I 

118TH CONGRESS 

2D SESSION H. R. 8848 

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 

JUNE 26, 2024 

Ms. SCHAKOWSKY (for herself, Mr. COHEN, Mr. DOGGETT, Mr. GRIJALVA, 

Ms. NORTON, Ms. OMAR, Ms. PINGREE, and Mr. POCAN) 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 of 2024’’. 

6 SEC. 2. FINDINGS; SENSE OF CONGRESS. 

7 (a) FINDINGS.—Congress finds the following: 


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1 (1) Prescription drug prices are, on average, 

2 2.78 times more expensive in the United States com3 pared to comparable countries in the Organisation 

4 for Economic Co-operation and Development 

5 (OECD). Drugs that are still under a patent are 

6 4.22 times more expensive in the United States than 

7 those in comparable nations in the OECD. 

8 (2) Multiple studies have demonstrated that 

9 tens of millions of Americans have opted to not fill 

10 a prescription due to the prohibitive cost of the pre11 scription. 

12 (3) The Food and Drug Administration has en13 tered into Mutual Recognition Agreements with the 

14 United Kingdom, the European Union, and Switzer15 land to recognize drug manufacturing inspections 

16 conducted by each entity as valid and equivalent to 

17 an inspection conducted by their own inspectors. 

18 (4) The Food and Drug Administration, in tes19 timony provided to Congress, acknowledged that 

20 fewer negative inspection outcomes were assessed to 

21 drug manufacturers in the European Union than in 

22 the United States, representing a drug manufac23 turing industry that is comparably safe and effective 

24 to that of the United States. 


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1 (5) In 2022, the Food and Drug Administra2 tion found that 57 percent of all finished dosage 

3 form manufacturing sites for drugs categorized as 

4 essential medicines were located in foreign nations 

5 and relied on importation to reach American pa6 tients. 

7 (6) Millions of Americans every year already 

8 benefit from safely importing their prescription 

9 drugs for personal use, which Federal law permits 

10 through enforcement discretion and waivers, but 

11 such importation remains technically illegal under 

12 most circumstances because many foreign drugs do 

13 not have the exact same formulations as the Food 

14 and Drug Administration-approved versions. Despite 

15 Federal law recognizing that ‘‘patients and their 

16 families sometimes have reason to import into the 

17 United States drugs that have been approved by the 

18 Food and Drug Administration’’ the existing restric19 tions mean Americans who are able to obtain relief 

20 from high prescription drug costs by importing pre21 scription drugs for personal use may occasionally 

22 lose access to these drugs as they are seized upon 

23 importation. 

24 (b) SENSE OF CONGRESS.—It is the sense of Con25 gress that— 


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1 (1) the cost of prescription drugs in the United 

2 States represents a crisis that endangers the safety 

3 of millions of Americans who must choose between 

4 their health and financial stability; 

5 (2) prohibitions on drug importation originally 

6 intended to protect American consumers have re7 sulted in artificially raised prices that harm the 

8 American people, even while the same drugs sell for 

9 significantly less in other countries; 

10 (3) since the initial prohibitions on drug impor11 tation were put in place, foreign nations, including 

12 Canada, the United Kingdom, Switzerland, and 

13 members of the European Union, have significantly 

14 advanced their ability to safely approve, manufac15 ture, and transport prescription drugs, including 

16 small molecules and biologics; 

17 (4) the American pharmaceutical supply chain 

18 already heavily relies on drugs that are manufac19 tured overseas and then imported to American pa20 tients, a process that has been done safely for dec21 ades and with exporting nations with which the 

22 Food and Drug Administration does not have a Mu23 tual Recognition Agreement; and 

24 (5) it is possible for the American people, with 

25 appropriate oversight from the Secretary of Health 


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1 and Human Services and the Food and Drug Ad2 ministration, to safely engage in a global pharma3 ceutical marketplace in order to obtain prescription 

4 drugs for fair prices. 

5 SEC. 3. IMPORTING AFFORDABLE AND SAFE DRUGS. 

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

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

8 read as follows: 

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

10 DRUGS BY WHOLESALE DISTRIBUTORS, 

11 PHARMACIES, AND INDIVIDUALS. 

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

13 date of enactment of the Affordable and Safe Prescription 

14 Drug Importation Act of 2024, the Secretary shall pro15 mulgate regulations permitting the importation of quali16 fying prescription drugs into the United States, in accord17 ance with this section. 

