The corporate name of this corporation shall be “The United States Pharmacopoeial Convention,”hereinafter referred to in this Constitution as the Pharmacopeial Convention.

The alternative spelling,“Pharmacopeial,”also shall be considered as official.

Its objects shall be those declared in its Certificate of Incorporation,and include (a)the revision and publication of the information contained in the Pharmacopeia of the United States of Americaand the National Formulary,also referred to as the United States Pharmacopeiaand as the USPand as the NF,respectively,and of the Supplementsthereto;(b)the establishment and dissemination of authoritative information for publication in the USP Drug Information (USP DI®)and elsewhere for the use of medicines and articles used in health care or for the improvement or maintenance of health by health care professionals,patients,and consumers;and (c)the publication regularly or at suitable times of other information of related scientific purpose.The term authorized shall be applied to such information when it has been prepared in accordance with the rules and procedures adopted by the Council of Experts,or otherwise by direction of the Board of Trustees.

The Pharmacopeia of the United States of Americaand the National Formulary,together with their Supplements,are compilations prepared under the authority of the Pharmacopeial Convention;they are prepared and regularly revised entirely or in part by a committee or committees of experts in medicine,pharmacy and other health care professional and scientific disciplines and other appropriately qualified individuals,chaired by elected members of the Council of Experts;their primary purpose is to provide authoritative standards and specifications for materials and substances and their preparations that are used in health care or for the improvement or maintenance of health;they establish titles,definitions,descriptions,and standards for identity,quality,strength,purity,packaging,and labeling,and also,where practicable,bioavailability,stability,procedures for proper handling,storage,and shipment,methods for their examination,and formulas for their manufacture or preparation.

The USP Drug Information (USP DI®),is a compilation of authoritative information,reviewed or prepared and regularly revised,entirely or in part,by committees chaired by elected members of the Council of Experts.Its primary purpose is to provide authoritative information relating to the use of articles that are used in health care or for the improvement or maintenance of health.

The members of the Pharmacopeial Convention shall consist of:accredited delegates representing the following educational institutions,professional and scientific organizations,and designated divisions of the federal government,hereafter designated as eligible organizations,and others as herein provided.

In this Constitution and Bylaws “state”or “United States”includes each of the several states,the District of Columbia,the Commonwealth of Puerto Rico,and all territorial possessions of the United States of America.

(a)Colleges and schools of medicine in the United States with programs accredited by the Liaison Committee on Medical Education sponsored by the Association of American Medical Colleges and by the Council on Medical Education of the American Medical Association;colleges and schools of pharmacy in the United States with programs accredited by the American Council on Pharmaceutical Education;state medical associations or state medical societies,which are constituents of the American Medical Association;and state pharmaceutical associations or state pharmaceutical societies,which are entitled to voting delegates in the House of Delegates of the American Pharmaceutical Association.

(b)Not more than seventy-five national and state professional and scientific organizations or sections thereof,designated by the Board of Trustees as eligible to appoint a delegate.The following national and state professional and scientific organizations shall be so designated:The American Association of Pharmaceutical Scientists;the American Chemical Society;the American Dental Association;the American Medical Association;the American Nurses Association;the American Pharmaceutical Association;the American Society for Clinical Pharmacology and Therapeutics;the American Society of Health-System Pharmacists;the American Society for Pharmacology and Experimental Therapeutics;the American Society for Quality;the American Society of Consultant Pharmacists;the American Veterinary Medical Association;the Association of Food and Drug Officials;the AOAC International;the Drug Information Association;the National Association of Boards of Pharmacy;the National Community Pharmacists Association;or the successors thereto.

(c)Not more than twenty governmental bodies or divisions thereof,designated by the Board of Trustees as eligible to appoint a delegate.The following governmental bodies shall be so designated:The Department of Veterans Affairs,Veterans Health Administration;the Food and Drug Administration;the Health Care Financing Administration;the National Institute of Standards and Technology;the Office of the Surgeon General,the Bureau of Medicine and Surgery,United States Navy;the Office of the Surgeon General,United States Air Force;the Office of the Surgeon General,United States Army;the Office of the Surgeon General,United States Public Health Service;and,the Office of the Secretary of the Department of Health and Human Services;or the successors thereto.

(d)Not more than five governmental bodies designated by the Board of Trustees as eligible to appoint a delegate to represent nations,other than the United States,that give official recognition to the standards of the USPor the NFor the USP DI.

(e)Not more than twenty-five organizations designated by the Board of Trustees as eligible to appoint a delegate to represent organizations representing the health sciences in other nations,international health,scientific,or professional organizations or other pharmacopeial bodies.

(f)Not more than twenty-five domestic or international consumer organizations designated as eligible to appoint a delegate or individuals representing the public interest designated by the Board of Trustees to serve as public members also shall be members of the Pharmacopeial Convention.

(g)The Officers,the Board of Trustees,and the Chairpersons of Committees directed to report at a stated meeting,serving by authority of the preceding stated Pharmacopeial Convention or the Constitution and Bylaws,also shall be members,ex officio,of the Pharmacopeial Convention.

(h)Not more than twenty-five members-at-large,selected by the Board of Trustees for their special competence in relation to the administrative or scientific needs of the Pharmacopeial Convention.

