The Rules and Procedures of the Council of Experts govern the activities of the Council of Experts, the Chairperson of the Council of Experts (Chairperson) and those bodies related to the Council of Experts. These bodies include the Council of Experts, the Executive Committee, Division Executive Committees, Expert Committees, Ad Hoc Advisory Panels, Multidisciplinary Coordinating Groups, Stakeholder Forums and Project Teams.

On procedural questions, the current edition of Robert's Rules of Order, Newly Revised shall prevail where the Rules and Procedures of the Council of Experts are silent.

These Rules and Procedures of the Council of Experts may be amended during the cycle in accordance with Chapter VII, Section 11 of the Bylaws.

The members of the Council of Experts and its related bodies shall be required to adhere to the USP Code of Ethics. [Code of Ethics to come]

Members of the Council of Experts, its Expert Committees, and ad hoc Advisory Panels serve USP as individual experts; they do not serve any outside interest. A member of the Council of Experts, its Expert Committees, or ad hoc Advisory Panels shall not use his or her membership in any way that is, or appears to be, motivated by private gain for himself, herself or any outside interest.

Members of the Council of Experts, Expert Committees, and ad hoc Advisory Panels are subject to periodic performance assessments.

Pursuant to Chapter VI, Section 11 and Chapter VII, Section 18 of the Bylaws, a member of the Council of Experts or an Expert Committee may be removed for cause by the Board of Trustees, upon recommendation of the Chairperson or the Executive Committee.

(a) As set forth in Chapter VII, Section 7 of the Bylaws, no member of the Council of Experts, an Expert Committee or ad hoc Advisory Panel who has a financial interest that may conflict, or may appear to conflict, with his or her duties and responsibilities, shall vote on a matter in which he or she has such financial interest. An employee's interest shall be presumed to coincide with that of his or her employer. It is the responsibility of each member to inform the USP Executive Secretariat and/or the chairperson of a particular Expert Committee should a situation arise in which he or she has or may have a conflict of interest.

(b) Where it appears that a conflict of interest may exist, or may be perceived to exist, any Council of Experts, Expert Committee, or ad hoc Advisory Panel member may excuse himself or herself from a Council of Experts, Expert Committee, or ad hoc Advisory Panel deliberation. Any member may be excused from such a deliberation by an affirmative vote of not less than two-thirds of the members of the deliberating body, other than himself or herself, provided, the minutes of such meeting shall note that the member was excused from such deliberation.

(c) No member shall be assigned the sole responsibility to work on an issue or question in which he or she has a conflict of interest or the appearance of a conflict of interest. He or she may, however, provide relevant scientific information.

(d) In the case where the chairperson of an Expert Committee has a conflict of interest or the appearance of a conflict of interest, the vice chairperson will serve.

(a) Each member of the Council of Experts, the Expert Committees, and ad hoc Advisory Panels shall submit to the Chairperson a statement of all employment, professional research, organizational memberships, and financial interests that relate either directly or indirectly to his or her duties and responsibilities. Such statement shall be submitted not later than six months after election and/or appointment, and shall be updated by the member as necessary to keep it current or as requested periodically by the Chairperson.

(b) If a member of the Council of Experts, Expert Committee, or ad hoc Advisory Panel fails to submit a conflict of interest statement, that member will not be allowed to participate in Expert Committee or ad hoc Advisory Panel deliberations.

(c) The USP Executive Secretariat shall be responsible for reviewing the conflict of interest statements. Where a question of conflict of interest arises, the USP Executive Secretariat shall work with the individual, and if necessary, the USP Secretary, to resolve the matter. If the matter cannot be resolved in this manner, the question shall be referred to the Executive Committee for resolution. The conflict shall be communicated to the chairperson of the affected Expert Committee or ad hoc Advisory Panel. Except as specified herein, the information provided in conflict of interest statements shall be kept confidential.

