Rules & Procedures of the 2010–2015 Council of Experts

7. USP–NF Standards

7.01 Official Publication of United States Pharmacopeia or National Formulary Standards

The final approved text of a revision to the United States Pharmacopeia (USP) or National Formulary (NF) shall be published and distributed to the public via print and/or electronic means through the following vehicles: annual editions of the USP–NF, Supplements to the annual edition, Interim Revision Announcements, Revision Bulletins, and Errata. Unless otherwise determined by USP, a revision that includes the use of a new USP Reference Standard shall not be published as final approved text until the required USP Reference Standard is available. All revisions shall become official six (6) months after publication, unless otherwise specified in the publication vehicle.

7.02 Accelerated Revision Processes

Accelerated revision processes are used to make revisions to the USP–NF official more quickly than through USP’s standard revision process when necessary to correct errors, address patient safety issues, or resolve compliance issues. Such accelerated revisions, which include Interim Revision Announcements, Revision Bulletins and Errata, do not always require notice and comment and allow for a revision to become official prior to the next USP–NF or Supplement. Accelerated revisions may be used only in the circumstances described in USP’s Guideline on the Use of Accelerated Processes for Revisions to the USP–NF, which is posted on USP’s website.

7.03 High Impact Revisions

  1. Design Phase. Prior to undertaking the development of or major revision to a standard that is expected to have a very broad impact on USP’s stakeholders (High Impact Revision), USP shall employ a “design phase” approach involving USP, affected industry, FDA and other regulators, and other interested stakeholders such as practitioners and patients. USP shall consider using a workshop, a Web meeting, or other similar forum to bring all parties together to discuss: the scientific and public health issues to be addressed by the High Impact Revision; the proposed scope of the High Impact Revision; a proposed timeline for development of the High Impact Revision; and implementation considerations. Such discussion shall also consider whether one or more Expert Panels are necessary or desirable to advance the High Impact Revision. Based on this discussion, USP shall develop a “roadmap” for the High Impact Revision, which shall be communicated to stakeholders and shall guide USP’s work on the High Impact Revision.
  2. Prepublication of Proposed Standard and Outreach. USP will consider publishing proposals for High Impact Revisions in the form of a Stimuli article or in some other manner that will allow stakeholder input prior to publication of a formal proposal for notice and comment in PF as provided in Section 7.06 below. As a High Impact Revision is developed, USP will also consider other mechanisms for ongoing stakeholder dialogue, including webcasts and other outreach opportunities.
  3. Delayed Implementation and Training. Based on stakeholder input and other considerations, USP shall determine the appropriate implementation date for a High Impact Revision. Delayed implementation dates will be considered in order to allow sufficient time for implementation by industry and regulatory authorities. USP will also consider the need for training and education during the implementation period to assist industry, regulators and others in understanding and determining how to implement the High Impact Revision.

7.04 International Harmonization

In USP’s effort to harmonize the USP–NF with the European Pharmacopoeia and the Japanese Pharmacopoeia through the Pharmacopeial Discussion Group (PDG), any harmonized standard that has been agreed to by a designated representative of USP shall be approved by the relevant Expert Committee in order for such standard or information to be considered official or authorized or adopted by USP. If a standard has been harmonized, such a standard shall not be modified beyond the addition of locally applicable text without first obtaining agreement of the partners in PDG, unless it is determined by the CoE Chairperson and the Expert Committee that such modification is necessary in the interest of public health. In such case, the CoE Chairperson or his designee shall immediately notify the PDG partners and provide the reasons for making such changes.

7.05 Requests for Revisions

  1. Submission of Requests for Revision. A Request for Revision is a proposal to revise the USP–NF, with either changed or new content. A Request for Revision must be submitted in accordance with the USP Guideline for Submitting Requests for Revision to USP–NF, available on USP’s website, and may be refused if it does not substantially conform to the Guideline. Proposals to revise the USP–NF may also be initiated by Expert Committees or by USP staff.
  2. Review of Request for Revision. All Requests for Revision shall be forwarded to the appropriate Scientific Liaison. The Scientific Liaison shall evaluate the relevancy, supportability, and urgency of the Request for Revision in accordance with established policies and procedures. The Scientific Liaison may initiate work on the Request for Revision or provide the Request for Revision to the relevant Expert Committee or Expert Panel for its recommendations.
  3. Notice of Intent to Revise. Upon request of any party, a Notice of Intent to Revise may be posted on USP’s website indicating the changes to be made upon approval by the relevant Expert Committee(s).  Such changes shall be made through a Request for Revision and handled in accordance with the procedures described in these Rules.
  4. Approved for Inclusion. As set forth in USP’s Guideline on Drugs Approved for Inclusion, available on USP’s website, upon the written commitment from a party to submit a Request for Revision, together with adequate supporting data and the bulk material required for any accompanying reference standard, USP shall notify the Centers for Medicare and Medicaid Services (CMS) that such article has been “approved for inclusion” in the USP-NF.  Such “approved for inclusion” status may be revoked at USP’s discretion upon the party’s failure to fulfill such commitment in a timely fashion.

