II 

Calendar No. 368 

114TH CONGRESS 

2D SESSION S. 483 

To improve enforcement efforts related to prescription drug diversion and 

abuse, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 12, 2015 

Mr. HATCH (for himself, Mr. WHITEHOUSE, Mr. RUBIO, Mr. VITTER, and Mr. 

CASSIDY) introduced the following bill; which was read twice and referred 

to the Committee on the Judiciary 

FEBRUARY 11, 2016 

Reported by Mr. GRASSLEY, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

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 2015’’. 


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1 SEC. 2. REGISTRATION PROCESS UNDER CONTROLLED 

2 SUBSTANCES ACT. 

3 (a) DEFINITIONS.— 

4 (1) FACTORS AS MAY BE RELEVANT TO AND

5 CONSISTENT WITH THE PUBLIC HEALTH AND SAFE6 TY.—Section 303 of the Controlled Substances Act 

7 (21 U.S.C. 823) is amended by adding at the end 

8 the following: 

9 ‘‘(i) In this section, the phrase ‘factors as may be rel10 evant to and consistent with the public health and safety’ 

11 means factors that are relevant to and consistent with the 

12 findings contained in section 101.’’. 

13 (2) IMMINENT DANGER TO THE PUBLIC

14 HEALTH OR SAFETY.—Section 304(d) of the Con15 trolled Substances Act (21 U.S.C. 824(d)) is amend16 ed— 

17 (A) by striking ‘‘(d) The Attorney Gen18 eral’’ and inserting ‘‘(d)(1) The Attorney Gen19 eral’’; and 

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

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

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

23 of an immediate suspension order, controlled substances 

24 will continue to be distributed or dispensed by a registrant 

25 who knows or should know through fulfilling the obliga26 tions of the registrant under this Act— 


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

2 of professional practice; 

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

4 present or foreseeable risk of adverse health con5 sequences or death due to the abuse or misuse of the 

6 controlled substances; or 

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

8 be diverted outside of legitimate distribution chan9 nels.’’. 

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; 

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

16 ‘‘(c)(1) Before’’; and 

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

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

19 shall— 

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

21 denial, revocation, or suspension, including specific 

22 citations to any laws or regulations alleged to be vio23 lated by the applicant or registrant; 

24 ‘‘(B) direct the applicant or registrant to ap25 pear before the Attorney General at a time and 


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

2 after the date of receipt of the order; and 

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

4 opportunity to submit a corrective action plan on or 

5 before the date of appearance. 

6 ‘‘(3) Upon review of any corrective action plan sub7 mitted by an applicant or registrant pursuant to para8 graph (2), the Attorney General shall determine whether 

9 denial, revocation or suspension proceedings should be dis10 continued, or deferred for the purposes of modification, 

11 amendment, or clarification to such plan. 

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

13 be conducted pursuant to this section in accordance with 

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

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

16 of, criminal prosecutions or other proceedings under this 

17 title or any other law of the United States. 

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

19 apply to the issuance of an immediate suspension order 

20 under subsection (d).’’. 

21 SEC. 3. REPORT TO CONGRESS ON EFFECTS OF LAW EN22 FORCEMENT ACTIVITIES ON PATIENT AC23 CESS TO MEDICATIONS. 

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

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


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1 Human Services, acting through the Commissioner of 

2 Food and Drugs and the Director of the Centers for Dis3 ease Control and Prevention, in coordination with the Ad4 ministrator of the Drug Enforcement Administration and 

5 in consultation with the Secretary of Defense and the Sec6 retary of Veterans Affairs, shall submit a report to the 

7 Committee on the Judiciary of the House of Representa8 tives, the Committee on Energy and Commerce of the 

9 House of Representatives, the Committee on the Judiciary 

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

11 Labor, and Pensions of the Senate identifying— 

12 (1) obstacles to legitimate patient access to con13 trolled substances; 

14 (2) issues with diversion of controlled sub15 stances; and 

16 (3) how collaboration between Federal, State, 

17 local, and tribal law enforcement agencies and the 

18 pharmaceutical industry can benefit patients and 

19 prevent diversion and abuse of controlled substances. 

20 (b) CONSULTATION.—The report under subsection 

21 (a) shall incorporate feedback and recommendations from 

22 the following: 

23 (1) Patient groups. 

24 (2) Pharmacies. 

25 (3) Drug manufacturers. 


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1 (4) Common or contract carriers and ware2 housemen. 

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

4 providers. 

5 (6) State attorneys general. 

6 (7) Federal, State, local, and tribal law enforce7 ment agencies. 

8 (8) Health insurance providers and entities that 

9 provide pharmacy benefit management services on 

10 behalf of a health insurance provider. 

11 (9) Wholesale drug distributors. 

12 (10) Veterinarians. 

13 SECTION 1. SHORT TITLE. 

14 This Act may be cited as the ‘‘Ensuring Patient Access 

15 and Effective Drug Enforcement Act of 2016’’. 

16 SEC. 2. REGISTRATION PROCESS UNDER CONTROLLED SUB17 STANCES ACT. 

18 (a) DEFINITIONS.— 

19 (1) FACTORS AS MAY BE RELEVANT TO AND CON20 SISTENT WITH THE PUBLIC HEALTH AND SAFETY.— 

21 Section 303 of the Controlled Substances Act (21 

22 U.S.C. 823) is amended by adding at the end the fol23 lowing: 

24 ‘‘(j) In this section, the phrase ‘factors as may be rel25 evant to and consistent with the public health and safety’ 


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1 means factors that are relevant to and consistent with the 

2 findings contained in section 101.’’. 

