of ninety (90) days from the date of publication in FCC Forum will be allowed for public review and comment. For good cause shown, the CoE Chairperson may alter the time specified.
  3. Approval by Expert Committee and Publication. Following the notice and comment period, the FI EC shall review all comments, accept or reject them, and make any final changes to the proposal it deems appropriate. Prior to publication in final form, the proposal must be approved by the FI EC using the voting procedures provided in Section 7.07 above. After approval by the FI EC, the FCC proposal shall be published in the next edition of the FCC or Supplement thereto, as applicable, and shall become effective 90 days from the date of publication unless otherwise provided. Unless otherwise determined by USP, a revision to the FCC that includes the use of a new USP Reference Standard shall not be published as final approved text until the required USP Reference Standard is available.
  4. Expedited Standards. If the FI EC determines that for public health or other appropriate reasons, a new or revised standard should be made available prior to publication of the next edition of the FCC or Supplement, it may be posted as final on the USP website following notice and comment under subsection (b) and approval by the FI EC under subsection (c). Such a standard (Expedited Standard) will be effective upon website publication, unless a delayed effective date is specified therein. Upon publication of the next edition of the FCC or Supplement thereto, as applicable, any Expedited Standard that has become effective since publication of the last edition or Supplement will be included in such volume and removed from the USP website.
  5. Immediate Standards. In those rare cases where the FI EC determines that a new or revised standard should be made available immediately because of an urgent public health need, a standard may be approved by the FI EC and posted as final on the USP website without the notice and comment period specified in subsection (b) above. Such a standard (Immediate Standard) will be effective upon website publication, unless a delayed effective date is specified therein. Upon publication of the next edition of the FCC or Supplement thereto, as applicable, any Immediate Standard that has become effective since the last edition or Supplement will be included in such volume and removed from the USP website.
  6. Errata. Errata are considered to be text erroneously published in the FCC or its Supplements that do not accurately reflect the intended requirements as approved by the FI EC. A list of errata and corresponding corrections to an edition of the FCC or to a Supplement shall be published on USP’s website, until the publication of the next edition of the FCC or Supplement, which shall then reflect such corrections. Errata shall not be subject to notice and comment and shall not require approval by the FI EC.

8.02 USP Medicines Compendium

  1. Requests for Revision. The public, USP staff, and USP Medicines Compendium (MC) Expert Committee members, may submit proposals to create new monographs or to revise monographs for medicines approved by regulatory authorities outside the United States, including reference materials suitable for use as comparison standards in MC tests and assays.  Such proposals for revision of MC standards shall be submitted in accordance with any applicable guidelines developed by USP.
  2. Notice and Comment Period. Except in rare cases where the MC Expert Committee(s) determine that a new or revised standard should be made available immediately because of an urgent public health need,  all proposals to revise the MC shall be published in draft on the MC web site, and provide an adequate period for public review and comment.
  3. Approval by Expert Committee. Following the notice and comment process outlined above and in any applicable guideline, the MC proposal must be approved by MC Expert Committee members using the voting procedures provided in Section 7.07(a) above.

  4. Publication. After approval by the MC Expert Committee, a MC proposed standard shall be published and maintained on the USP website as a final authorized standard.  Any subsequent comments received shall be treated as proposed revisions of a MC monograph in accordance with subsections (a), (b, and (c) above. Any errata will be corrected on the online version.  Each online version will have a “Revision History” that documents any changes.

8.03 Pending Monographs

  1. Request for Revision. Proposals to create new monographs for articles pending FDA approval shall be submitted in accordance with the USP Pending Monographs Guideline, available on USP’s website.
  2. Approval by Expert Committee. Following the notice and comment process outlined in the Guideline, the Pending Monograph proposal must be approved by the relevant Expert Committee using the voting procedures provided in Section 7.07(a) above.
  3. Publication. After approval by the relevant Expert Committee, a Pending Monograph shall be published and maintained on the USP website as a final Pending Monograph and shall be considered authorized text. Any subsequent comments received shall be treated as proposed revisions of a Pending Monograph in accordance with subsections (a) and (b) above. After FDA approves the article to be marketed in the US, the standard will become official and be moved to USP–NF by Revision Bulletin if approved by the relevant Expert Committee, as provided in the Pending Standards Guideline.

8.04 Medicare Model Guidelines

The Council of Experts shall be responsible for developing and approving revisions to the Model Guidelines and related information and documents that pertain to formularies and plan designs that may be used by prescription drug plans under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, consistent with the statutory role given to USP under the Act. Such work will be performed from time to time when requested by the Centers for Medicare and Medicaid Services.