IIB 

114TH CONGRESS 

1ST SESSION H. R. 471 

IN THE SENATE OF THE UNITED STATES 

APRIL 22, 2015 

Received; read twice and referred to the Committee on the Judiciary 

AN ACT 

To improve enforcement efforts related to prescription drug 

diversion and abuse, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Ensuring Patient Ac3 cess and Effective Drug Enforcement Act of 2015’’. 

4 SEC. 2. REGISTRATION PROCESS UNDER CONTROLLED 

5 SUBSTANCES ACT. 

6 (a) DEFINITIONS.— 

7 (1) FACTORS AS MAY BE RELEVANT TO AND

8 CONSISTENT WITH THE PUBLIC HEALTH AND SAFE9 TY.—Section 303 of the Controlled Substances Act 

10 (21 U.S.C. 823) is amended by adding at the end 

11 the following: 

12 ‘‘(i) In this section, the phrase ‘factors as may be rel13 evant to and consistent with the public health and safety’ 

14 means factors that are relevant to and consistent with the 

15 findings contained in section 101.’’. 

16 (2) IMMINENT DANGER TO THE PUBLIC

17 HEALTH OR SAFETY.—Section 304(d) of the Con18 trolled Substances Act (21 U.S.C. 824(d)) is amend19 ed— 

20 (A) by striking ‘‘(d) The Attorney Gen21 eral’’ and inserting ‘‘(d)(1) The Attorney Gen22 eral’’; and 

23 (B) by adding at the end the following: 

24 ‘‘(2) In this subsection, the phrase ‘imminent danger 

25 to the public health or safety’ means that, in the absence 

26 of an immediate suspension order, controlled substances 


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1 will continue to be distributed or dispensed by a registrant 

2 who knows or should know through fulfilling the obliga3 tions of the registrant under this Act— 

4 ‘‘(A) the dispensing is outside the usual course 

5 of professional practice; 

6 ‘‘(B) the distribution or dispensing poses a 

7 present or foreseeable risk of adverse health con8 sequences or death due to the abuse or misuse of the 

9 controlled substances; or 

10 ‘‘(C) the controlled substances will continue to 

11 be diverted outside of legitimate distribution chan12 nels.’’. 

13 (b) OPPORTUNITY TO SUBMIT CORRECTIVE ACTION

14 PLAN PRIOR TO REVOCATION OR SUSPENSION.—Sub15 section (c) of section 304 of the Controlled Substances Act 

16 (21 U.S.C. 824) is amended— 

17 (1) by striking the last two sentences; 

18 (2) by striking ‘‘(c) Before’’ and inserting 

19 ‘‘(c)(1) Before’’; and 

20 (3) by adding at the end the following: 

21 ‘‘(2) An order to show cause under paragraph (1) 

22 shall— 

23 ‘‘(A) contain a statement of the basis for the 

24 denial, revocation, or suspension, including specific 


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1 citations to any laws or regulations alleged to be vio2 lated by the applicant or registrant; 

3 ‘‘(B) direct the applicant or registrant to ap4 pear before the Attorney General at a time and 

5 place stated in the order, but not less than 30 days 

6 after the date of receipt of the order; and 

7 ‘‘(C) notify the applicant or registrant of the 

8 opportunity to submit a corrective action plan on or 

9 before the date of appearance. 

10 ‘‘(3) Upon review of any corrective action plan sub11 mitted by an applicant or registrant pursuant to para12 graph (2), the Attorney General shall determine whether 

13 denial, revocation or suspension proceedings should be dis14 continued, or deferred for the purposes of modification, 

15 amendment, or clarification to such plan. 

16 ‘‘(4) Proceedings to deny, revoke, or suspend shall 

17 be conducted pursuant to this section in accordance with 

18 subchapter II of chapter 5 of title 5, United States Code. 

19 Such proceedings shall be independent of, and not in lieu 

20 of, criminal prosecutions or other proceedings under this 

21 title or any other law of the United States. 

22 ‘‘(5) The requirements of this subsection shall not 

23 apply to the issuance of an immediate suspension order 

24 under subsection (d).’’. 


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1 SEC. 3. REPORT TO CONGRESS ON EFFECTS OF LAW EN2 FORCEMENT ACTIVITIES ON PATIENT AC3 CESS TO MEDICATIONS. 

4 (a) IN GENERAL.—Not later than 1 year after the 

5 date of enactment of this Act, the Secretary of Health and 

6 Human Services, acting through the Commissioner of 

7 Food and Drugs and the Director of the Centers for Dis8 ease Control and Prevention, in coordination with the Ad9 ministrator of the Drug Enforcement Administration and 

10 in consultation with the Secretary of Defense and the Sec11 retary of Veterans Affairs, shall submit a report to the 

12 Committee on the Judiciary of the House of Representa13 tives, the Committee on Energy and Commerce of the 

14 House of Representatives, the Committee on the Judiciary 

15 of the Senate, and the Committee on Health, Education, 

16 Labor, and Pensions of the Senate identifying— 

17 (1) obstacles to legitimate patient access to con18 trolled substances; 

19 (2) issues with diversion of controlled sub20 stances; and 

21 (3) how collaboration between Federal, State, 

22 local, and tribal law enforcement agencies and the 

23 pharmaceutical industry can benefit patients and 

24 prevent diversion and abuse of controlled substances. 


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1 (b) CONSULTATION.—The report under subsection 

2 (a) shall incorporate feedback and recommendations from 

3 the following: 

4 (1) Patient groups. 

5 (2) Pharmacies. 

6 (3) Drug manufacturers. 

7 (4) Common or contract carriers and ware8 housemen. 

9 (5) Hospitals, physicians, and other health care 

10 providers. 

11 (6) State attorneys general. 

12 (7) Federal, State, local, and tribal law enforce13 ment agencies. 

14 (8) Health insurance providers and entities that 

15 provide pharmacy benefit management services on 

16 behalf of a health insurance provider. 

17 (9) Wholesale drug distributors. 

18 (10) Veterinarians. 

Passed the House of Representatives April 21, 2015. 

Attest: KAREN L. HAAS, 

Clerk. 


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