(i)Not more than twenty-five organizations or divisions thereof,either domestic,international,or from other nations,designated by the Board of Trustees as eligible to appoint a delegate to represent manufacturers,trade,and affiliated associations.The following organizations shall be so designated:the American Hospital Association;the Animal Health Institute;Chemical Manufacturers Association;Consumer Healthcare Products Association;Cosmetic,Toiletry and Fragrance Association;Council for Responsible Nutrition;Generic Pharmaceutical Industry Association;Health Industry Manufacturers Association;National Association of Chain Drug Stores;National Pharmaceutical Alliance;National Wholesale Druggists Association;Parenteral Drug Association;the Pharmaceutical Research and Manufacturers of America.

(j)Nominees for elective offices,selected in accordance with Chapter IX,Sections 2and 3,of the Bylaws,shall be members of the Pharmacopeial Convention for the stated meeting when their names are presented as nominees in accordance with Chapter IV,Section 1(g),of the Bylaws,whether present or not.

In designating those organizations or governmental bodies or divisions or sections thereof as eligible to appoint a delegate to the USP Convention,the Board of Trustees shall consider the membership guidelines provided by the Convention at the previous stated meeting.Such designation of organizations,governmental bodies,or divisions or sections thereof by the Board of Trustees shall be announced not later than ninety (90)days following the adjournment of a stated meeting and shall indicate the date upon which such designation shall become effective;such effective date to be not less than sixty (60)days following the announcement of the initial designation.Thereafter,the Board shall at least annually review the composition of the Convention and designate any additional organizations,governmental bodies,or divisions or sections thereof as deemed necessary.

Each eligible organization entitled to representation in the Pharmacopeial Convention,as provided for in Article II,Section 1,of this Constitution shall elect or appoint in such manner as it may determine,one delegate and one alternate delegate.One of these shall be accredited and seated as a member of the Pharmacopeial Convention,as provided in the Bylaws.

Each delegate and alternate delegate,at the time of his or her election or appointment,and each member of the Convention,during his or her membership,except those individuals named by the Board under Article II,Sections 1(f),(g),and (h),shall be an officer or a member of the academic staff of the educational institution;an officer,active member,or employee of the organization;or an employee of the division of the federal government that he or she represents.

Honorary Members.By unanimous vote the Board of Trustees may elect honorary members to the Convention in recognition of their distinguished contribution to drug standardization,drug information,the sciences of medicine and pharmacy,the public health,or other special contribution to the USP.Each honorary member shall have the rights,privileges,and duties prescribed by the Constitution and Bylaws and defined by the Board of Trustees except the right to vote,to hold office,or to otherwise determine the policy and administration of the Convention.

The officers of the Pharmacopeial Convention shall be a President,a Past President,a Treasurer,and an Executive Vice President and Chief Executive Officer (CEO).The President and the Treasurer,each shall be a member of the Pharmacopeial Convention at the time of their election and shall be elected by majority vote by ballot at each stated meeting.The President and the Treasurer shall be elected by ballot at each stated meeting.The Committee of Tellers shall report to the President the number of votes cast for each nominee,and the President shall announce to the Convention the winner(s)in each office or position without disclosing the number of votes cast or the number received by each nominee.However,any nominee may publicly or privately obtain this information with regard to his or her own election and the election of others seeking election to the same position or classification,and,in such event,to the degree it is necessary to do so in order that the Convention may rule upon the propriety of the election,the votes cast may be disclosed publicly.

The Executive Vice President-CEOshall be an employee of the Convention,selected and hired by the Board of Trustees.

Vacancies in these offices shall be filled as provided in the Bylaws.

The stated meetings of the Pharmacopeial Convention shall be held in the United States at five-year intervals.The Board of Trustees is authorized to determine the day within the year and the place of the meeting.

The President shall call a special meeting upon the written request of not fewer than sixty-five members of the Pharmacopeial Convention.

Every proposition to amend this Constitution,except as hereinafter provided,shall be submitted to the Board of Trustees in writing,subscribed to by at least five members of the Pharmacopeial Convention,not later than one hundred and twenty days prior to a stated or a special meeting and,after review by the Board,shall be submitted,together with the Board's recommendation,not later than sixty days prior to a stated or a special meeting of the Pharmacopeial Convention,to the medical,pharmaceutical,and scientific press,to those authorized to send delegates to the Pharmacopeial Convention,and to those persons who are authorized to attend the stated or a special meeting.Except as provided in Section 3,at the next ensuing meeting of the Pharmacopeial Convention,after the expiration of the said sixty days,upon receiving the affirmative votes of not less than three-fourths of the members present and voting,the proposition shall become a part of this Constitution.

An amendment also may be proposed in writing by ten or more members at any session of a stated meeting except the final session.Such amendment shall be referred to the Board of Trustees,which shall report upon it at the next succeeding session when,upon receiving the affirmative votes of not less than seven-eighths of the members present and voting,it shall become a part of this Constitution.

The Board of Trustees may at its discretion mail to the members of the Convention a proposition to amend or alter this Constitution.Aperiod of sixty days shall be allowed for the submission of comments on the proposition.Asummary of the comments shall accompany the mail ballot by which the vote of the member may be recorded and returned within ninety days of the date appearing on the ballot.Upon receiving the affirmative vote of seven-eighths of the members voting,with a total of not less than one hundred and thirty members voting,the proposition shall become a part of this Constitution.

