Page:United States Statutes at Large Volume 76.djvu/838

 790

PUBLIC LAW 87-781-OCT. 10, 1962

60 Stat. 238.

[76 STAT.

" (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 oflEicial 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 Proccdure Act (5 U.S.C. 1003) designate the official name of the drug for which the request is made." (b) This section shall take effect on the date of its enactment. N A M E TO BE USED ON DRUG l A B E L

52 Stat. 1050.

^

Ante. p. 789.

SEC. 112. (a) Section 502(e) of such Act (21 U.S.C. 352(e)) is amended by— (1) inserting the subparagraph designation " (1) " after " (e) "; (2) striking out the words "If it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears (1) the common or usual name of the drug, if such there be; and (2), in case it is fabricated from two or more ingredients, the common or usual name of each active ingredient", and inserting in lieu thereof "If it is a drug, unless (A) its label bears, to the exclusion of any other nonproprietary name (except the applicable systematic chemical name or the chemical formula), (i) the established name (as defined in subparagraph (2)) of the drug, if such there be, and (ii), in case it is fabricated from two or more ingredients, the established name and quantity of each active ingredient"; (3) striking out the words "the name" and inserting in lieu thereof the words "the established name"; (4) inserting therein, immediately after the colon following the words "contained therein", the following: ''Provided, That the requirement for stating the quantity of the active ingredients, other than the quantity of those specifically named in this paragraph, shall apply only to prescription drugs; and (B) for any prescription drug the established name of such drug or ingredient, as the case may be, on such label (and on any labeling on which a name for such drug or ingredient is used) is printed prominently and in type at least half as large as that used thereon for any proprietary name or designation for such drug or ingredient:"; (5) striking out the words "clause (2) of this paragraph" in the proviso to such paragraph and inserting in lieu thereof "clause (A) (ii) or clause (B) of this subparagraph"; and (6) adding at the end of such paragraph the following new subparagraph: "(2) As used in this paragraph (e), the term 'established name', with respect to a drug or ingredient thereof, means (A) the applicable official name designated pursuant to section 508, or (B), if there is no such name and such drug, or such ingredient, is an article recognized in an official compendium, then.the official title thereof in such compendium, or (C) if neither clause (A) nor clause (B) of this subparagraph applies, then the common or usual name, if any, of such drug or of such ingredient: Provided further, That where clause (B) of this subparagraph applies to an article recognized in the United States

