THE UNITED STATES PHARMACOPEIA
`
`
`THE NATIONAL FORMULARY
`
`By authority of the United States Pharmacopeial
`Convention, Inc., meeting at Washington, D.C.,
`March 8-10, 1990. Prepared by the Committee of
`Revision and published by the Board of Trustees
`
`Official from January 1, I995
`
`L5‘L%
`
`UNITED STATES PHARMACOPEIAL CONVENTION, INC.
`12601 Twinbrook Parkway, Rockville, MD 20852
`
`ALKERMES EXH. 2002
`ALKERMES EXH. 2002
`Luye v. Alkermes
`Luye v. Alkermes
`|PR2016-1095 & IPRZO16-1096
`IPR2016-1095 & IPR2016-1096
`
`

`
`NOTICE AND WARNING
`
`The United States Fharmacopeial Convention, Inc.
`© 1994
`12601 Twinbrook Parkway, Rockville, MD 20852.
`All rights reserved
`ISSN 0195-7996 .
`ISBN 0-9 13595-76-4 (cloth)
`0-913595-81-0 (leather)
`
`
`
` Printed by Rand MCNally,
`
`1133 County Street, Taunton, MA 02780-3795
`
`
`
`

`
`Articles of Incorporation
`
`
`
`
`
`:‘The;..U.nited; States PharmacopoeialaConvention of
`May 1900, directed the Board of Trustees to take out
`articles of incorporation for the Convention under the
`laws of the District of Columbia. While the Con-
`vention had appointed certain of its “officers to sign‘
`the-‘articles, some changes were necessary because the
`
`lawsaforesaid require that a_ majoritytof the I_ncor-
`poratorsbe residents of the'District of Col_umbia. ,
`These preliminaries having been arranged, the fol-
`lowing..~certificate- of incorporation was drawn up,
`signed, and -recorded, finally, on the eleventh day of
`July, 1900:
`0
`
`Certificate of Incorporation
`
`’
`
`This is to certify that we, whose names are hereunto subscribed, citizens of the United‘ ~
`States, of full age, and a majority citizens of the District _of 'Columbia,‘ doassociate ourselves
`-together pursuant to the provisions of sections 545~552 inclusive of the Revised'Stat~utesV
`of the United States relating to the District of Columbia and of the Act of Congress to
`- amend the same, approved the twenty—third day of April’ 1884, under the corporate name’
`of The United'States Pharmacopoeial Convention.
`’
`" This ‘Association is organized fort-a period of ninerhundred ‘and ninety-"nine years.
`The particular objects and business of. this Association are the §encoura'gement' and pro-"
`motion of the scienceand art of medicine and pharmacy by selecting by research and
`experiment and other proper methods and by naming such materials as may be properly
`" used as medicines and drugs with formulas for their preparation; by establishing one uniform
`standard‘ and guide for the use of those engaged in the practice of medicine and -pharmacy‘
`in the United States whereby the identity, strength, and purity of all such medicines and
`drugs may be accurately determined, and for other like and similar purposes; and by printing
`and distributing at suitable intervals such formulas and the "results of such and ‘similar’
`L. selections, names and determinations among the members of this Association, pharmacists,’ ‘
`and physicians generally in the United States and others interested in pharmacy and med-
`icine.
`~
`-
`The management and control of the affairs, funds, and property [of this Association for‘ _
`the first year of its existence shall be vested in a Board of Trustees consisting of.the seven . 3
`"following persons:
`ALBERT E. EBERT.
`
`_ SAMUEL A. D. SHEPPARD.
`‘WILLIAM S. THOMPSON.
`CHARLES E. DOHME.'
`
`,
`‘
`
`_ “GEORGE W. SLOAN.
`HORATIO C._WOOD‘..'
`_. CHARLES RICE.
`
`I In testimonywhereof we have hereunto set our hands and affixed our seals this seventh
`day of'July, 1900.
`‘
`-
`WILLIAM S. THOMPSON.
`[SEAL]
`G. LLOYD MAGRUDER.
`[SEAL]
`JOHN T. WINTER.
