II 

Calendar No. 245 

114TH CONGRESS 

1ST SESSION S. 481 

To amend the Controlled Substances Act and the Federal Food, Drug, and 

Cosmetic 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 

FEBRUARY 12, 2015 

Mr. HATCH (for himself, Mr. WHITEHOUSE, and Mrs. MURRAY) introduced 

the following bill; which was read twice and referred to the Committee 

on Health, Education, Labor, and Pensions 

OCTOBER 1, 2015 

Reported by Mr. ALEXANDER, with an amendment 

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

A BILL 

To amend the Controlled Substances Act and the Federal 

Food, Drug, and Cosmetic 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, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Improving Regulatory 

3 Transparency for New Medical Therapies Act’’. 

4 SEC. 2. SCHEDULING OF SUBSTANCES INCLUDED IN NEW 

5 FDA-APPROVED DRUGS. 

6 (a) EFFECTIVE DATE OF APPROVAL.— 

7 (1) EFFECTIVE DATE OF DRUG APPROVAL.— 

8 Section 505 of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 355) is amended by adding at 

10 the end the following: 

11 ‘‘(x) DATE OF APPROVAL IN THE CASE OF REC12 OMMENDED CONTROLS UNDER THE CSA.— 

13 ‘‘(1) IN GENERAL.—In the case of an applica14 tion under subsection (b) with respect to a drug for 

15 which the Secretary provides notice to the sponsor 

16 that the Secretary intends to recommend controls 

17 under the Controlled Substances Act, approval of 

18 such application shall not take effect until the in19 terim final rule controlling the drug is issued in ac20 cordance with section 201(j) of the Controlled Sub21 stances Act. 

22 ‘‘(2) DATE OF APPROVAL.—For purposes of 

23 this section, with respect to an application described 

24 in paragraph (1), the term ‘date of approval’ shall 

25 mean the later of— 


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1 ‘‘(A) the date an application under sub2 section (b) is approved under subsection (c); or 

3 ‘‘(B) the date of issuance of the interim 

4 final rule controlling the drug.’’. 

5 (2) EFFECTIVE DATE OF APPROVAL OF BIO6 LOGICAL PRODUCTS.—Section 351 of the Public 

7 Health Service Act (42 U.S.C. 262) is amended by 

8 adding at the end the following: 

9 ‘‘(n) DATE OF APPROVAL IN THE CASE OF REC10 OMMENDED CONTROLS UNDER THE CSA.— 

11 ‘‘(1) IN GENERAL.—In the case of an applica12 tion under subsection (a) with respect to a biological 

13 product for which the Secretary provides notice to 

14 the sponsor that the Secretary intends to rec15 ommend controls under the Controlled Substances 

16 Act, approval of such application shall not take ef17 fect until the interim final rule controlling the bio18 logical product is issued in accordance with section 

19 201(j) of the Controlled Substances Act. 

20 ‘‘(2) DATE OF APPROVAL.—For purposes of 

21 this section, with respect to an application described 

22 in paragraph (1), references to the date of approval 

23 of such application, or licensure of the product sub24 ject to such application, shall mean the later of— 


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1 ‘‘(A) the date an application is approved 

2 under subsection (a); or 

3 ‘‘(B) the date of issuance of the interim 

4 final rule controlling the biological product.’’. 

5 (3) EFFECTIVE DATE OF APPROVAL OF ANIMAL

6 DRUGS.— 

7 (A) IN GENERAL.—Section 512 of the Fed8 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

9 360b) is amended by adding at the end the fol10 lowing: 

11 ‘‘(q) DATE OF APPROVAL IN THE CASE OF REC12 OMMENDED CONTROLS UNDER THE CSA.— 

13 ‘‘(1) IN GENERAL.—In the case of an applica14 tion under subsection (b) with respect to a drug for 

15 which the Secretary provides notice to the sponsor 

16 that the Secretary intends to recommend controls 

17 under the Controlled Substances Act, approval of 

18 such application shall not take effect until the in19 terim final rule controlling the drug is issued in ac20 cordance with section 201(j) of the Controlled Sub21 stances Act. 

22 ‘‘(2) DATE OF APPROVAL.—For purposes of 

23 this section, with respect to an application described 

24 in paragraph (1), the term ‘date of approval’ shall 

25 mean the later of— 


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1 ‘‘(A) the date an application under sub2 section (b) is approved under subsection (c); or 

3 ‘‘(B) the date of issuance of the interim 

4 final rule controlling the drug.’’. 