The President shall preside at all meetings of The United States Pharmacopeial Convention,hereinafter referred to in these Bylaws as the Pharmacopeial Convention.In the absence of the President or in the event of his or her inability to preside,a President pro tempore,to be appointed by the Board of Trustees,shall conduct the meeting.

The presiding officer shall present an address at the stated meeting.

The presiding officer shall have the right to call a member to the chair in order that he or she may take the floor in debate.

Not later than six months before the stated meeting of the Pharmacopeial Convention,the President shall appoint,subject to the advice and consent of the Board of Trustees,five members of the Convention as a Nominating Committee for Officers and Trustees,two of whom shall be members of the Board of Trustees.Of the members appointed from the Board of Trustees,one shall be representative of the pharmaceutical sciences and one shall be representative of the medical sciences.

The President shall appoint,with the advice and consent of the Board of Trustees,ten members of the Convention to serve on the Nominating Committee for the Council of Experts,none of whom shall be members of the Council of Experts,Expert Committees,the Board of Trustees,salaried employees,nor officers of the Pharmacopeial Convention.

The President shall appoint all committees of the Convention not otherwise provided for in these Bylaws.

Not later than one year prior to the stated meeting of the Pharmacopeial Convention,the President,through the Secretary,shall mail a notice of the meeting to all members and a request to prepare for the authorization of a delegate where none has been appointed and an alternate delegate to each of those organizations eligible for representation under the Constitution.He or she shall mail a second notice of the meeting to all members and the request for the authorization of a delegate where none has been appointed and an alternate delegate not later than six months prior to the stated meeting.He or she shall also request medical,pharmaceutical,and other appropriate journals to publish the announcement of the said meeting.Following the designation of an organization by the Board of Trustees as eligible for representation,and at suitable intervals thereafter,the President,through the Secretary,may request by mail from such organization,authorization or reauthorization of a delegate and alternate delegate.

The President shall be a member,ex officio,of the Board of Trustees and of all committees except the Council of Experts and its Expert Committees.

The President shall serve for one elected term and act as President until his or her successor shall have been elected and installed.

In the event of a vacancy in the office of President,the Board of Trustees shall,from the membership of the Pharmacopeial Convention,select a President.

In the event of a temporary disability or absence of the President,or inability to perform his or her duties,an acting President may be appointed from the membership of the Pharmacopeial Convention by the Board of Trustees to act in the place of the President.

The Past President shall be the immediate past president.

The Past President shall be a member,ex officio,of the Board of Trustees.

In the event the immediate past president is unable to serve as Past President,the office shall remain vacant.

The Executive Vice President shall serve as the chief executive officer (CEO)of the Convention.The Executive Vice President-CEOshall be an ex officio,non-voting member of the Board of Trustees.The Executive Vice President-CEOshall function within the framework of the policies and programs as determined by the Board of Trustees.

The Executive Vice President-CEOshall be a member,ex officio,and Chairperson of the Council of Experts and of the Executive Committee of the Council of Experts.

The Executive Vice President-CEOshall organize the Council of Experts in accordance with Chapter VIIof these Bylaws.The Executive Vice President-CEOshall appoint any ad hoc advisory bodies required for the work of the Council.

The Executive Vice President-CEOshall have charge of the work and shall cause to be prepared the final text of the United States Pharmacopeia,the National Formulary,the USP DI,and other authorized publications,and any supplements thereto.

The Executive Vice President-CEO,the Executive Committee of the Council of Experts,and the Division Executive Committees shall consult on matters of general policy concerning the planning and executing of the United States Pharmacopeia,the National Formulary,USP DI,other authorized publications,and of supplements thereto.

The Executive Vice President-CEOshall annually or more frequently,upon request of the Board of Trustees,certify in writing to the Board of Trustees that a new United States Pharmacopeiaand new National Formulary,or a new Supplementor any change thereto,has been prepared in accordance with the rules and procedures of the Council of Experts.The Executive Vice President-CEOshall annually or more frequently,upon the request of the Board of Trustees,certify that the information contained in the USP DIhas been prepared in accordance with the rules and procedures of the Council of Experts.The Executive Vice President-CEOshall also certify in writing to the Board of Trustees that an authorized publication or its supplement has been completed in accordance with existing rules and procedures.

The Executive Vice President-CEOshall present an annual report to the Board of Trustees and also shall present a report of the Council of Experts at the stated meeting of the Pharmacopeial Convention.

In the event of a vacancy in the Chair of an Expert Committee,the vice chair shall serve in his or her absence.In the event the vice chair is unable to serve,the Executive Vice President-CEOshall appoint an acting Chairperson until a new Chairperson is elected.

The Executive Vice President-CEO,with the advice and consent of the Board of Trustees,may appoint advisory bodies to provide advice on policy matters.

The Executive Vice President-CEOshall serve at the will of the Board of Trustees.

