‘‘(B) is manufactured in a facility reg-
istered under subsection (b)(1) or (i) of section 
510 that is in compliance with good manufac-
turing practices regulations of the Food and 
Drug Administration; 
‘‘(C) has the same active ingredient or in-
gredients, route of administration, and strength 
as an insulin approved under chapter V, or is 
biosimilar to an approved biological product and 
has the same route of administration and 
strength as the approved biological product; and 
‘‘(D) is labeled in accordance with— 
‘‘(i) the laws of Canada, or another 
country from which importation is per-
mitted pursuant to subsection (e); and 
‘‘(ii) the requirements promulgated by 
the Secretary, which shall include labeling 
in English; 
‘‘(6) VALID
PRESCRIPTION.—The term ‘valid 
prescription’ means a prescription that is issued for 
a legitimate medical purpose in the usual course of 
professional practice by— 
‘‘(A) a practitioner who has conducted at 
least 1 in-person medical evaluation of the pa-
tient; or 
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‘‘(B) a covering practitioner. 
‘‘(c) PUBLICATION OF CERTIFIED FOREIGN SELL-
ERS.—The Secretary shall publish on a dedicated internet 
website a list of certified foreign sellers, including the 
internet website address, physical address, and telephone 
number of each such certified foreign seller. 
‘‘(d) ADDITIONAL CRITERIA.— 
‘‘(1) CERTIFIED FOREIGN SELLERS.— 
‘‘(A) IN GENERAL.—To be a certified for-
eign seller, such seller shall— 
‘‘(i) be certified by the Secretary in 
accordance with subparagraph (B); 
‘‘(ii) pay the registration fee estab-
lished under subparagraph (C); and 
‘‘(iii) sell only qualifying insulin to im-
porters or individuals who import insulin 
into the United States in accordance with 
this section. 
‘‘(B) CERTIFICATION.—To be a certified 
foreign seller, the Secretary shall certify that 
such seller— 
‘‘(i) is a foreign wholesale distributor 
or licensed foreign pharmacy operating an 
establishment, which may include an online 
foreign pharmacy, that is located in Can-
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ada, or, subject to subsection (e), another 
permitted country; 
‘‘(ii) is engaged in the distribution or 
dispensing of an insulin that is imported or 
offered for importation into the United 
States; 
‘‘(iii) has been in existence for a pe-
riod of at least 5 years preceding the date 
of such certification and has a purpose 
other than to participate in the program 
established under this section; 
‘‘(iv) in the case of a certified foreign 
seller that is a licensed foreign pharmacy, 
agrees to dispense qualifying insulin to an 
individual in the United States only after 
receiving a valid prescription, as described 
in paragraph (2)(C); 
‘‘(v) has processes established by the 
seller, or participates in another estab-
lished process, to certify that the physical 
premises and data reporting procedures 
and licenses are in compliance with all ap-
plicable laws and regulations of Canada, 
or, subject to subsection (e), the permitted 
country in which the seller is located, and 
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has implemented policies designed to mon-
itor ongoing compliance with such laws 
and regulations; 
‘‘(vi) conducts or commits to partici-
pate in ongoing and comprehensive quality 
assurance programs and implements such 
quality 
assurance 
measures, 
including 
blind testing, to ensure the veracity and re-
liability of the findings of the quality as-
surance program; 
‘‘(vii) agrees that, pursuant to sub-
section (g), laboratories approved by the 
Secretary may be authorized to conduct in-
sulin testing to determine the chemical au-
thenticity of sample insulin products; 
‘‘(viii) agrees to notify the Secretary, 
importers, and individuals of insulin recalls 
in Canada, or pursuant to subsection (e), 
the permitted country in which the seller is 
located, and agrees to cease, or refrain 
from, exporting such insulin; 
‘‘(ix) has established, or will establish 
or participate in, a process for resolving 
grievances, as defined by the Secretary, 
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and will be held accountable for violations 
of established guidelines and rules; 
‘‘(x) except as otherwise permitted 
under this section, does not sell products 
that the seller could not otherwise legally 
sell in Canada, or, subject to subsection 
(e), the permitted country in which such 
seller is located to customers in the United 
States; and 
‘‘(xi) meets any other criteria estab-
lished by the Secretary. 
‘‘(C) CERTIFICATION FEE.—Not later than 
30 days before the start of each fiscal year, the 
Secretary shall establish a fee to be collected 
from foreign sellers for such fiscal year that are 
certified under subparagraph (B), in an amount 
that is sufficient, and not more than necessary, 
to pay the costs of administering the program 
under this section, and enforcing this section 
pursuant to section 303(h), for that fiscal year. 
‘‘(D) RECERTIFICATION.—A certification 
under subparagraph (B) shall be in effect for a 
period of 2 years, or until there is a material 
change in the circumstances under which the 
foreign seller meets the requirements under 
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such subparagraph, whichever occurs earlier. A 
foreign seller may reapply for certification 
under such subparagraph (B), in accordance 
with a process established by the Secretary. 