7.06 Publication in the Pharmacopeial Forum

  1. Publication in Pharmacopeial Forum. Except as provided in Section 7.02 above, all proposals for revisions to the USP-NF shall, at the direction of either an Expert Committee, or the Scientific Liaison (following notice to the appropriate Expert Committee), be published in the Pharmacopeial Forum (PF) 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 PF until a suitable reference standard bulk candidate has been received by USP.
  2. Public Notice. Consideration of Comments. Except as provided in Section 7.02 above, a period of at least ninety (90) days from the date of publication will be allowed for public review and comment.  The time allowed for public comments shall be noted in the publication in the PF.  The comment period for High Impact Proposals may be extended with approval of the CoE Chairperson to allow stakeholders additional opportunity to review, consider and comment on such proposals. 
  3. Consideration of Comments. A proposal published in PF for comment shall not be re-published in PF for additional comment prior to publication in the USP or the NF unless the Expert Committee or the CoE Chairperson determines that re-publishing is necessary due to the nature or significance of the comments received or changes made to the proposal.  No further opportunity for comment shall be required if changes made to the proposal are in response to comments received and do not create new compendial requirements not contained in the initial PF proposal.
  4. Comment Summary. Where a proposal is published in the USP or the NF without re-publishing in PF, such a summary or abstract of each type of comment received and a response to the comment from the Expert Committee or CoE Chairperson shall be posted on USP’s website.  Such summary shall not include any information marked as confidential by the submitter, consistent with USP’s Document Disclosure Policy.
  5. Additional Notice and Comment. In addition to publication in PF as provided herein, other means such as the USP website may be used to provide notice of and an opportunity to comment on proposals, if determined appropriate by the Expert Committee, or the CoE Chairperson.

7.07 Approval by Expert Committee

  1. New Standards and Accelerated Approvals; Conventional Balloting. Prior to publication as final text, all new or revised documentary standards (other than Errata) and the suitability of use of any Reference Standard in such documentary standards must be voted on and approved by the responsible Expert Committee. Voting shall be accomplished by ballot. Ballots may be issued or returned electronically, by mail, or any other method. Ballots must be returned by a majority of the members of the Expert Committee by the specified due date for the vote to be valid. Members who are abstaining from voting due to Conflict of Interest or other reasons shall indicate such abstention on their ballots and be counted towards this majority requirement.
  2. Responsibility for Approvals. When more than one Expert Committee collaborates on a particular proposal, one Expert Committee shall be designated by the CoE Chairperson as the lead Expert Committee and will be responsible for approvals. The other collaborating Expert Committee(s) shall be notified of the approval.

7.08 Postponement

  1. Request for Postponement. A request for postponement may be filed by anyone and shall be accompanied by a statement of the grounds upon which the postponement is requested and appropriate supporting data. A request for postponement submitted under this section shall be clearly distinguished from a Request for Revision.
  2. Untimely Requests. A request for postponement received within thirty (30) days prior to the official date may be refused for consideration by the CoE Chairperson if, solely within his or her discretion, he or she considers the request untimely or lacking adequate supporting data. Such decision shall not be subject to appeal, and the matter instead will be considered as a Request for Revision.
  3. Granting of Postponement. The Expert Committee responsible for approving the standard for which postponement is sought shall have the authority to postpone the official date of any requirement or textual material in such standards; provided that all decisions on postponement requests shall require review and approval by the CoE Chairperson, who may at his or her option refer the matter to the Executive Committee for its consideration. Any postponement shall stay in effect until the responsible Expert Committee considers or approves a subsequent revision to the postponed standard, or the CoE Chairperson or Executive Committee decides to lift the postponement.

7.09 Appeals

  1. Process. All appeals shall be received and considered as provided in Article VII, Section 6 of the Bylaws and this section.
  2. Timing of Appeals. A standard may properly be appealed only up to 30 days prior to its official date. Once official or issued, or within 30 days of being official, the matter is not subject to appeal, however, any interested party may request that the matter be considered as a Request for Revision.
  3. Submission of Appeals. All appeals must be submitted in writing and be accompanied by supporting data and evidence. An appeal submitted under this section shall be clearly distinguished from a Request for Revision. The appellant shall indicate whether an oral hearing is requested or if the appeal should be decided solely based on the submitted documents.
  4. Determination to Grant or Deny. All appeals of decisions made by an Expert Committee shall be submitted to the CoE Chairperson who, with the consent of the Executive Committee, will make the initial determination whether to grant or deny the appeal. This determination may be based upon whether or not the appeal is accompanied by sufficient data or evidence, is frivolous, or is untimely. The determination to deny an appeal is not subject to appeal; however, any appeal denied will be treated as a Request for Revision.
  5. Adjudication of Appeals. If an appeal of a decision made by an Expert Committee is granted, the CoE Chairperson shall submit it to the Executive Committee for adjudication. For an appeal via oral hearing, the Executive Committee shall determine the time and place of the hearing and the CoE Chairperson or his or her designee shall be the presiding officer. The oral hearing may be held by conference call or similar communication by means of which all persons participating in the meeting shall hear one another in the same period of time. The Executive Committee may invite other parties that it deems to have a substantial interest in the matter being appealed to participate in the appeal, including the Expert Committee whose decision is being appealed. At an oral hearing any party may offer such additional evidence deemed necessary to an understanding and determination of the issues. At an oral hearing, witnesses may be called, and a witness presented by one party may be questioned by any other party with regard to the evidence the witness has offered. The Executive Committee shall be the judge of the relevancy and materiality of the evidence offered and conformance to legal rules of evidence shall not be necessary.
  6. Appeal of Executive Committee Decisions. Where there is an appeal of a decision by the Executive Committee, the appeal will be adjudicated by the Board of Trustees.