II 

113TH CONGRESS 

2D SESSION S. 2862 

To amend the Controlled Substances Act with respect to drug scheduling 

recommendations by the Secretary of Health and Human Services, and 

with respect to registration of manufacturers and distributors seeking 

to conduct clinical testing, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 18, 2014 

Mr. HATCH (for himself and Mr. WHITEHOUSE) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Controlled Substances Act with respect to 

drug scheduling recommendations by the Secretary of 

Health and Human Services, and with respect to registration of manufacturers and distributors seeking to 

conduct clinical testing, 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 ‘‘Regulatory Trans5 parency, Patient Access, and Effective Drug Enforcement 

6 Act of 2014’’. 


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1 SEC. 2. SCHEDULING OF SUBSTANCES INCLUDED IN NEW 

2 FDA-APPROVED DRUGS. 

3 Section 201 of the Controlled Substances Act (21 

4 U.S.C. 811) is amended by inserting after subsection (h) 

5 the following: 

6 ‘‘(i) Within 45 days of receiving a recommendation 

7 from the Secretary to add a drug or substance that has 

8 never been marketed in the United States to a schedule 

9 under this title, the Attorney General shall, without regard 

10 to the findings required by subsection (a) of this section 

11 or section 202(b), issue an interim final rule, under the 

12 exception for good cause described in subparagraph (B) 

13 of section 553(b) of title 5, United States Code, placing 

14 the drug or substance into the schedule recommended by 

15 the Secretary. The interim final rule shall be made imme16 diately effective under section 553(d)(3) of title 5, United 

17 States Code.’’. 

18 SEC. 3. ENHANCING NEW DRUG DEVELOPMENT. 

19 Section 302 of the Controlled Substances Act (21 

20 U.S.C. 822) is amended by inserting after subsection (g) 

21 the following: 

22 ‘‘(h)(1) A person who submits an application for reg23 istration to manufacture or distribute a controlled sub24 stance in accordance with this section may indicate on the 

25 registration application that the substance will be used 

26 only in connection with clinical trials of a drug in accordVerDate Sep 11 2014 02:13 Oct 01, 2014 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2862.IS S2862

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1 ance with section 505(i) of the Federal Food, Drug, and 

2 Cosmetic Act. 

3 ‘‘(2) When an application for registration to manu4 facture or distribute a controlled substance includes an in5 dication that the controlled substance will be used only 

6 in connection with clinical trials of a drug in accordance 

7 with section 505(i) of the Federal Food, Drug, and Cos8 metic Act, the Attorney General shall— 

9 ‘‘(A) make a final decision on the application 

10 for registration within 180 days; or 

11 ‘‘(B) provide notice to the applicant in writing 

12 of— 

13 ‘‘(i) the outstanding issues that must be 

14 resolved in order to reach a final decision on 

15 the application; and 

16 ‘‘(ii) the estimated date on which a final 

17 decision on the application will be made.’’. 

18 SEC. 4. REGISTRATION PROCESS UNDER CONTROLLED 

19 SUBSTANCES ACT. 

20 (a) DEFINITIONS.— 

21 (1) FACTORS AS MAY BE RELEVANT TO AND

22 CONSISTENT WITH THE PUBLIC HEALTH AND SAFE23 TY.—Section 303 of the Controlled Substances Act 

24 (21 U.S.C. 823) is amended by adding at the end 

25 the following: 


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1 ‘‘(i) In this section, the phrase ‘factors as may be rel2 evant to and consistent with the public health and safety’ 

3 means factors that are relevant to and consistent with the 

4 findings contained in section 101.’’. 

5 (2) IMMINENT DANGER TO THE PUBLIC

6 HEALTH OR SAFETY.—Section 304(d) of the Con7 trolled Substances Act (21 U.S.C. 824(d)) is amend8 ed— 

9 (A) by striking ‘‘(d) The Attorney Gen10 eral’’ and inserting ‘‘(d)(1) The Attorney Gen11 eral’’; and 

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

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

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

15 of an immediate suspension order, controlled substances 

16 will continue to be distributed or dispensed by a registrant 

17 who knows or should know through fulfilling the obliga18 tions of the registrant under this Act, or has reason to 

19 believe that— 

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

21 of professional practice; 

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

23 present or foreseeable risk of adverse health con24 sequences or death due to the abuse or misuse of the 

25 controlled substances; or 


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

2 be diverted outside of legitimate distribution chan3 nels.’’. 

4 (b) OPPORTUNITY TO SUBMIT CORRECTIVE ACTION

5 PLAN PRIOR TO REVOCATION OR SUSPENSION.—Sub6 section (c) of section 304 of the Controlled Substances Act 

7 (21 U.S.C. 824) is amended— 

8 (1) by striking the last two sentences; 

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

10 ‘‘(c)(1) Before’’; and 

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

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

13 shall— 

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

15 denial, revocation, or suspension, including specific 

16 citations to any laws or regulations alleged to be vio17 lated by the applicant or registrant; 

18 ‘‘(B) direct the applicant or registrant to ap19 pear before the Attorney General at a time and 

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

21 after the date of receipt of the order; and 

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

23 opportunity to submit a corrective action plan on or 

24 before the date of appearance. 


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1 ‘‘(3) Upon review of any corrective action plan sub2 mitted by an applicant or registrant pursuant to para3 graph (2), the Attorney General shall determine whether 

4 denial, revocation or suspension proceedings should be dis5 continued, or deferred for the purposes of modification, 

6 amendment, or clarification to such plan. 

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

8 be conducted pursuant to this section in accordance with 

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

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

11 of, criminal prosecutions or other proceedings under this 

12 title or any other law of the United States. 

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

14 apply to the issuance of an immediate suspension order 

15 under subsection (d).’’. 

16 SEC. 5. REPORT TO CONGRESS ON EFFECTS OF LAW EN17 FORCEMENT ACTIVITIES ON PATIENT AC18 CESS TO MEDICATIONS. 

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

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

21 Human Services, acting through the Commissioner of 

22 Food and Drugs and the Director of the Centers for Dis23 ease Control and Prevention, and in consultation with the 

24 Administrator of the Drug Enforcement Administration 

25 and the Director of National Drug Control Policy, shall 


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1 submit a report to the Committees on the Judiciary of 

2 the House of Representatives, the Committee on Energy 

3 and Commerce of the House of Representatives, the Com4 mittee on the Judiciary of the Senate, and the Committee 

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

6 identifying— 

7 (1) obstacles to legitimate patient access to con8 trolled substances; 

9 (2) issues with diversion of controlled sub10 stances; and 

11 (3) how collaboration between Federal, State, 

12 local, and tribal law enforcement agencies and the 

13 pharmaceutical industry can benefit patients and 

14 prevent diversion and abuse of controlled substances. 

15 (b) CONSULTATION.—The report under subsection 

16 (a) shall incorporate feedback and recommendations from 

17 the following: 

18 (1) Patient groups. 

19 (2) Pharmacies. 

20 (3) Drug manufacturers. 

21 (4) Common or contract carriers and ware22 housemen. 

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

24 providers. 

25 (6) State attorneys general. 


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1 (7) Federal, State, local, and tribal law enforce2 ment agencies. 

3 (8) Health insurance providers and entities that 

4 provide pharmacy benefit management services on 

5 behalf of a health insurance provider. 

6 (9) Wholesale drug distributors. 

Æ 


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