`[SEAL]
`THOMAS C. SMITH.
`[SEAL]
`
`-MURRAY ‘G. MOTTERI.
`WILLIAM M. MEW.
`FRANK M. CRISWELL.
`
`f
`
`[SEAL]
`[SEAL]
`[SEAL]
`
`vvi;
`
`

`
`
`
`Constitution and Bylaws
`The United States Pharmacopeial Convention
`
`
`
`Under which USP 23 and NF 18 were prepared
`
`As revised by the Convention at its Quinquennial meeting,
`March 8-10, 1990
`
`CONSTITUTION
`
`Article I—Name and Objects
`
`Section 1. The corporate name of this corporation shall be
`“The United States Pharmacopoeial Convention,” hereinafter re-
`ferred to in this Constitution as the Pharmacopeial Convention.
`The alternative spelling, “Pharmacopeial,” also shall be con-
`sidered as official.
`Section 2.
`Its objects shall be those declared in its Certificate’
`of Incorporation, and include (a) the revision and publication of
`the Pharmacopeia of the United States of America and the Na-
`tional Formulary, also referred to as the United States Phar-
`macopeia and as the USP and as the NF, respectively, and of
`the Supplements thereto; and (b) 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 Committee of Revision, or otherwise by direction
`of the Board of Trustees. Approval of the Board of Trustees shall
`be required for publication in either case.
`Section 3. The Pharmacopeia of the United States of Anter-
`ica and the National Formulary, together with their Supple-
`ments, are published by and issued under the authority of the
`Pharmacopeial Convention; they are prepared and regularly re-
`vised entirely or in part by a committee or committees of rep-
`resentative medical and pharmaceutical experts and other ap-
`propriately qualified individuals;
`their primary purpose is to
`provide authoritative standards and specifications for materials
`and substances and their preparations that are used in the prac-
`tice of the healing arts; they establish titles, definitions, descrip-
`tions, and standards for identity, quality, strength, purity, pack-
`aging, and labeling, and also, where practicable, bioavailability,
`stability, procedures for proper handling and storage, and meth-
`ods for their examination and formulas for their manufacture or
`preparation.
`
`Article II—Membership
`
`Section 1. 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 pro-
`vided.
`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 Ed-
`ucation sponsored by the Association of American Medical Col-
`leges 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 Med-
`ical Association; and state pharmaceutical associations or state
`pharmaceutical societies, which are entitled to voting delegates
`in the House of Delegates of the American Pharmaceutical As-
`sociation.
`
`(b) The American Association of Pharmaceutical Scientists,
`the American Chemical Society, the American Dental Associ- ‘
`ation, the American Hospital 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 Hos-
`pital Pharmacists, the American Society for Pharmacology and ,
`Experimental Therapeutics, the American Society for Quality
`Control, the American Society of Consultant Pharmacists, the
`American'Veterinary Medical Association, the Association of
`Food and Drug Officials, the Association of Official Analytical
`Chemists, the Chemical Manufacturers Association, the Cos-
`metic, Toiletry, and Fragrance Association, the Drug Information
`Association, the Generic Pharmaceutical Industry Association,
`the Health Industry Manufacturers Association, the National
`Association of Boards of Pharmacy, the National Association of
`Chain Drug Stores, the National Association of Retail Druggists,
`the National Wholesale Druggists’ Association, the Nonprescrip-
`tion Drug Manufacturers Association, the Parenteral Drug As-
`sociation, and the Pharmaceutical Manufacturers Association; or
`the successors thereto.
`
`(c) The Bureau of Medicine and Surgery, United States Navy;
`. the Department of Medicine and Surgery, the Department of
`Veterans Affairs; the Food and Drug Administration; the Health
`Care Financing Administration; the National Institute of Stan-
`dards and Technology; 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; the Office of the Secretary of the De-
`partment of Health and Human Services; and the Office of the
`President of the United States to represent Consumer Affairs;
`or the successors thereto.
`
`(d) -An individual who has been appointed to be a delegate
`by one of not more than five organizations that have been des-
`ignated as eligible organizations by the Board of Trustees. Such
`designation by the Board of Trustees shall be effective until the
`next stated meeting.