The Secretary and General Counsel,hereinafter referred to as the Secretary,shall serve as Secretary of the Board of Trustees and the Convention.The Secretary shall act under the direction of the Executive Vice President-CEOand shall:

(a)Keep the minutes of each meeting of the Pharmacopeial Convention and receive all reports and other documents presented to the said meeting;

(b)Compile the proceedings of the stated and special meetings and submit them to the Board of Trustees and,upon its order,arrange for their publication;

(c)At each stated meeting of the Pharmacopeial Convention,present a summary of the minutes of the preceding stated meeting;

(d)Present to the Pharmacopeial Convention papers handed in for such purpose by the President;

(e)Record the ayes and nays when required;

(f)Notify the chairperson and other members of each committee of their appointment,giving each member the name of the chairperson of that committee and the names of the members and stating the business upon which the committee is to act;

(g)Immediately before the opening of the stated meeting of the Pharmacopeial Convention,post,in a conspicuous place in the meeting hall,the names of the Officers of the Pharmacopeial Convention,the members of the Board of Trustees,the members of the Council of Experts,and all members of the Expert Committees,the Chairpersons of Committees directed to report at the stated meeting,the persons selected by the Board of Trustees as members-at-large,the organizations designated as eligible organizations by the Board of Trustees,the persons selected by the Nominating Committee for Officers and Trustees as nominees for elected office,the delegates whose credentials have been approved by the Credentials Committee,and the order of business;

(h)During the stated meeting of the Pharmacopeial Convention,provide for each member two official ballots.One ballot shall contain the names of those nominated for President,and for Treasurer of the Pharmacopeial Convention,and for the eight elective memberships on the Board of Trustees.Asecond ballot shall contain the names of those nominated for the Council of Experts,classified according to the outline of the number and types of committees as provided in Chapter VII,Section 17,of these Bylaws;

(i)Deliver all reports,papers,and other documents of the Pharmacopeial Convention to the Board of Trustees;

(j)Issue such notices,announcements,and requests as provided for in Chapter I,Section 7,of these Bylaws,together with credential forms,and also mail the notices of special meetings as provided in Chapter XIII,Section 1,of these Bylaws;

(k)Submit to the Nominating Committee for the Council of Experts,not later than ninety days prior to the stated meeting of the Pharmacopeial Convention,all recommendations that have been submitted for membership on the Council of Experts;

(l)Acknowledge in writing the receipt of all resignations of membership of the Convention and report them to the Board of Trustees;

(m)Serve as Secretary of all committees of the Convention appointed by the President.

In the absence of the Secretary or in the event of his or her inability to serve as Secretary,the Chairperson of the Board of Trustees shall appoint an acting Secretary.

The Treasurer shall oversee the receipt of all moneys coming from any source to the Pharmacopeial Convention and shall ensure that the payment of moneys is made only on the authorization of and in accordance with the procedures adopted by the Board of Trustees.

The Treasurer shall present annually to the Board of Trustees an audited financial statement.The Treasurer shall present at the stated meeting of the Pharmacopeial Convention a complete financial statement for the period since the preceding stated meeting.

The Treasurer shall be a member,ex officio,of the Board of Trustees.

During any temporary disability or absence of the Treasurer,an Acting Treasurer may be appointed by the Board of Trustees to serve in place of the Treasurer.

The Treasurer shall act as Treasurer until his or her successor shall have been elected and installed.

No person shall be eligible for election as Treasurer if,at the adjournment of the stated meeting,he or she shall have served two successive elected terms as Treasurer.

Avacancy in the office of Treasurer shall be filled by the Board of Trustees from the membership of the Convention.

The Board of Trustees shall consist of eight members of the Pharmacopeial Convention elected by plurality vote at the stated meeting;and the President,the Past President,and the Treasurer,ex officio,and the Executive Vice President-CEO,who shall serve as a non-voting,ex officiomember of the Board of Trustees.

Of the eight members of the Board of Trustees elected by the Convention,two shall be representative of the pharmaceutical sciences,two shall be representative of the medical sciences,one shall be a public member,and three shall serve without restriction concerning their affiliation.

Except for the Executive Vice President-CEO,the members of the Board of Trustees shall not be members of the Council of Experts or its Expert Committees.

No person shall be eligible to be an elected member of the Board of Trustees who,at the adjournment of the stated meeting,shall have served two successive terms either as an elected member of the Board of Trustees or as an elected officer.

The officers of the Board of Trustees shall consist of a Chairperson,who shall be elected by a majority vote of the Board,and a Secretary.The Chairperson of the Board of Trustees shall serve as a member,ex officio,of the Membership Committee.The Secretary of the Board of Trustees need not be a member of the Board of Trustees or a member of the Pharmacopeial Convention.The Secretary of the Board of Trustees shall serve as Secretary of the Convention.

The Board of Trustees shall have the right to transact business by correspondence,including electronic or other means,as provided in the rules adopted by them.Amotion by such means shall require no second.

The Board of Trustees shall meet annually at such time and place as it shall determine.Special meetings of the Board of Trustees shall be called upon the written request of at least four members.The Chairperson shall have the right to call a special meeting whenever he or she shall deem it necessary.Six voting members of the Board of Trustees shall constitute a quorum.

Members of the Board of Trustees may participate in a special meeting of such Board by means of a telephone conference or similar communications equipment by means of which all persons participating in the meeting can hear each other or perceive each other's comments at the same time,and participation by such means shall constitute presence in person at a meeting.Such meetings shall be conducted in accordance with rules adopted by the Board of Trustees.

No member of the Board of Trustees elected by the Convention members shall receive compensation for his or her services.Members of the Board of Trustees elected by the Convention members 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.

No person,who during his or her service on the Board,has a financial interest that may conflict or may appear to conflict,with his or her duties and responsibilities,shall vote on matters,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.

