NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND COSMETICS.

SEC. 412. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND COSMETICS. (a) Nonprescription Drugs.—Chapter VII (21 U.S.C. 371 et seq.), as amended by section 411, is farther amended by adding at the end the following: 111 STAT. 2374 “Subchapter F—National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics “SEC. 751. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS. “(a) In General.—Except as provided in subsection (b), (c)(1), (d), (e), or (f), no State or political subdivision of a State may establish or continue in effect any requirement— “(1) that relates to the regulation of a drug that is not subject to the requirements of section 503(b)(1) or 503(f)(1)(A); and “(2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this Act, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.). “(b) Exemption.— “(1) In general.—Upon application of a State or political subdivision thereof, the Secretary may by regulation, after notice and opportunity for written and oral presentation of views, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a State or political subdivision requirement that— “(A) protects an important public interest that would otherwise be unprotected, including the health and safety of children; “(B) would not cause any drug to be in violation of any applicable requirement or prohibition under Federal law; and “(C) would not unduly burden interstate commerce. “(2) Timely action.—The Secretary shall make a decision on the exemption of a State or political subdivision requirement under paragraph (1) not later than 120 days after receiving the application of the State or political subdivision under paragraph (1). “(c) Scope.— “(1) In general.—This section shall not apply to— “(A) any State or political subdivision requirement that relates to the practice of pharmacy; or “(B) any State or political subdivision requirement that a drug be dispensed only upon the prescription of a practitioner licensed by law to administer such drug. “(2) Safety or effectiveness.—For purposes of subsection (a), a requirement that relates to the regulation of a drug shall be deemed to include any requirement relating to public information or any other form of public communication relating to a warning of any kind for a drug. “(d) Exceptions.— “(1) In general.—In the case of a drug described in subsection (a)(1) that is not the subject of an application approved under section 505 or section 507 (as in effect on the day before the date of enactment of the Food and Drug Administration Modernization Act of 1997) or a final regulation promulgated by the Secretary establishing conditions under which the drug is generally recognized as safe and effective and not misbranded, subsection (a) shall apply only with respect to a requirement of a State or political subdivision of a State that 111 STAT. 2375relates 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, antipyrine, 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 snail 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 111 STAT. 2376any labeling on which a name for such drug or ingredient is used) shall be 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, except that to the extent that compliance with the requirements of subclause (ii) or (iii) of clause (A) or this clause is impracticable, exemptions shall be established by regulations promulgated by the Secretary.”. (d) Cosmetics.—Subchapter F of chapter VII, as amended by subsection (a), is further amended by adding at the end the following: “SEC. 752. PREEMPTION FOR LABELING OR PACKAGING OF COSMETICS. “(a) In General.—Except as provided in subsection (b), (d), or (e), no State or political subdivision of a State may establish or continue in effect any requirement for labeling or packaging of a cosmetic that is different from or in addition to, or that is otherwise not identical with, a requirement specifically applicable to a particular cosmetic or class of cosmetics under this Act, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.). “(b) Exemption.—Upon application of a State or political subdivision thereof, the Secretary may by regulation, after notice and opportunity for written and oral presentation of views, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a State or political subdivision requirement for labeling or packaging that— “(1) protects an important public interest that would otherwise be unprotected; “(2) would not cause a cosmetic to be in violation of any applicable requirement or prohibition under Federal law; and “(3) would not unduly burden interstate commerce. “(c) Scope.—For purposes of subsection (a), a reference to a State requirement that relates to the packaging or labeling of a cosmetic means any specific requirement relating to the same aspect of such cosmetic as a requirement specifically applicable to that particular cosmetic or class of cosmetics under this Act for packaging or labeling, including any State requirement relating to public information or any other form of public communication. “(d) 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. “(e) State Initiative.—This section shall not apply to a State requirement adopted by a State public initiative or referendum enacted prior to September 1, 1997.”.