5 (B) CONDITIONAL APPROVAL.—Section 

6 571(d) of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 360ccc(d)) is amended by 

8 adding at the end the following: 

9 ‘‘(4)(A) In the case of an application under 

10 subsection (a) with respect to a drug for which the 

11 Secretary provides notice to the sponsor that the 

12 Secretary intends to recommend controls under the 

13 Controlled Substances Act, conditional approval of 

14 such application shall not take effect until the in15 terim final rule controlling the drug is issued in ac16 cordance with section 201(j) of the Controlled Sub17 stances Act. 

18 ‘‘(B) For purposes of this section, with respect 

19 to an application described in subparagraph (A), the 

20 term ‘date of approval’ shall mean the later of— 

21 ‘‘(i) the date an application under sub22 section (a) is conditionally approved under sub23 section (b); or 

24 ‘‘(ii) the date of issuance of the interim 

25 final rule controlling the drug.’’. 


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1 (C) INDEXING OF LEGALLY MARKETED

2 UNAPPROVED NEW ANIMAL DRUGS.—Section 

3 572 of the Federal Food, Drug, and Cosmetic 

4 Act (21 U.S.C. 360ccc–1) is amended by add5 ing at the end the following: 

6 ‘‘(k) In the case of a request under subsection (d) 

7 to add a drug to the index under subsection (a) with re8 spect to a drug for which the Secretary provides notice 

9 to the person filing the request that the Secretary intends 

10 to recommend controls under the Controlled Substances 

11 Act, a determination to grant the request to add such drug 

12 to the index shall not take effect, and the Secretary shall 

13 not list the drug on such index, until the interim final rule 

14 controlling the drug is issued in accordance with section 

15 201(j) of the Controlled Substances Act.’’. 

16 (4) DATE OF APPROVAL FOR DESIGNATED NEW

17 ANIMAL DRUGS.—Section 573(c) of the Federal 

18 Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc– 

19 2(c)) is amended by adding at the end the following: 

20 ‘‘(3) For purposes of determining the 7-year pe21 riod of exclusivity under paragraph (1) for a drug 

22 for which the Secretary intends to recommend con23 trols under the Controlled Substances Act, the drug 

24 shall not be considered approved or conditionally ap25 proved until the date that the interim final rule conVerDate Sep 11 2014 00:06 Oct 02, 2015 Jkt 049200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6401 E:\BILLS\S481.RS S481

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1 trolling the drug is issued in accordance with section 

2 201(j) of the Controlled Substances Act.’’. 

3 (b) SCHEDULING OF NEWLY APPROVED DRUGS.— 

4 Section 201 of the Controlled Substances Act (21 U.S.C. 

5 811) is amended by inserting after subsection (i) the fol6 lowing: 

7 ‘‘(j)(1) With respect to a drug referred to in sub8 section (f), if the Secretary of Health and Human Services 

9 recommends that the Attorney General add the drug to 

10 schedule II, III, IV, or V pursuant to subsections (a) and 

11 (b), the Attorney General shall, not later than 90 days 

12 after the date described in paragraph (2), issue an interim 

13 final rule controlling the drug in accordance with such 

14 subsections and section 202(b) using the procedures de15 scribed in paragraph (3). 

16 ‘‘(2) The date described in this paragraph shall be 

17 the later of— 

18 ‘‘(A) the date on which the Attorney General 

19 receives the scientific and medical evaluation and 

20 recommendations from the Secretary of Health and 

21 Human Services in accordance with subsection (b); 

22 or 

23 ‘‘(B) the date on which the Attorney General 

24 receives notification from the Secretary of Health 

25 and Human Services that the Secretary has apVerDate Sep 11 2014 00:06 Oct 02, 2015 Jkt 049200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6401 E:\BILLS\S481.RS S481

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1 proved an application under section 505(c), 512, 

2 571, or 572 of the Federal Food, Drug, and Cos3 metic Act or section 351(a) of the Public Health 

4 Service Act with respect to the drug described in 

5 paragraph (1). 

6 ‘‘(3) A rule issued by the Attorney General under 

7 paragraph (1) shall be in accordance with the procedures 

8 provided in subsection (a), except that the rule shall be9 come immediately effective as an interim final rule without 

10 requiring the Attorney General to demonstrate good cause 

11 therefor. After publication of the interim final rule, the 

12 Attorney General shall issue a final rule in accordance 

13 with the procedures provided in subsection (a).’’. 