The Board of Trustees shall manage and control the affairs,funds,and property of the Pharmacopeial Convention,except as is herein otherwise provided.

The Board of Trustees may invest the funds of the Pharmacopeial Convention,authorize the payment of all moneys due for services performed,transact business involving financial or other matters that may be for the best interests of the Pharmacopeial Convention,and perform such other duties as the Pharmacopeial Convention may direct.Any and all contracts or agreements authorized by the Pharmacopeial Convention or by the Board of Trustees shall be executed on behalf of the Pharmacopeial Convention by the Chairperson and Executive Vice President-CEO,or by such other person or persons as the Board may designate.

The Board of Trustees shall authorize the revision and release of text to the United States Pharmacopeiaand the National Formulary.Upon approval of the content by the Council of Experts,in accordance with the rules and procedures adopted under Section 9,the Board of Trustees shall then act upon releasing the text and upon designating the date when it is to become official,said date to be reasonably distant from the date of its release.The Executive Vice President-CEOshall,annually or more frequently,upon specific request of the Board of Trustees,certify that the information contained in the United States Pharmacopeia,National Formulary,USP DIor other authorized publications has been prepared in accordance with the rules and procedures under Section 9.

The Board of Trustees shall review all rules and procedures made or adopted by the Council of Experts and the Executive Committee of the Council and shall determine whether the rules and procedures conflict with the Constitution and Bylaws and whether they are sufficient to ensure the accuracy and adequacy of the content of the United States Pharmacopeia,the National Formulary,the USP DIand other authorized publications.The Board shall determine whether such rules and procedures shall be sufficient to provide adequate notice and opportunity for comment and full and impartial consideration of all proposed changes in,and additions to,the text.Where such conflict or insufficiency is found,the Board shall propose such amendments as may be indicated and,after having given the Council of Experts and the Executive Committee of the Council an opportunity to be heard,shall revise or modify the rules and procedures to bring about conformity with the Constitution and Bylaws and to ensure their sufficiency.The Board of Trustees shall arrange for suitable publication of the rules and procedures of the Council of Experts.

The Board of Trustees shall be informed of the decisions of the Executive Committee of the Council on appeals for reconsideration,revision,or abrogation of standards adopted and decisions made by a committee of the Council of Experts,Division Executive Committee,or other body.Upon consideration of the facts,where an appeal is determined by the Board to be on a matter of procedure,the Board may uphold the decision or remand the matter to the proper body for reconsideration under proper procedures;where the appeal is determined by the Board to be on a scientific matter,the Board may uphold the decision or may request the entire Council of Experts to review the decision.

Upon recommendation of the Executive Committee of the Council of Experts,the Board of Trustees may remove any member of the Council of Experts for cause.

The Board of Trustees shall issue an annual financial report of the Pharmacopeial Convention audited by a certified public accountant.

The Board of Trustees shall arrange for the bonding of Officers and employees to the extent necessary to protect the interests of the Pharmacopeial Convention.

The Pharmacopeial Convention may indemnify a current or former Trustee,Officer,Council of Experts or Expert Committee Member,Panelist,or employee against expenses,judgments,fines,penalties and settlements in connection with or arising out of any proceeding in which that person may be involved as a party or otherwise by reason of his/her having been such Officer,Trustee,Council of Experts or Expert Committee Member,Panelist,or employee.Such indemnification may be made only in accordance with the procedures adopted by the Board of Trustees.

The Board of Trustees shall maintain a headquarters for conducting the business of the Pharmacopeial Convention.

The Executive Vice President-CEOshall serve at the will of the Board of Trustees.In case of a vacancy in the position of Executive Vice President-CEO,the Chairperson of the Board of Trustees shall appoint an acting Executive Vice President-CEO,who shall serve until the Board of Trustees shall have selected an Executive Vice President-CEO.The Board of Trustees may request the advice of the Division Executive Committees and the Executive Committee of the Council of Experts before selecting an Executive Vice President-CEO.

The Board of Trustees shall provide for such assistants to the Executive Vice President-CEOas may be deemed necessary.

The Board of Trustees may select not more than twenty-five persons for their special competence in relation to the administrative or scientific needs of the Pharmacopeia to be members-at-large of the current or ensuing Pharmacopeial Convention.

The Board of Trustees shall designate those organizations,governmental bodies or divisions,or sections thereof as eligible to appoint a delegate.Such initial designation shall be announced not later than ninety (90)days following the adjournment of a stated meeting and shall indicate the date upon which the designations shall become effective;such effective date to be not less than sixty (60)days following the date of the initial announcement.In making such designations,the Board of Trustees shall consider the membership guidelines provided by the Convention at the previous stated meeting.Thereafter,the Board of Trustees shall at least annually review the composition of the Convention and designate any additional organizations,governmental bodies,or divisions or sections thereof as deemed necessary.

The Board of Trustees may invite the national medical,pharmaceutical and other health care professional and scientific associations of other nations to send representatives as observers to a stated meeting of the Pharmacopeial Convention.

The Chairperson of the Board of Trustees shall present a report for the Board at each stated meeting of the Pharmacopeial Convention.

The Board of Trustees shall receive from the Secretary and General Counsel proceedings of the stated and special meetings of the Pharmacopeial Convention and shall arrange for their publication.

The Board of Trustees shall receive and review any proposition to amend the Constitution and Bylaws and shall recommend such action as it deems advisable as provided in the Constitution and Bylaws.

