21 U.S.C. § 358 — Authority to designate official names

submitted 88 years ago by Pub. L. 87-781 to r/title-21-FOOD-AND-DRUGS · 624 words · no verdicts yet

in plain englishAI-generated · not legal advice

The FDA Secretary can give a drug or device an official name when it's needed for simplicity or usefulness. That name becomes the only official name used in compendiums. The Secretary reviews existing names periodically and can require a single name when there are duplicates, overly complex names, or no name at all.

(a) When and how names are set: The Secretary can designate an official name for a drug or device if doing so is necessary or useful for keeping things simple and usable. Once designated, that official name is the only official name used for that drug or device in any official compendium published after the naming, and for any other purpose under this chapter. The Secretary can never pick a name that infringes on a valid trademark. (b) Reviewing existing names: Within a reasonable time after October 10, 1962, and again whenever the Secretary thinks it's needed, the Secretary must review the official names used for drugs in the U.S. Pharmacopoeia, the Homoeopathic Pharmacopoeia of the United States, the National Formulary, and their supplements. The Secretary must also review device names in any official compendium, to decide whether any names should be revised for simplicity or usefulness. (c) When the Secretary can act: After a review, if the Secretary finds that (1) a name is too complicated or otherwise not useful, (2) two or more official names apply to one drug or device — or to two or more drugs that are chemically and pharmacologically identical and nearly identical in strength, quality, and purity, or to two or more devices that are substantially equivalent in design and purpose — or (3) a useful drug or device has no official name at all, the Secretary must ask, in writing, each compendium that lists that drug or device to recommend a single simple, useful name. If no name is recommended within 180 days, or if the Secretary decides a recommended name isn't useful, the Secretary designates the official name directly. If the recommended name is useful, the Secretary adopts it as the official name. Either way, this designation must be made as a formal regulation, with public notice, following the rulemaking procedure in section 553 of title 5. (d) Publishing updated names: After each review, and whenever else the Secretary thinks it's needed, the Secretary must compile, publish, and distribute to the public a list of all revised official names, along with whatever descriptions or explanations are needed to use those names effectively. (e) Requests from compendium compilers: If a compendium compiler asks in writing for the Secretary to use this naming authority, the Secretary must designate the official name for the requested drug or device, again with public notice and following the section 553 rulemaking procedure.

the actual law source: uscode.house.gov ↗public domain

(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.

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.

Source credit: (June 25, 1938, ch. 675, § 508, as added Pub. L. 87–781, title I, § 111(a), Oct. 10, 1962, 76 Stat. 789; amended Pub. L. 94–295, § 5(b), May 28, 1976, 90 Stat. 581; Pub. L. 103–80, § 3(q), Aug. 13, 1993, 107 Stat. 777.)

history & why it existsrecord from the source credit

1938Enacted · Pub. L. 87-781 · 76 Stat. 789
1976Amended · Pub. L. 94-295 · 90 Stat. 581
1993Amended · Pub. L. 103-80 · 107 Stat. 777

A history note hasn’t been published yet. The record shows enactment by Pub. L. 87-781 on 1938-06-25.

all 0 arguments · sorted by: best

no arguments yet — make the first case