14 (c) EXTENSION OF PATENT TERM.—Section 156 of 

15 title 35, United States Code, is amended— 

16 (1) in subsection (d)(1), in the matter pre17 ceding subparagraph (A), by inserting ‘‘, or in the 

18 case of a drug product described in subsection (i) 

19 within the sixty-day period beginning on the covered 

20 date (as defined in subsection (i))’’ after ‘‘marketing 

21 or use’’; and 

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

23 ‘‘(i)(1) For purposes of this section, if the Secretary 

24 of Health and Human Services provides notice to the 

25 sponsor of an application or request for approval, condiVerDate Sep 11 2014 00:06 Oct 02, 2015 Jkt 049200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6401 E:\BILLS\S481.RS S481

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1 tional approval, or indexing of a drug product for which 

2 the Secretary intends to recommend controls under the 

3 Controlled Substances Act, beginning on the covered date, 

4 the drug product shall be considered to— 

5 ‘‘(A) have been approved; and 

6 ‘‘(B) have permission for commercial marketing 

7 or use. 

8 ‘‘(2) In this subsection, the term ‘covered date’ means 

9 the later of— 

10 ‘‘(A) the date an application is approved— 

11 ‘‘(i) under section 351(a)(2)(C) of the 

12 Public Health Service Act; or 

13 ‘‘(ii) under section 505(b) or 512(c) of the 

14 Federal Food, Drug, and Cosmetic Act; 

15 ‘‘(B) the date an application is conditionally ap16 proved under section 571(b) of the Federal Food, 

17 Drug, and Cosmetic Act; 

18 ‘‘(C) the date a request for indexing is granted 

19 under section 572(d) of the Federal Food, Drug, 

20 and Cosmetic Act; or 

21 ‘‘(D) the date of issuance of the interim final 

22 rule controlling the drug under section 201(j) of the 

23 Controlled Substances Act.’’. 


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1 SEC. 3. ENHANCING NEW DRUG DEVELOPMENT. 

2 Section 303 of the Controlled Substances Act (21 

3 U.S.C. 823) is amended by adding at the end the fol4 lowing: 

5 ‘‘(i)(1) For purposes of registration to manufacture 

6 a controlled substance under subsection (d) for use only 

7 in a clinical trial, the Attorney General shall register the 

8 applicant, or serve an order to show cause upon the appli9 cant in accordance with section 304(c), not later than 180 

10 days after the date on which the application is accepted 

11 for filing. 

12 ‘‘(2) For purposes of registration to manufacture a 

13 controlled substance under subsection (a) for use only in 

14 a clinical trial, the Attorney General shall, in accordance 

15 with the regulations issued by the Attorney General, issue 

16 a notice of application not later than 90 days after the 

17 application is accepted for filing. Not later than 90 days 

18 after the date on which the period for comment pursuant 

19 to such notice ends, the Attorney General shall register 

20 the applicant, or serve an order to show cause upon the 

21 applicant in accordance with section 304(c), unless the At22 torney General has granted a hearing on the application 

23 under section 1008(i) of the Controlled Substances Import 

24 and Export Act.’’. 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Improving Regulatory 

3 Transparency for New Medical Therapies Act’’. 

4 SEC. 2. SCHEDULING OF SUBSTANCES INCLUDED IN NEW 

5 FDA-APPROVED DRUGS. 

6 (a) EFFECTIVE DATE OF APPROVAL.— 

7 (1) EFFECTIVE DATE OF DRUG APPROVAL.—Sec8 tion 505 of the Federal Food, Drug, and Cosmetic Act 

9 (21 U.S.C. 355) is amended by adding at the end the 

10 following: 

11 ‘‘(x) DATE OF APPROVAL IN THE CASE OF REC12 OMMENDED CONTROLS UNDER THE CSA.— 

13 ‘‘(1) IN GENERAL.—In the case of an application 

14 under subsection (b) with respect to a drug for which 

15 the Secretary provides notice to the sponsor that the 

16 Secretary intends to issue a scientific and medical 

17 evaluation and recommend controls under the Con18 trolled Substances Act, approval of such application 

19 shall not take effect until the interim final rule con20 trolling the drug is issued in accordance with section 

21 201(j) of the Controlled Substances Act. 

22 ‘‘(2) DATE OF APPROVAL.—For purposes of this 

23 section, with respect to an application described in 

24 paragraph (1), the term ‘date of approval’ shall mean 

25 the later of— 


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1 ‘‘(A) the date an application under sub2 section (b) is approved under subsection (c); or 

3 ‘‘(B) the date of issuance of the interim 

4 final rule controlling the drug.’’. 