The Board of Trustees shall fill vacancies for unexpired terms of office of the eight elected members of the Board of Trustees;the President,and the Treasurer;from the membership of the Pharmacopeial Convention;and the Executive Vice President-CEOas herein provided.

Any officer or member of the Board of Trustees may be removed for cause by an affirmative vote of not less than two-thirds of the members of the Board,other than himself or herself.

The Board of Trustees shall approve the number and types of expert committees prepared by the Division Executive Committees of the Council of Experts and deemed necessary for the work of the Council of Experts in preparing the United States Pharmacopeia,the National Formulary,the USP DIand other authorized publications.

The Board of Trustees may provide advice to the Nominating Committee on factors to be considered during the selection of candidates,so as to achieve appropriate balance and diversity.

In the event it is determined that expertise is needed,which is not encompassed by existing divisions,the Chairperson of the Council of Experts,in consultation with,and with the approval of the Executive Committee and the Board of Trustees,shall determine the additional number and types of Expert Committees needed.

The Board of Trustees shall approve the number of persons to be elected to each Expert Committee.

Between stated meetings of the Pharmacopeial Convention,the Board of Trustees may,at its discretion,send the members of the Convention a proposal to be voted on.On any such vote,not less than one hundred and thirty members shall cast a ballot to constitute a valid action and a majority of those voting shall determine the action.The Board of Trustees shall promulgate rules to ensure adequate opportunity for comment,fairness,and confidentiality.

The Board of Trustees may designate representatives to other organizations to represent the USP Convention;it may allow the USP Convention,as an organization,to participate in other organizations.

The Board of Trustees shall adopt rules and procedures to govern its management of the affairs,funds,and property of the Pharmacopeial Convention and any conflict of interest of its members.Such rules and procedures shall be made available to members of the Convention and the public.

The Council of Experts shall be composed of appropriately qualified individuals,elected by the Convention primarily from those nations that utilize the USP–NFas 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.

The Executive Vice President-CEOshall be Chairperson of the Council of Experts and of the Executive Committee of the Council.

After a stated meeting,the Council of Experts shall be organized by the Executive Vice President-CEOwith 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 Committee of the Council of Experts shall establish the parameters within which a division shall operate.

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

The Chairpersons of the Expert Committees in the multidisciplinary coordinating group,along with 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.

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.

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.

Upon request of the Chairperson of an Expert Committee,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.

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.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.

During the period between stated meetings additional members may be added to the Council of Experts if the Board of Trustees,based on the advice of the Council of Experts and its 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.

The chairs of the Expert Committees in a division shall elect a division executive committee chairperson.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.Avacancy 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.

The Executive Committee of the Council of Experts shall be composed of the chairs of each Division Executive Committee and twice that number of at-large members appointed by the Chairperson of the Council of Experts from among the members of the Council with the advice and consent of the Division Executive Committees.

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,the USP DI,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.

The Division Executive Committees shall 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,the USP DI,and other authorized publications,having regard for the principles laid down by the Pharmacopeial Convention at its last meeting.

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

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-CEOshall appoint an acting chairperson until a new chairperson is elected.

The Executive Committee of the Council of Experts,the Division Executive Committees,and the Executive Vice President-CEOshall consult on matters of general policy concerning the planning and executing of the United States Pharmacopeia,the National Formulary,the USP DI,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.

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.

At least one year before the stated meeting of the Pharmacopeial Convention,the Division Executive Committees of the Council of Experts shall 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,the USP DI,and other authorized publications.For scientific areas not currently encompassed by the expertise of the Division Executive 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.

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.

The Committee on Resolutions,hereinafter referred to in this chapter as the Committee,shall consist of at least five members of the Pharmacopeial Convention.

At least sixty days prior to the stated meeting of the Pharmacopeial Convention,the President shall appoint at least five members of the Pharmacopeial Convention to serve as members of the Committee,one of whom shall be designated as Chairperson,and such additional associates,who need not be members of the Convention,as may be required to aid the Committee.

The Committee shall be responsible for reviewing the recommendations made in the addresses and reports of the Officers,Committees,and Board of Trustees;reviewing resolutions that have been submitted to it in written form at least thirty days prior to a stated meeting by eligible organizations and prior to the first session by individual members of the Pharmacopeial Convention,conferring with the parties concerned whenever necessary about the intent or any other aspect of the resolution;for drafting statements in resolution form that shall reflect the official policy of the Pharmacopeial Convention;and for presenting all resolutions to the Convention for consideration,unless later introduction of a resolution by a member is permitted by two-thirds vote of the members present and voting.

Prior to the stated meeting,the Committee shall present all resolutions for a needs assessment to the Board of Trustees and the appropriate Division Executive Committees.If the resolution calls for activity in a new area,then the Executive Committee of the Council of Experts and the Board of Trustees shall determine the need for a new Expert Committee or Committees.

The Committee shall make an initial report in at least one session prior to the Final Session of the meeting;the final report of the Committee and the vote on the resolutions submitted by the Committee shall be conducted in the Final Session.If it has been determined that additional Council of Experts members are necessary to implement an adopted resolution or resolutions,the election may occur,if possible,after the vote on the resolutions.

