The United States Pharmacopeia and the National Formulary (USP–NF)are recognized as official compendia and are referenced in various statutes as a basis for determining the identity,strength,quality,purity,packaging,and labeling of drugs and related articles.Similarly the USP DIis recognized by several statutes as an authoritative source of information.As such,their texts may have significant legal consequences.The U.S.Pharmacopeial Convention (USP)attempts to publish these compendia in plain,explicit language in accordance with its editorial principles,nevertheless,questions sometimes arise regarding their interpretation.

Importantly,it is the text in these publications that is so recognized,not the comments,explanations,interpretations,or pronouncements of the USPthat may appear elsewhere.Because the publications have legal consequences,their language must stand on its own.The USPcannot provide an official ex post facto interpretation to one party,thereby placing other parties without that interpretation at a possible disadvantage.The requirements must be uniformly and equally available to all parties.Any interpretation provided by USPstaff,a member of the Council of Experts,an Expert Committee or advisory panel,officer or trustee,etc.,regarding USP DIor USP–NFrequirements or language shall be regarded solely as a personal opinion of the individual providing the interpretation and not necessarily an official position of the USP.

Similarly,the commentary section,which appears in an official Supplementis not to be considered a part of the official text to which it refers.Where there is a difference between the commentary section and an official monograph,the text of the official monograph prevails.In the event of a dispute or question of interpretation,the language of the official text without benefit of the comments shall prevail.

Conformance of a particular article to compendial requirements is properly a matter of compliance,not of standards setting.The policy of the USPis not to provide an interpretation or opinion as to whether a particular article does or does not comply with compendial requirements.Any such opinion or interpretation by a member of the Council of Experts,an Expert Committee,an advisory panel,the Board of Trustees,or the USPstaff shall be regarded solely as a personal opinion and is not to be construed as a USPinterpretation.

Any matter that has been agreed to by a designated representative of the USPregarding the standardization of an article or development of information on the use of such an article,prior to its becoming official or considered authorized or adopted by the USP,must be approved by the appropriate division Executive Committee of the Council of Experts.

In the event a difference in language occurs in two publications of the same work that are intended to be identical,the Executive Vice President-CEOmay indicate which of the two publications accurately reflects the decision of the Council of Experts.

Formal statements reflecting the policy,opinion,or position of USPmay emanate only in the following manner: