I 

113TH CONGRESS 

2D SESSION H. R. 4069 

To improve enforcement efforts related to prescription drug diversion and 

abuse, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 18, 2014 

Mr. MARINO (for himself and Mrs. BLACKBURN) introduced the following bill; 

which was referred to the Committee 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 jurisdiction of the committee concerned 

A BILL 

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, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Ensuring Patient Ac5 cess and Effective Drug Enforcement Act of 2013’’. 

6 SEC. 2. REGISTRATION PROCESS UNDER CONTROLLED 

7 SUBSTANCES ACT. 

8 (a) DEFINITIONS.— 


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1 (1) CONSISTENT WITH THE PUBLIC HEALTH

2 AND SAFETY.—Section 303 of the Controlled Sub3 stances Act (21 U.S.C. 823) is amended by adding 

4 at the end the following: 

5 ‘‘(j) In this section, the phrase ‘consistent with the 

6 public health and safety’ means having a substantial rela7 tionship to this Act’s purpose of preventing diversion and 

8 abuse of controlled substances.’’. 

9 (2) IMMINENT DANGER.—Section 304(d) of the 

10 Controlled Substances Act (21 U.S.C. 824(d)) is 

11 amended— 

12 (A) by striking ‘‘(d) The Attorney Gen13 eral’’ and inserting ‘‘(d)(1) The Attorney Gen14 eral’’; and 

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

16 ‘‘(2) In this subsection, the term ‘imminent danger’ 

17 means a significant and present risk of death or serious 

18 bodily harm that is more likely than not to occur in the 

19 absence of an immediate suspension order.’’. 

20 (b) CRIMINAL BACKGROUND CHECKS AND DRUG

21 TESTING FOR EMPLOYEES WITH ACCESS TO CON22 TROLLED SUBSTANCES.— 

23 (1) REQUIREMENTS.—Section 303 of the Con24 trolled Substances Act (21 U.S.C. 823) is amended 


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1 by inserting before subsection (j) (as added by sub2 section (a)(1)) the following: 

3 ‘‘(i)(1) The Attorney General shall require all reg4 istrants under subsections (a), (b), (d), or (e), as a condi5 tion of such registration— 

6 ‘‘(A) to obtain a criminal background check on 

7 each of the registrant’s employees who has or will 

8 have access to facility areas where controlled sub9 stances under the registrant’s possession or control 

10 are stored, such as a cage, vault, or safe; and 

11 ‘‘(B) to perform drug testing on each such em12 ployee in accordance with Federal and State law. 

13 ‘‘(2) The criminal background checks required by 

14 paragraph (1) shall be obtained— 

15 ‘‘(A) periodically, but not more frequently than 

16 every 2 years, for all employees of the registrant who 

17 are described in paragraph (1)(A); and 

18 ‘‘(B) at the time of hire, for such employees 

19 who are hired after the date of enactment of the En20 suring Patient Access and Effective Drug Enforce21 ment Act of 2013. 

22 ‘‘(3) The term ‘drug testing’ means testing designed 

23 to detect the illegal use of a controlled substance.’’. 


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1 (2) CONFORMING CHANGE.—Section 304(a) of 

2 the Controlled Substances Act (21 U.S.C. 823(a)) is 

3 amended— 

4 (A) in paragraph (4), by striking ‘‘or’’ at 

5 the end; 

6 (B) in paragraph (5), by striking the pe7 riod at the end and inserting ‘‘; or’’; and 

8 (C) by adding at the end the following: 

9 ‘‘(6) has failed to comply with the requirements 

10 under section 303(i) (relating to criminal back11 ground checks and drug testing).’’. 

12 (3) ALTERNATIVE CIVIL PENALTY FOR FAILURE

13 TO COMPLY WITH CRIMINAL BACKGROUND CHECK

14 AND DRUG TESTING REQUIREMENTS.— 

15 (A) PROHIBITED ACT.—Section 402(a) of 

16 the Controlled Substances Act (21 U.S.C. 

17 842(a)) is amended— 

18 (i) in paragraph (14), by striking ‘‘or’’ 

19 at the end; 

20 (ii) in paragraph (15), by striking the 

21 period at the end and inserting ‘‘; or’’; and 

22 (iii) by inserting after paragraph (15) 

23 the following: 


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1 ‘‘(16) who is a registrant to fail to comply with 

2 the requirements under section 303(i) (relating to 

3 criminal background checks and drug testing);’’. 