(a) Each member of the Council of Experts, the Expert Committees, and ad hoc Advisory Panels shall maintain the confidentiality of all information gained in the course of his or her activities as a Council of Experts, Expert Committee, or ad hoc Advisory Panel member, and shall not use or disclose such information for any purpose, unless such information is already publicly available. In case of doubt as to whether information is deemed confidential, the information shall be treated as confidential until otherwise indicated by the Executive Secretariat or USP Secretary.

(b)Prior to assuming office, each member of the Council of Experts, Expert Committee, or ad hoc Advisory Panel shall sign a confidentiality agreement with USP.

(c)If a member of the Council of Experts, Expert Committee, or ad hoc Advisory Panel fails to submit a confidentiality agreement, that member will not be allowed to participate in the Expert Committee or ad hoc Advisory Panel deliberations.

In accordance with Chapter III, Sections 1 through 9 of the Bylaws of USP, the Chairperson shall establish policies and workplans, assign responsibilities, and adjust tasks as needed for the Council of Experts and Expert Committees. The Chairperson shall chair all meetings of the Council of Experts and the Executive Committee. In the event of the temporary absence of the Chairperson, the Chief Science Officer or the Chairperson's designee shall act in his or her stead.

The Council of Experts shall be elected in accordance with Chapter VII, Section 1 of the Bylaws. In the event a member of the Council of Experts is unwilling or unable to serve, a new member shall be elected by the USP Convention membership.

The Council of Experts and its Expert Committees shall function to determine and approve official content of the official compendia and other authorized publications. The Council of Experts and its Expert Committees may be assigned additional tasks by the Chairperson with the advice of the Executive Committee.

The Executive Committee shall be appointed by the Chairperson pursuant to Chapter VII, Section 10 of the Bylaws. Unless sooner removed as provided herein, members of the Executive Committee shall serve a one year term and shall be eligible for re-appointment by the Chairperson. Members of the Executive Committee may be removed by the Chairperson at any time.

The Executive Committee shall have those duties and responsibilities set forth in Chapter VII of the Bylaws, and shall perform such functions as are specified herein.

If the Chairperson elects to organize the Council of Experts into divisions, a Division Executive Committee shall be appointed for each division in accordance with Chapter VII, Section 9 of the Bylaws. Such divisional organization may be modified during the period between elections by the Chairperson with the approval of the Board of Trustees.

The chairperson of each Division Executive Committee shall be appointed by the Chairperson, after consultation with the chairs of the Expert Committees in such Division, pursuant to Chapter VII, Section 9 of the Bylaws. A Division Executive Committee chairperson may be removed by the Chairperson at any time. In the event of an absence of the chairperson of a Division Executive Committee, the Chairperson or his or her designee shall act in his or her stead.

The number of individuals to be elected to an Expert Committee shall be determined by the Chairperson, after consultation with the chairperson of the Expert Committee. The Board of Trustees shall approve the number of persons to be elected to each Expert Committee, in accordance with Chapter VI, Section 29 of the Bylaws.

Members of each Expert Committee shall be elected by the chairpersons of the Expert Committees in the division in which the Expert Committee is placed. An individual may be elected to more than one Expert Committee. A chairperson of an Expert Committee may be elected to serve as a member of any other Expert Committee. In the event of a vacancy in an Expert Committee or if additional members are determined to be needed, such vacancy shall be filled or additional members added in accordance with this section.

Each Expert Committee shall elect a vice chairperson to serve in the temporary absence of the chairperson. In the event of a permanent vacancy of the chairperson's office, the vice chairperson shall serve as chairperson until a new chairperson can be elected by the Convention membership.

An Expert Committee shall serve and act until its successor committee is installed or until dissolved by the Chairperson. Each Expert Committee shall work within the areas determined by the Chairperson, as provided in Section 3 above.

Each Expert Committee, working with the Chairperson, shall conduct a periodic assessment of the Committee's effectiveness in fulfilling USP's program objectives.

