Browse Arkansas Code titles and sections
21 U.S.C. § 358 — Authority to designate official names
Federal law — U.S. Code and appendices · legal_authorities
**(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 st
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 358
Stored review status: release_metadata_unconfirmed. A text match is a research starting point; applicability is not established.
Original supplied file — preserved unchanged
Download original Markdown file
File SHA-256: b9edf1bd81d6d502a16fd32da845933fab0b33d5e38ac5a9577ab55295ac08ee. The original may include catalog metadata, neighboring provisions, or embedded records outside this collection's scope. Search shows only the selected federal record. Historical editions and unverified snapshots are not a statement of current law.
Authority boundary: historical or unconfirmed source not current law verified.
Open the recorded source website ↗
Record provenance
Stable record: federal_law:legal_authorities:record_usc_f9f4cc55bf45be0a226c7af0
Source file: Laws/federal/codes/united-states-code/title-21/section-358-authority-to-designate-official-names--da50d5d308.md
Pages: Not recorded – Not recorded
Passage SHA-256: e426802a8174dca5c9602c363c70c678605bcd27c0159d9e73750275120c4707
Source location: Title 21, Chapter 9, § 358; chapter-009-federal-food-drug-and-cosmetic-act.md
Stored source content
**(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section553&num=0&edition=prelim).
**(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section553&num=0&edition=prelim) designate the official name of the drug or device for which the request is made.
Cross-references
Connections may be documented source relationships, shared citations or nearby passages. Each explains its basis; a connection alone does not establish applicability to your situation.
Federal law — U.S. Code and appendices · legal_authorities
**(a) In General.—** This chapter, and any rule, order, or regulation promulgated under this chapter, shall apply to each advisory committee except to the extent that the Act establishing the advisory committee specifically provides otherwise.
**(b) Exemptions Relating to Certain Federal Entities.—** Nothing in this chapter shall be construed to apply to an advisory committee established or utilized by—
(1) the Central Intelligence Agency;
(2) the Federal Reserve System; or
(3) the Office of the Director of National Intelligence, if the Director of National Intelligence determines that for reasons of national security the advisory committee cannot comply with the requirements of this chapter.
**(c) Exemptions Relating to Certain Local and State Entities.—** Nothing in this chapter shall be construed to apply to any local civic group whose primary function is that of rendering a public service with respect to a Federal program, or any State or local committee, council, board, commission, or similar group established to advise or make recommendations to State or local officials or agencies.
Source: Supplied U.S. Code snapshot — release unconfirmed · 5 U.S.C. § 1003
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
**(a)** This section applies, according to the provisions thereof, except to the extent that there is involved—
(1) a military or foreign affairs function of the United States; or
(2) a matter relating to agency management or personnel or to public property, loans, grants, benefits, or contracts.
**(b)** General notice of proposed rule making shall be published in the Federal Register, unless persons subject thereto are named and either personally served or otherwise have actual notice thereof in accordance with law. The notice shall include—
(1) a statement of the time, place, and nature of public rule making proceedings;
(2) reference to the legal authority under which the rule is proposed;
(3) either the terms or substance of the proposed rule or a description of the subjects and issues involved; and
(4) the Internet address of a summary of not more than 100 words in length of the proposed rule, in plain language, that shall be posted on the Internet website under section 206(d) of the E-Government Act of 2002 ([44 U.S.C. 3501](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title44-section3501&num=0&edition=prelim) note) (commonly known as regulations.gov).
Except when notice or hearing is required by statute, this subsection does not apply—
(A) to interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice; or
(B) when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.
**(c)** After notice required by this section, the agency shall give interested persons an opportunity to participate in the rule making through subm
Source: Supplied U.S. Code snapshot — release unconfirmed · 5 U.S.C. § 553
Stored review status: release_metadata_unconfirmed. Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
A drug or device shall be deemed to be misbranded—
**(a) False or misleading label**
(1) If its labeling is false or misleading in any particular. Health care economic information provided to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis, carrying out its responsibilities for the selection of drugs or devices for coverage or reimbursement, shall not be considered to be false or misleading under this paragraph if the health care economic information relates to an indication approved under section 355, 360(k), 360c(f)(2), or 360e of this title or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) for such drug or device, is based on competent and reliable scientific evidence, and includes, where applicable, a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug or device under section 355, 360(k), 360c(f)(2), or 360e of this title or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim). The requirements set forth in section 355, 360(k), 360c(f)(2), or 360e of this title or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) shall not apply to health care economic information provided to such a payor, committee, or entity in accordance with this paragraph. Information that is relevant to the substantiation of the health care economic information presented pursuant to this paragraph shall be made available to the Secretary upon request.
(2)
(A) For purposes of th
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 352
Stored review status: release_metadata_unconfirmed. Incoming connection: Explicit cross-reference supplied in source Markdown; currentness and applicability require review.
Federal law — U.S. Code and appendices · legal_authorities
Page 300
TITLE 21—FOOD AND DRUGS
§ 358
shall finalize the taxonomy not later than 1 year
after the close of the public comment period.’’
§ 358. Authority to designate official names
(a) Necessity or desirability; use in official com-
pendiums; 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 de-
vice shall be the only official name of that drug
or device used in any official compendium pub-
lished after such name has been prescribed or for
any other purpose of this chapter. In no event,
however, shall the Secretary establish an offi-
cial 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 Pharma-
copoeia, the official Homoeopathic Pharma-
copoeia of the United States, and the official
National Formulary, and all supplements there-
to, 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 of-
ficial 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 com-
plex or is not useful for any other reason,
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 358
Stored review status: historical_2024_not_currentness_verified. Same stored citation; legal effect and authority still require review.