4 (B) MAXIMUM CIVIL PENALTY OF

5 $10,000.—Subsection (c)(1)(B) of the Controlled 

6 Substances Act (21 U.S.C. 842(c)(1)(B)) is 

7 amended by striking ‘‘paragraph (5) or (10)’’ 

8 and inserting ‘‘paragraph (5), (10), or (16)’’. 

9 (4) REGULATIONS, GUIDANCE.—The Attorney 

10 General of the United States shall finalize such reg11 ulations and guidance as the Attorney General 

12 deems necessary to carry out the amendments made 

13 by this subsection. 

14 (5) APPLICABILITY.—The amendments made 

15 by this subsection shall apply beginning on the date 

16 that is 2 years after the date of enactment of this 

17 Act. 

18 (c) OPPORTUNITY TO SUBMIT CORRECTIVE ACTION

19 PLAN PRIOR TO REVOCATION OR SUSPENSION.—Section 

20 304(c) of the Controlled Substances Act (21 U.S.C. 

21 824(c)) is amended— 

22 (1) by striking ‘‘(c) Before’’ and inserting 

23 ‘‘(c)(1) Before’’; and 

24 (2) by adding at the end the following: 


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1 ‘‘(2) Before revoking or suspending a registration 

2 pursuant to section 303, the Attorney General shall— 

3 ‘‘(A) provide— 

4 ‘‘(i) notice to the registrant of the grounds 

5 for revocation or suspension; and 

6 ‘‘(ii) in the case of any such grounds con7 sisting of a violation of law, a specific citation 

8 to such law; 

9 ‘‘(B) give the registrant an opportunity to sub10 mit a corrective action plan within a reasonable pe11 riod of time to demonstrate how the registrant plans 

12 to correct the grounds for revocation or suspension; 

13 and 

14 ‘‘(C) determine whether— 

15 ‘‘(i) in light of the plan, revocation or sus16 pension proceedings should be discontinued or 

17 deferred; or 

18 ‘‘(ii) additional changes need to be made in 

19 the corrective action plan.’’. 

20 SEC. 3. COMBATING PRESCRIPTION DRUG ABUSE WORKING 

21 GROUP. 

22 (a) ESTABLISHMENT.—There is established the Com23 bating Prescription Drug Abuse Working Group (referred 

24 to in this section as the ‘‘Working Group’’). 

25 (b) MEMBERSHIP.— 


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1 (1) APPOINTMENT.— 

2 (A) IN GENERAL.—Not later than 180 

3 days after the date of the enactment of this 

4 Act, the President shall appoint each member 

5 of the Working Group. 

6 (B) COMPOSITION.—The Working Group 

7 shall be composed of not more than 20 mem8 bers and shall include at least 1 and not more 

9 than 3 of each of the following: 

10 (i) Public policy experts. 

11 (ii) Representatives of the Drug En12 forcement Administration. 

13 (iii) Representatives of the Food and 

14 Drug Administration. 

15 (iv) Representatives of the Office of 

16 National Drug Control Policy. 

17 (v) Representatives of patient groups. 

18 (vi) Representatives of pharmacies. 

19 (vii) Representatives of manufacturers 

20 of drugs. 

21 (viii) Representatives of wholesale dis22 tributors of drugs. 

23 (ix) Representatives of hospitals, phy24 sicians, and other health care providers. 


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1 (x) Representatives of State attorneys 

2 general. 

3 (xi) Representatives of law enforce4 ment officials, including local law enforce5 ment officials. 

6 (xii) Representatives of health benefits 

7 plans and entities that provide pharmacy 

8 benefits management services on behalf of 

9 a health benefits plans. 

10 (2) CO-CHAIRS.—The co-chairs shall be elected 

11 by the members of the Working Group. The Work12 ing Group shall select for election from the members 

13 of the Group two individuals, of whom— 

14 (A) one shall be a representative of the 

15 Federal Government or a State government; 

16 and 

17 (B) one shall be a representative of a non18 governmental entity. 

