name to be used on drug label

name to be used on drug label 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 or 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 76 Stat. 791Pharmacopeia and in the Homoeopathic Pharmacopoeia under different official titles, the official title used in the United States Pharmacopeia shall apply unless it is labeled and offered for sale as a homoeopathic drug, in which case the official title used in the Homoeopathic Pharmacopoeia shall apply.” (b) Section 502(g) of such Act (21 U.S.C. 352(g)) is amended by inserting immediately before the period at the end thereof a colon and the following proviso: “Provided further, That, in the event of inconsistency between the requirements of this paragraph and those of paragraph (e) as to the name by which the drug or its ingredients shall be designated, the requirements of paragraph (e) shall prevail”. (c) This section shall take effect on the first day of the seventh calendar month following the month in which this Act is enacted.