II 

116TH CONGRESS 

1ST SESSION S. 97 

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

importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals. 

IN THE SENATE OF THE UNITED STATES 

JANUARY 10, 2019 

Mr. SANDERS (for himself, Mr. BOOKER, Mr. CASEY, Ms. BALDWIN, Mr. 

BLUMENTHAL, Mr. BROWN, Ms. CANTWELL, Mrs. GILLIBRAND, Ms. 

HARRIS, Ms. HASSAN, Mr. HEINRICH, Mr. KING, Mr. LEAHY, Ms. KLOBUCHAR, Mr. MANCHIN, Mr. MERKLEY, Mr. REED, Mrs. SHAHEEN, Ms. 

SMITH, Ms. STABENOW, Mr. UDALL, Mr. VAN HOLLEN, Ms. WARREN, 

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 Federal Food, Drug, and Cosmetic Act to 

allow for the importation of affordable and safe drugs 

by wholesale distributors, pharmacies, and individuals. 

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 ‘‘Affordable and Safe 

5 Prescription Drug Importation Act’’. 


kjohnson on DSK79L0C42 with BILLS
2 

•S 97 IS

1 SEC. 2. IMPORTING AFFORDABLE AND SAFE DRUGS. 

2 (a) IN GENERAL.—Section 804 of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 384) is amended to 

4 read as follows: 

5 ‘‘SEC. 804. IMPORTATION OF SAFE AND AFFORDABLE 

6 DRUGS BY WHOLESALE DISTRIBUTORS, 

7 PHARMACIES, AND INDIVIDUALS. 

8 ‘‘(a) IN GENERAL.—Not later than 180 days after 

9 the date of enactment of the Affordable and Safe Prescrip10 tion Drug Importation Act, the Secretary shall promulgate 

11 regulations permitting the importation of qualifying pre12 scription drugs into the United States, in accordance with 

13 this section. 

14 ‘‘(b) DEFINITIONS.—For purposes of this section: 

15 ‘‘(1) CERTIFIED FOREIGN SELLER.—The term 

16 ‘certified foreign seller’ means a licensed foreign 

17 pharmacy or foreign wholesale distributor that the 

18 Secretary certifies under subsection (d)(1)(B), that 

19 pays the fee required under subsection (d)(1)(C), 

20 and that is included on the list described in sub21 section (c). 

22 ‘‘(2) FOREIGN WHOLESALE DISTRIBUTOR.— 

23 The term ‘foreign wholesale distributor’ means a 

24 person (other than a manufacturer, a manufactur25 er’s co-licensed partner, a third-party logistics proVerDate Sep 11 2014 02:18 Jan 17, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S97.IS S97

kjohnson on DSK79L0C42 with BILLS
3 

•S 97 IS

1 vider, or a repackager) engaged in wholesale dis2 tribution. 

3 ‘‘(3) IMPORTER.—The term ‘importer’ means a 

4 dispenser (as defined in section 581(3)) or wholesale 

5 distributor registered under section 503(e) who im6 ports prescription drugs into the United States in 

7 accordance with this section. 

8 ‘‘(4) LICENSED FOREIGN PHARMACY.—The 

9 term ‘licensed foreign pharmacy’ means a pharmacy 

10 located in Canada, or subject to subsection (e), an11 other applicable country, that— 

12 ‘‘(A) operates in accordance with applica13 ble pharmacy standards set forth by the provin14 cial pharmacy rules and regulations enacted in 

15 Canada, or, subject to subsection (e), such ap16 plicable rules and regulations of the permitted 

17 country in which such seller is located; and 

18 ‘‘(B) is licensed to operate and dispense 

19 prescription drugs to individuals in Canada, or, 

20 subject to subsection (e), the permitted country 

21 in which the pharmacy is located. 

