I 

116TH CONGRESS 

1ST SESSION H. R. 447 

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 HOUSE OF REPRESENTATIVES 

JANUARY 10, 2019 

Mr. CUMMINGS (for himself, Mr. DOGGETT, Mr. WELCH, Mr. COHEN, Mr. 

KHANNA, Ms. LEE of California, Ms. NORTON, Ms. PINGREE, Ms. 

DELAURO, Mr. SHERMAN, Mr. POCAN, Ms. JAYAPAL, Ms. OMAR, Mr. 

KRISHNAMOORTHI, Ms. GABBARD, Mr. LANGEVIN, Ms. JACKSON LEE, 

Mr. BLUMENAUER, Ms. SCHAKOWSKY, Mr. NEGUSE, Ms. OCASIO-CORTEZ, and Ms. TLAIB) introduced the following bill; which was referred to 

the Committee on Energy and Commerce 

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’’. 


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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 this section, the Secretary shall 

10 promulgate regulations permitting the importation of 

11 qualifying prescription drugs into the United States, in ac12 cordance with this section. 

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

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

15 ‘certified foreign seller’ means a licensed foreign 

16 pharmacy or foreign wholesale distributor that the 

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

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

19 and that is included on the list described in sub20 section (c). 

21 ‘‘(2) FOREIGN WHOLESALE DISTRIBUTOR.— 

22 The term ‘foreign wholesale distributor’ means a 

23 person (other than a manufacturer, a manufactur24 er’s co-licensed partner, a third-party logistics pro25 vider, or a repackager) engaged in wholesale dis26 tribution. 


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

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

3 distributor registered under section 503(e) who im4 ports prescription drugs into the United States in 

5 accordance with this section. 

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

7 term ‘licensed foreign pharmacy’ means a pharmacy 

8 located in Canada, or subject to subsection (e), an9 other applicable country, that— 

10 ‘‘(A) operates in accordance with applica11 ble pharmacy standards set forth by the provin12 cial pharmacy rules and regulations enacted in 

13 Canada, or, subject to subsection (e), such ap14 plicable rules and regulations of the permitted 

15 country in which such seller is located; and 

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

17 prescription drugs to individuals in Canada, or, 

18 subject to subsection (e), the permitted country 

19 in which the pharmacy is located. 

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

21 term ‘qualifying prescription drug’— 

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

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

24 and marketed, in Canada, or subject to 

25 subsection (e), approved for use in paVerDate Sep 11 2014 22:31 Jan 24, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H447.IH H447

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1 tients, and marketed, in another permitted 

2 country; 

3 ‘‘(ii) is manufactured in a facility reg4 istered under subsection (b)(1) or (i) of 

5 section 510 that is in compliance with good 

6 manufacturing practices regulations of the 

7 Food and Drug Administration; 

8 ‘‘(iii) has the same active ingredient 

9 or ingredients, route of administration, and 

10 strength as a prescription drug approved 

11 under chapter V, or, for purposes of sub12 paragraph (B)(iv), is biosimilar to an ap13 proved biological product and has the same 

14 route of administration and strength as the 

15 approved biological product; and 

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

17 ‘‘(I) the laws of Canada, or an18 other country from which importation 

19 is permitted pursuant to subsection 

20 (e); and 

21 ‘‘(II) the requirements promul22 gated by the Secretary, which shall in23 clude labeling in English; 

24 ‘‘(B) with respect to importers only, in25 cludes— 


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1 ‘‘(i) peritoneal dialysis solution; 

2 ‘‘(ii) insulin; 

3 ‘‘(iii) a drug for which a risk evalua4 tion and mitigation strategy is required 

5 under section 505–1; 

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

7 section 351 of the Public Health Service 

8 Act that are proteins (except any chemi9 cally synthesized polypeptides) or analo10 gous products; and 

11 ‘‘(v) intravenously infused drugs; and 

12 ‘‘(C) does not include— 

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

14 in section 102 of the Controlled Sub15 stances Act); 

16 ‘‘(ii) an anesthetic drug inhaled dur17 ing surgery; or 

18 ‘‘(iii) a compounded drug. 

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

20 prescription’ means a prescription that is issued for 

21 a legitimate medical purpose in the usual course of 

22 professional practice by— 

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

24 least 1 in-person medical evaluation of the pa25 tient; or 


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1 ‘‘(B) a covering practitioner. 

