1.01The Council of Experts shall be composed of individuals elected by the USP Convention.

1.02Each member of the Council of Experts shall chair an Expert Committee.The Executive Vice President and Chief Executive Officer (EVP-CEO)shall be the Chairperson of the Council of Experts and of the Executive Committee of the Council of Experts.He or she exercises the authority vested by and responsibilities as provided in the Bylaws of the Pharmacopeial Convention and shall also operate and be governed by these rules.In the event of the temporary absence of the Executive Vice President,the Senior Vice President,Secretary and General Counsel shall act in his or her stead.

1.03The Executive Committee of the Council of Experts shall be composed of the Chairpersons of each of the Division Executive Committees and twice that number of at-large members selected from members of the Council by the Chairperson of the Council,with the advice and consent of the Division Executive Committees.The Chairperson of the Executive Committee of the Council of Experts shall not vote except in case of tie.

1.04In the event a member of the Council of Experts is unwilling or unable to serve,a new member shall be elected by the membership of the Convention.

1.05The Council of Experts and its Expert Committees shall function to determine or approve the content of the United States Pharmacopeia(USP),and the National Formulary(NF),and other authorized publications.

1.06The Council of Experts and its Expert Committees shall function to approve the content of USP Drug Information (USP-DI)publications.

1.07The Council of Experts and its Expert Committees shall function to determine authoritative information on the appropriate use of medicines,dietary supplements and other related articles.

1.08The Council of Experts and its Expert Committees may be assigned additional tasks,related to the purposes of the Convention,by the Chairperson of the Council of Experts with the approval of the Executive Committee of the Council of Experts.

1.09An Executive Committee,Expert Committee,ad hoc Advisory Panel or other body of the Council of Experts may meet upon the call of its Chairperson or upon the request of the Chairperson of the Council of Experts or his or her designee.Where an expenditure of funds is involved in connection with such a meeting,prior authorization shall be obtained from the Chairperson of the Council of Experts or his or her designee.

1.10Each Expert Committee shall determine the rules under which it shall operate.Such rules shall be consistent and conform with the general rules of the Council of Experts.Acopy of the proposed rules shall be provided to the Chairperson of the Council of Experts.The Chairperson of the Council of Experts shall review the rules for consistency with these rules and the Constitution and Bylaws.Upon acceptance,he or she shall make these rules available to the Board of Trustees for review.The rules shall provide for:

2.01The Executive Committee of the Council of Experts shall determine the parameters within which each division shall operate and prepare an outline of the scope of the responsibilities of each division.

2.02Each Division Executive Committee and the Executive Committee of the Council of Experts shall carry out such assignments as have been directed to them by the U.S.Pharmacopeial Convention,the Board of Trustees,the Council of Experts or the Chairperson of the Council of Experts.

2.03The Executive Committee of the Council of Experts and the Division Executive Committee concerned shall consult with the Chairperson of the Council of Experts or his or her designee on general policy concerning the content of,and the planning and executing of changes to databases,and related products.

2.04Any matter that has been agreed to by a designated representative of the USP Convention that deals with standardization of drugs or other articles or the development of information regarding the use of medicines or related articles,must be approved by the respective Division Executive Committee and the Executive Committee of the Council of Experts,in order for such standard or information to be considered official or authorized or adopted by the USP Convention.If a matter has been agreed to by another recognized standard setting body and mutually agreed to by both bodies not to modify such agreements without mutual consent,such matter shall not be modified without first obtaining agreement of the other body,unless it is determined by the Chairperson of the Council of Experts and the Executive Committee of the Council of Experts,that such modification is necessary in the interest of public health.In such case,the Chairperson of the Council of Experts shall notify the other body and provide the reasons for making such changes.

2.05The Chairperson of the Council of Experts shall appoint a Reference Standards Committee composed of members from the Council of Experts or its Expert Committees.The Reference Standards Committee shall be composed of not less than five nor more than eleven individuals.The Reference Standards Committee shall be responsible for ascertaining the initial and continued suitability of materials to be utilized for reference materials as provided for in the USPand NF,or otherwise deemed necessary.All reference materials shall be handled,tested,and approved prior to release in accordance with the procedures adopted by the Reference Standards Committee.The Chairperson of the Council of Experts,or his or her designee shall serve as the Chairperson of the Reference Standards Committee.The Chairperson may appoint an Industry Advisory Panel to assist the Committee.