22 ‘‘(5) QUALIFYING PRESCRIPTION DRUG.—The 

23 term ‘qualifying prescription drug’— 

24 ‘‘(A) means a prescription drug that— 


kjohnson on DSK79L0C42 with BILLS
4 

•S 97 IS

1 ‘‘(i) is approved for use in patients, 

2 and marketed, in Canada, or subject to 

3 subsection (e), approved for use in pa4 tients, and marketed, in another permitted 

5 country; 

6 ‘‘(ii) is manufactured in a facility reg7 istered under subsection (b)(1) or (i) of 

8 section 510 that is in compliance with good 

9 manufacturing practices regulations of the 

10 Food and Drug Administration; 

11 ‘‘(iii) has the same active ingredient 

12 or ingredients, route of administration, and 

13 strength as a prescription drug approved 

14 under chapter V, or, for purposes of sub15 paragraph (B)(iv), is biosimilar to an ap16 proved biological product and has the same 

17 route of administration and strength as the 

18 approved biological product; and 

19 ‘‘(iv) is labeled in accordance with— 

20 ‘‘(I) the laws of Canada, or an21 other country from which importation 

22 is permitted pursuant to subsection 

23 (e); and 


kjohnson on DSK79L0C42 with BILLS
5 

•S 97 IS

1 ‘‘(II) the requirements promul2 gated by the Secretary, which shall in3 clude labeling in English; 

4 ‘‘(B) with respect to importers only, in5 cludes— 

6 ‘‘(i) peritoneal dialysis solution; 

7 ‘‘(ii) insulin; 

8 ‘‘(iii) a drug for which a risk evalua9 tion and mitigation strategy is required 

10 under section 505–1; 

11 ‘‘(iv) biological products, as defined in 

12 section 351 of the Public Health Service 

13 Act that are proteins (except any chemi14 cally synthesized polypeptides) or analo15 gous products; and 

16 ‘‘(v) intravenously infused drugs; and 

17 ‘‘(C) does not include— 

18 ‘‘(i) a controlled substance (as defined 

19 in section 102 of the Controlled Sub20 stances Act); 

21 ‘‘(ii) an anesthetic drug inhaled dur22 ing surgery; or 

23 ‘‘(iii) a compounded drug. 

24 ‘‘(6) VALID PRESCRIPTION.—The term ‘valid 

25 prescription’ means a prescription that is issued for 


kjohnson on DSK79L0C42 with BILLS
6 

•S 97 IS

1 a legitimate medical purpose in the usual course of 

2 professional practice by— 

3 ‘‘(A) a practitioner who has conducted at 

4 least one in-person medical evaluation of the 

5 patient; or 

6 ‘‘(B) a covering practitioner. 

7 ‘‘(c) PUBLICATION OF CERTIFIED FOREIGN SELL8 ERS.—The Secretary shall publish on a dedicated internet 

9 website a list of certified foreign sellers, including the 

10 internet website address, physical address, and telephone 

11 number of each such certified foreign seller. 

12 ‘‘(d) ADDITIONAL CRITERIA.— 

13 ‘‘(1) CERTIFIED FOREIGN SELLERS.— 

14 ‘‘(A) IN GENERAL.—To be a certified for15 eign seller, such seller shall— 

16 ‘‘(i) be certified by the Secretary in 

17 accordance with subparagraph (B); 

18 ‘‘(ii) pay the registration fee estab19 lished under subparagraph (C); and 

20 ‘‘(iii) sell only qualifying prescription 

21 drugs to importers or individuals who im22 port prescription drugs into the United 

23 States in accordance with this section. 


kjohnson on DSK79L0C42 with BILLS
7 

•S 97 IS

1 ‘‘(B) CERTIFICATION.—To be a certified 

2 foreign seller, the Secretary shall certify that 

3 such seller— 

4 ‘‘(i) is a foreign wholesale distributor 

5 or licensed foreign pharmacy operating an 

6 establishment, which may include an online 

7 foreign pharmacy, that is located in Can8 ada, or, subject to subsection (e), another 

9 permitted country; 

10 ‘‘(ii) is engaged in the distribution or 

11 dispensing of a prescription drug that is 

12 imported or offered for importation into 

13 the United States; 