2 ‘‘(c) PUBLICATION OF CERTIFIED FOREIGN SELL3 ERS.—The Secretary shall publish on a dedicated internet 

4 website a list of certified foreign sellers, including the 

5 internet website address, physical address, and telephone 

6 number of each such certified foreign seller. 

7 ‘‘(d) ADDITIONAL CRITERIA.— 

8 ‘‘(1) CERTIFIED FOREIGN SELLERS.— 

9 ‘‘(A) IN GENERAL.—To be a certified for10 eign seller, such seller shall— 

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

12 accordance with subparagraph (B); 

13 ‘‘(ii) pay the registration fee estab14 lished under subparagraph (C); and 

15 ‘‘(iii) sell only qualifying prescription 

16 drugs to importers or individuals who im17 port prescription drugs into the United 

18 States in accordance with this section. 

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

20 foreign seller, the Secretary shall certify that 

21 such seller— 

22 ‘‘(i) is a foreign wholesale distributor 

23 or licensed foreign pharmacy operating an 

24 establishment, which may include an online 

25 foreign pharmacy, that is located in CanVerDate Sep 11 2014 22:31 Jan 24, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H447.IH H447

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1 ada, or, subject to subsection (e), another 

2 permitted country; 

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

4 dispensing of a prescription drug that is 

5 imported or offered for importation into 

6 the United States; 

7 ‘‘(iii) has been in existence for a pe8 riod of at least 5 years preceding the date 

9 of such certification and has a purpose 

10 other than to participate in the program 

11 established under this section; 

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

13 seller that is a licensed foreign pharmacy, 

14 agrees to dispense a qualifying prescription 

15 drug to an individual in the United States 

16 only after receiving a valid prescription, as 

17 described in paragraph (2)(C); 

18 ‘‘(v) has processes established by the 

19 seller, or participates in another estab20 lished process, to certify that the physical 

21 premises and data reporting procedures 

22 and licenses are in compliance with all ap23 plicable laws and regulations of Canada, 

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

25 country in which the seller is located, and 


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1 has implemented policies designed to mon2 itor ongoing compliance with such laws 

3 and regulations; 

4 ‘‘(vi) conducts or commits to partici5 pate in ongoing and comprehensive quality 

6 assurance programs and implements such 

7 quality assurance measures, including 

8 blind testing, to ensure the veracity and re9 liability of the findings of the quality as10 surance program; 

11 ‘‘(vii) agrees that, pursuant to sub12 section (g), laboratories approved by the 

13 Secretary may be authorized to conduct 

14 product testing to determine the chemical 

15 authenticity of sample pharmaceutical 

16 products; 

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

18 importers, and individuals of product re19 calls in Canada, or pursuant to subsection 

20 (e), the permitted country in which the 

21 seller is located, and agrees to cease, or re22 frain from, exporting such product; 

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

24 or participate in, a process for resolving 

25 grievances, as defined by the Secretary, 


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1 and will be held accountable for violations 

2 of established guidelines and rules; 

3 ‘‘(x) except as otherwise permitted 

4 under this section, does not sell products 

5 that the seller could not otherwise legally 

6 sell in Canada, or, subject to subsection 

7 (e), the permitted country in which such 

8 seller is located to customers in the United 

9 States; and 

10 ‘‘(xi) meets any other criteria estab11 lished by the Secretary. 

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

13 30 days before the start of each fiscal year, the 

14 Secretary shall establish a fee to be collected 

15 from foreign sellers for such fiscal year that are 

16 certified under subparagraph (B), in an amount 

17 that is sufficient, and not more than necessary, 

18 to pay the costs of administering the program 

19 under this section, and enforcing this section 

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

21 ‘‘(D) RECERTIFICATION.—A certification 

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

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

24 change in the circumstances under which the 

25 foreign seller meets the requirements under 


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1 such subparagraph, whichever occurs earlier. A 

2 foreign seller may reapply for certification 

3 under such subparagraph (B), in accordance 

4 with a process established by the Secretary. 

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

6 a qualifying prescription drug described in sub7 section (b) from Canada or another country pursu8 ant to subsection (e) if such drug— 

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

10 online pharmacy, by a certified foreign seller 

11 that is a licensed foreign pharmacy; 

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

13 individual, not for resale, in quantities that do 

14 not exceed a 90-day supply; and 

15 ‘‘(C) is filled only after providing to the li16 censed foreign pharmacy a valid prescription 

17 issued by a health care practitioner licensed to 

18 practice in a State in the United States. 

