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October 2000
Vol. 3, No. 8, pp. 35–36,

Rules and Regulators

More names

Legal, scientific, and regulatory demands require an unambiguous system for identifying these highly regulated products.

opening art of DNA strand The pharmaceutical industry is filled with technical, proprietary, nonproprietary, official, and trivial names. These terms serve many purposes and arise from the varied legal, regulatory, marketing, and scientific nomenclature needs of the drug industry.

In the last issue, I described the process by which nonproprietary names are devised for drug substances. The cumbersome length and pronunciation of chemical names, combined with the intellectual property protections associated with a trademark, give rise to the need for devising nonproprietary names for drug substances. The nonproprietary name is entirely in the public domain and may be used freely by anyone. This allows unrestricted communication between scientists and investigators by removing possible trademark obligations. Also known as the generic or common name, the official nonproprietary names for drug substances are provided by national and international nomenclature bodies.

The official nonproprietary names of both drug substances and drug products are sometimes referred to as the established names (also compendial or pharmacopeial names) for an official article. These are “established” by appearing in the official pharmacopeia of a country (e.g., the United States Pharmacopeia; USP). When developing titles for the compendial monographs of drug products, the USP uses the official nonproprietary name of the drug substance, the route of administration, and the dosage form to prepare what will become the entire established name for the drug product when the monograph is final. The established name is used for all legal and regulatory matters that might pertain to an individual drug substance or drug product and should be used in all official correspondence.

This article examines the process by which nonproprietary names for drug products are devised. Rules for naming drug products extend these rules, encompassing the goals of creating a unique, descriptive name that will not be confusing for physician, pharmacist, or patient.

A discussion of other drug names concludes the article. These names—chemical, proprietary, trivial, pharmacy equivalent, and proper—are useful in a variety of arenas and are often used in conjunction with nonproprietary names.

Drug products
Most conventional pharmaceutical products (tablets, capsules, creams, etc.) can be easily named using the United States Adopted Names (USAN) of the drug substance; a standardized descriptor from the General Information Chapter, Pharmaceutical Dosage Forms, of the United States Pharmacopeia; and the route of administration (when necessary).

However, formulation science is a rapidly evolving and highly competitive area of pharmaceutical research. New dosage forms use complex technologies and defy simple classification. How are these novel dosage forms to be named in a way that will satisfy the drug innovator, the FDA, and the USP in a timely manner?

When a reviewing division at the FDA’s Center for Drug Evaluation and Research (CDER) encounters one of these novel products, it usually asks for advice from the CDER Labeling and Nomenclature Committee (LNC). The LNC evaluates the innovator’s proposal and provides an opinion to the reviewing division on the acceptability of the proposed established name. The LNC tries to coordinate the discussions of key groups with an interest in nomenclature within the agency so that a consolidated position is developed. In particular, the Office of Post-Marketing Drug Risk Assessment is consulted for an opinion about the risk of medical error in using a particular naming convention.

Once this position has been agreed to within the FDA, usually the chair of the LNC and the chief of the Compendial Operations Staff at the FDA present the recommended naming convention to the USP nomenclature committee. This committee is responsible for adopting nomenclature for all articles that appear in the Pharmacopeia proper and in the USP Dispensing Information.

Hopefully, before FDA approval, a consensus will be reached between the drug innovator, the FDA, and the USP about the most acceptable nomenclature. However, the FDA may need to approve an application before the USP has a chance to officially adopt the proposed terminology. In these cases, the FDA-approved name is the interim established name for the product. If the USP chooses a different naming convention, the approved name is changed to coincide with the pharmacopeial name. Recent examples of coordinated nomenclature efforts for novel products include orally disintegrating tablets, liposomes, and microspheres.

It should be noted that the Center for Biologics Evaluation and Research (CBER) at the FDA uses an independent approach to naming new drugs. It does not generally use the CDER LNC or compendial operations in developing what is known in CBER as the proper name for a biologic product.

Other useful names
Chemical. The chemical name for a specific molecule is devised by using the nomenclature rules of the International Union of Pure and Applied Chemistry (IUPAC). Some modifications of the IUPAC rules are used to provide the Chemical Abstracts Service (CAS) name. CAS is an indexing and referencing system to the world’s chemical literature that is administered by the American Chemical Society. The CAS name and registry number provide a unique coding system that permits straightforward literature searching. These names generally provide valuable information to the practicing chemist but are often very long, complex, and unpronounceable, which makes them of little help to healthcare professionals.


Proprietary. The proprietary name for a product or technology is owned by an individual company and is developed as part of a company’s intellectual property portfolio, including patents, licenses, and copyrights. Trademark laws provide protection against improper use of a proprietary name. Also known as brand names or trademarks, they may be registered with the patent and trademark office of the country where the company sells its products. However, a trademark does not have to be registered with the U.S. Patent and Trademark Office to enjoy the benefits of trademark law. A trade name is the name used by a firm under which it does business. There are certain advantages to registration, and practically all companies register their trademarks.

Trivial. A trivial acronym such as HCTZ (hydrochlorthiazide) or AZT (azidothymidine, later to be officially called zidovudine) may be coined for convenience in a research paper, at a hospital site during a drug study, or as a mnemonic for computer databases. A trivial name may also arise through the loss of a proprietary name to the public domain by ineffectual protection efforts by the owner. Examples of such names are aspirin, cellophane, and escalator, all former trademarks. These trivial names are persistent and sometimes hamper the adoption of formally developed official nomenclature.

Pharmacy equivalent. Some official pharmacopeias (including the USP) have proposed Pharmacy Equivalent Names (PENs) for complicated products in cases in which it may be impractical to write the complete official title. These are informational names for convenience only and do not supersede a complete title. An example of a PEN is Co-trimoxazole, obtained by combining euphonious syllables from the individual ingredients, trimethoprim and sulfamethoxazole. A PEN is not an official name and is not required in the labeling of a drug product.

Proper name. CBER develops what is termed the proper name for a biologic in conjunction with the manufacturer. The proper name of a biologic, as applied to a product, means the name designated in the license for use on each package of the product.

Because there are many confusing synonyms for drug substances (nonproprietary name, generic name, common name, established name, compendial name, etc.), it can be difficult to understand naming conventions and processes. Legal, scientific, and regulatory demands require an unambiguous system for identifying these highly regulated products. A clear, concise name promotes accurate product selection and provides safer health care for all.

I thank Stephen P. Miller, Bonnie Dunn, and Yuan-Yuan Chiu for their assistance in preparing this article.

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