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

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

20 ‘certified foreign seller’ means a licensed foreign 

21 pharmacy or foreign wholesale distributor that the 

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

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

24 and that is included on the list described in sub25 section (c). 


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1 ‘‘(2) FOREIGN WHOLESALE DISTRIBUTOR.— 

2 The term ‘foreign wholesale distributor’ means a 

3 person (other than a manufacturer, a manufactur4 er’s co-licensed partner, a third-party logistics pro5 vider, or a repackager) engaged in wholesale dis6 tribution. 

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

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

9 distributor registered under section 503(e) who im10 ports prescription drugs into the United States in 

11 accordance with this section. 

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

13 term ‘licensed foreign pharmacy’ means a pharmacy 

14 located in Canada, the United Kingdom, a member 

15 state of the European Union, Switzerland, or subject 

16 to subsection (e), another applicable country, that— 

17 ‘‘(A) operates in accordance with applica18 ble pharmacy standards set forth by the phar19 macy laws and regulations of the country in 

20 which the pharmacy is located; and 

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

22 prescription drugs to individuals in the country 

23 in which the pharmacy is located. 

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

25 term ‘qualifying prescription drug’— 


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

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

3 and marketed, in Canada, the United 

4 Kingdom, a member state of the European 

5 Union, Switzerland, or subject to sub6 section (e), in another permitted country; 

7 ‘‘(ii) has the same active ingredient or 

8 ingredients, route of administration, and 

9 strength as a prescription drug approved 

10 under chapter V, or, for purposes of sub11 paragraph (B)(iv), is biosimilar to an ap12 proved biological product and has the same 

13 route of administration and strength as the 

14 approved biological product; and 

15 ‘‘(iii) is labeled in accordance with— 

16 ‘‘(I) the laws of Canada, the 

17 United Kingdom, a member state of 

18 the European Union, Switzerland, or 

19 another country from which importa20 tion is permitted pursuant to sub21 section (e); and 

22 ‘‘(II) the requirements promul23 gated by the Secretary, which shall in24 clude labeling in English; 


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1 ‘‘(B) with respect to importers only, in2 cludes— 

3 ‘‘(i) peritoneal dialysis solution; 

4 ‘‘(ii) insulin; 

5 ‘‘(iii) a drug for which a risk evalua6 tion and mitigation strategy is required 

7 under section 505–1; 

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

9 section 351 of the Public Health Service 

10 Act that are proteins (except any chemi11 cally synthesized polypeptides) or analo12 gous products; and 

13 ‘‘(v) intravenously infused drugs; and 

14 ‘‘(C) does not include— 

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

16 in section 102 of the Controlled Sub17 stances Act); 

18 ‘‘(ii) an anesthetic drug inhaled dur19 ing surgery; or 

20 ‘‘(iii) a compounded drug. 

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

22 prescription’ means a prescription that is issued for 

23 a legitimate medical purpose in the usual course of 

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1 ducted at least one in-person medical evaluation of 

2 the patient. 

3 ‘‘(c) PUBLICATION OF CERTIFIED FOREIGN SELL4 ERS.—The Secretary shall publish on a dedicated internet 

5 website a list of certified foreign sellers, including the 

6 internet website address, physical address, and telephone 

7 number of each such certified foreign seller. 

8 ‘‘(d) ADDITIONAL CRITERIA.— 

9 ‘‘(1) CERTIFIED FOREIGN SELLERS.— 

10 ‘‘(A) IN GENERAL.—To be a certified for11 eign seller, such seller shall— 

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

13 accordance with subparagraph (B); 

14 ‘‘(ii) pay the registration fee estab15 lished under subparagraph (C); and 

16 ‘‘(iii) sell only qualifying prescription 

17 drugs to importers or individuals who im18 port prescription drugs into the United 

19 States in accordance with this section. 

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

21 foreign seller, the Secretary shall certify that 

22 such seller— 

23 ‘‘(i) is a foreign wholesale distributor 

24 or licensed foreign pharmacy operating an 

25 establishment, which may include an online 


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1 foreign pharmacy, that is located in Can2 ada, the United Kingdom, a member state 