14 ‘‘(iii) has been in existence for a pe15 riod of at least 5 years preceding the date 

16 of such certification and has a purpose 

17 other than to participate in the program 

18 established under this section; 

19 ‘‘(iv) in the case of a certified foreign 

20 seller that is a licensed foreign pharmacy, 

21 agrees to dispense a qualifying prescription 

22 drug to an individual in the United States 

23 only after receiving a valid prescription, as 

24 described in paragraph (2)(C); 


kjohnson on DSK79L0C42 with BILLS
8 

•S 97 IS

1 ‘‘(v) has processes established by the 

2 seller, or participates in another estab3 lished process, to certify that the physical 

4 premises and data reporting procedures 

5 and licenses are in compliance with all ap6 plicable laws and regulations of Canada, 

7 or, subject to subsection (e), the permitted 

8 country in which the seller is located, and 

9 has implemented policies designed to mon10 itor ongoing compliance with such laws 

11 and regulations; 

12 ‘‘(vi) conducts or commits to partici13 pate in ongoing and comprehensive quality 

14 assurance programs and implements such 

15 quality assurance measures, including 

16 blind testing, to ensure the veracity and re17 liability of the findings of the quality as18 surance program; 

19 ‘‘(vii) agrees that, pursuant to sub20 section (g), laboratories approved by the 

21 Secretary may be authorized to conduct 

22 product testing to determine the chemical 

23 authenticity of sample pharmaceutical 

24 products; 


kjohnson on DSK79L0C42 with BILLS
9 

•S 97 IS

1 ‘‘(viii) agrees to notify the Secretary, 

2 importers, and individuals of product re3 calls in Canada, or pursuant to subsection 

4 (e), the permitted country in which the 

5 seller is located, and agrees to cease, or re6 frain from, exporting such product; 

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

8 or participate in, a process for resolving 

9 grievances, as defined by the Secretary, 

10 and will be held accountable for violations 

11 of established guidelines and rules; 

12 ‘‘(x) except as otherwise permitted 

13 under this section, does not sell products 

14 that the seller could not otherwise legally 

15 sell in Canada, or, subject to subsection 

16 (e), the permitted country in which such 

17 seller is located to customers in the United 

18 States; and 

19 ‘‘(xi) meets any other criteria estab20 lished by the Secretary. 

21 ‘‘(C) CERTIFICATION FEE.—Not later than 

22 30 days before the start of each fiscal year, the 

23 Secretary shall establish a fee to be collected 

24 from foreign sellers for such fiscal year that are 

25 certified under subparagraph (B), in an amount 


kjohnson on DSK79L0C42 with BILLS
10 

•S 97 IS

1 that is sufficient, and not more than necessary, 

2 to pay the costs of administering the program 

3 under this section, and enforcing this section 

4 pursuant to section 303(h), for that fiscal year. 

5 ‘‘(D) RECERTIFICATION.—A certification 

6 under subparagraph (B) shall be in effect for a 

7 period of 2 years, or until there is a material 

8 change in the circumstances under which the 

9 foreign seller meets the requirements under 

10 such subparagraph, whichever occurs earlier. A 

11 foreign seller may reapply for certification 

12 under such subparagraph (B), in accordance 

13 with a process established by the Secretary. 

14 ‘‘(2) INDIVIDUALS.—An individual may import 

15 a qualifying prescription drug described in sub16 section (b) from Canada or another country pursu17 ant to subsection (e) if such drug— 

18 ‘‘(A) is dispensed, including through an 

19 online pharmacy, by a certified foreign seller 

20 that is a licensed foreign pharmacy; 

21 ‘‘(B) is purchased for personal use by the 

22 individual, not for resale, in quantities that do 

23 not exceed a 90-day supply; and 

24 ‘‘(C) is filled only after providing to the li25 censed foreign pharmacy a valid prescription 


kjohnson on DSK79L0C42 with BILLS
11 

•S 97 IS

1 issued by a health care practitioner licensed to 

2 practice in a State in the United States. 