`
`xxiii
`
`
`
`

`
`xxiv
`
`Constitution / Preamble
`
`(e) The Officers, the Board of Trustees, and the Chairmen 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.
`(f) Not more than twenty members-at-large, selected by the
`Board of Trustees for their special competence in relation to the
`administrative or scientific needs of the Pharmacopeia, also shall
`‘be members of the Pharmacopeial Convention until the next stated
`meeting, with such membership to begin upon the individual’s
`acceptance.
`(g) Not more than five members-at-large selected by the Board
`of Trustees to serve as public members also shall be members of
`the Pharmacopeial Convention until the next stated meeting, with
`such membership to begin upon the individual’s acceptance.
`(h) Not more than five members-at-large selected by the Board
`of Trustees to representnations, other than the United States,
`that give official recognition to the standards of the USP or the
`NF also shall be members of the Pharmacopeial Convention until
`the next stated meeting, with such membership to begin upon
`the individual’s acceptance.
`(i) Not more than ten members-at-large selected by the Board
`of Trustees to represent international organizations or foreign
`pharmacopeial bodies also shall be members of the Pharmaco-
`peial Convention until the next stated meeting, with such mem-
`bership to begin upon the individual’s acceptance.
`(j) Nominees for elective offices, selected in accordance with
`Chapter IX, Sections 2 and 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 Chap-
`ter IV, Section 13 (h), of the Bylaws, whether present or not.
`Section 2. Each eligible organization entitled to representa-_
`tion 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 del-
`egate. One of these shall be accredited and seated as a member
`of the Pharmacopeial Convention, as provided in the Bylaws.
`Section 3. 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 named
`under Article II, Sections 1 (f) and (g), 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.
`Section 4. Honorary Members. By unanimous vote the Board
`of Trustees may elect honorary members to the Convention in
`recognition of their distinguished contribution to drug standard-
`ization, drug information, the sciences of medicine and phar-
`macy, and the public health. 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.
`
`Article III-—0fficers
`
`Section I . The officers of the Pharmacopeial Convention shall
`be a President and a Vice-President, each of whom, at the time
`of his or her election, shall be a member of the Pharmacopeial
`Convention; a Past President; a Treasurer; and a Secretary. The
`President, the Vice-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
`
`USP 23~NF 18
`
`may rule upon the propriety of the election, the votes cast may
`be disclosed publicly.
`The Secretary of the Board of Trustees shall act as Secretary
`of the Pharmacopeial Convention.
`Section 2. Vacancies in these offices shall be filled as pro-
`vided in the Bylaws.
`
`Article IV—Board of Trustees
`
`The members of the Pharmacopeial Convention shall elect a
`Board of Trustees from the members of the Convention at each
`stated meeting, as provided in the Bylaws. The Committee of
`Tellers shall report to the President the number of votes cast for
`each nominee, and the President shall announce to the Conven-
`tion 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 in-
`formation 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.
`
`Article V—The General Committee of Revision
`
`The members of the Pharmacopeial Convention shall elect a
`General Committee of Revision at each stated meeting, as pro-
`vided in the Bylaws. The members of the Committee shall act
`as the Committee until its successor committee shall have been
`elected and shall have assumed the duties of the Committee.
`
`Article VI—Meetings
`
`Section I. The stated meetings of the Pharmacopeial Con-
`vention shall be held in the United States at five-year intervals,
`beginning in 1980. The Board of Trustees is authorized to de-
`termine the day within the year and the place of the meeting.
`Section 2. The President shall call a special meeting upon
`the written request of not fewer than fifty members of the Phar-
`macopeial Convention.
`
`Article VII—Quorum
`
`At any session of a meeting of the Pharmacopeial Convention,
`one hundred members who are eligible to vote shall constitute a
`quorum.
`
`Article VIII—Amendments
`
`Section 1. Every proposition to amend this Constitution, ex-
`cept 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
`and pharmaceutical 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 Phar-
`macopeial 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.
`Section 2. 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.