3 of the European Union, Switzerland, or, 

4 subject to subsection (e), another per5 mitted country; 

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

7 dispensing of a prescription drug that is 

8 imported or offered for importation into 

9 the United States; 

10 ‘‘(iii) in the case of a certified foreign 

11 seller that is a licensed foreign pharmacy, 

12 agrees to dispense a qualifying prescription 

13 drug to an individual in the United States 

14 only after receiving a valid prescription, as 

15 described in paragraph (2)(C); 

16 ‘‘(iv) has processes established by the 

17 seller, or participates in another estab18 lished process, to certify that the physical 

19 premises and data reporting procedures 

20 and licenses are in compliance with all ap21 plicable laws and regulations of the coun22 try in which the seller is located and has 

23 implemented policies designed to monitor 

24 ongoing compliance with such laws and 

25 regulations; 


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1 ‘‘(v) conducts or commits to partici2 pate in ongoing and comprehensive quality 

3 assurance programs and implements such 

4 quality assurance measures, including 

5 blind testing, to ensure the veracity and re6 liability of the findings of the quality as7 surance program; 

8 ‘‘(vi) agrees that, pursuant to sub9 section (g), laboratories approved by the 

10 Secretary may be authorized to conduct 

11 product testing to determine the chemical 

12 authenticity of sample pharmaceutical 

13 products; 

14 ‘‘(vii) agrees to notify the Secretary, 

15 importers, and individuals of product re16 calls in the country in which the seller is 

17 located, and agrees to cease, or refrain 

18 from, exporting such product; 

19 ‘‘(viii) has established, or will estab20 lish or participate in, a process for resolv21 ing grievances, as defined by the Secretary, 

22 and will be held accountable for violations 

23 of established guidelines and rules; 

24 ‘‘(ix) except as otherwise permitted 

25 under this section, does not sell products 


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1 that the seller could not otherwise legally 

2 sell in the country in which the seller is lo3 cated to customers in the United States; 

4 and 

5 ‘‘(x) meets any other criteria estab6 lished by the Secretary. 

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

8 30 days before the start of each fiscal year, the 

9 Secretary shall establish a fee to be collected 

10 from foreign sellers for such fiscal year that are 

11 certified under subparagraph (B), in an amount 

12 that is sufficient, and not more than necessary, 

13 to pay the costs of administering the program 

14 under this section, and enforcing this section 

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

16 ‘‘(D) RECERTIFICATION.—A certification 

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

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

19 change in the circumstances under which the 

20 foreign seller meets the requirements under 

21 such subparagraph, whichever occurs earlier. A 

22 foreign seller may reapply for certification 

23 under such subparagraph (B), in accordance 

24 with a process established by the Secretary. 


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

2 a qualifying prescription drug described in sub3 section (b) from Canada, the United Kingdom, a 

4 member state of the European Union, Switzerland, 

5 or another country pursuant to subsection (e) if 

6 such drug— 

7 ‘‘(A) is dispensed, including a drug ordered 

8 from an online pharmacy, by a certified foreign 

9 seller that is a licensed foreign pharmacy; 

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

11 individual, not for resale, in quantities that do 

12 not exceed a 90-day supply; and 

13 ‘‘(C) is filled only after providing to the li14 censed foreign pharmacy a valid prescription 

15 issued by a health care practitioner licensed to 

16 practice in a State in the United States. 

17 ‘‘(e) IMPORTATION FROM OTHER COUNTRIES.—Be18 ginning on the date that is 1 year after the date on which 

19 final regulations are promulgated to carry out this section, 

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

21 effective date, including the reports submitted under sec22 tion 2(d) of the Affordable and Safe Prescription Drug 

23 Importation Act of 2024, that importation of qualifying 

24 prescription drugs from Canada, the United Kingdom, a 

25 member state of the European Union, and Switzerland 


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1 under this section was conducted safely, the Secretary 

2 shall have the authority to permit importation of quali3 fying prescription drugs by importers and individuals 

4 from, in addition to Canada, the United Kingdom, a mem5 ber state of the European Union, and Switzerland, any 