19 ‘‘(e) IMPORTATION FROM OTHER COUNTRIES.—Be20 ginning on the date that is 2 years after the date on which 

21 final regulations are promulgated to carry out this section, 

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

23 effective date, including the reports submitted under sec24 tion 2(d) of the Affordable and Safe Prescription Drug 

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1 tion drugs from Canada under this section resulted in cost 

2 savings for consumers in the United States and increased 

3 access to safe medication, the Secretary shall have the au4 thority to permit importation of qualifying prescription 

5 drugs by importers and individuals from, in addition to 

6 Canada, any country that— 

7 ‘‘(1) is a member of the Organisation for Eco8 nomic Co-operation and Development; and 

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

10 the approval and sale of prescription drugs that are 

11 comparable to the standards in the United States 

12 and that— 

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

14 if a drug has been determined to be safe and 

15 effective by experts employed by or acting on 

16 behalf of a governmental entity and qualified by 

17 scientific training and experience to evaluate 

18 the safety and effectiveness of drugs; 

19 ‘‘(B) requires that any determination of 

20 safety and effectiveness described in subpara21 graph (A) be made on the basis of adequate 

22 and well-controlled investigations, including 

23 clinical investigations, as appropriate, con24 ducted by experts qualified by scientific training 


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1 and experience to evaluate the safety and effec2 tiveness of drugs; 

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

4 facilities and controls used for, the manufac5 ture, processing, and packing of drugs in the 

6 country to be adequate to preserve the identity, 

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

8 ‘‘(D) requires the reporting of adverse re9 actions to drugs and establish procedures to re10 call, and withdraw approval of, drugs found not 

11 to be safe or effective. 

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

13 imported that meets the labeling requirements described 

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

15 purposes of section 502. 

16 ‘‘(g) DRUG TESTING LABORATORIES.—The Sec17 retary may approve one or more laboratories to conduct 

18 random testing of prescription drugs sold by certified for19 eign sellers to assess the chemical authenticity of such 

20 drugs. 

21 ‘‘(h) UNFAIR AND DISCRIMINATORY ACTS AND PRAC22 TICES.—It is unlawful for a manufacturer, directly or indi23 rectly (including by being a party to a licensing agreement 

24 or other agreement)— 


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

2 for a prescription drug sold to a certified foreign 

3 seller that sells such drug to an importer in accord4 ance with this section than the price that is charged, 

5 inclusive of rebates or other incentives to the coun6 try from which the drug is exported, to another per7 son that is in the same country and that does not 

8 import such a drug into the United States in accord9 ance with this section; 

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

11 on the drug shortage list under section 506E, dis12 criminate by denying, restricting, or delaying sup13 plies of a prescription drug to a certified foreign sell14 er, on account of such seller’s status as a certified 

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

16 accordance with this section, or by publicly, pri17 vately, or otherwise refusing to do business with 

18 such a certified foreign seller on account of such 

19 seller’s status as a certified foreign seller; 

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

21 difference in active ingredient, route of administra22 tion, bioequivalence, strength, formulation, manufac23 turing establishment, manufacturing process, or per24 son that manufactures the drug) between a prescrip25 tion drug for distribution in the United States and 


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1 the drug for distribution in Canada or another per2 mitted country, subject to subsection (e), for the 

3 purpose of avoiding sales by certified foreign sellers; 

4 or 

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

6 on the drug shortage list under section 506E, en7 gage in any other action to restrict, prohibit, or 

8 delay the importation of a prescription drug under 

9 this section. 

10 ‘‘(i) INFORMATION AND RECORDS.— 

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

12 submit biannual reports to the Secretary which shall 

13 contain, for each qualifying prescription drug im14 ported into the United States— 

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

16 manufacturer of the drug, described in section 

17 510; 

18 ‘‘(B) the transaction information described 

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

20 described in subparagraph (C)); and 

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

22 drug. 

23 ‘‘(2) MAINTENANCE OF RECORDS BY SEC24 RETARY.—The Secretary shall maintain information 

25 and documentation submitted under paragraph (1) 


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1 for such period of time as the Secretary determines 

2 to be appropriate. 

