Page:United States Statutes at Large Volume 111 Part 3.djvu/287

 PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2375 relates to the same subject as, but is different from or in addition to, or that is otherwise not identical with— "(A) a regulation in effect with respect to the drug pursuant to a statute described in subsection (a)(2); or "(B) any other requirement in effect with respect to the drug pursuant to an amendment to such a statute made on or after the date of enactment of the Food and Drug Administration Modernization Act of 1997. "(2) STATE INITIATIVES.—This section shall not apply to a State requirement adopted by a State public initiative or referendum enacted prior to September 1, 1997. "(e) No EFFECT ON PRODUCT LIABILITY LAW.— Nothing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State. "(f) STATE ENFORCEMENT AUTHORITY.— Nothing in this section shall prevent a State or political subdivision thereof from enforcing, under any relevant civil or other enforcement authority, a requirement that is identical to a requirement of this Act.". (b) INSPECTIONS.— Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended by striking "prescription drugs" each place it appears and inserting "prescription drugs, nonprescription drugs intended for human use,". (c) MISBRANDING.— Subparagraph (1) of section 502(e) (21 U.S.C. 352(e)(1)) is amended to read as follows: "(1)(A) If it is a drug, unless 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 (3)) of the drug, if there is such a name; "(ii) the established name and quantity or, if determined to be appropriate by the Secretary, the proportion of each active ingredient, including the quantity, kind, and proportion of any alcohol, and also including whether active or not the established name and quantity or if determined to be appropriate by the Secretary, the proportion of any bromides, ether, chloroform, acetanilide, acetophenetidin, amidopyrine, anti- P3rrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein, except that the requirement for stating the quantity of the active ingredients, other than the quantity of those specifically named in this subclause, shall not apply to nonprescription drugs not intended for human use; and "(iii) the established name of each inactive ingredient listed in alphabetical order on the outside container of the retail package and, if determined to be appropriate by the Secretary, on the immediate container, as prescribed in regulation promulgated by the Secretary, except that nothing in this subclause shall be deemed to require that any trade secret be divulged, and except that the requirements of this subclause with respect to alphabetical order shall apply only to nonprescription drugs that are not also cosmetics and that this subclause shall not apply to nonprescription drugs not intended for human use. "(B) For any prescription drug the established name of such drug or ingredient, as the case may be, on such label (and on

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