SUBCHAPTER F -- NATIONAL UNIFORMITY
FOR NONPRESCRIPTION DRUGS AND PREEMPTION FOR LABELING OR PACKAGING OF COSMETICS
SEC. 751. [379r] NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS.
- (a) IN GENERAL.--Except as provided in subsection (b), (c)(l), (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)(l)(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, alter notice and opportunity
for written and oral presentation of views, exempt fiom 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 EFFECTNENESS. 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 mis- branded, subsection (a) shall apply only with respect
to a requirement of a State or political subdivision of a State that
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 ref- erendum 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.
SEC. 752. [379s] PREEMPIION 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 ces- metic that is different
from or in addition to, or that is otherwise not identical with, a requirement
specifically applicable to a par- ticular 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, alter 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.
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