The USP (or NF) titles are legally recognized as the designations for use in labeling the articles to which they apply.
The value of designating each drug by one and only one nonproprietary1
name is obvious, in terms of achieving simplicity and uniformity in drug nomenclature. In support of the U.S. Adopted Names program (see Preface
), of which the U.S. Pharmacopeial Convention is a co-sponsor, the USP Committee of Revision gives consideration to the adoption of the U.S. Adopted Name, if any, as the official title for any compound that attains compendial recognition.
A compilation of the U.S. Adopted Names (USAN) published from the start of the USAN program in 1961, as well as other names for drugs, both current and retrospective, is provided in USAN and the USP Dictionary of Drug Names.
This publication serves as a book of names useful for identifying and distinguishing all kinds of names for drugs, whether public or proprietary or chemical or code-designated names.2
A nonproprietary name of a drug serves numerous and varied purposes, its principal function being to identify the substance to which it applies by means of a designation that may be used by the professional and lay public free from the restrictions associated with registered trademarks. Teaching in pharmacy and medicine requires a common designation, especially for a drug that is available from several sources or is incorporated into a combination drug product; nonproprietary names facilitate communication among physicians; nonproprietary names must be used as the titles of the articles recognized by official drug compendia; a nonproprietary name is essential to the pharmaceutical manufacturer as a means of protecting trademark rights in the brand name for the article concerned; and, finally, the manufacturer is obligated by federal law to include the established nonproprietary name in advertising and labeling.
Under the terms of the Drug Amendments of 1962 to the Federal Food, Drug, and Cosmetic Act, which became law October 10, 1962, the Secretary of Health and Human Services is authorized to designate an official name for any drug wherever deemed necessary or desirable in the interest of usefulness and simplicity. 3
The Commissioner of Food and Drugs and the Secretary of Health and Human Services published in the Federal Register regulations effective November 26, 1984, which state, in part:
Sec. 299.4 Established names of drugs.
(e) The Food and Drug Administration will not routinely designate official names under section 508 of the act. As a result, the established name under section 502(e) of the act will ordinarily be either the compendial name of the drug or, if there is no compendial name, the common or usual name of the drug. Interested persons, in the absence of the designation by the Food and Drug Administration of an official name, may rely on as the established name for any drug the current compendial name or the USAN adopted name listed in USAN and the USP Dictionary of Drug Names...
It will be noted that the monographs on the biologics, which are produced under licenses issued by the Secretary of the U.S. Department of Health and Human Services, represent a special case. Although efforts continue toward achieving uniformity, there may be a difference between the respective title required by federal law and the USP title. Such differences are fewer than in past revisions of the Pharmacopeia. The USP title, where different from the FDA Bureau of Biologics title, does not constitute a synonym for labeling purposes; the conditions of licensing the biologic concerned require that each such article be designated by the name appearing in the product license issued to the manufacturer. Where a USP title differs from the title in the federal regulations, the former has been adopted with a view to usefulness, simplicity, and conformity with the principles governing the selection of monograph titles generally.
The term generic has been widely used in place of the more accurate and descriptive term nonproprietary, with reference to drug nomenclature.
USAN and the USP Dictionary of Drug Names is obtainable on order from the USAN Division, USP Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852.
F.D.&C. Act, Sec. 508 .
53 Fed. Reg. 5369 (1988) amending 21 CFR § 299.4.