2.06Not less than one year before the stated meeting of the Pharmacopeial Convention,the Division Executive Committees shall prepare a description of the areas of expertise needed to conduct the work by the succeeding Council of Experts along with a statement of the number and types of committees needed.This outline shall be followed by the nominating committee in submitting 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.

2.07In the event it is determined that expertise is needed in an area outside the scope of expertise of any existing division,the Chairperson of the Council of Experts,in consultation with,and with the approval of the Council of Experts Executive Committee and Board of Trustees shall determine the additional categories and number and types of committees needed.

2.08The Executive Committee of the Council of Experts shall appoint twenty individuals,with not less than two and not more than ten members from any one division,to serve on the Nominating Committee to select the nominees for the Council of Experts for the forthcoming cycle.

2.09The Executive Committee of the Council of Experts may recommend to the Board of Trustees the removal,for violation of these rules or otherwise for cause,of any member from the Council of Experts,its Expert Committees,or Advisory Panels.Repeated or gross failure to perform assigned tasks or to respond to requests may be deemed to be cause for removal.

2.10The Executive Committee of the Council of Experts shall make recommendations to the Board of Trustees with respect to the need for additional members to be added to the Council of Experts prior to the next stated meeting of the Pharmacopeial Convention.

3.01Each member of the Council of Experts shall chair an Expert Committee.The number of individuals to be elected to an Expert Committee shall be determined by the Chairperson of the Council of Experts,after consultation with the Chair of the Expert Committee.Members of each Expert Committee shall be elected by the Chairpersons of the Expert Committees in the division or divisions in which the Expert Committee is placed.An individual may be elected to more than one Expert Committee.A Chairperson may be elected to serve on any other Expert Committee.

3.02Nomination for election to an Expert Committee shall be made by a Nominating Committee for the Expert Committee composed of the Chairperson of the Expert Committee,the Chairperson of the Council of Experts,the President of the Convention and the Vice Chairperson of the Nominating Committee for the Council of Experts.To the extent practicable and desirable,there should be two nominees for each elected position;however,election of individuals from a slate of nominees is also permissible.

3.03Nominees for election to an Expert Committee shall,to the extent possible be selected from individuals put forth by the Nominating Committee for the Council of Experts.

3.04The Chairpersons of the Expert Committees will elect the members of the Expert Committees in their division.

3.05Election of members of the Expert Committees shall be by plurality vote of the votes cast.In the event of a tie,the Chairperson of the Council of Experts shall cast the deciding vote.

3.06Each Expert Committee shall elect a Vice Chairperson to serve in the temporary absence of the Chairperson.In the event of a vacancy of the Chairperson's office,the Vice Chairperson shall serve as Chairperson until a new Chairperson shall be elected by the Convention membership.

3.07Each Expert Committee shall function until its successor committee is elected and organized,or until such date determined by the Chairperson of the Council of Experts.

3.08In the event of a vacancy in an Expert Committee or if additional members are determined to be needed,such vacancy shall be filled or additional members added in accordance with paragraphs 2,3,and 4of this chapter.

3.09An Expert Committee may be placed into more than one division and/or multidisciplinary coordinating group.

3.10Each Expert Committee shall work within the areas determined by the Chairperson of the Council of Experts.

3.11Each Expert Committee shall annually or at other suitable times agreed to by the Chairperson of the Council of Experts,conduct an assessment of the Committee's effectiveness in fulfilling USP's program objectives.Such assessment shall be carried out by the Expert Committee and the Chairperson of the Council of Experts.

3.12The Chairperson of the Council of Experts shall appoint a staff member to act as liaison for each Expert Committee.

4.01The Expert Committees shall be organized into divisions and/or multidisciplinary coordinating groups by the Chairperson of the Council of Experts with the approval of the Board of Trustees.

4.02Such organizations may be modified during the period between elections by the Chairperson of the Council of Experts with the approval of the Board of Trustees.

4.03The Chairpersons of the Expert Committees within a division shall elect a Chairperson of the Division's Executive Committee.The Division Executive Committee Chairperson shall then appoint from among the Chairpersons of the Expert Committees in that division,the members of the Division Executive Committee.Such appointment shall be with the advice and consent of the Chairpersons of the Expert Committees within that division.Each division shall determine the terms of office of the Chairperson of the Division Executive Committee and the members of the Division Executive Committee.

4.04In the event of a temporary vacancy in the chair of a Division Executive Committee,the Chairperson of the Council of Experts or his or her designee shall act for the Chairperson.

4.05Each Division Executive Committee shall approve the rules of each Expert Committee within its division and may establish rules of procedure within its division.

4.06Each division shall determine the limits for the contents of decisions made within the division,based upon parameters established by the Executive Committee of the Council of Experts.

5.01Two or more Expert Committees may be organized by the Chairperson of the Council of Experts,with the approval of the Board of Trustees into Multidisciplinary Coordinating Groups.Such coordinating groups may be organized because of similarity of technology or for performance of a specific task.Such grouping shall continue until the election of a new Council of Experts or until dissolved by the Chairperson of the Council of Experts.

5.02The Chairpersons of each Expert Committee and the Chairperson of the Council of Experts shall act in lieu of a Division Executive Committee to coordinate the activities,provide oversight,and approve the decisions of the Expert Committees within the group.Each Multidisciplinary Coordinating Group shall establish the rules of procedure for its operation consistent with these rules and the Constitution and Bylaws.

6.01An ad hoc Advisory Panel may be appointed by the Chairperson of the Council of Experts upon request of the Chairperson of an Expert Committee.The Nominating Committee of the Council of Experts may provide advice to the Chairperson of the Council of Experts,prior to the appointment of individuals to Advisory Panels.

6.02The scope of work of an ad hoc Advisory Panel shall be clearly defined prior to appointment of the panel.

6.03The Advisory Panel shall be discharged by the Chairperson of the Council of Experts upon the advice of the Chairperson of the Expert Committee concerned when its assigned task has been completed.

6.04An ad hoc Advisory Panel shall be chaired by a member of the Expert Committee to which it reports.The Chairperson of the Advisory Panel shall be responsible for communicating the panel's recommendations to the Expert Committee.

6.05Each ad hoc Advisory Panel shall work within the area determined by the Chairperson of the Council of Experts

6.06Joint panels may be established in cooperation with other organizations having interests in common with those of a division of the Council of Experts.

7.01Awritten communication directed to the USPthat calls into question a standard,procedure,or other written text proposed in Pharmacopeial Forum,or appearing in the USP,NF,USP DIor other authorized publication,or that criticizes a lack thereof,that requests consideration of change with respect to the matter called into question,that involves a question of medical or scientific judgment,and that is accompanied by reasonable grounds and,where necessary,supporting data,shall be forwarded to the appropriate Expert Committee or ad hoc Advisory Panel for consideration.

7.02Committee members and panelists shall forward copies of all pertinent correspondence received,to the group Chairperson and to the division director or the Executive Secretariat.

7.03The Council of Experts shall publish guidance for the general content for submissions.Information and supporting data necessary to validate the accuracy and reliability of the submission must be provided to enable the member(s)of the Expert Committee to complete their evaluation.Arequest for consideration of a new or revised standard or compendial assay or method may be refused if the submission does not substantially conform to the required content for submissions.

7.04The final text of a revision proposal or in-process revision shall be supplied by the Executive Secretariat and approved by the Chairperson of the Expert Committee.Such text shall be consistent with established policies and accurately reflect the decision made.Explanations of the text may be issued by the Chairperson of the Council of Experts or his or her designee with the approval of the Chairperson of the expert body.

7.05The USPshall have a mechanism that provides an opportunity for public review and comment on activities affecting the work of the USP Convention,including the USP,the NF,the USP-DIor other authorized publications,or other activities of the USP Convention.Such mechanism may be in print and/or electronic form.

7.06Pharmacopeial Forumshall be the official published mechanism for the USPand NF.In order to provide for adequate notice and opportunity for comment,all proposed additions,deletions,or modifications of standards,procedures,or other written text in the USPor NFshall be published in Pharmacopeial Forumexcept in instances where the Chairperson of the Council of Experts determines for good cause that it is impracticable,unnecessary,or contrary to the public interest.

7.07The decision to proceed with a proposal,either via In-Process Revisionor Preview,is within the discretion of the particular Expert Committee.

7.08All published proposals shall be accompanied by a date by which comments must be received for consideration.Such date shall be not less than that appearing in these or an Expert Committee's rules,unless it is determined by the Chairperson of the Council of Experts for good cause that such period should be shortened or eliminated.

