IB 
Union Calendar No. 63 
114TH CONGRESS 
1ST SESSION 
H. R. 471 
[Report No. 114–85, Part I] 
To improve enforcement efforts related to prescription drug diversion and 
abuse, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 22, 2015 
Mr. MARINO (for himself, Mr. WELCH, Mrs. BLACKBURN, and Ms. CHU of 
California) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce, and in addition to the Committee on 
the Judiciary, for a period to be subsequently determined by the Speaker, 
in each case for consideration of such provisions as fall within the juris-
diction of the committee concerned 
APRIL 20, 2015 
Additional sponsors: Mr. COLLINS of Georgia, Mr. BILIRAKIS, and Mr. 
COSTELLO of Pennsylvania 
APRIL 20, 2015 
Reported from the Committee on Energy and Commerce 
APRIL 20, 2015 
The Committee on the Judiciary discharged; committed to the Committee of 
the Whole House on the State of the Union and ordered to be printed 
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A BILL 
To improve enforcement efforts related to prescription drug 
diversion and abuse, and for other purposes. 
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‘‘(2) In this subsection, the phrase ‘imminent danger 
to the public health or safety’ means that, in the absence 
of an immediate suspension order, controlled substances— 
‘‘(A) will continue to be intentionally distrib-
uted or dispensed— 
‘‘(i) outside the usual course of profes-
sional practice; or 
‘‘(ii) in a manner that poses a present or 
foreseeable risk of serious adverse health con-
sequences or death; or 
‘‘(B) will continue to be intentionally diverted 
outside of legitimate distribution channels.’’. 
(b) OPPORTUNITY TO SUBMIT CORRECTIVE ACTION 
PLAN PRIOR
TO REVOCATION
OR SUSPENSION.—Sub-
section (c) of section 304 of the Controlled Substances Act 
(21 U.S.C. 824) is amended— 
(1) by striking the last two sentences in such 
subsection; 
(2) by striking ‘‘(c) Before’’ and inserting 
‘‘(c)(1) Before’’; and 
(3) by adding at the end the following: 
‘‘(2) An order to show cause under paragraph (1) 
shall— 
‘‘(A) contain a statement of the basis for the 
denial, revocation, or suspension, including specific 
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citations to any laws or regulations alleged to be vio-
lated by the applicant or registrant; 
‘‘(B) direct the applicant or registrant to ap-
pear before the Attorney General at a time and 
place stated in the order, but no less than thirty 
days after the date of receipt of the order; and 
‘‘(C) notify the applicant or registrant of the 
opportunity to submit a corrective action plan on or 
before the date of appearance. 
‘‘(3) Upon review of any corrective action plan sub-
mitted by an applicant or registrant pursuant to para-
graph (2), the Attorney General shall determine whether 
denial, revocation or suspension proceedings should be dis-
continued, or deferred for the purposes of modification, 
amendment, or clarification to such plan. 
‘‘(4) Proceedings to deny, revoke, or suspend shall 
be conducted pursuant to this section in accordance with 
subchapter II of chapter 5 of title 5. Such proceedings 
shall be independent of, and not in lieu of, criminal pros-
ecutions or other proceedings under this title or any other 
law of the United States. 
‘‘(5) The requirements of this subsection shall not 
apply to the issuance of an immediate suspension order 
under subsection (d).’’. 
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SEC. 3. REPORT TO CONGRESS ON EFFECTS OF LAW EN-
FORCEMENT ACTIVITIES ON PATIENT AC-
CESS TO MEDICATIONS. 
(a) IN GENERAL.—Not later than one year after the 
date of enactment of this Act, the Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs and the Director of the Centers for Dis-
ease Control and Prevention, and in consultation with the 
Administrator of the Drug Enforcement Administration 
and the Director of National Drug Control Policy, shall 
submit a report to the Committee on the Judiciary of the 
House of Representatives, the Committee on Energy and 
Commerce of the House of Representatives, the Com-
mittee on the Judiciary of the Senate, and the Committee 
on Health, Education, Labor, and Pensions of the Senate 
identifying— 
(1) obstacles to legitimate patient access to con-
trolled substances; 
(2) issues with diversion of controlled sub-
stances; and 
(3) how collaboration between Federal, State, 
local, and tribal law enforcement agencies and the 
pharmaceutical industry can benefit patients and 
prevent diversion and abuse of controlled substances. 
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(b) CONSULTATION.—The report under subsection 
(a) shall incorporate feedback and recommendations from 
the following: 
(1) Patient groups. 
(2) Pharmacies. 
(3) Drug manufacturers. 
(4) Common or contract carriers and ware-
housemen. 
(5) Hospitals, physicians, and other health care 
providers. 
(6) State attorneys general. 
(7) Federal, State, local, and tribal law enforce-
ment agencies. 
(8) Health insurance providers and entities that 
provide pharmacy benefit management services on 
behalf of a health insurance provider. 
(9) Wholesale drug distributors. 
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Union Calendar No. 63 
114TH CONGRESS 
1ST SESSION 
H. R. 471 
[Report No. 114–85, Part I] 
A BILL 
To improve enforcement efforts related to prescrip-
tion drug diversion and abuse, and for other pur-
poses. 
APRIL 20, 2015 
Reported from the Committee on Energy and Commerce 
APRIL 20, 2015 
The Committee on the Judiciary discharged; committed 
to the Committee of the Whole House on the State of 
the Union and ordered to be printed 
VerDate Sep 11 2014 
21:16 Apr 20, 2015
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PO 00000
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