3 ‘‘(e) IMPORTATION FROM OTHER COUNTRIES.—Be4 ginning on the date that is 2 years after the date on which 

5 final regulations are promulgated to carry out this section, 

6 if, based on a review of the evidence obtained after such 

7 effective date, including the reports submitted under sec8 tion 2(d) of the Affordable and Safe Prescription Drug 

9 Importation Act, that importation of qualifying prescrip10 tion drugs from Canada under this section resulted in cost 

11 savings for consumers in the United States and increased 

12 access to safe medication, the Secretary shall have the au13 thority to permit importation of qualifying prescription 

14 drugs by importers and individuals from, in addition to 

15 Canada, any country that— 

16 ‘‘(1) is a member of the Organisation for Eco17 nomic Co-operation and Development; and 

18 ‘‘(2) has statutory or regulatory standards for 

19 the approval and sale of prescription drugs that are 

20 comparable to the standards in the United States 

21 and that— 

22 ‘‘(A) authorizes the approval of drugs only 

23 if a drug has been determined to be safe and 

24 effective by experts employed by or acting on 

25 behalf of a governmental entity and qualified by 


kjohnson on DSK79L0C42 with BILLS
12 

•S 97 IS

1 scientific training and experience to evaluate 

2 the safety and effectiveness of drugs; 

3 ‘‘(B) requires that any determination of 

4 safety and effectiveness described in subpara5 graph (A) be made on the basis of adequate 

6 and well-controlled investigations, including 

7 clinical investigations, as appropriate, con8 ducted by experts qualified by scientific training 

9 and experience to evaluate the safety and effec10 tiveness of drugs; 

11 ‘‘(C) requires the methods used in, and the 

12 facilities and controls used for, the manufac13 ture, processing, and packing of drugs in the 

14 country to be adequate to preserve the identity, 

15 quality, purity, and strength of the drugs; and 

16 ‘‘(D) requires the reporting of adverse re17 actions to drugs and establish procedures to re18 call, and withdraw approval of, drugs found not 

19 to be safe or effective. 

20 ‘‘(f) LABELING.—Any qualifying prescription drug 

21 imported that meets the labeling requirements described 

22 in subsection (b)(5)(A)(iv) is deemed not misbranded for 

23 purposes of section 502. 

24 ‘‘(g) DRUG TESTING LABORATORIES.—The Sec25 retary may approve one or more laboratories to conduct 


kjohnson on DSK79L0C42 with BILLS
13 

•S 97 IS

1 random testing of prescription drugs sold by certified for2 eign sellers to assess the chemical authenticity of such 

3 drugs. 

4 ‘‘(h) UNFAIR AND DISCRIMINATORY ACTS AND PRAC5 TICES.—It is unlawful for a manufacturer, directly or indi6 rectly (including by being a party to a licensing agreement 

7 or other agreement)— 

8 ‘‘(1) to discriminate by charging a higher price 

9 for a prescription drug sold to a certified foreign 

10 seller that sells such drug to an importer in accord11 ance with this section than the price that is charged, 

12 inclusive of rebates or other incentives to the coun13 try from which the drug is exported, to another per14 son that is in the same country and that does not 

15 import such a drug into the United States in accord16 ance with this section; 

17 ‘‘(2) except with respect to a prescription drug 

18 on the drug shortage list under section 506E, dis19 criminate by denying, restricting, or delaying sup20 plies of a prescription drug to a certified foreign sell21 er, on account of such seller’s status as a certified 

22 foreign seller, that sells such drug to an importer in 

23 accordance with this section, or by publicly, pri24 vately, or otherwise refusing to do business with 


kjohnson on DSK79L0C42 with BILLS
14 

•S 97 IS

1 such a certified foreign seller on account of such 

2 seller’s status as a certified foreign seller; 

3 ‘‘(3) cause there to be a difference (including a 

4 difference in active ingredient, route of administra5 tion, bioequivalence, strength, formulation, manufac6 turing establishment, manufacturing process, or per7 son that manufactures the drug) between a prescrip8 tion drug for distribution in the United States and 

9 the drug for distribution in Canada or another per10 mitted country, subject to subsection (e), for the 

11 purpose of avoiding sales by certified foreign sellers; 

12 or 

13 ‘‘(4) except with respect to a prescription drug 

14 on the drug shortage list under section 506E, en15 gage in any other action to restrict, prohibit, or 

16 delay the importation of a prescription drug under 

17 this section. 