7.09Any proposal published in Pharmacopeial Forumfor comment that does not evoke significant adverse comment or objection,or that as a result of the comments received does not result in material modification,need not be reprinted in final format prior to publication in the USPor the NF.Where a proposal is published in final form in the USPor the NF,such publication may be accompanied by a summary or abstract of each type of comment received and may be accompanied by a statement directed to the comment from the Expert Committee,Division Executive Committee,or Chairperson of the Council of Experts.

7.10Where a proposal published in Pharmacopeial Forumhas been materially modified,it shall be reprinted for comment in Pharmacopeial Forum unless otherwise determined by the Chairperson of the Council of Experts for good cause.Such publication shall be accompanied by a summary or abstract of each type of comment received and by a statement of the Expert Committee,the Division Executive Committee,or the Chairperson of the Council of Experts directed to the comment.

7.11General decisions may be reached by an individual Expert Committee member,the Expert Committee,Division Executive Committee,Executive Committee of the Council of Experts,or ad hoc Advisory Panel in accordance with procedures established under the rules,or in their absence,through a simple majority vote of those voting.Such ballot may be issued or returned electronically,by mail,facsimile transmission or any other method selected by an individual voting.Such ballot shall state a reasonable period of time by which ballots shall be received.Where an individual member of a Committee or ad hoc Advisory Panel fails to respond,the Chairperson or his or her designee may telephone the individual to obtain his or her vote.

7.12The results of voting shall be reported back to the Committee and such report may include the substance of comments received.The showing of substantial opposition by a minority of persons commenting as judged by the Chairperson of the Council of Experts may be the basis for a subsequent reconsideration of the issue involved,following circulation of the adverse comments,despite the matter having received a majority vote.

7.13Any Committee of the Council of Experts may hold a meeting by means of a conference telephone call or other communications equipment by means of which all persons participating in the meeting shall hear one another or perceive each other's comments in the same period of time.Participation by such means shall constitute presence in person at a meeting.Ameeting held by utilization of computer technology shall provide opportunity for public viewing (and if desired,comment)unless it is determined to close the meeting in accordance with 7.14.Such procedures may also be utilized to provide a hearing under 8.04.Such meetings shall be held in accordance with rules adopted by the Committee conducting the meeting.Ameeting held by telephone conference call need not be public.

7.14Ameeting of an Expert Committee,Advisory Panel,or other body shall be open to the public,except that a meeting or a portion of a meeting may be held in closed session if the Chairperson of the Expert Committee,Advisory Panel or other body and the Chairperson of the Council of Experts determine that there is good and sufficient reason for closure.Such reasons may include among others:review or discussion of trade secret or confidential,commercial information;or review or discussion of matters the premature disclosure of which could be detrimental to the USP.

7.15To the extent possible,all public meetings shall be announced beforehand in the Weekly Calendar,the USPwebsite,and if possible in the Pharmacopeial Forum,a copy of which shall be made available in the USPlibrary and public reception areas.Records of meetings open to the public shall be made available.Such records shall be approved by the Chairperson of the body and submitted to the Executive Secretariat.

7.16Background material presented to Committees,Advisory Panels,or other bodies may be disclosed only consistent with USPdocument disclosure rules.

8.01Amatter may properly be appealed only prior to its placement in the United States Pharmacopeia,the National Formulary,the USP DI,other authorized publication,or in the case of a reference material,prior to its issuance.Once issued or released for publication or to a database,the matter is not subject to appeal,however,any interested party may request that the matter be considered anew in the revision process.Failure of the Council of Experts to take action on a request for consideration of a revision may properly be appealed at any time.An appeal submitted under this rule shall be clearly distinguished from a request for consideration of revision and provide adequate evidence for the appeal.

8.02The Executive Committee of the Council of Experts shall receive and rule upon all appeals for reconsideration,revision,or abrogation of standards adopted or decisions made by an Expert Committee,Division Executive Committee,or Advisory Panel in those cases where the appellant has specifically requested a hearing.The Chairperson of the Executive Committee of the Council of Experts or his or her designee shall be the presiding officer.

8.03Such appeal shall be submitted to the Chairperson of the Council of Experts who shall submit it to the Executive Committee of the Council of Experts and shall be accompanied by the evidence or data in support of the appellant's request.The Chairperson of the Council of Experts need not submit an appeal to the Executive Committee of the Council of Experts if he or she determines that the appeal is not accompanied by sufficient evidence or adequate supporting data,is frivolous,or untimely.Such decision shall be unappealable.Where an appeal is not granted,the appeal will be treated as a request for revision.The Executive Committee of the Council of Experts may invite other parties that it deems to have a substantial interest in the matter being appealed to participate in the appeal,including the Committee or body whose decision is being appealed.