`
`
`
`

`
`USP 23—NF 18
`
`Preamble / Bylaws
`
`xxv
`
`Section 3. The Board of Trustees may at its discretion mail
`to the members of the Convention a proposition to amend or alter
`this Constitution. A period of sixty days shall be allowed for the
`submission of comments on the proposition. A summary 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 affirm-
`ative vote of seven-eighths of the members voting, with a total
`of not less than one hundred members voting, the proposition
`shall become a part of this Constitution.
`
`BYLAWS
`
`Chapter I—The President
`
`Section 1. 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,
`the Vice-President, or in the absence or inability of both, a Pres-
`ident pro tempore, to be appointed by the Board of Trustees, shall
`conduct the meeting.
`Section 2. The presiding officer shall present an address at
`the stated meeting.
`Section 3. 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. The presiding officer shall not vote except in case of
`a tie, when he or she shall cast the deciding ballot.
`Section 4. Not later than six months before the stated meet-
`ing 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 Of-
`ficers and Trustees, two of whom shall be members of the Board
`of Trustees. Of the members appointed from the Board of Trust-
`ees, one shall be representative of the pharmaceutical sciences
`and one shall be representative of the medical sciences_.
`Section 5. The President shall appoint all committees not
`otherwise provided for in these Bylaws.
`Section 6. Not later than one year prior to the stated meeting
`of the Pharmacopeial Convention, the President, through the Sec-
`retary, shall mail a notice of the meeting and a request to prepare
`for the authorization or reauthorization of a delegate and an
`alternate delegate to each of those organizations eligible for rep-
`resentation under the Constitution. He or she shall mail a second
`notice of the meeting and the request for the authorization or
`reauthorization of a delegate 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. At suitable
`intervals the President, through the Secretary, may request by
`mail from an eligible organization, authorization or reauthori-
`zation of a delegate and alternate delegate.
`Section 7. The President shall be a member, ex officio, of
`the Board of Trustees and of all committees except the Com-
`mittee of Revision.
`Section 8. The President shall act as President until his or
`her successor shall have been elected and installed.
`Section 9.
`In the event of a vacancy in the office of President,
`the Vice-President shall become President, or in the event the
`Vice-President is unable to serve, the Board of Trustees shall
`elect a President.
`
`Chapter II—The Vice-President
`
`Section 1. The Vice-President shall preside in the absence of
`the President or in the event of his or her inability to serve.
`Section 2. The Vice-President shall become President in case
`of a vacancy in the office of President.
`Section 3. The Vice-President shall be a member, ex officio,
`of the Board of Trustees.
`
`Section 4. The Vice-President shall act as Vice-President un-
`til his or her successor shall have been elected and installed.
`Section 5. A vacancy in the office of Vice-President shall be
`filled by the Board of Trustees.
`
`Chapter III—The Past President
`Section I. The Past President shall be the immediate past
`president.
`Section 2. The Past President shall be a member, ex officio,
`of the Board of Trustees.
`Section 3.
`In the event the immediate past president is unable
`to serve as Past President, the office shall remain vacant.
`
`Chapter IV—The Executive Director and Secretary
`Section I. The Executive Director shall be elected by the
`Board of Trustees as provided in Chapter VI, Section 19, of these
`Bylaws.
`Section 2. The Executive Director shall be a member, ex
`officio, and Chairman of the General Committee of Revision and
`of the Executive Committee of Revision.
`Section 3. The Executive Director shall organize the General
`Committee of Revision in accordance with Chapter VII of these
`Bylaws. The Executive Director shall appoint all other commit-
`tees required for the work of revision.
`Section 4. The Executive Director shall have charge of the
`work of revision and shall cause to be prepared the final manu-
`script of the United States Pharmacopeia,
`the National For-
`mulary, other authorized publications, and any supplements
`thereto.
`\
`Section 5. The Executive Director, the Executive Committee
`of Revision, and the Division Executive Committees shall consult
`on matters of general policy concerning the planning and exe-
`cuting of the revision of the United States Pharmacopeia, the
`National Formulary, other authorized publications, and of sup-
`plements thereto.
