Detailed Instructions: In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.
Problem:SECTION 1. SHORT TITLE.

This Act may be cited as the ''Stop Tampering of Prescription Pills
Act of 2012''.

SEC. 2. TAMPER-RESISTANT TECHNOLOGY.

(a) Definition.--Section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the
following:
''(ss) The term 'tamper-resistant drug' means a drug that--
''(1) contains as an active moiety a controlled substance
that has been classified as opium, an opiate, or a derivative
thereof, as such terms are defined or used in section 102 of
the Controlled Substances Act;
''(2) has been formulated for oral administration; and
''(3)(A) exhibits physicochemical properties (demonstrated
by in vitro, in vivo, or other testing, or some combination
thereof, as determined appropriate by the Secretary) that make
product manipulation significantly more difficult or
ineffective in altering the characteristics of the drug for
purposes of misuse or abuse when compared to drugs without such
properties; or
''(B) contains one or more additional active or inactive
ingredients that are intended to deter abuse through potential
pharmacological effects, the effectiveness of which has been
demonstrated by at least one adequate and well-controlled
investigation.''.
(b) Required Information in Application for Approval of Brand Name
Drugs.--Section 505(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(b)) is amended by adding at the end the following:
''(7) Tamper-resistant drugs.--If an application submitted
under this subsection is potentially subject to refusal under
subsection (d)(7), the application shall include such
information as the Secretary determines necessary to
demonstrate that the application is not subject to such
refusal.''.
(c) Approval of New Brand Name Drugs.--Section 505(d) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)) is amended--
(1) by inserting ''(7)(A) such drug has been formulated for
oral administration; (B) such drug contains as an active moiety
a controlled substance that has been classified as opium, an
opiate, or a derivative thereof, as such terms are defined or
used in section 102 of the Controlled Substances Act; (C) such
drug is not a tamper-resistant drug; and (D) the Secretary has
previously approved pursuant to an application submitted under
subsection (b) or (j) a drug that (i) contains the same active
moiety; (ii) is a tamper-resistant drug, and (iii) has not been
discontinued from marketing; or'' after ''(6) the application
failed to contain the patent information prescribed by
subsection (b); or'';
(2) by striking ''(7) based on fair'' and inserting ''(8)
based on fair'';
(3) by striking ''clauses (1) through (6)'' and inserting
''paragraphs (1) through (7)''; and
(4) by inserting ''The Secretary may issue an order
approving an application, even if paragraph (7) applies, upon a
finding that paragraphs (1) through (6) and paragraph (8) do
not apply and that such approval is necessary either to prevent
or alleviate a drug shortage or to otherwise address a
significant unmet public health need.'' before ''As used in
this subsection and subsection (e)''.
(d) Generic Drugs.--Section 505(j) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)) is amended--
(1) in paragraph (2)--
(A) subparagraph (A)--
(i) in clause (vii), by striking ''and'' at
the end;
(ii) in clause (viii), by striking the
period at the end and inserting ''; and'';
(iii) by inserting after clause (viii) the
following:
''(ix) if the listed drug is a tamper-resistant drug due to
its physicochemical properties, information from comparative in
vitro, in vivo, or other testing, or some combination thereof,
as appropriate based on the type of data submitted for the
listed drug, that demonstrates the new drug resists
manipulation or the effect of manipulation to a degree at least
comparable to the listed drug.''; and
(iv) in the continuation text at the end of
the subparagraph, by striking ''clauses (i)
through (viii)'' and inserting ''clauses (i)
through (ix)'';
(B) in subparagraph (C)--
(i) in clause (i), by striking ''or'' at
the end;
(ii) in clause (ii), by striking the period
at the end and inserting ''; or''; and
(iii) by adding at the end the following:
''(iii) that the listed drug is a tamper-resistant drug and
one or more of the new drug's active moieties differ in any
material respect (in amount or otherwise) from those of the
listed drug.'';
(2) in paragraph (5), by adding at the end the following:
''(G) If a drug has been approved pursuant to an application
submitted under paragraph (2), and thereafter the listed drug referred
to in the application becomes a tamper-resistant drug, the drug so
approved shall not be considered to be bioequivalent to, or to have the
same therapeutic effect as, the listed drug (as described in paragraph
(2)(A)(iv)) unless and until the drug so approved has been found by the
Secretary to meet the requirements of paragraph (2)(A)(ix).''; and
(3) in paragraph (6)--
(A) by striking ''(6) If a drug'' and inserting
''(6)(A) If a drug'';
(B) by striking ''(A) for the'' and inserting ''(i)
for the'';