18 ‘‘(i) INFORMATION AND RECORDS.— 

19 ‘‘(1) BIANNUAL REPORTS.—Each importer shall 

20 submit biannual reports to the Secretary which shall 

21 contain, for each qualifying prescription drug im22 ported into the United States— 

23 ‘‘(A) the unique facility identifier of the 

24 manufacturer of the drug, described in section 

25 510; 


kjohnson on DSK79L0C42 with BILLS
15 

•S 97 IS

1 ‘‘(B) the transaction information described 

2 in section 581(26) (other than the information 

3 described in subparagraph (C)); and 

4 ‘‘(C) the price paid by the importer for the 

5 drug. 

6 ‘‘(2) MAINTENANCE OF RECORDS BY SEC7 RETARY.—The Secretary shall maintain information 

8 and documentation submitted under paragraph (1) 

9 for such period of time as the Secretary determines 

10 to be appropriate. 

11 ‘‘(j) SUSPENSION OF IMPORTATION.— 

12 ‘‘(1) PATTERNS OF NONCOMPLIANCE.—The 

13 Secretary shall require that importation of a specific 

14 qualifying prescription drug or importation by a spe15 cific certified foreign seller or importer pursuant to 

16 this section be immediately suspended if the Sec17 retary determines that there is a pattern of importa18 tion of such specific drug or by such specific seller 

19 or importer that involves counterfeit drugs, drugs 

20 that have been recalled or withdrawn, or drugs in 

21 violation of any requirement of this section, until an 

22 investigation is completed and the Secretary deter23 mines that importation of such drug or by such sell24 er or importer does not endanger the public health. 


kjohnson on DSK79L0C42 with BILLS
16 

•S 97 IS

1 ‘‘(2) TEMPORARY SUSPENSION.—The Secretary 

2 may require that importation of a specific qualifying 

3 prescription drug or importation by a specific cer4 tified foreign seller or importer pursuant to this sec5 tion be temporarily suspended if, with respect to 

6 such drug, seller, or importer, there is a violation of 

7 any requirement of this section or if the Secretary 

8 determines that importation of such drug or by such 

9 seller or importer might endanger the public health. 

10 Such temporary suspension shall apply until the Sec11 retary completes an investigation and determines 

12 that importation of such drug or by such seller or 

13 importer does not endanger the public health. 

14 ‘‘(k) SUPPLY CHAIN SECURITY.— 

15 ‘‘(1) PURCHASE FROM REGISTERED FACILITIES

16 AND CERTIFIED FOREIGN SELLERS.— 

17 ‘‘(A) IN GENERAL.—Except as provided in 

18 subparagraph (B), certified foreign sellers who 

19 sell qualifying prescription drugs for importa20 tion into the United States pursuant to this 

21 section may purchase such drugs only from 

22 manufacturers or entities registered under sec23 tion 510 or other certified foreign sellers. 

24 ‘‘(B) EXCEPTION.—Certified foreign sellers 

25 who sell qualifying prescription drugs for imVerDate Sep 11 2014 02:18 Jan 17, 2019 Jkt 089200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\S97.IS S97

kjohnson on DSK79L0C42 with BILLS
17 

•S 97 IS

1 portation into the United States pursuant to 

2 this section may purchase such drugs from for3 eign sellers in Canada or another permitted 

4 country, even if such foreign seller is not a 

5 manufacturer registered under section 510 or a 

6 certified foreign seller, if the Secretary enters 

7 into a memorandum of understanding or coop8 erative agreement with Canada, or such other 

9 permitted country, to ensure compliance, to the 

10 extent appropriate and feasible, with subchapter 

11 H of chapter V. The Secretary shall seek to 

12 enter into such a memorandum of under13 standing or cooperative agreement with Canada 

14 and each country from which importation is 

15 permitted under subsection (e). 