3 (2) IMMINENT DANGER TO THE PUBLIC HEALTH

4 OR SAFETY.—Section 304(d) of the Controlled Sub5 stances Act (21 U.S.C. 824(d)) is amended— 

6 (A) by striking ‘‘(d) The Attorney General’’ 

7 and inserting ‘‘(d)(1) The Attorney General’’; 

8 and 

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

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

11 to the public health or safety’ means that, due to the failure 

12 of the registrant to maintain effective controls against di13 version or otherwise comply with the obligations of a reg14 istrant under this title or title III, there is a substantial 

15 likelihood of an immediate threat that death, serious bodily 

16 harm, or abuse of a controlled substance will occur in the 

17 absence of an immediate suspension of the registration.’’. 

18 (b) OPPORTUNITY TO SUBMIT CORRECTIVE ACTION

19 PLAN PRIOR TO REVOCATION OR SUSPENSION.—Subsection 

20 (c) of section 304 of the Controlled Substances Act (21 

21 U.S.C. 824) is amended— 

22 (1) by striking the last three sentences; 

23 (2) by striking ‘‘(c) Before’’ and inserting ‘‘(c)(1) 

24 Before’’; and 

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


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

2 shall— 

3 ‘‘(A) contain a statement of the basis for the de4 nial, revocation, or suspension, including specific ci5 tations to any laws or regulations alleged to be vio6 lated by the applicant or registrant; 

7 ‘‘(B) direct the applicant or registrant to appear 

8 before the Attorney General at a time and place stat9 ed in the order, but not less than 30 days after the 

10 date of receipt of the order; and 

11 ‘‘(C) notify the applicant or registrant of the op12 portunity to submit a corrective action plan on or be13 fore the date of appearance. 

14 ‘‘(3) Upon review of any corrective action plan sub15 mitted by an applicant or registrant pursuant to para16 graph (2), the Attorney General shall determine whether de17 nial, revocation, or suspension proceedings should be dis18 continued, or deferred for the purposes of modification, 

19 amendment, or clarification to such plan. 

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

21 conducted pursuant to this section in accordance with sub22 chapter II of chapter 5 of title 5, United States Code. Such 

23 proceedings shall be independent of, and not in lieu of, 

24 criminal prosecutions or other proceedings under this title 

25 or any other law of the United States. 


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

2 apply to the issuance of an immediate suspension order 

3 under subsection (d).’’. 

4 SEC. 3. REPORT TO CONGRESS. 

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

6 of enactment of this Act, the Secretary of Health and 

7 Human Services, acting through the Commissioner of Food 

8 and Drugs, the Administrator of the Substance Abuse and 

9 Mental Health Services Administration, the Director of the 

10 Agency for Healthcare Research and Quality, and the Di11 rector of the Centers for Disease Control and Prevention, 

12 in coordination with the Administrator of the Drug En13 forcement Administration and in consultation with the Sec14 retary of Defense and the Secretary of Veterans Affairs, 

15 shall submit a report to the Committee on the Judiciary 

16 of the House of Representatives, the Committee on Energy 

17 and Commerce of the House of Representatives, the Com18 mittee on the Judiciary of the Senate, and the Committee 

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

20 identifying— 

21 (1) obstacles to legitimate patient access to con22 trolled substances; 

23 (2) issues with diversion of controlled substances; 

24 (3) how collaboration between Federal, State, 

25 local, and tribal law enforcement agencies and the 


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1 pharmaceutical industry can benefit patients and 

2 prevent diversion and abuse of controlled substances; 

3 (4) the availability of medical education, train4 ing opportunities, and comprehensive clinical guid5 ance for pain management and opioid prescribing, 

6 and any gaps that should be addressed; 

7 (5) beneficial enhancements to State prescription 

8 drug monitoring programs, including enhancements 

9 to require comprehensive prescriber input and to ex10 pand access to the programs for appropriate author11 ized users; and 

12 (6) steps to improve reporting requirements so 

13 that the public and Congress have more information 

14 regarding prescription opioids, such as the volume 

15 and formulation of prescription opioids prescribed 

16 annually, the dispensing of such prescription opioids, 

17 and outliers and trends within large data sets. 

18 (b) CONSULTATION.—The report under subsection (a) 

19 shall incorporate feedback and recommendations from the 

20 following: 

21 (1) Patient groups. 

22 (2) Pharmacies. 

23 (3) Drug manufacturers. 

24 (4) Common or contract carriers and warehouse25 men. 


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

2 providers. 

3 (6) State attorneys general. 

4 (7) Federal, State, local, and tribal law enforce5 ment agencies. 

6 (8) Health insurance providers and entities that 

7 provide pharmacy benefit management services on be8 half of a health insurance provider. 

9 (9) Wholesale drug distributors. 

10 (10) Veterinarians. 

11 (11) Professional medical societies and boards. 

12 (12) State and local public health authorities. 

13 (13) Health services research organizations. 


srobinson on DSK5SPTVN1PROD with BILLS
Calendar No. 368 

114TH CONGRESS 

2D SESSION S. 483 

A BILL 

To improve enforcement efforts related to prescripposes. tion drug diversion and abuse, and for other purFEBRUARY 11, 2016 

Reported with an amendment 


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