`.
`Section 6. Whenever the occasion requires, the Executive Di-
`rector shall certify in writing to the Board of Trustees that a new
`United States Pharmacopeia and new National Formulary, or a
`new Supplement, has been completed, that each section of it has
`been approved by the appropriate body to which its revision or
`preparation was assigned, and that the text in its entirety has
`been approved by the Division Executive Committee and the
`Executive Committee of Revision. The Executive Director shall
`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.
`Section 7. The Executive Director shall present an annual
`« report to the Board of Trustees and also shall present a report of
`the General Committee of Revision at the stated meeting of the
`Pharmacopeial Convention.
`Section 8. The Executive Director shall fill vacancies in the
`General Committee of Revision with the advice and consent of
`the General Committee of Revision and of the Board of Trustees.
`Section 9. The Executive Director, with the advice and con-
`sent of the Board of Trustees, may appoint a committee composed
`of individuals representing foreign pharmacopeial bodies or from
`other nations who by law recognize or utilize the standards of
`the United States Pharmacopeia or the National Formulary to
`provide advice to the Committee of Revision.
`Section 10. The Executive Director shall act as Executive
`Director until his or her successor shall have been elected and
`shall have assumed the duties of the office.
`Section 11.
`In case of a vacancy in the position of Executive
`Director, the Chairman of the Board of Trustees shall appoint
`an Executive Director pro tempore, who shall serve until an Ex-
`ecutive Director shall have been elected by the Board of Trustees.
`Section 12. The Executive Director shall serve as the Sec-
`retary of the Board of Trustees and as Secretary of the Phar-
`macopeial Convention.
`
`on,
`C 8.
`
`ex-
`l of
`; of
`and
`fter
`rd’s
`or a
`.ical
`ates
`are
`It as
`har-
`ays,
`.rths
`ome
`
`itinlg
`cept
`oard
`ding
`less
`shall
`
`
`
`

`
`xxvi
`
`Bylaws / Preamble
`
`Section 13. Acting as the Secretary, the Executive Director
`shall:
`(a) Keep the. minutes of each meeting of the Pharmacopeial
`Convention and receive all reports, essays, and papers presented
`to the said meeting;
`(b) Compile abstracts of 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 meet-
`in ;
`g(d) Present a report at the stated meeting of the Pharmacopeial
`Convention;
`‘
`(e) Present to the Pharmacopeial Convention papers handed
`in for such purpose by the President;
`(f) Record the ayes and nays when required;
`(g) Notify the chairman and other members of each committee
`of their appointment, giving each member the name of the chair-
`man of that committee and the names of the members and stating
`the business upon which the committee is to act;
`(h)
`Immediately before the opening of the stated meeting of
`the Pharmacopeial Convention, post, in a conspicuous place in
`the meeting hall, a roll containing the names of the Officers of
`the Pharmacopeial Convention, the members of the Board of
`Trustees, the members of the General Committee of Revision,
`the Chairmen of Committees directed to report at the stated
`meeting, the persons selected by the Board of Trustees as mem-
`bers-at-large, the organizations designated as eligible organiza-
`tions by the Board of Trustees, the persons selected by the Nom-
`inating Committee for Officers and Trustees as nominees for
`elected office, the delegates whose credentials have been ap-
`proved by the Credentials Committee, and the order of business;
`(i) During the stated meeting of the Pharmacopeial Conven-
`tion, provide for each member two official ballots. One ballot
`shall contain the names of those nominated for President, for
`Vice-President, and for Treasurer of the Pharmacopeial Conven-
`tion, and for the seven elective memberships on the Board of
`Trustees. A second ballot shall contain the names of those nom-
`inated for the General Committee of Revision, classified accord-
`ing to the outline of specific classifications of service prepared
`by the Executive Committee of Revision as provided in Chapter
`VI, Section 14, of these Bylaws, and designate the number to be
`elected in each classification, as provided in said outline;
`.