16 ‘‘(2) IMPORTATION TRACING.—Certified foreign 

17 sellers shall provide importers with the unique facil18 ity identifier associated with the manufacturer reg19 istered under section 510 of the qualifying prescrip20 tion drug and the information under paragraph 

21 (25), paragraph (26) (other than subparagraph (C)), 

22 and subparagraphs (D), (F), and (G) of paragraph 

23 (27) of section 581. Certified foreign sellers shall 

24 provide such information to individuals purchasing 

25 such drugs, upon request. 


kjohnson on DSK79L0C42 with BILLS
18 

•S 97 IS

1 ‘‘(l) REMS.—In the case of an importer that imports 

2 a qualifying prescription drug, where the drug with the 

3 same active ingredient or ingredients (or that is biosimilar 

4 to an approved biological product), route of administra5 tion, and strength that is approved under chapter V or 

6 section 351 of the Public Health Service Act is subject 

7 to elements to assure safe use under section 505–1, such 

8 importer shall be subject to such elements to assure safe 

9 use, as applicable and appropriate. 

10 ‘‘(m) CONSTRUCTION.—Nothing in this section limits 

11 the authority of the Secretary relating to the importation 

12 of prescription drugs, other than with respect to section 

13 801(d)(1) as provided in this section.’’. 

14 (b) PENALTIES WITH RESPECT TO ONLINE PHAR15 MACIES.—Section 303 of the Federal Food, Drug, and 

16 Cosmetic Act (21 U.S.C. 333) is amended by adding at 

17 the end the following: 

18 ‘‘(h) In the case of person operating an internet 

19 website, whether in the United States or in another coun20 try, that violates section 301(aa) by— 

21 ‘‘(1) selling, by means of the internet, with the 

22 intent to defraud or mislead or with reckless dis23 regard for safety of the public, an adulterated or 

24 counterfeit drug to an individual in the United 

25 States; or 


kjohnson on DSK79L0C42 with BILLS
19 

•S 97 IS

1 ‘‘(2) dispenses, by means of the internet, a drug 

2 to an individual in the United States who the person 

3 knows or has reasonable cause to believe, does not 

4 possess a valid prescription for that drug, 

5 such person shall be imprisoned for not more than 

6 10 years or fined not more than $250,000.’’. 

7 (c) NO PREEMPTION.—Nothing in this Act, including 

8 the amendments made by this Act, shall be construed to 

9 preempt, alter, displace, abridge, or supplant any remedy 

10 available under any State or Federal law, including com11 mon law, that provides a remedy for civil relief. 

12 (d) REPORTS.— 

13 (1) HHS.—Not later than 1 year after the date 

14 on which final regulations are promulgated to carry 

15 out section 804 of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 384), as amended by this Act, 

17 and every 2 years thereafter, the Secretary of 

18 Health and Human Services, after consultation with 

19 appropriate Federal agencies, shall submit to Con20 gress and make public a report on the importation 

21 of drugs into the United States. 

22 (2) GAO REPORT.—Not later than 18 months 

23 after the date on which final regulations are promul24 gated to carry out section 804 of the Federal Food, 

25 Drug, and Cosmetic Act (21 U.S.C. 384), as amendVerDate Sep 11 2014 02:18 Jan 17, 2019 Jkt 089200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\S97.IS S97

kjohnson on DSK79L0C42 with BILLS
20 

•S 97 IS

1 ed by this Act, the Comptroller General of the 

2 United States shall submit to Congress a report con3 taining an analysis of the implementation of the 

4 amendments made by this Act, including a review of 

5 drug safety and cost-savings and expenses, including 

6 cost-savings to consumers in the United States and 

7 trans-shipment and importation tracing processes, 

8 resulting from such implementation. 

Æ 


kjohnson on DSK79L0C42 with BILLS