3 ‘‘(j) SUSPENSION OF IMPORTATION.— 

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

5 Secretary shall require that importation of a specific 

6 qualifying prescription drug or importation by a spe7 cific certified foreign seller or importer pursuant to 

8 this section be immediately suspended if the Sec9 retary determines that there is a pattern of importa10 tion of such specific drug or by such specific seller 

11 or importer that involves counterfeit drugs, drugs 

12 that have been recalled or withdrawn, or drugs in 

13 violation of any requirement of this section, until an 

14 investigation is completed and the Secretary deter15 mines that importation of such drug or by such sell16 er or importer does not endanger the public health. 

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

18 may require that importation of a specific qualifying 

19 prescription drug or importation by a specific cer20 tified foreign seller or importer pursuant to this sec21 tion be temporarily suspended if, with respect to 

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

23 any requirement of this section or if the Secretary 

24 determines that importation of such drug or by such 

25 seller or importer might endanger the public health. 


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1 Such temporary suspension shall apply until the Sec2 retary completes an investigation and determines 

3 that importation of such drug or by such seller or 

4 importer does not endanger the public health. 

5 ‘‘(k) SUPPLY CHAIN SECURITY.— 

6 ‘‘(1) PURCHASE FROM REGISTERED FACILITIES

7 AND CERTIFIED FOREIGN SELLERS.— 

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

9 subparagraph (B), certified foreign sellers who 

10 sell qualifying prescription drugs for importa11 tion into the United States pursuant to this 

12 section may purchase such drugs only from 

13 manufacturers or entities registered under sec14 tion 510 or other certified foreign sellers. 

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

16 who sell qualifying prescription drugs for im17 portation into the United States pursuant to 

18 this section may purchase such drugs from for19 eign sellers in Canada or another permitted 

20 country, even if such foreign seller is not a 

21 manufacturer registered under section 510 or a 

22 certified foreign seller, if the Secretary enters 

23 into a memorandum of understanding or coop24 erative agreement with Canada, or such other 

25 permitted country, to ensure compliance, to the 


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1 extent appropriate and feasible, with subchapter 

2 H of chapter V. The Secretary shall seek to 

3 enter into such a memorandum of under4 standing or cooperative agreement with Canada 

5 and each country from which importation is 

6 permitted under subsection (e). 

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

8 sellers shall provide importers with the unique facil9 ity identifier associated with the manufacturer reg10 istered under section 510 of the qualifying prescrip11 tion drug and the information under paragraph 

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

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

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

15 provide such information to individuals purchasing 

16 such drugs, upon request. 

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

18 a qualifying prescription drug, where the drug with the 

19 same active ingredient or ingredients (or that is biosimilar 

20 to an approved biological product), route of administra21 tion, and strength that is approved under chapter V or 

22 section 351 of the Public Health Service Act is subject 

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

24 importer shall be subject to such elements to assure safe 

25 use, as applicable and appropriate. 


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

2 the authority of the Secretary relating to the importation 

3 of prescription drugs, other than with respect to section 

4 801(d)(1) as provided in this section.’’. 

5 (b) PENALTIES WITH RESPECT TO ONLINE PHAR6 MACIES.—Section 303 of the Federal Food, Drug, and 

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

8 the end the following: 

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

10 website, whether in the United States or in another coun11 try, that violates section 301(aa) by— 

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

13 intent to defraud or mislead or with reckless dis14 regard for safety of the public, an adulterated or 

15 counterfeit drug to an individual in the United 

16 States; or 

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

18 to an individual in the United States who the person 

19 knows or has reasonable cause to believe, does not 

20 possess a valid prescription for that drug, 

21 such person shall be imprisoned for not more than 

22 10 years or fined not more than $250,000.’’. 

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

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

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


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1 available under any State or Federal law, including com2 mon law, that provides a remedy for civil relief. 

3 (d) REPORTS.— 

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

5 on which final regulations are promulgated to carry 

6 out section 804 of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 384), as amended by this Act, 

8 and every 2 years thereafter, the Secretary of 

9 Health and Human Services, after consultation with 

10 appropriate Federal agencies, shall submit to Con11 gress and make public a report on the importation 

12 of drugs into the United States. 

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

14 after the date on which final regulations are promul15 gated to carry out section 804 of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 384), as amend17 ed by this Act, the Comptroller General of the 

18 United States shall submit to Congress a report con19 taining an analysis of the implementation of the 

20 amendments made by this Act, including a review of 

21 drug safety and cost-savings and expenses, including 

22 cost-savings to consumers in the United States and 

23 trans-shipment and importation tracing processes, 

24 resulting from such implementation. 

Æ 


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