II 

114TH CONGRESS 

1ST 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 and Mr. WHITEHOUSE) introduced the following bill; 

which was read twice and referred to the Committee on the Judiciary 

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’’. 

6 SEC. 2. REGISTRATION PROCESS UNDER CONTROLLED 

7 SUBSTANCES ACT. 

8 (a) DEFINITIONS.— 

9 (1) FACTORS AS MAY BE RELEVANT TO AND

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1 TY.—Section 303 of the Controlled Substances Act 

2 (21 U.S.C. 823) is amended by adding at the end 

3 the following: 

4 ‘‘(i) In this section, the phrase ‘factors as may be rel5 evant to and consistent with the public health and safety’ 

6 means factors that are relevant to and consistent with the 

7 findings contained in section 101.’’. 

8 (2) IMMINENT DANGER TO THE PUBLIC

9 HEALTH OR SAFETY.—Section 304(d) of the Con10 trolled Substances Act (21 U.S.C. 824(d)) is amend11 ed— 

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 phrase ‘imminent danger 

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

18 of an immediate suspension order, controlled substances 

19 will continue to be distributed or dispensed by a registrant 

20 who knows or should know through fulfilling the obliga21 tions of the registrant under this Act— 

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

23 of professional practice; 

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

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1 sequences or death due to the abuse or misuse of the 

2 controlled substances; or 

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

4 be diverted outside of legitimate distribution chan5 nels.’’. 

6 (b) OPPORTUNITY TO SUBMIT CORRECTIVE ACTION

7 PLAN PRIOR TO REVOCATION OR SUSPENSION.—Sub8 section (c) of section 304 of the Controlled Substances Act 

9 (21 U.S.C. 824) is amended— 

10 (1) by striking the last two sentences; 

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

12 ‘‘(c)(1) Before’’; and 

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

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

15 shall— 

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

17 denial, revocation, or suspension, including specific 

18 citations to any laws or regulations alleged to be vio19 lated by the applicant or registrant; 

20 ‘‘(B) direct the applicant or registrant to ap21 pear before the Attorney General at a time and 

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

23 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 dis8 continued, 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 ON EFFECTS OF LAW EN20 FORCEMENT ACTIVITIES ON PATIENT AC21 CESS TO MEDICATIONS. 

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

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

24 Human Services, acting through the Commissioner of 

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1 ease Control and Prevention, in coordination with the Ad2 ministrator of the Drug Enforcement Administration and 

3 in consultation with the Secretary of Defense and the Sec4 retary of Veterans Affairs, shall submit a report to the 

5 Committee on the Judiciary of the House of Representa6 tives, the Committee on Energy and Commerce of the 

7 House of Representatives, the Committee on the Judiciary 

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

9 Labor, and Pensions of the Senate identifying— 

10 (1) obstacles to legitimate patient access to con11 trolled substances; 

12 (2) issues with diversion of controlled sub13 stances; and 

14 (3) how collaboration between Federal, State, 

15 local, and tribal law enforcement agencies and the 

16 pharmaceutical industry can benefit patients and 

17 prevent diversion and abuse of controlled substances. 

18 (b) CONSULTATION.—The report under subsection 

19 (a) shall incorporate feedback and recommendations from 

20 the following: 

21 (1) Patient groups. 

22 (2) Pharmacies. 

23 (3) Drug manufacturers. 

24 (4) Common or contract carriers and ware25 housemen. 


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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 

8 behalf of a health insurance provider. 

9 (9) Wholesale drug distributors. 

10 (10) Veterinarians. 

Æ 


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