(C) by striking ''(B) if the'' and inserting ''(ii)
if the''; and
(D) by adding at the end the following:
''(B) For purposes of this paragraph and paragraph (7)(C), a
withdrawal or suspension of a drug formulated for oral administration
shall be considered to have been for safety or effectiveness reasons
if--
''(i) the approval of a listed drug, which is not a tamper-
resistant drug, is withdrawn or suspended, or a listed drug,
which is not a tamper-resistant drug, is withdrawn from sale;
and
''(ii) the Secretary has previously approved pursuant to an
application under subsection (b) a drug that--
''(I) is in the same dosage form;
''(II) contains the same controlled substance as an
active moiety;
''(III) is a tamper-resistant drug; and
''(IV) has not been discontinued from marketing.''.
(e) Withdrawal of Previously Approved Brand Name and Generic
Drugs.--Section 505(e) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(e)) is amended--
(1) by inserting ''or (6)(A) the drug contains as an active
moiety a controlled substance that has been classified as
opium, an opiate, or a derivative thereof, as such terms are
defined or used in section 102 of the Controlled Substances
Act; (B) the drug is formulated for oral administration; (C)
the drug is not a tamper-resistant drug; and (D) the Secretary
has previously approved pursuant to an application submitted
under subsection (b) or (j) a drug that contains the same
active moiety, is a tamper-resistant drug, and has not been
discontinued from marketing'' before '': Provided,''; and
(2) by adding at the end the following: ''The Secretary may
waive the application of paragraph (6) of the first sentence of
this subsection in the case of a drug intended for use in a
special needs population. In withdrawing (under paragraph (6)
of the first sentence of this subsection) the approval of an
application with respect to any drug, the Secretary shall, on a
case-by-case basis, delay the effective date of such withdrawal
for a period deemed sufficient by the Secretary to give the
sponsor an opportunity to obtain approval under this section
for a formulation of the drug meeting the criteria described in
paragraph (2) of the definition of a 'tamper-resistant drug' in
section 201(ss).''.
(f) Listed Drugs.--Section 505(j)(7) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(7)) is amended by adding at the end the
following:
''(D) Beginning 60 days after the date of the enactment of the Stop
Tampering of Prescription Pills Act of 2012, the Secretary shall--
''(i) include in the list under subparagraph (A) a list of
each drug or category of drugs which the Secretary has found to
be tamper-resistant drugs; and
''(ii) update the list under subparagraph (A)--
''(I) to remove from the list of tamper-resistant
drugs any drug the Secretary later determines is not a
tamper-resistant drug; and
''(II) as required by subparagraph (C) to reflect
the application of paragraph (6)(B) to drugs that are
withdrawn or suspended.''.
Solution:
Stop Tampering of Prescription Pills Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to prescribe new drug application requirements for tamper-resistant drugs: (1) containing as an active moiety (the part of the drug that makes it work the way it does) a controlled substance classified as opium, an opiate, or a derivative; (2) formulated for oral administration; (3) exhibiting physicochemical properties making them significantly more difficult or ineffective in altering the drug's characteristics for purposes of misuse or abuse; and (4) containing one or more additional ingredients intended to deter abuse through potential pharmacological effects.

Requires the Secretary to refuse a new drug application for any new (brand name) drug containing opium, an opiate, or a derivative as an active moiety that is not tamper-resistant if a tamper-resistant drug containing the same active moiety has been approved and has not been discontinued from marketing. Authorizes the Secretary to approve an application failing to meet such requirements, however, if approval is necessary to prevent or alleviate a drug shortage or otherwise address a significant unmet public health need.

Requires an abbreviated new (generic) drug application for a tamper-resistant drug to include testing information demonstrating that the generic drug resists manipulation or the effect of manipulation to a degree at least comparable to the listed drug. Authorizes the Secretary to deny approval of a generic application if the listed drug is tamper-resistant and one or more of the generic drug's active moieties differ in any material respect from those of the listed drug.

Declares that an approved generic drug shall not be considered bioequivalent to, or as having the same therapeutic effect as, a listed drug if the listed drug becomes tamper-resistant unless and until the generic drug demonstrates that it resists manipulation or the effect of manipulation to a degree at least comparable to the listed drug.

Prescribes requirements governing when a drug which is not tamper-resistant may have its approval withdrawn or suspended.