8.04It is preferred that appeals be handled electronically or by any means of correspondence.In the event an oral hearing is requested by the appellant,the reason therefore should be given and the Executive Committee of the Council of Experts shall determine whether or not to grant such an oral hearing.Such decision shall be referred to the Board of Trustees for review.After such review the Board may uphold or reverse the decision of the Executive Committee of the Council of Experts as to whether to grant an oral hearing.An oral hearing may be held by conference call or similar communication by means of which all persons participating in the meeting shall hear one another in the same period of time.The Executive Committee of the Council of Experts shall determine the time and place of the hearing.At an oral hearing any party may offer such additional evidence deemed necessary to an understanding and determination of the issues.In an oral hearing,witnesses may be called;a witness presented by one party at an oral hearing may be questioned by any other party with reference to the evidence the witness has offered.The Executive Committee of the Council of Experts shall be the judge of the relevancy and materiality of the evidence offered and conformance to legal rules of evidence shall not be necessary.In the event a question should arise not covered by these rules,the Executive Committee of the Council of Experts shall determine by majority vote of those voting the rules by which it shall operate.

8.05Adecision of the Executive Committee of the Council of Experts on such appeals shall be referred to the Board of Trustees.Where an appeal is determined by the Board to be primarily on a procedural matter,the Board may uphold the decision or remand the decision to the proper body for reconsideration under proper procedures.Where a decision is determined to be primarily on a scientific issue,upon consideration of the facts,the Board may request the Council of Experts to review the decision.After such review,which shall be given as promptly as practicable,the Council of Experts may uphold or reverse the decision of the Executive Committee of the Council of Experts by a majority of the members voting.

8.06Where there is an appeal of a decision that originated in the Executive Committee of the Council of Experts,the matter shall be referred to the Board of Trustees,which upon consideration of the facts,may request the Council of Experts to review the decision.After such review,which shall be given as promptly as practicable,the members of the Council of Experts may uphold or reverse the decision of the Executive Committee of the Council of Experts by a majority of the members voting.

8.07The person or Committee responsible for providing oversight to the person or body responsible for making the decision for which postponement is sought shall have the authority to postpone the effective or official date of any requirement or textual material appearing in the USP,the NF,or any other authorized text.In their absence or in the event more than one Expert Committee or Advisory Panel is involved,then the Executive Committee of the Council of Experts shall have such authority.Arequest for postponement submitted under this section shall be clearly distinguished from a request for consideration of revision.Arequest for consideration of postponement shall be accompanied by a statement of the grounds upon which the postponement is requested and appropriate supporting data.Arequest for consideration of postponement received within 30days of the effective or official date may be refused by the Chairperson of the Council of Experts if,solely within his or her discretion,he or she considers the request untimely or lacking adequate supporting data.Such decision shall be unappealable.Where postponement is not granted,the matter will be considered as a request for consideration of revision.

8.08Where a new reference standard is required in a new monograph or in a revision of an existing monograph but is not yet available,the official date of any portion of the monograph utilizing such reference standard shall be postponed until such reference standard is available.During the period of such unavailability,the Chairperson of the Council of Experts shall publish the name of such reference standards and indicate that it is not yet available.Subsequently,the availability of the reference standards shall be announced and the effective date of the postponed portion(s)of the monograph shall be announced.

9.01Council of Experts members,members of Expert Committees,and ad hoc Advisory Panelists shall conduct themselves according to standards of ethical behavior of the highest order.

9.02Council of Experts members,or members of an Expert Committee,shall not vote on the proposal or approval of any item in which he or she has a conflict of interest or the appearance of a conflict of interest.An employee's interest shall be presumed to coincide with that of his or her employer.

9.03No individual shall be assigned the sole responsibility to work on an issue or question in which he or she has a conflict of interest.He or she may,however,provide scientific information to the committee member who is responsible.

9.04An individual who,during his or her membership on the Council of Experts or an Expert Committee represents anyone else before the USPin a particular matter in which he or she has at any time participated personally and substantially in the course of his or her membership shall no longer personally and substantially participate in that particular matter on behalf of the USP.