The Chairperson or his or her designee shall appoint a staff member to act as Scientific Liaison for each Expert Committee. Scientific Liaisons, in concert with the Chairperson, shall be responsible for the assignment of tasks within the committees, subject to approval of the individuals to whom the tasks are assigned.

The Chairperson may form an ad hoc Advisory Panel in accordance with Chapter VII, Section 6 of the Bylaws to perform an assigned task for a particular Expert Committee or Expert Committees. The Chairperson shall appoint the members of the ad hoc Advisory Panel, who may be removed by the Chairperson at any time.

The Chairperson shall appoint the chairperson of an ad hoc Advisory Panel, who shall be a member of the Expert Committee to which the ad hoc Advisory Panel reports and who shall be responsible for communicating the panel's recommendations to the Expert Committee. The chairperson of an ad hoc Advisory Panel may be removed by the Chairperson at any time.

Joint Advisory Panels may be established in cooperation with other Expert Committees or organizations having interests in common with those of a particular Expert Committee. The Chairperson shall appoint the chairperson of a Joint Advisory Panel. Such chairperson may be removed by the Chairperson at any time.

The Chairperson may form a Multidisciplinary Coordinating Group in accordance with Chapter VII, Section 3 of the Bylaws.

A Multidisciplinary Coordinating Group shall continue until the election of a new Council of Experts or until dissolved by the Chairperson. The Chairperson shall coordinate the work of the Expert Committees within the Multidisciplinary Coordinating Group.

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.

With regard to the effort to harmonize the U.S. Pharmacopeia, the European Pharmacopoeia, and the Japanese Pharmacopoeia, any matter that has been agreed to by a designated representative of USP that deals with standardization of drugs or other articles or the development of information regarding the use of medicines or related articles must be approved by the respective Division Executive Committee and the 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 Chairperson and the Expert Committee that such modification is necessary in the interest of public health. In such case, the Chairperson shall notify the other body and provide the reasons for making such changes.

(a) A Request for Revision is a proposal to revise the USP–NF. The Council of Experts shall publish guidance 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 guidance.

(b) All Requests for Revisions 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.

(a) All proposed revisions to articles or the proposed addition of new articles shall be published in the Pharmacopeial Forum (PF) for public review and comment. Approval for publication in PF shall be in accordance with the following Revision Approval Process table:

Revision Approval Process

(b) 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 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. Such individuals shall review the comments and accept or reject them, and shall determine whether to proceed with the proposal.

(c) Any proposal published in PF for comment that does not evoke significant adverse comment or objection, or is not materially modified as a result of the comments received, need not be reprinted in PF in final form prior to publication in the USP or the NF. Where a proposal is published in the USP or the NF without such reprinting, such publication may be accompanied by a summary or abstract of each type of comment received and a response to the comment from the Expert Committee, Division Executive Committee, or Chairperson.

(d) Where a proposal published in PF has been materially modified, it shall be reprinted for comment in PF unless otherwise determined by the Chairperson for good cause. Such publication shall be accompanied by a summary or abstract of each type of comment received and a response to the comment from the Expert Committee, the Division Executive Committee, or the Chairperson.

(a) Prior to publication in the USP or NF, proposals must be balloted on and approved by the appropriate Expert Committee. A record of the proposal in PF, the evaluation and approvals for the item, public comments, and initial request will be provided to the Expert Committee not less than twenty (20) business days prior to the end of the ballot period.

(b) 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, which shall not be less than the twenty (20) business day period provided for herein. The results of voting shall be reported back to the Expert Committee and such report may include the substance of comments received.

(c) 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) When more than one Expert Committee collaborates on a particular topic, one Expert Committee shall be designated by the Chairperson as the lead Expert Committee and will be responsible for approvals. The other collaborating Expert Committee(s) shall be notified of the approval.

(a) 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.

(b) A request for postponement received within thirty (30) days of the official date may be refused by the 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. Where postponement is not granted, the matter will be considered as a Request for Revision.

