Prescription Drug & Medication Mistakes

More Federal Code on Medical Errors

Code 299.4.

[Code of Federal Regulations]
[Title 21, Volume 4, Parts 200 to 299]
[Revised as of April 1, 2000]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR299.4]

[Page 178-179]

TITLE 21--FOOD AND DRUGS

HUMAN SERVICES

PART 299--DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES--Table of Contents

Subpart A--General Provisions

Sec. 299.4 Established names for drugs.

(a) Section 508 of the Federal Food, Drug, and Cosmetic Act (added
by the Kefauver-Harris Drug Amendments of 1962; Pub. L. 87-781)
authorizes the Commissioner of Food and Drugs to designate an official
name for any drug if he determines that such action is necessary or
desirable in the interest of usefulness and simplicity. Section 502(e)
of the act (as amended by said Drug Amendments) prescribes that the
labeling of a drug must bear its established name, if there is one, to
the exclusion of any other nonproprietary name (except the applicable
systematic chemical name or the chemical formula) and, if the drug is
fabricated from two or more ingredients, the established name of each
active ingredient.
(b) The term established name is defined in section 502(e)(3) of the
act as (1) an official name designated pursuant to section 508 of the
act; (2) if no such official name has been designated for the drug and
the drug is an article recognized in an official compendium, then the
official title thereof in such compendium; and (3) if neither paragraphs
(b) (1) or (2) of this section applies, then the common or usual name of
the drug.
(c) The Food and Drug Administration recognizes the skill and
experience of the U.S. Adopted Names Council (USAN) in deriving names
for drugs. The U.S. Adopted Names Council is a private organization
sponsored by the American Medical Association, the United States
Pharmacopeia, and the

[[Page 179]]

American Pharmaceutical Association, and has been engaged in the
assignment of names to drugs since January 1964. The Council negotiates
with manufacturing firms in the selection of nonproprietary names for
drugs.
(d) The Food and Drug Administration cooperates with and is
represented on the USAN Council. In addition, the Food and Drug
Administration agrees with ``Guiding Principles for Coining U.S. Adopted
Names for Drugs,'' published in USAN and the USP Dictionary of Drug
Names (USAN 1985 ed., 1961-1984 cumulative list), which is incorporated
by reference. Copies are available from: U.S. Pharmacopeial Convention,
Inc., 12601 Twinbrook Parkway, Rockville, MD 20852, or are available for
inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408. All applicants for new-
drug applications and sponsors for ``Investigational New Drug
Applications'' (IND's) are encouraged to contact the USAN Council for
assistance in selection of a simple and useful name for a new chemical
entity. Approval of a new-drug application providing for the use of a
new drug substance may be delayed if a simple and useful nonproprietary
name does not exist for the substance and if one is not proposed in the
application that meets the above-cited guidelines. Prior use of a name
in the medical literature or otherwise will not commit the Food and Drug
Administration to adopting such terminology as official.
(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 and 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. The Food and Drug Administration, however,
will continue to publish official names under the provisions of section
508 of the act when the agency determines that:
(1) The USAN or other official or common or usual name is unduly
complex or is not useful for any other reason;
(2) Two or more official names have been applied to a single drug,
or to two or more drugs that are identical in chemical structure and
pharmacological action and that are substantially identical in strength,
quality, and purity; or
(3) No USAN or other official or common or usual name has been
applied to a medically useful drug. Any official name published under
section 508 of the act will be the established name of the drug.
(f) A cumulative list of U.S. adopted names selected and released
since June 15, 1961, is published yearly by the U.S. Pharmacopeial
Convention, Inc., in USAN and the USP Dictionary of Drug Names. Copies
may be purchased from the U.S. Pharmacopeial Convention, Inc., 12601
Twinbrook Parkway, Rockville, MD 20852.

[40 FR 14041, Mar. 27, 1975, as amended at 49 FR 37575, Sept. 25, 1984;
53 FR 5369, Feb. 24, 1988; 55 FR 11577, Mar. 29, 1990; 64 FR 401, Jan.
5, 1999]