The Nominating Committee for Officers and Trustees,hereinafter referred to in this chapter as the Committee,shall consist of five members of the Pharmacopeial Convention,one of whom shall be designated as Chairperson,appointed by the President with the advice and consent of the Board of Trustees,not later than six months before the stated meeting.Two of the members appointed shall be members of the Board of Trustees.

The Committee shall nominate from the membership of the Pharmacopeial Convention or the Council of Experts,two members for the office of President,and two members for the office of Treasurer.

The Committee shall nominate from the membership of the Pharmacopeial Convention or the Council of Experts sixteen members for the elected office of Trustee,divided into four classes:four shall represent pharmaceutical sciences,four shall represent medical sciences,six shall be without restriction concerning their affiliations,and two shall represent the public.Taking into account the nominees'backgrounds,the Committee may subdivide the ballot within each class,so as to present two nominees for each elected position within the sub-classification.

The report of the Committee shall be submitted to the Secretary of the Pharmacopeial Convention not later than sixty days before the stated meeting;not later than forty-five days before the stated meeting,the Secretary shall notify the nominees of their selection by the Committee and the date of the stated meeting.

The Committee shall present its report to the Convention,at which time additional nominations of Convention or Council of Experts members may be made from the floor for Officers and the Board of Trustees,which shall be seconded by at least ten members of the Pharmacopeial Convention and submitted in writing at once to the Secretary.Anomination for Trustee shall indicate in which of the four classes the nomination is being made or,if the ballot has been subdivided,which sub-classification.

The Nominating Committee for the Council of Experts,hereinafter referred to in this chapter as the Committee,shall consist of ten members of the Pharmacopeial Convention,appointed by the President with the advice and consent of the Board of Trustees,together with twenty members of the Council of Experts,not more than ten from any one division,appointed by the Executive Committee of the Council.The ten members of the Convention,appointed by the President,who serve on the Nominating Committee for the Council of Experts may not be members of the Council of Experts,Expert Committees,the Board of Trustees,salaried employees,or officers of the Pharmacopeial Convention.

The President of the Pharmacopeial Convention shall serve as the chairperson of the Committee.The Executive Vice President-CEOshall be a member,ex officio,of the Committee.The Committee shall elect a Vice Chairperson.The Secretary of the Convention shall serve as Secretary of the Committee.

The Committee shall be organized at least six months after the stated meeting of the Pharmacopeial Convention,and shall continue until its successor committee is appointed,approximately six months after the adjournment of the next stated meeting.

Not later than seven months prior to the stated meeting of the Pharmacopeial Convention,the Secretary of the Committee shall issue to all who are entitled to representation in the Pharmacopeial Convention,as provided in Article II,Section 1,of the Constitution,to all members of the Convention and to the members of the Council of Experts,its Expert Committees and its advisory panels,a request that they submit the names of persons whose qualifications entitle them to consideration as nominees for membership on the Council of Experts.Each name submitted shall be accompanied by a statement on an official form supplied by the Committee indicating affiliations,academic and professional backgrounds,and the qualifications for the specific classification or classifications of membership on the Council of Experts as set forth in the outline referred to in Chapter VII,Section 17,of these Bylaws.All recommendations shall be mailed to the Secretary of the Pharmacopeial Convention not later than one hundred and twenty days prior to the stated meeting.

All recommendations received by the Secretary shall be submitted to the Committee not later than ninety days prior to the stated meeting and shall be given primary consideration by the Committee in selecting nominees for membership for the Council of Experts.

At the stated meeting of the Pharmacopeial Convention,the Committee shall submit,through the Secretary,to each member,a list of names of persons whom it deems qualified to serve on the Council of Experts,together with a statement covering the classification for which each nominee is deemed best qualified,and the affiliations,academic and professional backgrounds and specific qualifications of each nominee.

The Committee shall nominate,insofar as possible,twice the number of qualified persons to be elected to meet each need shown in the outline referred to in Chapter VII,Section 17,of these Bylaws.

Additional nominations may be made from the floor for membership on the Council of Experts and shall be seconded on the floor by at least ten members of the Pharmacopeial Convention.Each such nomination shall be submitted on the official form and presented at once to the Secretary of the Pharmacopeial Convention.

Between meetings of the Convention,the Committee will operate on a continuing basis and will be the source of providing the names of nominees for election to the Council of Experts,if needed.The Committee shall also provide the names of qualified experts as potential nominees for election to Expert Committees,in accordance with Chapter VII,Section 5of the Bylaws.

The Committee shall provide advice and consent to the Executive Vice President-CEOprior to the appointment of individuals to advisory panels to the Council of Experts.

The Membership Committee shall consist of ten members and shall be appointed by the President.Six members shall represent the organizational membership categories as defined in Article IIof the Constitution and four members shall be appointed without regard to their affiliation.The President shall appoint the Committee and name the chairperson,not later than sixty days after the stated meeting of the Pharmacopeial Convention.The Chairperson of the Board of Trustees,the President,and the Executive Vice President-CEOshall be members,ex officio,of the Membership Committee.The Secretary of the Pharmacopeial Convention shall serve as the secretary.Members of the Membership Committee shall retain their Pharmacopeial Convention membership until their successors are appointed.