`(j) Deliver all reports, papers, and other documents of the
`Pharmacopeial Convention to the Board of Trustees;
`(k)
`Issue such notices, announcements, and requests as pro-
`vided for in Chapter 1, Section 6, of these Bylaws, together with
`credential forms which shall be mailed with the second notice,
`and also mail the notices of special meetings as provided in Chap-
`ter XIII, Section 1, of these Bylaws;
`(1) Submit to the Nominating Committee for the General Com-
`mittee of Revision, not later than ninety days prior to the stated
`meetingqof the Pharmacopeial Convention, all recommendations
`that have been submitted for membership on the General Com-
`mittee of Revision;
`(rn) Acknowledge in writing the receipt of all resignations of
`membership and report them to the Board of Trustees;
`(n) Serve as Secretary of all committees appointed by the
`President.
`'
`Section 14.
`In the absence of the Executive Director or in
`the event of his or her inability to serve as Secretary, the Chair-
`man of the Board of Trustees shall appoint a Secretary pro tem-
`pore.
`Section 15. The Executive Director shall act as Secretary
`until his or her successor shall have assumed the duties of the
`office.
`
`Chapter V—The Treasurer
`
`Section I. The Treasurer shall receive all moneys coming
`from any source to the Pharmacopeial Convention and shall pay
`
`USP 23—NF 18
`
`out moneys only on the authorization of and in accordance with
`the procedures adopted by the Board of Trustees.
`Section 2. The Treasurer shall present annually to the Board
`of Trustees a complete financial statement and shall present at
`the stated meeting of the Pharmacopeial Convention a complete
`financial statement for the period since the preceding stated.meet-
`mg.
`The above statements of the Treasurer shall be audited by a
`certified public accountant.
`Section 3. The Treasurer shall be a member, ex officio, of
`the Board of Trustees.
`Section 4. 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.
`Section 5. The Treasurer shall act as Treasurer until his or
`her successor shall have been elected and installed.
`Section 6. A vacancy in the office of Treasurer shall be filled
`by the Board of Trustees.
`
`Chapter VI-—The Board of Trustees
`Section 1. The Board of Trustees shall consist of seven mem-
`bers of the Pharmacopeial Convention elected by plurality vote
`at the stated meeting; and the President, the Past President, the
`Vice-President, and the Treasurer, ex officio.
`Of the seven elected members of the Board of Trustees, at least
`two shall be representative of the pharmaceutical sciences, and
`at least two shall be representative of the medical sciences. At
`least one of the elected members of the Board of Trustees shall
`be a public member.
`The members of the Board of Trustees shall not be members
`of the General Committee of Revision.
`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 as an elected member of
`the Board of Trustees.
`Section 2. The officers of the Board of Trustees shall consist
`of a Chairman, who shall be elected by a majority vote of the
`Board, and a Secretary. The Chairman of the Board of Trustees
`shall serve as a member, ex officio, of the Credentials Committee.
`The Secretary of the Board of Trustees need not be a member
`o-f 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.
`Section 3. The Board of Trustees shall have the right to trans-
`act business by correspondence. A motion by mail shall require
`no seconder.
`Section 4. 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 Chairman shall have the right to call
`a special meeting whenever he shall deem it necessary. Six mem-
`bers of the Board of Trustees shall constitute a quorum.
`Section 5. 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 meetingcan hear each other
`at the same time, and participation by such means shall constitute
`presence in person at a meeting.
`Section 6. No member of the Board of Trustees shall receive
`compensation for his services. Members of the Board of Trustees
`shall be reimbursed from the funds of the Pharmacopeial Con-
`vention for traveling and other necessary expenses that may be
`incurred by them in the performance of their duties.
`Section 7. 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 Pharma-
`copeial 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
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`USP 23—NF 18
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`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 Con-
`vention by the Chairman and the Secretary of the Board of Trust-
`ees, or by such other person or persons as the Board» may des-
`ignate.
`Section 8. The Board of Trustees shall authorize the revision
`and publication of the United States Pharmacopeia, the National
`Formulary, or other authorized publication at suitable intervals
`and such supplements during the intervening periods as may be
`deemed necessary.
`Upon receipt of written certification from the Executive Di-
`rector that a new Uni