6 country that— 

7 ‘‘(1) has statutory or regulatory standards for 

8 the approval and sale of prescription drugs that 

9 would enable safe importation of prescription drugs 

10 into the United States; 

11 ‘‘(2) authorizes the approval of drugs only if a 

12 drug has been determined to be safe and effective by 

13 experts employed by or acting on behalf of a govern14 mental entity and qualified by scientific training and 

15 experience to evaluate the safety and effectiveness of 

16 drugs; 

17 ‘‘(3) requires that any determination of safety 

18 and effectiveness described in paragraph (2) be 

19 made on the basis of adequate and well-controlled 

20 investigations, including clinical investigations, as 

21 appropriate, conducted by experts qualified by sci22 entific training and experience to evaluate the safety 

23 and effectiveness of drugs; 

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1 essing, and packing of drugs in the country to be 

2 adequate to preserve the identity, quality, purity, 

3 and strength of the drugs; and 

4 ‘‘(5) requires the reporting of adverse reactions 

5 to drugs and establish procedures to recall, and 

6 withdraw approval of, drugs found not to be safe or 

7 effective. 

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

9 imported that meets the labeling requirements described 

10 in subsection (b)(5)(A)(iii) is deemed not misbranded for 

11 purposes of section 502. 

12 ‘‘(g) DRUG TESTING LABORATORIES.—The Sec13 retary may approve one or more laboratories to conduct 

14 random testing of prescription drugs sold by certified for15 eign sellers to assess the chemical authenticity of such 

16 drugs. 

17 ‘‘(h) UNFAIR AND DISCRIMINATORY ACTS AND PRAC18 TICES.—It is unlawful for a manufacturer, directly or indi19 rectly (including by being a party to a licensing agreement 

20 or other agreement)— 

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

22 for a prescription drug sold to a certified foreign 

23 seller that sells such drug to an importer in accord24 ance with this section than the price that is charged, 

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1 try from which the drug is exported, to another per2 son that is in the same country and that does not 

3 import such a drug into the United States in accord4 ance with this section; 

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

6 on the drug shortage list under section 506E, dis7 criminate by denying, restricting, or delaying sup8 plies of a prescription drug to a certified foreign sell9 er, on account of such seller’s status as a certified 

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

11 accordance with this section, or by publicly, pri12 vately, or otherwise refusing to do business with 

13 such a certified foreign seller on account of such 

14 seller’s status as a certified foreign seller; 

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

16 difference in active ingredient, route of administra17 tion, bioequivalence, strength, formulation, manufac18 turing establishment, manufacturing process, or per19 son that manufactures the drug) between a prescrip20 tion drug for distribution in the United States and 

21 the drug for distribution in Canada, the United 

22 Kingdom, a member state of the European Union, 

23 Switzerland, or another permitted country, subject 

24 to subsection (e), for the purpose of avoiding sales 

25 by certified foreign sellers; or 


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

2 on the drug shortage list under section 506E, en3 gage in any other action to restrict, prohibit, or 

4 delay the importation of a prescription drug under 

5 this section. 

6 ‘‘(i) ENFORCEMENT DISCRETION AND WAIVER AU7 THORITY FOR IMPORTATION BY INDIVIDUALS.— 

8 ‘‘(1) DECLARATIONS.—Congress declares that 

9 in the enforcement against individuals of the prohi10 bition of importation of prescription drugs and de11 vices, the Secretary should— 

12 ‘‘(A) focus enforcement on cases in which 

13 the importation by an individual poses a signifi14 cant threat to public health; and 

15 ‘‘(B) exercise discretion to permit individ16 uals to make such importations in cir17 cumstances in which— 

18 ‘‘(i) the importation is clearly for per19 sonal use; and 

20 ‘‘(ii) the prescription drug or device 

21 imported does not appear to present an 

22 unreasonable risk to the individual. 

23 ‘‘(2) WAIVER AUTHORITY.— 

24 ‘‘(A) IN GENERAL.—The Secretary may 

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1 by-case basis, a waiver of the prohibition of im2 portation of a prescription drug or device or 

3 class of prescription drugs or devices, under 

4 such conditions as the Secretary determines to 

5 be appropriate. 