5 (2) EFFECTIVE DATE OF APPROVAL OF BIOLOGI6 CAL PRODUCTS.—Section 351 of the Public Health 

7 Service Act (42 U.S.C. 262) is amended by adding at 

8 the end the following: 

9 ‘‘(n) DATE OF APPROVAL IN THE CASE OF REC10 OMMENDED CONTROLS UNDER THE CSA.— 

11 ‘‘(1) IN GENERAL.—In the case of an application 

12 under subsection (a) with respect to a biological prod13 uct for which the Secretary provides notice to the 

14 sponsor that the Secretary intends to issue a scientific 

15 and medical evaluation and recommend controls 

16 under the Controlled Substances Act, approval of such 

17 application shall not take effect until the interim 

18 final rule controlling the biological product is issued 

19 in accordance with section 201(j) of the Controlled 

20 Substances Act. 

21 ‘‘(2) DATE OF APPROVAL.—For purposes of this 

22 section, with respect to an application described in 

23 paragraph (1), references to the date of approval of 

24 such application, or licensure of the product subject to 

25 such application, shall mean the later of— 


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1 ‘‘(A) the date an application is approved 

2 under subsection (a); or 

3 ‘‘(B) the date of issuance of the interim 

4 final rule controlling the biological product.’’. 

5 (3) EFFECTIVE DATE OF APPROVAL OF ANIMAL

6 DRUGS.— 

7 (A) IN GENERAL.—Section 512 of the Fed8 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

9 360b) is amended by adding at the end the fol10 lowing: 

11 ‘‘(q) DATE OF APPROVAL IN THE CASE OF REC12 OMMENDED CONTROLS UNDER THE CSA.— 

13 ‘‘(1) IN GENERAL.—In the case of an application 

14 under subsection (b) with respect to a drug for which 

15 the Secretary provides notice to the sponsor that the 

16 Secretary intends to issue a scientific and medical 

17 evaluation and recommend controls under the Con18 trolled Substances Act, approval of such application 

19 shall not take effect until the interim final rule con20 trolling the drug is issued in accordance with section 

21 201(j) of the Controlled Substances Act. 

22 ‘‘(2) DATE OF APPROVAL.—For purposes of this 

23 section, with respect to an application described in 

24 paragraph (1), the term ‘date of approval’ shall mean 

25 the later of— 


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1 ‘‘(A) the date an application under sub2 section (b) is approved under subsection (c); or 

3 ‘‘(B) the date of issuance of the interim 

4 final rule controlling the drug.’’. 

5 (B) CONDITIONAL APPROVAL.—Section 

6 571(d) of the Federal Food, Drug, and Cosmetic 

7 Act (21 U.S.C. 360ccc(d)) is amended by adding 

8 at the end the following: 

9 ‘‘(4)(A) In the case of an application under sub10 section (a) with respect to a drug for which the Sec11 retary provides notice to the sponsor that the Sec12 retary intends to issue a scientific and medical eval13 uation and recommend controls under the Controlled 

14 Substances Act, conditional approval of such applica15 tion shall not take effect until the interim final rule 

16 controlling the drug is issued in accordance with sec17 tion 201(j) of the Controlled Substances Act. 

18 ‘‘(B) For purposes of this section, with respect to 

19 an application described in subparagraph (A), the 

20 term ‘date of approval’ shall mean the later of— 

21 ‘‘(i) the date an application under sub22 section (a) is conditionally approved under sub23 section (b); or 

24 ‘‘(ii) the date of issuance of the interim 

25 final rule controlling the drug.’’. 


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1 (C) INDEXING OF LEGALLY MARKETED UN2 APPROVED NEW ANIMAL DRUGS.—Section 572 of 

3 the Federal Food, Drug, and Cosmetic Act (21 

4 U.S.C. 360ccc–1) is amended by adding at the 

5 end the following: 

6 ‘‘(k) In the case of a request under subsection (d) to 

7 add a drug to the index under subsection (a) with respect 

8 to a drug for which the Secretary provides notice to the 

9 person filing the request that the Secretary intends to issue 

10 a scientific and medical evaluation and recommend controls 

11 under the Controlled Substances Act, a determination to 

12 grant the request to add such drug to the index shall not 

13 take effect until the interim final rule controlling the drug 

14 is issued in accordance with section 201(j) of the Controlled 

15 Substances Act.’’. 

16 (4) DATE OF APPROVAL FOR DESIGNATED NEW

17 ANIMAL DRUGS.—Section 573(c) of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 360ccc–2(c)) is 

19 amended by adding at the end the following: 

20 ‘‘(3) For purposes of determining the 7-year pe21 riod of exclusivity under paragraph (1) for a drug for 

22 which the Secretary intends to issue a scientific and 

23 medical evaluation and recommend controls under the 

24 Controlled Substances Act, the drug shall not be con25 sidered approved or conditionally approved until the 


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1 date that the interim final rule controlling the drug 

2 is issued in accordance with section 201(j) of the Con3 trolled Substances Act.’’. 

