Rules and Procedures of the 2005–2010 Council of Experts

9. STANDARDS EXPERT COMMITTEES; USP–NF STANDARDS

9.01 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, and Revision Bulletins. Unless otherwise determined by USP, a revision that includes the use of a new USP Reference Standard shall not be published as final approved text until the required USP Reference Standard is available for purchase. All revisions shall become official six (6) months after publication, unless otherwise specified in the publication vehicle.

9.02 Interim Revision Announcements, Direct Interim Revision Announcements, and Revision Bulletins

(a) Use of Interim Revision Announcements and Revision Bulletins:. Interim Revision Announcements (IRA) and Revision Bulletins shall be used for publication of official text only when there is a need for expedited publication as determined by the Scientific Liaison with the approval of the Director, the Department Vice President, the Chief Science Officer, and the appropriate Expert Committee. The use of a direct IRA or a Revision Bulletin, as described in Sections 9.02 (c) and (d) below, shall also require approval of the CoE Chairperson. Direct IRAs and Revision Bulletins also may be used for postponements, as described in Section 9.08 below.

(b) Proposed IRAs. A proposed IRA shall be published in PF as provided in Section 9.06 below; provided, however, that there shall be an expedited comment period as indicated in the PF publication. Following approval by the Expert Committee as set forth in Section 9.07 below, the IRA shall be published as final in the second edition of PF following the edition in which the proposal was published, and shall be official on the first day of the second month of such PF.

(c) Direct IRAs. If the circumstances require more expedited publication of a proposal or postponement, such proposal or postponement may be published in PF as final, without a comment period, as a direct IRA. Direct IRAs shall become official on the first day of the second month of the PF in which they are published.

(d) Revision Bulletins. If the circumstances require immediate publication of official text, a proposal or postponement may be published through a Revision Bulletin. Revision Bulletins shall be posted on the USP Web site, and published in the next USP–NF or Supplement, as applicable. Revision Bulletins shall be official immediately unless otherwise specified in the Revision Bulletin.

9.03 Errata

Errata are considered to be text erroneously published in the USP–NF or its Supplements that does not accurately reflect the intended official requirements as approved by the Council of Experts. A list of errata and corresponding corrections to an annual edition of the USP–NF or to a Supplement shall be published on USP's Web site, in each PF and in each following Supplement until the publication of the next annual edition of the USP–NF, which shall then reflect such corrections. Errata shall not be subject to notice and comment.

9.04 International Harmonization

With regard to the effort to harmonize the USP–NF, the European Pharmacopeia, and the Japanese Pharmacopeia, 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 matter has been agreed to by another recognized standard setting body and there has been an agreement not to modify such matter without mutual consent, such matter shall not be modified without first obtaining agreement of the other body, 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 shall notify the other body and provide the reasons for making such changes.

9.05 Requests for Revisions

(a) Submission of Requests for Revision. A Request for Revision is a proposal to revise the USP–NF. USP shall publish guidelines for the general content for submissions of Requests for Revision. Information and supporting data necessary to validate the accuracy and reliability of the submission must be provided to enable evaluation of the submission. A Request for Revision may be refused if the submission does not substantially conform to the guidelines.

(b) Review of Request for Revision. All Requests for Revision shall be forwarded to the appropriate Scientific Liaison. The Scientific Liaison and his or her immediate supervisor shall evaluate the relevancy, supportability, and urgency of the Request for Revision in accordance with established policies and procedures. The Scientific Liaison may provide the Request for Revision to the relevant Expert Committee or ad hoc Advisory Panel for its recommendations.

(c) Notice of Intent to Revise. If it is determined that revisions to a monograph or general chapter should be made, and upon request of any party, a Notice of Intent to Revise will be posted on USP's Web site indicating the changes to be made upon approval by the relevant Expert Committee(s). Such changes shall be made through a Request for Revision in accordance with the procedures described herein.

(d) Approved for Inclusion. Upon the written commitment from a party to submit a Request for Revision, adequate supporting data, and the bulk material required for any accompanying reference standard, USP may 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.

9.06 Publication in the Pharmacopeial Forum

(a) Approval for Publication in Pharmacopeial Forum. Except as provided in Sections 9.02 and 9.03 above, all proposals for revisions to articles in or the addition of new articles to the USP–NF shall be published in the Pharmacopeial Forum (PF) for public review and comment. Approval for publication in PF shall be in accordance with the Revision Approval Process table set forth below. 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.

Revision Approval Process

Level of Impact*	Publication in PF
Level of Impact*	Approval	Notification
		Staff	Committee
Low (less than 5 monographs; editorial changes)	Scientific Liaison	Director	Entire Committee
Medium (5–100 monographs)	Scientific Liaison and Director	Department Vice President	Entire Committee
High (>100 monographs)	Scientific Liaison and Director	Department Vice President and Chief Science Officer	Entire Committee

*The Level of Impact is determined by the level of impact that the revision has upon the users of the USP–NF. Low is defined as having an impact on up to five monographs or editorial in nature. Medium is defined as affecting more than 5 and up to 100 monographs. High is defined as affecting over 100 monographs or potentially having a significant impact on the users of the USP–NF. For those proposed revisions that have no direct association to monographs or where the level of impact cannot easily be determined by the Scientific Liaison, his or her immediate supervisor and the Expert Committee Chair or member will determine the impact level.