The Membership Committee shall identify and recommend organizations eligible to appoint a delegate for the Board of Trustees'consideration.Such recommendations shall take into account any guidelines provided by the Convention at the previous stated meetings.The Membership Committee shall adopt such procedures and criteria as are sufficient to ensure the fair and orderly consideration in the identification and recommendation of organizations eligible to appoint a delegate.The Board of Trustees shall approve such procedures.The Membership Committee shall report to the Board of Trustees at least annually on the composition of the Pharmacopeial Convention and the work of the committee since its last report.

The Membership Committee shall also examine carefully the credentials of all delegates or alternate delegates in the absence of delegates.Credentials issued in blank,with the names of the delegates and alternate delegates to be inserted subsequently by other than the regularly constituted officers of the appointing eligible organization shall not be accepted.Credential forms presented for the first time at a meeting shall be independently verified before acceptance.Immediately prior to the opening of the stated meeting of the Pharmacopeial Convention,the Committee shall furnish to the Secretary of the Pharmacopeial Convention a list of delegates whose credentials have been approved by the Committee and a list of alternate delegates whom it has approved in lieu of delegates who are absent.

The Membership Committee shall make a report to the Pharmacopeial Convention concerning all credentials that have not been approved.Amajority vote of the members of the Pharmacopeial Convention shall be required to overrule a decision approving or disapproving the credentials of any person by the Membership Committee.

The Membership Committee shall make a report to the Pharmacopeial Convention regarding the composition of the Convention and the work of the committee since the last stated meeting.The Membership Committee shall also provide to the Resolutions Committee guidelines for the types of institutions and bodies that should be invited to appoint a delegate for the following stated meeting.

Each delegate shall present his or her credentials to the Membership Committee and,upon report by that Committee that the credentials are approved,shall be accredited and be seated as a member.If a member is absent from the stated meeting the alternate delegate shall present credentials as Alternate Delegate to the Membership Committee and,upon report that the credentials are approved,shall be accredited and be seated as the member for that stated meeting.

The Officers of the Pharmacopeial Convention,the Board of Trustees,the Chairpersons of Committees directed to report at the stated meeting,serving by authority of the preceding stated Pharmacopeial Convention or the Constitution and Bylaws shall be members,ex officio,of the Pharmacopeial Convention.The persons selected by the Board of Trustees as members-at-large shall be members of the Convention.

Nominees selected by the Nominating Committee for Officers and Trustees for the Board of Trustees,the office of President and the office of Treasurer shall be members of the Pharmacopeial Convention for the stated meeting when their names are presented as nominees in accordance with Chapter IV,Section 1(g),of the Bylaws,whether present or not.

Amember of the Pharmacopeial Convention shall continue to be a member until the effective date of the initial designation determined by the Board of Trustees in Chapter VI,Section 19of these Bylaws,following the next stated meeting of the Convention unless he or she dies,resigns,or fails to meet the requirements as provided in Article II,Section 4,of the Constitution or until his or her successor has been authorized by the eligible organization and his or her successor's credentials approved by the Credentials Committee.

Amember shall represent not more than one educational institution,organization,or designated division of the Federal Government.

Amember may be expelled for improper conduct or for violation of the Constitution and Bylaws,by a vote of not less than two-thirds of the members present and voting.

Resignations of membership in the Pharmacopeial Convention shall be submitted in writing to the Secretary of the Convention.All resignations shall be acknowledged in writing by the Secretary and shall be reported to the Board of Trustees.

Meetings of the Pharmacopeial Convention shall be held as provided in Article VIof the Constitution.

The call for a stated meeting of the Pharmacopeial Convention shall be issued as provided in Chapter I,Section 7,of these Bylaws.

The call for a special meeting of the Pharmacopeial Convention shall state the purpose for which the meeting is called and shall be mailed by the Secretary to all members and to all those entitled to representation under the Constitution,not later than sixty days prior to the meeting.The business of a special meeting shall be limited to the purpose for which the meeting has been called.

Each stated or special meeting of the Pharmacopeial Convention shall consist of an opening and a final session and such number of intervening sessions as the Convention may direct in order to conduct the business of the Convention.At least one hour shall elapse between any two sessions,and no session shall be opened at a time earlier than that announced at the session immediately preceding.

Any session may be recessed by a majority vote and shall be reconvened at the time specified in the recess motion.

The Secretary and General Counsel,with the advice and consent of the President and the Executive Vice President-CEO,shall prepare the order of business for each stated meeting and shall distribute it to the Members,Delegates,and Alternate Delegates at least thirty days prior to the meeting.That order of business shall govern unless otherwise directed by the affirmative votes of not less than two-thirds of the members present and voting.

On all questions of procedure,the latest edition of Robert's Rules of Order,Newly Revised,shall prevail,unless otherwise specified herein.

Every proposition to amend these Bylaws,except as hereinafter provided,shall be submitted in accordance with the procedures to amend the Constitution as set forth in Article VIII,Sections 1and 2,of the Constitution,and shall,under either procedure,upon receiving the affirmative votes of not less than three-fourths of the members present and voting,become a part of these Bylaws.

The Board of Trustees may at its discretion mail to the members of the Pharmacopeial Convention a proposition to amend or alter these Bylaws.Aperiod of sixty days shall be allowed for the submission of comments on the proposition.Asummary of the comments shall accompany the mail ballot by which the vote of the member may be recorded and returned within ninety days of the date printed on the ballot.Upon receiving the affirmative vote of seven-eighths of the members voting,with a total of not less than one hundred and thirty members voting,it shall become a part of these Bylaws.