4 (b) SCHEDULING OF NEWLY APPROVED DRUGS.—Sec5 tion 201 of the Controlled Substances Act (21 U.S.C. 811) 

6 is amended by inserting after subsection (i) the following: 

7 ‘‘(j)(1) With respect to a drug referred to in subsection 

8 (f), if the Secretary of Health and Human Services rec9 ommends that the Attorney General control the drug in 

10 schedule II, III, IV, or V pursuant to subsections (a) and 

11 (b), the Attorney General shall, not later than 90 days after 

12 the date described in paragraph (2), issue an interim final 

13 rule controlling the drug in accordance with such sub14 sections and section 202(b) using the procedures described 

15 in paragraph (3). 

16 ‘‘(2) The date described in this paragraph shall be the 

17 later of— 

18 ‘‘(A) the date on which the Attorney General re19 ceives the scientific and medical evaluation and the 

20 scheduling recommendation from the Secretary of 

21 Health and Human Services in accordance with sub22 section (b); or 

23 ‘‘(B) the date on which the Attorney General re24 ceives notification from the Secretary of Health and 

25 Human Services that the Secretary has approved an 


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1 application under section 505(c), 512, or 571 of the 

2 Federal Food, Drug, and Cosmetic Act or section 

3 351(a) of the Public Health Service Act, or indexed 

4 a drug under section 572 of the Federal Food, Drug, 

5 and Cosmetic Act, with respect to the drug described 

6 in paragraph (1). 

7 ‘‘(3) A rule issued by the Attorney General under para8 graph (1) shall become immediately effective as an interim 

9 final rule without requiring the Attorney General to dem10 onstrate good cause therefor. The interim final rule shall 

11 give interested persons the opportunity to comment and to 

12 request a hearing. After the conclusion of such proceedings, 

13 the Attorney General shall issue a final rule in accordance 

14 with the scheduling criteria of subsections (b), (c), and (d) 

15 of this section and section 202(b).’’. 

16 (c) EXTENSION OF PATENT TERM.—Section 156 of 

17 title 35, United States Code, is amended— 

18 (1) in subsection (d)(1), in the matter preceding 

19 subparagraph (A), by inserting ‘‘, or in the case of a 

20 drug product described in subsection (i), within the 

21 sixty-day period beginning on the covered date (as de22 fined in subsection (i))’’ after ‘‘marketing or use’’; 

23 and 

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


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1 ‘‘(i)(1) For purposes of this section, if the Secretary 

2 of Health and Human Services provides notice to the spon3 sor of an application or request for approval, conditional 

4 approval, or indexing of a drug product for which the Sec5 retary intends to recommend controls under the Controlled 

6 Substances Act, beginning on the covered date, the drug 

7 product shall be considered to— 

8 ‘‘(A) have been approved or indexed under the 

9 relevant provision of the Public Health Service Act or 

10 Federal Food, Drug, and Cosmetic Act; and 

11 ‘‘(B) have permission for commercial marketing 

12 or use. 

13 ‘‘(2) In this subsection, the term ‘covered date’ means 

14 the later of— 

15 ‘‘(A) the date an application is approved— 

16 ‘‘(i) under section 351(a)(2)(C) of the Pub17 lic Health Service Act; or 

18 ‘‘(ii) under section 505(b) or 512(c) of the 

19 Federal Food, Drug, and Cosmetic Act; 

20 ‘‘(B) the date an application is conditionally ap21 proved under section 571(b) of the Federal Food, 

22 Drug, and Cosmetic Act; 

23 ‘‘(C) the date a request for indexing is granted 

24 under section 572(d) of the Federal Food, Drug, and 

25 Cosmetic Act; or 


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1 ‘‘(D) the date of issuance of the interim final 

2 rule controlling the drug under section 201(j) of the 

3 Controlled Substances Act.’’. 

4 SEC. 3. ENHANCING NEW DRUG DEVELOPMENT. 

5 Section 303 of the Controlled Substances Act (21 

6 U.S.C. 823) is amended by adding at the end the following: 

7 ‘‘(i)(1) For purposes of registration to manufacture a 

8 controlled substance under subsection (d) for use only in 

9 a clinical trial, the Attorney General shall register the ap10 plicant, or serve an order to show cause upon the applicant 

11 in accordance with section 304(c), not later than 180 days 

12 after the date on which the application is accepted for fil13 ing. 

