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Constitution and Bylaws

Bylaws

Chapter VII—The Council of Experts and the Executive Committee of the Council

Section 1

The Council of Experts shall be composed of appropriately qualified individuals, elected by the Convention primarily from those nations that utilize the USP–NF as their official compendia, together with the Executive Vice President-CEO, ex officio. The members of the Council of Experts shall be elected at the stated meeting or by mail or electronic ballot between meetings by a plurality of the votes cast by the members of the Pharmacopeial Convention as provided in these Bylaws.

Section 2

(a) The Executive Vice President-CEO shall be Chairperson of the Council of Experts and of the Executive Committee of the Council. In this Chapter, the terms "Executive Vice President-CEO" and "Chairperson of the Council of Experts" may be used interchangeably.

(b) After a stated meeting, the Council of Experts may be organized by the Executive Vice President- CEO with the approval of the Board of Trustees into appropriate divisions, taking into consideration, among other things, the distinctiveness of the scope of work, the number of committees that would comprise a division, and efficiencies in the work. The Executive Vice President-CEO shall, after consultation with the Executive Committee of the Council of Experts, establish the parameters within which a division shall operate.

(c) All references to divisions or Division Executive Committees throughout the Bylaws presume that the Executive Vice President-CEO shall have divided the Council of Experts according to the provisions of this section. Such references shall not have application to the extent the Council of Experts is not so divided.

Section 3

Two or more Expert Committees from different divisions may be organized by the Chairperson of the Council of Experts, after consultation with the Executive Committee, into multidisciplinary coordinating groups based on similarities of technology or other scientific reason.

The Chairperson of the Council of Experts, shall coordinate the work of the Expert Committees within the multidisciplinary coordinating group.

Where a multidisciplinary coordinating group is formed, the chairpersons of the Expert Committees of the multidisciplinary coordinating group, shall act in lieu of a division executive committee to approve the decisions emanating from the multidisciplinary coordinating group.

Section 4

(a) Each elected member of the Council of Experts shall chair an Expert Committee. Each Expert Committee shall function until its successor committee is elected or until such date specified by the Chairperson of the Council of Experts.

(b) To become effective at the stated meeting in 2010, a chair of an Expert Committee shall be ineligible to hold the same office for more than two consecutive terms. A member of the Council of Experts who has served as a chair of an Expert Committee for two consecutive terms may be nominated for re-election to the Council of Experts only if he or she stands for election as Chair to a different expert committee of the Council of Experts (it shall not be permissible to stand for election as Chair of an Expert Committee if that Committee has been re-named).

Section 5

(a) Each Expert Committee shall be composed of individuals elected by the chairs of the Expert Committees within the division or divisions in which the committee is placed. Individuals eligible for election to an Expert Committee shall be nominated by a committee composed of the President, the Vice Chairperson of the Nominating Committee for the Council of Experts, the Chairperson of the Council of Experts and the Chair of the Expert Committee. This Nominating Committee for Expert Committees shall, to the extent practical and necessary, select two nominees for each Expert Committee position from the names of qualified experts submitted to it by the Nominating Committee for the Council of Experts.

(b) The immediate past chair of an Expert Committee shall be a member of the said Expert Committee without the requirement of nomination and election unless he or she shall stand for re-election to the Council of Experts.

Section 6

Upon request of the Chairperson of an Expert Committee, or upon his or her own initiative, the Chairperson of the Council of Experts may appoint an ad hoc Advisory Panel. Such ad hoc Advisory Panel shall be chaired by a member of the Expert Committee to which it reports. The scope of work of the ad hoc Advisory Panel shall be clearly defined and the panel terminated upon completion of its task.

Section 7

No person who, during his or her service on an Expert Committee, 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. Except for the Executive Vice President-CEO, no member of the Committee shall receive compensation for his or her services, unless authorized by the Board of Trustees. Members of the Committee shall be reimbursed from the funds of the Pharmacopeial Convention for travel and other necessary expenses that may be incurred by them in the performance of their duties.

Section 8

During the period between stated meetings additional members may be added to the Council of Experts if the Board of Trustees, with the advice of the Executive Vice President-CEO, Council of Experts or Executive Committee, determines that such a need exists. The Nominating Committee for the Council of Experts shall nominate twice the number of qualified persons, from among whom the Convention members shall elect the additional Council members. Such election may be by mail and/or electronic ballot.

