114TH CONGRESS 

2D SESSION S. 483 

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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†S 483 ES

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Ensuring Patient Ac3 cess and Effective Drug Enforcement Act of 2016’’. 

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 ‘‘(j) In this section, the phrase ‘factors as may be 

13 relevant to and consistent with the public health and safe14 ty’ means factors that are relevant to and consistent with 

15 the 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, due to the fail26 ure of the registrant to maintain effective controls against 
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1 diversion or otherwise comply with the obligations of a reg2 istrant under this title or title III, there is a substantial 

3 likelihood of an immediate threat that death, serious bod4 ily harm, or abuse of a controlled substance will occur in 

5 the absence of an immediate suspension of the registra6 tion.’’. 

7 (b) OPPORTUNITY TO SUBMIT CORRECTIVE ACTION

8 PLAN PRIOR TO REVOCATION OR SUSPENSION.—Sub9 section (c) of section 304 of the Controlled Substances Act 

10 (21 U.S.C. 824) is amended— 

11 (1) by striking the last three sentences; 

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

13 ‘‘(c)(1) Before’’; and 

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

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

16 shall— 

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

18 denial, revocation, or suspension, including specific 

19 citations to any laws or regulations alleged to be vio20 lated by the applicant or registrant; 

21 ‘‘(B) direct the applicant or registrant to ap22 pear before the Attorney General at a time and 

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

24 after the date of receipt of the order; and 
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1 ‘‘(C) notify the applicant or registrant of the 

2 opportunity to submit a corrective action plan on or 

3 before the date of appearance. 

4 ‘‘(3) Upon review of any corrective action plan sub5 mitted by an applicant or registrant pursuant to para6 graph (2), the Attorney General shall determine whether 

7 denial, revocation, or suspension proceedings should be 

8 discontinued, or deferred for the purposes of modification, 

9 amendment, or clarification to such plan. 

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

11 be conducted pursuant to this section in accordance with 

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

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

14 of, criminal prosecutions or other proceedings under this 

15 title or any other law of the United States. 

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

17 apply to the issuance of an immediate suspension order 

18 under subsection (d).’’. 

19 SEC. 3. REPORT TO CONGRESS. 

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

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

22 Human Services, acting through the Commissioner of 

23 Food and Drugs, the Administrator of the Substance 

24 Abuse and Mental Health Services Administration, the Di25 rector of the Agency for Healthcare Research and Quality, 
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1 and the Director of the Centers for Disease Control and 

2 Prevention, in coordination with the Administrator of the 

3 Drug Enforcement Administration and in consultation 

4 with the Secretary of Defense and the Secretary of Vet5 erans Affairs, shall submit a report to the Committee on 

6 the Judiciary of the House of Representatives, the Com7 mittee on Energy and Commerce of the House of Rep8 resentatives, the Committee on the Judiciary of the Sen9 ate, and the Committee on Health, Education, Labor, and 

10 Pensions of the Senate identifying— 

11 (1) obstacles to legitimate patient access to con12 trolled substances; 

13 (2) issues with diversion of controlled sub14 stances; 

15 (3) how collaboration between Federal, State, 

16 local, and tribal law enforcement agencies and the 

17 pharmaceutical industry can benefit patients and 

18 prevent diversion and abuse of controlled substances; 

19 (4) the availability of medical education, train20 ing opportunities, and comprehensive clinical guid21 ance for pain management and opioid prescribing, 

22 and any gaps that should be addressed; 

23 (5) beneficial enhancements to State prescrip24 tion drug monitoring programs, including enhance25 ments to require comprehensive prescriber input and 
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1 to expand access to the programs for appropriate 

2 authorized users; and 

3 (6) steps to improve reporting requirements so 

4 that the public and Congress have more information 

5 regarding prescription opioids, such as the volume 

6 and formulation of prescription opioids prescribed 

7 annually, the dispensing of such prescription opioids, 

8 and outliers and trends within large data sets. 

9 (b) CONSULTATION.—The report under subsection 

10 (a) shall incorporate feedback and recommendations from 

11 the following: 

12 (1) Patient groups. 

13 (2) Pharmacies. 

14 (3) Drug manufacturers. 

15 (4) Common or contract carriers and ware16 housemen. 

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

18 providers. 

19 (6) State attorneys general. 

20 (7) Federal, State, local, and tribal law enforce21 ment agencies. 

22 (8) Health insurance providers and entities that 

23 provide pharmacy benefit management services on 

24 behalf of a health insurance provider. 

25 (9) Wholesale drug distributors. 
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1 (10) Veterinarians. 

2 (11) Professional medical societies and boards. 

3 (12) State and local public health authorities. 

4 (13) Health services research organizations. 

Passed the Senate March 17, 2016. 

Attest: 

Secretary. 
114TH CONGRESS 

2D SESSION S. 483 

AN ACT 

To improve enforcement efforts related to prescripposes. tion drug diversion and abuse, and for other pur-