PRIA, Government Policy, Made Personal

Summary

The Secretary may choose one official name for any drug or device when doing so will make names simpler and more useful. Once picked, that name must be the only official name used in the official drug and device books and for purposes of this law. The Secretary must not pick a name that violates a valid trademark. After October 10, 1962, and whenever needed, the Secretary must review the names used in the United States Pharmacopoeia, the Homoeopathic Pharmacopoeia of the United States, the National Formulary, and any official device compendiums. If a name is too complex, if multiple names refer to the same product, or if a useful product has no official name, the Secretary will ask the compilers of those books to recommend a single name. If no recommendation arrives in one hundred and eighty days, or the recommendation is not suitable, the Secretary will pick the name. Official name decisions are made by public notice and the rulemaking process in section 553 of title 5. The Secretary must also publish and distribute lists of revised official names and must act when a compendium compiler asks in writing for a name.

Title 21, §358

Food and Drugs, Source: USLM XML via OLRC

(a)Necessity or desirability; use in official compendiums; infringement of trademarks

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)Review of names in official compendiums

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)Determinations of complexity, usefulness, multiplicity, or lack of name; designation by Secretary

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)Revised official names; compilation, publication, and public distribution of listings

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)Request by compiler of official compendium for designation of name

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