(c) The Expert Committee responsible for approving the monograph or monograph revision for which postponement is sought shall have the authority to postpone the official date of any requirement or textual material in such monograph or monograph revision; provided, however, that all postponements shall be reviewed and approved by the Chairperson, who may at his or her option refer the matter to the Executive Committee for its consideration.

(d) 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 standard 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.

(a) 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 requirement or material should become official as scheduled, or whether the matter should be considered as a Request for Revision.

(b) 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 requirement or textual material, shall be published as quickly as possible with an official date assigned to it. Parties that are deemed to be affected by this decision may also be notified.

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

(b) 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. Failure of the Council of Experts to take action on a Request for Revision may properly be appealed at any time.

(c) 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) All appeals of decisions made by an Expert Committee shall be submitted to the 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) If an appeal of a decision made by an Expert Committee is granted, the 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 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) 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) 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.

Stakeholder Forums and Project Teams may be formed by the Chairperson in accordance with Chapter III, Section 9 of the Bylaws. The Chairperson shall appoint the members of all Stakeholder Forums and Project Teams and shall have the right to remove any member at any time.

Stakeholder Forum and Project Team members serve as representatives of a particular interest, group and/or company and not as representatives of USP. Members of the Board of Trustees, Council of Experts, and Expert Committees may participate in Stakeholder Forum and Project Team discussions, but only as representatives of USP.

Stakeholder Forum and Project Team deliberations are advisory and are not binding in any way on the Council of Experts, its Expert Committees, or USP staff.

When attending a meeting, Stakeholder Forum and Project Team members' travel and accommodation arrangements and costs are the responsibility of the individual Stakeholder Forum or Project Team member, unless otherwise indicated by USP.

a) Stakeholder Forums shall be formed to enable an exchange of information and perspectives between USP and the affected public, with the ultimate goal of improving USP standards and information.

(b) The decision to form a Stakeholder Forum will be made by the Chairperson, with input from the Council of Experts. When establishing a Stakeholder Forum, the Chairperson shall develop a specific charge for the Stakeholder Forum, including goals and expected outcomes. Stakeholder Forums will continue until dissolved by the Chairperson.

(c) Membership of Stakeholder Forums will consist of organizations that may be affected by USP actions and who, in turn, might affect USP activities. Member organizations may be drawn from the USP Convention membership and elsewhere depending on the topic being considered. Each member organization may appoint up to six representatives to attend a Stakeholder Forum meeting.

(d) The Stakeholder Forum members, with the advice and consent of the Chairperson, will select the chairperson(s) of such Stakeholder Forum. Subsequent rotation of chairperson(s) of a Stakeholder Form is at the Stakeholder Forum's discretion. The chairperson(s) of a Stakeholder Forum leadership shall work with USP staff to create agendas for each meeting, and may elect to create a planning committee to manage that activity. The chairperson(s) will preside over the Stakeholder Forum meetings.

(e) Stakeholder Forum meeting dates and times will be posted on the USP website and are open to attendance by other interested individuals who may attend as observers. Meeting notes will be prepared by USP staff, endorsed by the Stakeholder Forum chairperson, and distributed and posted on the USP website. Recommended action items will be considered by USP after each Stakeholder Forum. Those accepted by USP will be tracked and progress reported at each Stakeholder Forum meeting.

(f) Summary reports of a Stakeholder Forum will be prepared at least annually and presented to the USP Executive Committee for review and comment. After this presentation, at the discretion of the Chairperson, further reports may be provided to USP's Board of Trustees, Convention or Council of the Convention. USP will respond to the issues in writing, in a timely fashion.

(a) Project Teams will be formed to enable stakeholders with a specific technical or scientific expertise to provide information, perspectives, advice, and assistance to the Council of Experts, its Expert Committees, and USP staff on a particular topic or set of topics, with the goal of improving USP standards and information. Project Teams will function under a particular Stakeholder Forum and generally will be advisory to a particular Expert Committee.

