II 

114TH CONGRESS 

1ST SESSION S. 1790 

To amend the Federal Food, Drug, and Cosmetic Act to allow for the 

personal importation of safe and affordable prescription drugs from approved pharmacies. 

IN THE SENATE OF THE UNITED STATES 

JULY 16, 2015 

Mr. VITTER introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

allow for the personal importation of safe and affordable 

prescription drugs from approved pharmacies. 

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 ‘‘Safe and Affordable 

5 Prescription Drugs Act of 2015’’. 

6 SEC. 2. SAFE AND AFFORDABLE PRESCRIPTION DRUGS. 

7 Chapter VIII of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 381 et seq.) is amended by adding 

9 at the end the following: 


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1 ‘‘SEC. 810. IMPORTATION BY INDIVIDUALS OF PRESCRIP2 TION DRUGS. 

3 ‘‘(a) IN GENERAL.—Notwithstanding any other pro4 vision of this Act, not later than 180 days after the date 

5 of enactment of this section, the Secretary shall promul6 gate regulations permitting individuals to safely import 

7 into the United States a prescription drug described in 

8 subsection (b). 

9 ‘‘(b) PRESCRIPTION DRUG.—A prescription drug de10 scribed in this subsection— 

11 ‘‘(1) is a prescription drug that— 

12 ‘‘(A) is purchased from an approved phar13 macy; 

14 ‘‘(B) is dispensed by a pharmacist licensed 

15 to practice pharmacy and dispense prescription 

16 drugs in the country in which the pharmacy is 

17 located; 

18 ‘‘(C) is purchased for personal use by the 

19 individual, not for resale, in quantities that do 

20 not exceed a 90-day supply; 

21 ‘‘(D) is filled using a valid prescription 

22 issued by a physician licensed to practice in a 

23 State in the United States; and 

24 ‘‘(E) has the same active ingredient or in25 gredients, route of administration, dosage form, 


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1 and strength as a prescription drug approved 

2 by the Secretary under chapter V; and 

3 ‘‘(2) does not include— 

4 ‘‘(A) a controlled substance (as defined in 

5 section 102 of the Controlled Substances Act 

6 (21 U.S.C. 802)); 

7 ‘‘(B) a biological product (as defined in 

8 section 351 of the Public Health Service Act 

9 (42 U.S.C. 262)); 

10 ‘‘(C) an infused drug (including a peri11 toneal dialysis solution); 

12 ‘‘(D) an intravenously injected drug; 

13 ‘‘(E) a drug that is inhaled during surgery; 

14 ‘‘(F) a parenteral drug; 

15 ‘‘(G) a drug manufactured through 1 or 

16 more biotechnology processes, including— 

17 ‘‘(i) a therapeutic DNA plasmid prod18 uct; 

19 ‘‘(ii) a therapeutic synthetic peptide 

20 product of not more than 40 amino acids; 

21 ‘‘(iii) a monoclonal antibody product 

22 for in vivo use; and 

23 ‘‘(iv) a therapeutic recombinant DNA24 derived product; 


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1 ‘‘(H) a drug required to be refrigerated at 

2 any time during manufacturing, packing, proc3 essing, or holding; or 

4 ‘‘(I) a photoreactive drug. 

5 ‘‘(c) APPROVED PHARMACY.— 

6 ‘‘(1) IN GENERAL.—In this section, an ap7 proved pharmacy is a pharmacy that— 

8 ‘‘(A) is located in a country listed or de9 scribed in section 802(b)(1)(A); and 

10 ‘‘(B) the Secretary certifies— 

11 ‘‘(i) is licensed to operate and dis12 pense prescription drugs to individuals in 

13 the country in which such pharmacy is lo14 cated; and 

15 ‘‘(ii) meets the criteria under para16 graph (3). 

17 ‘‘(2) PUBLICATION OF APPROVED PHAR18 MACIES.—The Secretary shall publish on the Inter19 net Web site of the Food and Drug Administration 

20 a list of approved pharmacies, including the Internet 

21 Web site address of each such approved pharmacy, 

22 from which individuals may purchase prescription 

23 drugs in accordance with subsection (a). 


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1 ‘‘(3) ADDITIONAL CRITERIA.—To be an ap2 proved pharmacy, the Secretary shall certify that the 

3 pharmacy— 

4 ‘‘(A) has been in existence for a period of 

5 at least 5 years preceding the date of such cer6 tification and has a purpose other than to par7 ticipate in the program established under this 

8 section; 

9 ‘‘(B) operates in accordance with phar10 macy standards set forth by the pharmacy rules 

11 and regulations enacted in the country in which 

12 it is located; 

13 ‘‘(C) has processes established by the phar14 macy, or participates in another established 

15 process, to certify that the physical premises 

16 and data reporting procedures and licenses are 

17 in compliance with all applicable laws and regu18 lations, and has implemented policies designed 

19 to monitor ongoing compliance with such laws 

20 and regulations; 

21 ‘‘(D) conducts or commits to participate in 

22 ongoing and comprehensive quality assurance 

23 programs and implements such quality assur24 ance measures, including blind testing, to enVerDate Sep 11 2014 23:56 Jul 20, 2015 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1790.IS S1790

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1 sure the veracity and reliability of the findings 

2 of the quality assurance program; 

3 ‘‘(E) agrees that laboratories approved by 

4 the Secretary shall be used to conduct product 

5 testing to determine the safety and efficacy of 

6 sample pharmaceutical products; 

7 ‘‘(F) has established, or will establish or 

8 participate in, a process for resolving grievances 

9 and will be held accountable for violations of es10 tablished guidelines and rules; 

11 ‘‘(G) does not resell products from online 

12 pharmacies located outside the country in which 

13 the pharmacy is located to customers in the 

14 United States; and 

15 ‘‘(H) meets any other criteria established 

16 by the Secretary.’’. 

Æ 


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