19 (3) TERM; VACANCIES.—Each member shall be 

20 appointed for the life of the Working Group. Any va21 cancy in the Working Group shall not affect the 

22 powers of the Working Group and shall be filled in 

23 the same manner in which the original appointment 

24 was made. 


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1 (4) PAY PROHIBITED.—Members of the Work2 ing Group shall serve without pay. 

3 (c) MEETINGS.—The Working Group shall meet at 

4 the call of the co-chairs. The Working Group shall conduct 

5 at least two public meetings, at which the Working Group 

6 shall provide opportunity for public comment. 

7 (d) DUTIES OF THE WORKING GROUP.— 

8 (1) IN GENERAL.—The Working Group shall— 

9 (A) review and report to Congress on Fed10 eral initiatives with respect to efforts to reduce 

11 prescription drug diversion and abuse; 

12 (B) identify gaps and opportunities with 

13 respect to ensuring the safe use of prescription 

14 drugs with the potential for diversion and 

15 abuse; 

16 (C) examine recommendations to transfer 

17 one or more controlled substances from sched18 ule III to schedule II under the Controlled Sub19 stances Act (21 U.S.C. 801 et seq.) to evalu20 ate— 

21 (i) the effectiveness of such a transfer 

22 in reducing diversion and abuse; and 

23 (ii) any effect of such a transfer on 

24 access to prescription drugs for legitimate 

25 medical purposes; and 


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1 (D) make recommendations on specific 

2 ways to reduce the diversion and abuse of pre3 scription drugs. 

4 (2) REPORT.— 

5 (A) IN GENERAL.—Not later than one year 

6 after the date of the enactment of this Act, the 

7 Working Group shall issue a report to Congress 

8 that describes the efforts of the Working Group 

9 to prevent or reduce prescription drug diversion 

10 and abuse to ensure that patients continue to 

11 have access to medications. 

12 (B) RECOMMENDATIONS.—The report de13 scribed in subparagraph (A) shall include spe14 cific recommendations for the Drug Enforce15 ment Administration, the Food and Drug Ad16 ministration, and other Federal and State agen17 cies, as appropriate, and shall address the fol18 lowing topics: 

19 (i) Systems for prescription drug 

20 monitoring. 

21 (ii) Illegal prescription drug Internet 

22 sites and facilities that distribute and fill 

23 prescriptions indiscriminately. 

24 (iii) Facilitating proper disposal of 

25 prescription drugs. 


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1 (iv) Identifying active geographic 

2 areas in which prescription drug abuse is 

3 prevalent. 

4 (v) Ensuring access to prescription 

5 drugs for legitimate medical purposes. 

6 (vi) Improving collaboration among 

7 Federal agencies, especially the Drug En8 forcement Administration and the Food 

9 and Drug Administration, for purposes of 

10 coordinating prevention and enforcement 

11 efforts to reduce prescription drug diver12 sion and abuse. 

13 (vii) Improving collaboration among 

14 Federal agencies and State agencies for 

15 purposes of coordinating prevention and 

16 enforcement efforts to reduce prescription 

17 drug diversion and abuse. 

18 (viii) The resource needs for law en19 forcement with respect to prescription drug 

20 abuse. 

21 (ix) The need for education of pro22 viders, patients, parents, and youth on pre23 scription drug abuse. 

24 (x) Development of abuse-resistant 

25 prescription drug products. 


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1 (xi) Recommendations for reducing 

2 robberies, burglaries, and cargo theft of 

3 prescription drugs. 

4 (e) POWERS OF THE WORKING GROUP.— 

5 (1) HEARINGS.—The Working Group may, for 

6 the purpose of carrying out this section, hold hear7 ings, sit and act at times and places, take testimony, 

8 and receive evidence as the Working Group considers 

9 necessary. 

10 (2) INFORMATION FROM FEDERAL AGENCIES.— 

11 The Working Group may secure directly from any 

12 Federal department or agency such information as 

13 the Working Group considers necessary to carry out 

14 this section. Upon the request of the co-chairs of the 

15 Working Group, the head of such department or 

16 agency shall furnish such information to the Work17 ing Group in a timely manner. 

18 (f) TERMINATION OF THE WORKING GROUP.—The 

19 Working Group shall terminate two years after the date 

20 on which the members are appointed under subsection (b). 

Æ 


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