IIB 

113TH CONGRESS 

2D SESSION H. R. 4709 

IN THE SENATE OF THE UNITED STATES 

JULY 30, 2014 

Received; read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

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, 


smartinez on DSK4TPTVN1PROD with BILLS
2 

HR 4709 RFS 

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Ensuring Patient Ac3 cess and Effective Drug Enforcement Act of 2014’’. 

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— 


smartinez on DSK4TPTVN1PROD with BILLS
3 

HR 4709 RFS 

1 ‘‘(A) will continue to be intentionally distrib2 uted or dispensed— 

3 ‘‘(i) outside the usual course of profes4 sional practice; or 

5 ‘‘(ii) in a manner that poses a present or 

6 foreseeable risk of serious adverse health con7 sequences or death; or 

8 ‘‘(B) will continue to be intentionally diverted 

9 outside of legitimate distribution channels.’’. 

10 (b) OPPORTUNITY TO SUBMIT CORRECTIVE ACTION

11 PLAN PRIOR TO REVOCATION OR SUSPENSION.—Sub12 section (c) of section 304 of the Controlled Substances Act 

13 (21 U.S.C. 824) is amended— 

14 (1) by striking the last two sentences in such 

15 subsection; 

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

17 ‘‘(c)(1) Before’’; and 

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

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

20 shall— 

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

22 denial, revocation, or suspension, including specific 

23 citations to any laws or regulations alleged to be vio24 lated by the applicant or registrant; 


smartinez on DSK4TPTVN1PROD with BILLS
4 

HR 4709 RFS 

1 ‘‘(B) direct the applicant or registrant to ap2 pear before the Attorney General at a time and 

3 place stated in the order, but no less than thirty 

4 days after the date of receipt of the order; and 

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

6 opportunity to submit a corrective action plan on or 

7 before the date of appearance. 

8 ‘‘(3) Upon review of any corrective action plan sub9 mitted by an applicant or registrant pursuant to para10 graph (2), the Attorney General shall determine whether 

11 denial, revocation or suspension proceedings should be dis12 continued, or deferred for the purposes of modification, 

13 amendment, or clarification to such plan. 

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

15 be conducted pursuant to this section in accordance with 

16 subchapter II of chapter 5 of title 5. Such proceedings 

17 shall be independent of, and not in lieu of, criminal pros18 ecutions or other proceedings under this title or any other 

19 law of the United States. 

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

21 apply to the issuance of an immediate suspension order 

22 under subsection (d).’’. 


smartinez on DSK4TPTVN1PROD with BILLS
5 

HR 4709 RFS 

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 one 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, and in consultation with the 

9 Administrator of the Drug Enforcement Administration 

10 and the Director of National Drug Control Policy, shall 

11 submit a report to the Committees on the Judiciary of 

12 the House of Representatives, the Committee on Energy 

13 and Commerce of the House of Representatives, the Com14 mittee on the Judiciary of the Senate, and the Committee 

15 on Health, Education, Labor and Pensions of the Senate 

16 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. 


smartinez on DSK4TPTVN1PROD with BILLS
6 

HR 4709 RFS 

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. 

Passed the House of Representatives July 29, 2014. 

Attest: KAREN L. HAAS, 

Clerk. 


smartinez on DSK4TPTVN1PROD with BILLS