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Rules and Procedures of the 2005–2010 Council of Experts

10. STANDARDS EXPERT COMMITTEES; OTHER STANDARDS

10.01 Food Chemicals Codex.

(a) 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 and his or her immediate supervisor, 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 shall notify the Food Ingredients Expert Committee (FIEC) of a pending FCC request for revision. The Scientific Liaison may provide the request to other relevant Expert Committees or ad hoc Advisory Panels.

(b) 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 Web site 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. The Scientific Liaison will review the comments and, together with his or her supervisor, shall determine whether to proceed with committee approval as set forth in subsection (c) below.

(c) Approval by Expert Committee and Publication. Following the notice and comment period, the FIEC 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 FIEC using the voting procedures provided in Section 9.07 above. After approval by the FIEC, the FCC proposal shall be published as final in the next edition of the FCC or Supplement thereto, as applicable, and shall be effective as of the date of publication. Unless otherwise determined by USP, a revision to the FCC that includes the use of a new USP Reference Standard shall not be published as final approved text until the required USP Reference Standard is available for purchase.

(d) Expedited Standards. If the FIEC 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 Web site following notice and comment under subsection (b) and approval by the FIEC under subsection (c). Such a standard (Expedited Standard) will be effective upon Web site 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 Web site.

(e) Immediate Standards. In those rare cases where the FIEC 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 FIEC and posted as final on the USP Web site without the notice and comment period specified in subsection (b) above. Such a standard (Immediate Standard) will be effective upon Web site 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 Web site.

(f) Errata. Errata are considered to be text erroneously published in the FCC or its Supplements that does not accurately reflect the intended requirements as approved by the FIEC. A list of errata and corresponding corrections to an edition of the FCC or to a Supplement shall be published on USP's Web site, 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

10.02 Standards for Articles Legally Marketed Outside the U.S. (SALMOUS)

(a) Requests for Revision. Proposals to create new monographs or to revise monographs for articles legally marketed outside of the U.S. (SALMOUS proposals) shall be developed in accordance with the USP Guidelines on Standards for Articles Legally Marked Outside the U.S., available at http://www.usp.org/standards/international/guidelines.html. The Scientific Liaison and his or her immediate supervisor shall evaluate the relevancy, supportability, and urgency of the SALMOUS proposal in accordance with the established policies and procedures, and determine whether to proceed with the proposal. The Scientific Liaison shall notify the relevant Expert Committee of a pending SALMOUS proposal.

(b) Notice and Comment Period. All SALMOUS proposals shall be published on USP's Web site for public review and comment. A period of at least ninety (90) days from the date of publication will be allowed for public review and comment. For good cause shown, the CoE Chairperson may alter the time specified. The Scientific Liaison will review the comments and, together with his or her supervisor, shall determine whether to proceed with committee approval as set forth in subsection (c) below.

(c) Approval by Expert Committee. Following the notice and comment period, the International Health Expert Committee 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 SALMOUS proposal must be approved by the relevant Expert Committee using the voting procedures provided in Section 9.07 above.

(d) Publication. After approval by the relevant Expert Committee, a SALMOUS proposal shall be published and maintained on the USP Web site as a final SALMOUS monograph and shall be considered authorized text. Any subsequent comments received shall be treated as proposed revisions of a SALMOUS monograph in accordance with subsections (a), (b) and (c) above.

10.03 Pending Standards (PS)

(a) Request for Revision. Proposals to create new monographs for articles pending FDA approval shall be submitted in accordance with the USP Pending Standards Guideline, available at http://www.usp.org/standards/pending/guidelines.html. The Scientific Liaison and his or her immediate supervisor shall evaluate the relevancy, supportability and urgency of the PS proposal in accordance with the established policies and procedures, and determine whether to proceed with the proposal. The Scientific Liaison shall notify the relevant Expert Committee of a pending PS proposal.

(b) Notice and Comment Period. All PS proposals shall be published on USP's Web site for public review and comment. A period of at least ninety (90) days from the date of publication will be allowed for public review and comment. For good cause shown, the CoE Chairperson may alter the time specified. The Scientific Liaison will review the comments and, together with his or her supervisor, shall determine whether to proceed with committee approval as set forth in subsection (c) below.

(c) Approval by Expert Committee. Following the notice and comment period, the relevant Expert Committee 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 PS proposal must be approved by the relevant Expert Committee using the voting procedures provided in Section 9.07 above.

(d) Publication. After approval by the relevant Expert Committee, a PS proposal shall be published and maintained on the USP Web site as a final PS monograph and shall be considered authorized text. After FDA approves the article to be marketed in the U.S., the standard will become official and be moved to USP-NF as provided in the Pending Standards Guideline.

10.04 Information Monographs Developed by Standards Expert Committees

Information monographs may be developed by Standards Expert Committees including the Veterinary Medicine Expert Committee and Radiopharmaceutical Information Expert Committee. Such monographs shall be posted on the USP Web site for public comment for a period of thirty (30) days. The relevant Expert Committee shall review all comments, alter the text as appropriate, and approve the monograph using the voting procedures described in Section 9.07 above.