(b) Project Teams generally shall be formed to address a specific compendial topic. The formation of a Project Team may be recommended by the members of a Stakeholder Forum or by the Chairperson. When forming a Project Team, the Chairperson shall develop a specific charge for the Project Team, including goals and expected outcomes. Project Teams will continue until dissolved by the Chairperson.

(c) Members of Project Teams shall be appointed by the Chairperson, with input from the related Stakeholder Forum, based on their scientific or technical expertise. The membership shall be primarily organization-based, reflecting the composition of the related Stakeholder Forum. The Chairperson shall determine the appropriate number and type of representatives on the Project Team.

(d) The Chairperson will select the chairperson of each new Project Team. Subsequent rotation of chairpersons of a Project Team is at the Project Team's discretion, with the review and consent by the Chairperson. The chairperson shall preside over the Project Team meeting.

(e) Meetings will occur as needed, and may be face-to-face or via teleconference or webcast. Meeting notes will be prepared by USP staff, endorsed by Project Team chairperson, and posted on the USP website. Action items will be tracked and reported at each subsequent Project Team meeting.

(f) Project Teams are encouraged to report progress to the appropriate Expert Committee and Stakeholder Forum. The Project Team, on its conclusion, shall prepare a final report with conclusions and recommendations based on its findings. The relevant Expert Committee, with the assistance of USP staff, will respond to the issues, in writing, as appropriate and necessary.

(a) A meeting of an Expert Committee or ad hoc Advisory Panel shall be open to the public, except that a meeting or a portion of a meeting may be closed if the chairperson of the Expert Committee or ad hoc Advisory Panel and the Chairperson determine that there is good and sufficient reason for closure. Such reasons may include, without limitation: review or discussion of trade secret or confidential, commercial information; or review or discussion of matters the premature disclosure of which could be detrimental to the USP.

(b) An Expert Committee or ad hoc Advisory Panel may hold a meeting by means of a conference telephone call, computer technology, or other communications equipment by means of which all persons participating in the meeting shall hear one another or perceive each other's comments in the same period of time. Participation by such means shall constitute presence in person at a meeting. A meeting held by means of a telephone conference call, computer technology, or other communications equipment shall provide an opportunity for public listening, viewing, and comment unless the meeting is closed as provided above.

Meetings of the Division Executive Committee and the Executive Committee shall be closed unless otherwise indicated.

To the extent possible, all USP open meetings shall be announced beforehand by appropriate means, which shall include the USP website. Summaries of open meetings shall be approved by the chairperson of the body who met and published on the USP website.

When a USP meeting is open to the public, a non-Expert Committee member may participate in one of two ways:

(a) Invited guests are non-members who are invited specifically to share a particular expertise or express their particular point of view. This shall be carried out under the control of the chairperson of the Expert Committee and shall be subject to the Rules and Procedures of the Council of Experts. These non-members shall be provided with appropriate briefing materials, excluding confidential information. The Expert Committee chairperson shall ask the invited guest to be excused during a confidential discussion or deliberation.

(b) Observers are non-members who themselves choose to attend the Expert Committee meeting. Observers must notify the Scientific Liaison at least five days in advance of the meeting of their proposed attendance, and provide necessary background information about themselves. Observers may or may not receive briefing materials. USP retains the right to refuse allowing the Observer to attend the meeting. The Expert Committee chairperson shall ask the observer to be excused during a confidential discussion or deliberation.

Two or more members of an Expert Committee may engage in informal dialogue and working sessions as part of their committee work, and an Expert Committee may hold informal teleconferences to discuss the status of work being performed by committee members, without the need to call or conduct a formal meeting of the Expert Committee as provided herein. Notes shall be taken at status conferences by the Scientific Liaison. Notwithstanding the foregoing, any decision on any substantive issue shall be made by an Expert Committee only at a meeting called and conducted in accordance with the provisions of Sections 12.01 through 12.04 above.