6 ‘‘(B) GUIDANCE ON CASE-BY-CASE WAIV7 ERS.—The Secretary shall publish, and update 

8 as necessary, guidance that accurately describes 

9 circumstances in which the Secretary will con10 sistently grant waivers on a case-by-case basis 

11 under subparagraph (A), so that individuals 

12 may know with the greatest practicable degree 

13 of certainty whether a particular importation 

14 for personal use will be permitted. 

15 ‘‘(j) INFORMATION AND RECORDS.— 

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

17 submit biannual reports to the Secretary which shall 

18 contain, for each qualifying prescription drug im19 ported into the United States— 

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

21 manufacturer of the drug, described in section 

22 510; 

23 ‘‘(B) the transaction information described 

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

25 described in subparagraph (C)); and 


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

2 drug. 

3 ‘‘(2) MAINTENANCE OF RECORDS BY SEC4 RETARY.—The Secretary shall maintain information 

5 and documentation submitted under paragraph (1) 

6 for such period of time as the Secretary determines 

7 to be appropriate. 

8 ‘‘(k) SUSPENSION OF IMPORTATION.— 

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

10 Secretary shall require that importation of a specific 

11 qualifying prescription drug or importation by a spe12 cific certified foreign seller or importer pursuant to 

13 this section be immediately suspended if the Sec14 retary determines that there is a pattern of importa15 tion of such specific drug or by such specific seller 

16 or importer that involves counterfeit drugs, drugs 

17 that have been recalled or withdrawn, or drugs in 

18 violation of any requirement of this section, until an 

19 investigation is completed and the Secretary deter20 mines that importation of such drug or by such sell21 er or importer does not endanger the public health. 

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

23 may require that importation of a specific qualifying 

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1 tion be temporarily suspended if, with respect to 

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

3 any requirement of this section or if the Secretary 

4 determines that importation of such drug or by such 

5 seller or importer might endanger the public health. 

6 Such temporary suspension shall apply until the Sec7 retary completes an investigation and determines 

8 that importation of such drug or by such seller or 

9 importer does not endanger the public health. 

10 ‘‘(l) SUPPLY CHAIN SECURITY.— 

11 ‘‘(1) PURCHASE FROM REGISTERED FACILITIES

12 AND CERTIFIED FOREIGN SELLERS.— 

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

14 subparagraph (B), certified foreign sellers who 

15 sell qualifying prescription drugs for importa16 tion into the United States pursuant to this 

17 section may purchase such drugs only from 

18 manufacturers or entities registered under sec19 tion 510 or other certified foreign sellers. 

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

21 who sell qualifying prescription drugs for im22 portation into the United States pursuant to 

23 this section may purchase such drugs from for24 eign sellers in Canada, the United Kingdom, a 

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1 land, or another permitted country, subject to 

2 subsection (e), even if such foreign seller is not 

3 a manufacturer registered under section 510 or 

4 a certified foreign seller, if the Secretary enters 

5 into a memorandum of understanding or coop6 erative agreement with the respective country, 

7 to ensure compliance, to the extent appropriate 

8 and feasible, with subchapter H of chapter V. 

9 The Secretary shall seek to enter into such a 

10 memorandum of understanding or cooperative 

11 agreement with Canada, the United Kingdom, 

12 the European Union, Switzerland, and each 

13 country from which importation is permitted 

14 under subsection (e). 

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

16 sellers shall provide importers with the name and 

17 address of the manufacturer registered under section 

18 510 of the qualifying prescription drug and the in19 formation under paragraph (25), paragraph (26) 

20 (other than subparagraph (C)), and subparagraphs 

21 (D), (F), and (G) of paragraph (27) of section 581. 

22 Certified foreign sellers shall provide such informa23 tion to individuals purchasing such drugs, upon re24 quest. 


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1 ‘‘(m) REMS.—In the case of an importer that im2 ports a qualifying prescription drug, where the drug with 

3 the same active ingredient or ingredients (or that is bio4 similar to an approved biological product), route of admin5 istration, and strength that is approved under chapter V 

6 or 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 ‘‘(n) 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

15 SALES.—Section 303 of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 333) is amended by adding at the 

17 end the following: 

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

19 internet website, whether in the United States or in an20 other country, 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 


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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 10 

6 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, 

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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 


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