Section 9

The Chairperson of the Council of Experts shall appoint a division executive committee chairperson, after consultation with the chairs of the Expert Committees in such division, if the Council of Experts is divided into divisions as provided for in Section 2 of this Chapter. A Division Executive Committee shall be appointed by the Chairperson of that division from among the chairpersons of the Expert Committees within that division with the advice and consent of the Chairpersons in that division. A vacancy in a Division Executive Committee shall be filled by the Chairperson of the Division Executive Committee with the advice and consent of the Division Executive Committee.

Section 10

The Executive Committee of the Council of Experts shall be composed of not more than fifteen persons appointed by the Chairperson of the Council of Experts from among the members of the Council.

Section 11

The Council of Experts and the Executive Committee of the Council shall make such rules and adopt such procedures, not in conflict with the Constitution and Bylaws, as are sufficient to ensure the accuracy and adequacy of the content of the United States Pharmacopeia, the National Formulary, and other authorized publications, and to provide for adequate notice and opportunity for public comment and full and impartial consideration of all proposed changes in, and additions to, the content, as may be necessary to the proper discharge of their respective functions. Each Division and Expert Committee may make rules and adopt procedures for its operation, provided such rules and procedures are consistent with those of the Council of Experts. Prior to adoption, the proposed rules and procedures of the Council of Experts shall be made available to the members of the Pharmacopeial Convention for comment. The Committees shall submit the proposed rules and procedures so made for review by the Board and shall comment upon any proposals made by the latter pursuant to such review.

Section 12

The Chairperson of the Council of Experts shall, after consultation with the Division Executive Committees, determine the boundaries for the content of decisions made within the division, based on parameters established by the Executive Committee of the Council of Experts. Each Expert Committee shall function as a scientific decision-making body regarding the content of United States Pharmacopeia, National Formulary, and other authorized publications, having regard for the principles laid down by the Pharmacopeial Convention at its last meeting.

Section 13

The Council of Experts, through the Executive Vice President-CEO, shall present a report at the stated meeting of the Pharmacopeial Convention.

Section 14

Each Expert Committee shall elect a vice chairperson. In the event of a vacancy in the chair the vice chairperson shall become the acting chair until a new member of the Council of Experts is elected. In the event the vice chairperson cannot serve, the Executive Vice President-CEO shall appoint an acting chairperson until a new chairperson is elected.

Section 15

The Executive Committee of the Council of Experts, and the Division Executive Committees shall consult with the Executive Vice President-CEO on matters of general policy concerning the planning and executing of the United States Pharmacopeia, the National Formulary, and other authorized publications and of supplements thereto. The Executive Committee shall determine the proper placement of text within the publications of the Convention. The respective Division Executive Committees shall determine in their published rules and procedures the process by which decision making shall take place and be reviewed within that division. The respective Division Executive Committee shall authorize that appropriate notice and opportunity for public comment be given to all such proposals prior to their final approval and shall consider suggestions for changes contained in the comments received.

Section 16

The Executive Committee of the Council of Experts shall receive and rule upon all appeals for reconsideration, revision, or abrogation of standards adopted and decisions made by a Division Executive Committee or other Council body. Each decision of the Executive Committee on such appeals shall be referred to the Board of Trustees. If the Board of Trustees determines the appeal is one of a matter of procedure, the Board may uphold the decision or remand it to the responsible body for reconsideration under proper procedures. If the matter on appeal is determined to be a scientific matter, the Board of Trustees may uphold the decision or remand it for review and vote by the full membership of the Council of Experts. After such review, which shall be given as promptly as practicable, the Council of Experts may uphold or reverse the Executive Committee's decision by a majority vote of the members voting.

Section 17

At least one year before the stated meeting of the Pharmacopeial Convention, the Executive Committee of the Council of Experts or the Division Executive Committees of the Council of Experts (if any) shall, at the request of the Chairperson of the Council of Experts, determine, prepare, and publish an outline of the number and types of Expert Committees deemed necessary for the efficient prosecution of the work of the next United States Pharmacopeia, the National Formulary, and other authorized publications. For scientific areas not currently encompassed by the present expert committees, the Chairperson of the Council of Experts shall consult with the Executive Committee of the Council and the Board of Trustees to determine the number and types of Expert Committees needed. Upon approval of the Board of Trustees, these determinations shall be followed in submitting to the Nominating Committee for the Council of Experts the names of persons to be considered for membership on the Council of Experts that is to be elected at the forthcoming stated meeting of the Pharmacopeial Convention.

Section 18

The Executive Committee of the Council of Experts may recommend to the Board of Trustees the removal, for cause, of any member of the Council of Experts or an Expert Committee.