
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC358]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
                        Part A--Drugs and Devices
 
Sec. 358. Authority to designate official names


(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) of this section, 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.

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


                               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''.


                             Effective Date

    Section 111(b) of Pub. L. 87-781 provided that: ``This section 
[enacting this section] shall take effect on the date of its enactment 
[Oct. 10, 1962].''

                  Section Referred to in Other Sections

    This section is referred to in section 352 of this title.
