§ 358. Authority to designate official names

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Drug Amendments of 1962

   Pub. L. 87–781 title I § 111(a) · 76 Stat. 780

   Enacted · 21 U.S.C. § 358

   June 25, 1938, ch. 675, § 508, as added Pub. L. 87–781, title I, § 111(a), Oct. 10, 1962, 76 Stat. 789

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 508, as added Pub. L. 87–781, title I, § 111(a), Oct. 10, 1962, 76 Stat. 789

   Enacted provision · exact public law section
   (a) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.), as amended by this Act, is further amended by adding at the end of chapter V the following new section: “Sec. 508. “authority to designate official names (a) The Secretary may designate an official name for any drug 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 shall be the only official name of that drug used in any official compendium published after such name has been prescribed or for any other purpose of this Act. In no event, however, shall the Secretary establish an official name so as to infringe a valid trademark. “(b) Within a reasonable time after the effective date of this section, 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 drug Review of names. are identified in the official United States Pharmacopeia, the official Homoeopathic Pharmacopoeia of the United States, and the official National Formulary, 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 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 (3) no official name has been applied to a medically useful drug, he shall transmit in writing to the compiler of each official compendium in which that drug or drugs are identified and recognized his request for the recommendation of a single official name for such drug or drugs 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. Whenever he determines that the name so recommended is useful, he shall designate that name as the official name of such drug or drugs. Such designation shall be made as a regulation upon public notice and in accordance with the procedure set forth in section 4 of the Administrative Procedure Act (5 U.S.C. 1003). 60 Stat. 238. “(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 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 section 508(a), he shall upon public notice and in accordance with the procedure set forth in section 4 of the Administrative Procedure 60 Stat. 238. Act (5 U.S.C. 1003) designate the official name of the drug for which the request is made.”

2. 1976

   Medical Device Amendments of 1976

   Pub. L. 94–295 § 5(b) · 90 Stat. 539

   Substituted · 21 U.S.C. § 358(a)

   Pub. L. 94–295 substituted “drug or device” for “drug” wherever appearing

   Source evidence

   Code amendment note
   Subsec. (a). Pub. L. 94–295 substituted “drug or device” for “drug” wherever appearing.

   Enacted provision · exact public law section
   (b) Section 508 is amended (1) in subsections (a) and (e) by adding “or device” after “drug” each time it appears; (2) in subsection (b) by adding after “all supplements thereto,” the following: “and at such times as he may deem necessary shall cause a review Review. to be made of the official names by which devices are identified in any official compendium (and all supplements thereto)”; (3) in subsection (c) (2) by adding “or device” after “single drug”, and by adding “or to two or more devices which are substantially equivalent in design mid purpose.” after “purity,”; (4) in subsection (c)(3) by adding “or device” after “useful drug”, and after “drug or drugs’ each time it appears; and (5) in subsection (d) by adding “or devices” after “drugs”.

3. 1976

   Medical Device Amendments of 1976

   Pub. L. 94–295 § 5(b) · 90 Stat. 539

   Substituted · 21 U.S.C. § 358(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,”

   Source evidence

   Code amendment note
   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,”.

   Enacted provision · exact public law section
   (b) Section 508 is amended (1) in subsections (a) and (e) by adding “or device” after “drug” each time it appears; (2) in subsection (b) by adding after “all supplements thereto,” the following: “and at such times as he may deem necessary shall cause a review Review. to be made of the official names by which devices are identified in any official compendium (and all supplements thereto)”; (3) in subsection (c) (2) by adding “or device” after “single drug”, and by adding “or to two or more devices which are substantially equivalent in design mid purpose.” after “purity,”; (4) in subsection (c)(3) by adding “or device” after “useful drug”, and after “drug or drugs’ each time it appears; and (5) in subsection (d) by adding “or devices” after “drugs”.

4. 1976

   Medical Device Amendments of 1976

   Pub. L. 94–295 § 5(b) · 90 Stat. 539

   Inserted · 21 U.S.C. § 358(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,”

   Source evidence

   Code amendment note
   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,”.