9.05Prior to assuming office,each member of the Council of Experts,Expert Committee,or ad hoc Advisory Panel shall sign a confidentiality agreement with the USPapproved by the Executive Committee of the Council of Experts.Amember of the Council of Experts or an Expert Committee,or ad hoc Advisory Panel shall not use information not generally available to those persons outside the Council of Experts for the special benefit of a business or other entity in which he or she has a financial interest or organization in which he or she is a member.Information intentionally not publicly available shall be held confidential by the Committee member or Advisory Panelist and shall not be divulged to his/her employer or client.In case of doubt as to whether information is generally available to the public,the member should confer with the Chairperson of the Council of Experts or his or her designee.

9.06Amember of the Council of Experts or an Expert Committee,or an ad hoc Advisory Panel shall not use his or her membership in any way that is,or appears to be,motivated by private gain for himself/herself or of other persons,particularly those with whom he or she has family,business,or organizational or financial ties.

9.07Prior to assuming office,each member of the Council of Experts or an Expert Committee,or an ad hoc Advisory Panel shall submit to the Chairperson of the Council of Experts a statement of all employment,professional research,and financial interests that relate either directly or indirectly to his or her duties and responsibilities,which have not been disclosed previously to the Convention members in the report of the Nominating Committee for the Council of Experts or which are not evident by identity of his or her employer.

9.08Each member of the Council of Experts or an Expert Committee,or ad hoc Advisory Panel shall submit such statement as prescribed in 9.07not later than four months after election and/or appointment,and shall keep it current throughout the revision period by the submission of supplementary statements as required or as requested periodically by the Chairperson of the Council of Experts.

9.09The Chairperson of the Council of Experts or his/her designee shall be responsible for reviewing the statements of employment and financial interests.Where no conflict of interest is disclosed by the review of the statements,no further action is necessary.Where a question of conflict of interest arises,the Chairperson of the Council of Experts shall work with the individual to resolve the matter,or in the event this is not possible,shall refer the question to the Executive Committee of the Council of Experts for further consideration and advice and resolution in accordance with USPconflict of interest policies and standards.The Chairperson of the Council of Experts shall inform the division director and the Chairperson of the group involved of all instances in which he or she believes a conflict of interest may exist.

9.10Except as specified in the foregoing sections such statements shall be regarded as wholly confidential.

9.11It is the responsibility of the members of the Council of Experts,Expert Committees or ad hoc Advisory Panels to advise the Chairperson of the Council of Experts should a particular situation arise in which he or she has or may have a conflict of interest.

9.12Except for the Chairperson of the Council of Experts,no member of the Council of Experts or Expert Committee,or ad hoc Advisory Panel shall receive compensation for his or her services.Members of a Committee or ad hoc Advisory Panel may be reimbursed for travel and other necessary expenses that may be incurred by them in the performance of their duties.

9.13Each member of the Council of Experts or Expert Committee or ad hoc Advisory Panel shall carry out such assignments as have been directed.In the event of repeated or gross failure to carry out such assignments,the Chairperson of the Council of Experts shall refer the matter to the Executive Committee of the Council of Experts for consideration of a recommendation of removal for cause from the Council of Experts,Expert Committee or an Advisory Panel to the Board of Trustees in accordance with section 2.09.

10.01On all questions of procedure,the current edition of Robert's Rules of Order,Newly Revisedshall prevail,unless otherwise specified herein.

10.02Acopy of these rules shall be made available upon written request.

10.03Amember of the Council of Experts shall serve and shall act until his or her successor has been elected and installed.An Expert Committee or ad hoc Advisory Panel shall serve and act until its successor committee or panel is installed or until dissolved by the Chairperson of the Council of Experts.

10.04The following information and their publications,or their successors,shall be deemed authorized:USP Dictionary of USANand International Drug Names.

10.05The use of terminology in these rules and procedures and in communications of the Council of Experts indicating a particular gender shall be interpreted to apply to both genders.As used in these rules and procedures the term body or group refers to a committee,panel or other organized subdivision of the Council of Experts.

10.06These rules and procedures may be amended during the revision period in accordance with Chapter VII,Section 11of the Bylaws of the USP Convention.

10.07Where a standard,method of analysis,or other document is incorporated by reference in an official or authorized publication,such reference shall be limited to the edition of the publication that is approved and shall not automatically include future revisions or publications.

10.08The term publication as used in these rules and procedures means any work whether in print,perceivable by electronic means,or in any other format distributed to the public containing USP-developed information.