§358 — Title 21 Food and Drugs | U.S. Code

Summary

The Secretary can give an official name to any drug or medical device when doing so will make names simpler or more useful. Once an official name is set, that name must be the only official name used in official compendia and for the purposes of this law. The Secretary must not pick a name that violates a valid trademark. Soon after October 10, 1962, and whenever needed, the Secretary must review the names used in the main drug books (for example, the United States Pharmacopoeia, the Homoeopathic Pharmacopoeia, and the National Formulary) and in device compendia to see if names should change. If a name is too complex, if there are duplicate names for the same drug or device, or if a useful drug or device has no official name, the Secretary asks the compilers of those books to recommend one simple name. If no recommendation arrives within 180 days, or the recommendation is not useful, the Secretary will choose the official name. If a recommended name is useful, the Secretary will adopt it. Name decisions are published as regulations with public notice and follow the rulemaking steps in section 553 of title 5. The Secretary will publish a list of revised official names with helpful descriptions, and will act if a compiler asks in writing.

Title 21, §358

Food and Drugs — Source: USLM XML via OLRC

(a)The Secretary may designate an official name for any drug or device if he determines that such action is necessary or desirable in the interest of usefulness and simplicity. Any official name designated under this section for any drug or device shall be the only official name of that drug or device used in any official compendium published after such name has been prescribed or for any other purpose of this chapter. In no event, however, shall the Secretary establish an official name so as to infringe a valid trademark.

(b)Within a reasonable time after October 10, 1962, and at such other times as he may deem necessary, the Secretary shall cause a review to be made of the official names by which drugs are identified in the official United States Pharmacopoeia, the official Homoeopathic Pharmacopoeia of the United States, and the official National Formulary, and all supplements thereto, and at such times as he may deem necessary shall cause a review to be made of the official names by which devices are identified in any official compendium (and all supplements thereto) to determine whether revision of any of those names is necessary or desirable in the interest of usefulness and simplicity.

(c)Whenever he determines after any such review that (1) any such official 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 device, or to two or more drugs which are identical in chemical structure and pharmacological action and which are substantially identical in strength, quality, and purity, or to two or more devices which are substantially equivalent in design and purpose or (3) no official name has been applied to a medically useful drug or device, he shall transmit in writing to the compiler of each official compendium in which that drug or drugs or device are identified and recognized his request for the recommendation of a single official name for such drug or drugs or device which will have usefulness and simplicity. Whenever such a single official name has not been recommended within one hundred and eighty days after such request, or the Secretary determines that any name so recommended is not useful for any reason, he shall designate a single official name for such drug or drugs or device. Whenever he determines that the name so recommended is useful, he shall designate that name as the official name of such drug or drugs or device. Such designation shall be made as a regulation upon public notice and in accordance with the procedure set forth in section 553 of title 5.

(d)After each such review, and at such other times as the Secretary may determine to be necessary or desirable, the Secretary shall cause to be compiled, published, and publicly distributed a list which shall list all revised official names of drugs or devices designated under this section and shall contain such descriptive and explanatory matter as the Secretary may determine to be required for the effective use of those names.

(e)Upon a request in writing by any compiler of an official compendium that the Secretary exercise the authority granted to him under subsection (a), he shall upon public notice and in accordance with the procedure set forth in section 553 of title 5 designate the official name of the drug or device for which the request is made.

Notes & Related Subsidiaries

Editorial Notes

Amendments

1993—Subsecs. (c), (e). Pub. L. 103–80 substituted reference to section 553 of title 5 for “section 4 of the Administrative Procedure Act (5 U.S.C. 1003)”. 1976—Subsec. (a). Pub. L. 94–295 substituted “drug or device” for “drug” wherever appearing. Subsec. (b). Pub. L. 94–295 substituted “National Formulary, and all supplements thereto, and at such times as he may deem necessary shall cause a review to be made of the official names by which devices are identified in any official compendium (and all supplements thereto)” for “National Formulary, and all supplements thereto,”. Subsec. (c)(2). Pub. L. 94–295 inserted “or device” after “single drug”, and “or to two or more devices which are substantially equivalent in design and purpose” after “purity,”. Subsec. (c)(3). Pub. L. 94–295 inserted “or device” after “useful drug” and after “drug or drugs” wherever appearing. Subsec. (d). Pub. L. 94–295 inserted “or devices” after “drugs”. Subsec. (e). Pub. L. 94–295 substituted “drug or device” for “drug”.

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 87–781, title I, § 111(b), Oct. 10, 1962, 76 Stat. 790, provided that: “This section [enacting this section] shall take effect on the date of its enactment [Oct. 10, 1962].”

§358 Authority to Designate Official Names