14 ‘‘(2) For purposes of registration to manufacture a 

15 controlled substance under subsection (a) for use only in 

16 a clinical trial, the Attorney General shall, in accordance 

17 with the regulations issued by the Attorney General, issue 

18 a notice of application not later than 90 days after the ap19 plication is accepted for filing. Not later than 90 days after 

20 the date on which the period for comment pursuant to such 

21 notice ends, the Attorney General shall register the appli22 cant, or serve an order to show cause upon the applicant 

23 in accordance with section 304(c), unless the Attorney Gen24 eral has granted a hearing on the application under section 


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1 1008(i) of the Controlled Substances Import and Export 

2 Act.’’. 

3 SEC. 4. RE-EXPORTATION AMONG MEMBERS OF THE EURO4 PEAN ECONOMIC AREA. 

5 Section 1003 of the Controlled Substances Import and 

6 Export Act (21 U.S.C. 953) is amended— 

7 (1) in subsection(f)— 

8 (A) in paragraph (5)— 

9 (i) by striking ‘‘(5)’’ and inserting 

10 ‘‘(5)(A)’’; 

11 (ii) by inserting ‘‘, except that the con12 trolled substance may be exported from a 

13 second country that is a member of the Eu14 ropean Economic Area to another country 

15 that is a member of the European Economic 

16 Area, provided that the first country is also 

17 a member of the European Economic Area’’ 

18 before the period at the end; and 

19 (iii) by adding at the end the fol20 lowing: 

21 ‘‘(B) Subsequent to any re-exportation described 

22 in subparagraph (A), a controlled substance may con23 tinue to be exported from any country that is a mem24 ber of the European Economic Area to any other such 

25 country, if— 


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1 ‘‘(i) the conditions applicable with respect 

2 to the first country under paragraphs (1), (2), 

3 (3), (4), (6), and (7) are met by each subsequent 

4 country from which the controlled substance is 

5 exported pursuant to this paragraph; and 

6 ‘‘(ii) the conditions applicable with respect 

7 to the second country under paragraphs (1), (2), 

8 (3), (4), (6), and (7) are met by each subsequent 

9 country to which the controlled substance is ex10 ported pursuant to this paragraph.’’; and 

11 (B) in paragraph (6)— 

12 (i) by striking ‘‘(6)’’ and inserting 

13 ‘‘(6)(A)’’; and 

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

15 ‘‘(B) In the case of re-exportation among mem16 bers of the European Economic Area, within 30 days 

17 after each re-exportation, the person who exported the 

18 controlled substance from the United States delivers to 

19 the Attorney General— 

20 ‘‘(i) documentation certifying that such re21 exportation has occurred; and 

22 ‘‘(ii) information concerning the consignee, 

23 country, and product.’’; and 

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


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1 ‘‘(g) LIMITATION.—Subject to paragraphs (5) and (6) 

2 of subsection (f) in the case of any controlled substance in 

3 schedule I or II or any narcotic drug in schedule III or 

4 IV, the Attorney General shall not promulgate nor enforce 

5 any regulation, subregulatory guidance, or enforcement pol6 icy which impedes re-exportation of any controlled sub7 stance among European Economic Area countries, includ8 ing by promulgating or enforcing any requirement that— 

9 ‘‘(1) re-exportation from the first country to the 

10 second country or re-exportation from the second 

11 country to another country occur within a specified 

12 period of time; or 

13 ‘‘(2) information concerning the consignee, coun14 try, and product be provided prior to exportation of 

15 the controlled substance from the United States or 

16 prior to each re-exportation among members of the 

17 European Economic Area.’’. 


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Calendar No. 245 

114TH CONGRESS 

1ST SESSION S. 481 

A BILL 

To amend the Controlled Substances Act and the 

and for other purposes. distributors seeking to conduct clinical testing, with respect to registration of manufacturers and Secretary of Health and Human Services, and spect to drug scheduling recommendations by the Federal Food, Drug, and Cosmetic Act with reOCTOBER 1, 2015 

Reported with an amendment 


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