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CDER DATA STANDARDS MANUAL |
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CDER DATA STANDARDS MANUAL |
CDER Policy:
Policy for Use of Drug Name Terms. Appropriate terms shall be used when referring to the different types of drug names, as defined below. This includes, but is not limited to, the mention of these terms in the Code of Federal Regulations, databases, outgoing correspondence, and on the Internet/Intranet. Of particular concern is the improper usage of the term "Trade Name" where the term "Proprietary Name" is often meant.
Term Definitions:
Brand Name: (See Proprietary Name) A word, name, symbol, etc., especially one legally registered as a trademark, used by a manufacturer to identify its products distinctively from others of the same type.
Chemical Name: The name generated using the nomenclature conventions of the International Union of Pure and Applied Chemistry (IUPAC). Several correct names may be formulated using these rules but ordinarily the accepted chemical name will be the name listed by the Chemical Abstracts Service (CAS) and is conveniently located in the USAN dictionary.
Compendial Name: The name of an article for which a monograph is provided in an official compendia (e.g., United States Pharmacopeia, National Formulary, or Homeopathic Pharmacopeia) recognized by the Food, Drug, and Cosmetic Act. An article may be an official substance or official preparation.
Drug: As defined under the Federal Food, Drug, and Cosmetic Act, as amended (section 201(g)), applies to both drug substances and drug products.
Established Name: The designated FDA Official name, the Compendial name, the USAN Council name or the common or usual name (section 502(e)(3) of the Act and 21 CFR 299.4). Ordinarily, the established name of a drug will be the compendial name. However, FDA may designate an established name in cases where a monograph does not exist.
Generic Name: An official or unofficial designation by which a drug is commonly available, unprotected by a trademark.
INN Name: The International Nonproprietary Name designated by the World Health Organization (WHO). Usually the USAN and INN name are identical. WHO only assigns names to active drug moieties.
Nonproprietary Name: A name unprotected by trademark rights that is entirely in the public domain. It may be used without restriction by the public at large, both lay and professional.
Official: The word "official" as used in the United States Pharmacopeia, is synonymous with "Pharmacopeial", with "USP", and with "compendial."
Official Name: The name designated under the provisions of section 508(a) of the Federal Food, Drug, and Cosmetic Act.
Official Preparation: A drug product, a nutritional supplement or a finished device.
Official Substance: An active drug entity, a recognized nutrient, or a pharmaceutic ingredient for which the USP monograph title includes no indication of the nature of the finished form.
Proprietary Name: The exclusive name of a drug substance or drug product owned by a company under trademark law regardless of registration status with the PTO.
Trademark: The words, names, slogans, pictures or symbols that are used to identify the source of a particular company's drug or technology.
Tradename: The words, names, slogans, pictures or symbols that are used to identify a company. In common usage, tradename is often used inappropriately for brand name and trademark.
USAN Name: The Official nonproprietary name published in the USP Dictionary of USAN and International Drug NamesA by the United States Adopted names Council.
CDER Approval Date: November 8, 1996.