(b) Public Notice; Comments. Except as provided in Section 9.02 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. For good cause shown, the CoE Chairperson may alter the time specified. The Scientific Liaison will compile the comments received and forward them to any individuals who were involved in the decision to publish the proposal for publication in PF under Section 9.06(a) above and to the appropriate Expert Committee or Committees, who shall review the comments and accept or reject them, make any additional changes to the text it deems appropriate, and determine whether to proceed with the proposal. If the determination is made to proceed, the proposal must be approved by formal vote of the Expert Committee prior to publication in the USP or NF pursuant to Section 9.07 below.

(c) Republication in PF. A proposal published in PF for comment shall not be reprinted in PF for additional comment prior to publication in the USP or the NF unless the Expert Committee, the Division Executive Committee or the CoE Chairperson determines that reprinting is necessary due to the nature or significance of the comments received or changes made to the proposal.

(d) Comment Summary. Where a proposal is published in the USP or the NF without reprinting in PF, such a summary or abstract of each type of comment received and a response to the comment from the Expert Committee, Division Executive Committee, or CoE Chairperson shall be posted on USP's Web site.

(e) Additional Notice and Comment. In addition to publication in PF as provided herein, other means such as the USP Web site may be used to provide notice of and an opportunity to comment on proposals, if determined appropriate by the Expert Committee, the Division Executive Committee, or the CoE Chairperson.

9.07 Approval by Expert Committee

(a) Voting. Prior to publication as final text, proposals must be voted on and approved by the appropriate Expert Committee. Voting may occur at a meeting of the Expert Committee held in accordance with Section 13 below or by written ballot. A specific section or sections of a proposal may be voted on and approved separately by the appropriate Expert Committee. Voting on a proposal or any aspect thereof may not occur prior to the end of the public comment period specified in Section 9.06(b) above. A record of the proposal, the evaluation and approvals for the item, all public comments, and the initial Request for Revision will be made available to the Expert Committee not less than twenty (20) business days prior to the end of the voting period.

(b) Ballots. If voting is by ballot, such ballot may be issued or returned electronically, by mail, facsimile transmission or any other method. Such ballot shall state a reasonable period of time by which ballots must be received. Ballots must be returned by a majority of the members of the Expert Committee 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. The results of voting shall be reported back to the Expert Committee.

(c) Resolution of Issues. The Executive Secretariat shall bring to the attention of the Scientific Liaison and chairperson of the Expert Committee any issues or questions arising with the approval process for resolution.

(d) 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.

9.08 Postponement

(a) Request for Postponement. A request for postponement 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. A request for postponement may originate from a USP–NF user, an Expert Committee or other USP volunteer body, or staff.

(b) Untimely Requests. A request for postponement received within thirty (30) days of 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.

(c) 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, however, that all decisions to postpone 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.

(d) Postponement Due to Unavailability of Reference Standards. Where a new reference standard is required in a new monograph or in a revision of an existing monograph but is not yet available, the official date of any portion of the monograph or monograph revision utilizing such reference standard shall be postponed until such reference standard is available. The postponement and the name of such unavailable reference standards shall be published. At such time as such reference standards become available, their availability and the official date of the postponed portion(s) of the monograph shall be announced.

9.09 Lifting a Postponement

(a) Evaluation of Issues. In the event that a postponement is granted, the Expert Committee shall take reasonable action to evaluate the issues involved and determine as promptly as practicable whether the postponement should be lifted and the standards should become official as scheduled, or whether the standards should be revised based on the issues presented.

(b) Decision to Lift Postponement. In making the determination to lift a postponement, the Expert Committee shall consider all information reasonably relevant and material to the matter. To gather this information, the Expert Committee may invite other parties it deems to have an interest in the matter to submit information. When a postponement is lifted, this decision, along with the postponed standard shall be published as quickly as possible in PF and on USP's Web site with an official date assigned to it. Parties that are deemed to be affected by this decision may also be notified.

9.10 Appeals

(a) Process. All appeals shall be received and considered as provided in Chapter VII, Section 16 of the Bylaws and this section.

(b) Timing of Appeals. A matter may properly be appealed only prior to its official date or, in the case of a reference standard, prior to its issuance. Once official or issued, the matter is not subject to appeal, however, any interested party may request that the matter be considered as a Request for Revision.

(c) Submission of Appeals. All appeals must be submitted in writing and be accompanied by supporting data and evidence. Electronic submission is preferred but not required. 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.

(d) Determination to Grant or Deny. All appeals of decisions made by an Expert Committee shall be submitted to the CoE Chairperson who will make the initial determination whether or not to grant 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. For appeals of a decision made by the Executive Committee, the initial determination whether or not to grant the appeal shall be reviewed by the Board of Trustees. The determination to not grant an appeal is not subject to appeal. Where an appeal is not granted, the appeal will be treated as a Request for Revision.

(e) Adjudication by Executive Committee. 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. In 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.

(f) Referral to Board of Trustees. A decision of the Executive Committee on an appeal shall be referred to the Board of Trustees. Where an appeal is determined by the Board to be primarily on a procedural matter, the Board may uphold the decision or remand the decision to the appropriate Expert Committee for reconsideration under proper procedures. Where a decision is determined by the Board to be primarily on a scientific issue, the Board may request the Council of Experts to review the decision. After such review, which shall be given as promptly as practicable, the Council of Experts may uphold or reverse the decision of the Executive Committee.

(g) Review by Council of Experts. Where there is an appeal of a decision originally made by the Executive Committee, the appeal will be adjudicated by the Board of Trustees, which upon consideration of the facts may request the Council of Experts to review the decision. After such review, which shall be given as promptly as practicable, the members of the Council of Experts may uphold or reverse the decision of the Executive Committee.