   Enacted provision · exact public law section
   (b) Section 508 is amended (1) in subsections (a) and (e) by adding “or device” after “drug” each time it appears; (2) in subsection (b) by adding after “all supplements thereto,” the following: “and at such times as he may deem necessary shall cause a review Review. to be made of the official names by which devices are identified in any official compendium (and all supplements thereto)”; (3) in subsection (c) (2) by adding “or device” after “single drug”, and by adding “or to two or more devices which are substantially equivalent in design mid purpose.” after “purity,”; (4) in subsection (c)(3) by adding “or device” after “useful drug”, and after “drug or drugs’ each time it appears; and (5) in subsection (d) by adding “or devices” after “drugs”.

5. 1976

   Medical Device Amendments of 1976

   Pub. L. 94–295 § 5(b) · 90 Stat. 539

   Inserted · 21 U.S.C. § 358(c)(3)

   Pub. L. 94–295 inserted “or device” after “useful drug” and after “drug or drugs” wherever appearing

   Source evidence

   Code amendment note
   Subsec. (c)(3). Pub. L. 94–295 inserted “or device” after “useful drug” and after “drug or drugs” wherever appearing.

   Enacted provision · exact public law section
   (b) Section 508 is amended (1) in subsections (a) and (e) by adding “or device” after “drug” each time it appears; (2) in subsection (b) by adding after “all supplements thereto,” the following: “and at such times as he may deem necessary shall cause a review Review. to be made of the official names by which devices are identified in any official compendium (and all supplements thereto)”; (3) in subsection (c) (2) by adding “or device” after “single drug”, and by adding “or to two or more devices which are substantially equivalent in design mid purpose.” after “purity,”; (4) in subsection (c)(3) by adding “or device” after “useful drug”, and after “drug or drugs’ each time it appears; and (5) in subsection (d) by adding “or devices” after “drugs”.

6. 1976

   Medical Device Amendments of 1976

   Pub. L. 94–295 § 5(b) · 90 Stat. 539

   Inserted · 21 U.S.C. § 358(d)

   Pub. L. 94–295 inserted “or devices” after “drugs”

   Source evidence

   Code amendment note
   Subsec. (d). Pub. L. 94–295 inserted “or devices” after “drugs”.

   Enacted provision · exact public law section
   (b) Section 508 is amended (1) in subsections (a) and (e) by adding “or device” after “drug” each time it appears; (2) in subsection (b) by adding after “all supplements thereto,” the following: “and at such times as he may deem necessary shall cause a review Review. to be made of the official names by which devices are identified in any official compendium (and all supplements thereto)”; (3) in subsection (c) (2) by adding “or device” after “single drug”, and by adding “or to two or more devices which are substantially equivalent in design mid purpose.” after “purity,”; (4) in subsection (c)(3) by adding “or device” after “useful drug”, and after “drug or drugs’ each time it appears; and (5) in subsection (d) by adding “or devices” after “drugs”.

7. 1976

   Medical Device Amendments of 1976

   Pub. L. 94–295 § 5(b) · 90 Stat. 539

   Substituted · 21 U.S.C. § 358(e)

   Pub. L. 94–295 substituted “drug or device” for “drug”

   Source evidence

   Code amendment note
   Subsec. (e). Pub. L. 94–295 substituted “drug or device” for “drug”.

   Enacted provision · exact public law section
   (b) Section 508 is amended (1) in subsections (a) and (e) by adding “or device” after “drug” each time it appears; (2) in subsection (b) by adding after “all supplements thereto,” the following: “and at such times as he may deem necessary shall cause a review Review. to be made of the official names by which devices are identified in any official compendium (and all supplements thereto)”; (3) in subsection (c) (2) by adding “or device” after “single drug”, and by adding “or to two or more devices which are substantially equivalent in design mid purpose.” after “purity,”; (4) in subsection (c)(3) by adding “or device” after “useful drug”, and after “drug or drugs’ each time it appears; and (5) in subsection (d) by adding “or devices” after “drugs”.

8. 1993

   Nutrition Labeling and Education Act Amendments of 1993

   Pub. L. 103–80 § 3(q) · 107 Stat. 773

   Substituted · 21 U.S.C. § 358(c); 21 U.S.C. § 358(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)”

   Source evidence

   Code amendment note
   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)”.

   Enacted provision · exact public law section
   (q) Section 508.— Subsections (c) and (e) of section 508 (21 U.S.C. 358) are each amended by striking out “section 4 of the Administrative Procedure Act (5 U.S.C. 1003)” and inserting in lieu thereof “section 553 of title 5, United States Code”.

8 of 8 references resolved to an enrolled provision