I 
112TH CONGRESS 
2D SESSION 
H. R. 6160 
To amend the Federal Food, Drug, and Cosmetic Act to incentivize the 
development of tamper-resistant drugs. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 19, 2012 
Mr. KEATING (for himself, Mrs. BONO MACK, Mr. ROGERS of Kentucky, Mr. 
LYNCH, Mr. RAHALL, Mr. TOWNS, and Mr. TIERNEY) introduced the fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
incentivize the development of tamper-resistant drugs. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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: 
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‘‘(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 opi-
ate, or a derivative thereof, as such terms are de-
fined or used in section 102 of the Controlled Sub-
stances Act; 
‘‘(2) has been formulated for oral administra-
tion; and 
‘‘(3)(A) exhibits physicochemical properties 
(demonstrated by in vitro, in vivo, or other testing, 
or some combination thereof, as determined appro-
priate by the Secretary) that make product manipu-
lation significantly more difficult or ineffective in al-
tering 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 effec-
tiveness 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 
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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 appli-
cation submitted under this subsection is potentially 
subject to refusal under subsection (d)(7), the appli-
cation shall include such information as the Sec-
retary determines necessary to demonstrate that the 
application is not subject to such refusal.’’. 
(c) APPROVAL OF NEW BRAND NAME DRUGS.—Sec-
tion 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 de-
rivative 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 ap-
plication failed to contain the patent information 
prescribed by subsection (b); or’’; 
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(2) by striking ‘‘(7) based on fair’’ and insert-
ing ‘‘(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 pe-
riod 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, informa-
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tion from comparative in vitro, in vivo, or other test-
ing, or some combination thereof, as appropriate 
based on the type of data submitted for the listed 
drug, that demonstrates the new drug resists manip-
ulation 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 pe-
riod at the end and inserting ‘‘; or’’; and 
(iii) by adding at the end the fol-
lowing: 
‘‘(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 ap-
plication submitted under paragraph (2), and thereafter 
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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 para-
graph (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 insert-
ing ‘‘(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 
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‘‘(ii) the Secretary has previously approved pur-
suant to an application under subsection (b) a drug 
that— 
‘‘(I) is in the same dosage form; 
‘‘(II) contains the same controlled sub-
stance as an active moiety; 
‘‘(III) is a tamper-resistant drug; and 
‘‘(IV) has not been discontinued from mar-
keting.’’. 
(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 Sec-
retary has previously approved pursuant to an appli-
cation 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 
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(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 Sec-
retary shall, on a case-by-case basis, delay the effec-
tive date of such withdrawal for a period deemed 
sufficient by the Secretary to give the sponsor an op-
portunity to obtain approval under this section for 
a formulation of the drug meeting the criteria de-
scribed in paragraph (2) of the definition of a ‘tam-
per-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 enact-
ment 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)— 
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‘‘(I) to remove from the list of tamper-re-
sistant drugs any drug the Secretary later de-
termines 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.’’. 
Æ 
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