‘‘(2) INDIVIDUALS.—An individual may import 
a qualifying insulin described in subsection (b) from 
Canada or another country pursuant to subsection 
(e) if such qualifying insulin— 
‘‘(A) is dispensed, including through an 
online pharmacy, by a certified foreign seller 
that is a licensed foreign pharmacy; 
‘‘(B) is purchased for personal use by the 
individual, not for resale; and 
‘‘(C) is filled only after providing to the li-
censed foreign pharmacy a valid prescription 
issued by a health care practitioner licensed to 
practice in a State in the United States. 
‘‘(e) IMPORTATION FROM OTHER COUNTRIES.—Be-
ginning on the date that is 2 years after the date on which 
final regulations are promulgated to carry out this section, 
if, based on a review of the evidence obtained after such 
effective date, including the reports submitted under sec-
tion 2(d) of the Affordable Insulin Act of 2019, that im-
portation of qualifying insulin from Canada under this 
section resulted in cost savings for consumers in the 
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United States and increased access to safe insulin, the 
Secretary shall have the authority to permit importation 
of qualifying insulin by importers and individuals from, 
in addition to Canada, any country that— 
‘‘(1) is a member of the Organisation for Eco-
nomic Co-operation and Development; and 
‘‘(2) has statutory or regulatory standards for 
the approval and sale of insulin that are comparable 
to the standards in the United States and that— 
‘‘(A) authorize the approval of drugs only 
if a drug has been determined to be safe and 
effective by experts employed by or acting on 
behalf of a governmental entity and qualified by 
scientific training and experience to evaluate 
the safety and effectiveness of drugs; 
‘‘(B) require that any determination of 
safety and effectiveness described in subpara-
graph (A) be made on the basis of adequate 
and well-controlled investigations, including 
clinical investigations, as appropriate, con-
ducted by experts qualified by scientific training 
and experience to evaluate the safety and effec-
tiveness of drugs; 
‘‘(C) require the methods used in, and the 
facilities and controls used for, the manufac-
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ture, processing, and packing of drugs in the 
country to be adequate to preserve the identity, 
quality, purity, and strength of the drugs; and 
‘‘(D) require the reporting of adverse reac-
tions to drugs and establish procedures to re-
call, and withdraw approval of, drugs found not 
to be safe or effective. 
‘‘(f) LABELING.—Any qualifying insulin imported 
that meets the labeling requirements described in sub-
section (b)(5)(A)(iv) is deemed not misbranded for pur-
poses of section 502. 
‘‘(g) INSULIN TESTING LABORATORIES.—The Sec-
retary may approve one or more laboratories to conduct 
random testing of insulin sold by certified foreign sellers 
to assess the chemical authenticity of such insulin. 
‘‘(h) UNFAIR AND DISCRIMINATORY ACTS AND PRAC-
TICES.—It is unlawful for a manufacturer, directly or indi-
rectly (including by being a party to a licensing agreement 
or other agreement)— 
‘‘(1) to discriminate by charging a higher price 
for an insulin sold to a certified foreign seller that 
sells such insulin to an importer in accordance with 
this section than the price that is charged, inclusive 
of rebates or other incentives to the country from 
which the insulin is exported, to another person that 
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is in the same country and that does not import 
such insulin into the United States in accordance 
with this section; 
‘‘(2) except with respect to an insulin on the 
drug shortage list under section 506E, discriminate 
by denying, restricting, or delaying supplies of an in-
sulin to a certified foreign seller, on account of such 
seller’s status as a certified foreign seller, that sells 
such insulin to an importer in accordance with this 
section, or by publicly, privately, or otherwise refus-
ing to do business with such a certified foreign seller 
on account of such seller’s status as a certified for-
eign seller; 
‘‘(3) cause there to be a difference (including a 
difference in active ingredient, route of administra-
tion, bioequivalence, strength, formulation, manufac-
turing establishment, manufacturing process, or per-
son that manufactures the insulin) between an insu-
lin for distribution in the United States and the in-
sulin for distribution in Canada or another per-
mitted country, subject to subsection (e), for the 
purpose of avoiding sales by certified foreign sellers; 
or 
‘‘(4) except with respect to an insulin on the 
drug shortage list under section 506E, engage in 
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any other action to restrict, prohibit, or delay the 
importation of an insulin under this section. 
‘‘(i) INFORMATION AND RECORDS.— 
‘‘(1) BIANNUAL REPORTS.—Each importer shall 
submit biannual reports to the Secretary which shall 
contain, for each qualifying insulin imported into the 
United States— 
‘‘(A) the unique facility identifier of the 
manufacturer of the insulin, described in sec-
tion 510; 
‘‘(B) the transaction information described 
in section 581(26) (other than the information 
described in subparagraph (C)); and 
‘‘(C) the price paid by the importer for the 
insulin. 
‘‘(2) MAINTENANCE
OF
RECORDS
BY
SEC-
RETARY.—The Secretary shall maintain information 
and documentation submitted under paragraph (1) 
for such period of time as the Secretary determines 
to be appropriate. 
‘‘(j) SUSPENSION OF IMPORTATION.— 
‘‘(1) PATTERNS
OF
NONCOMPLIANCE.—The 
Secretary shall require that importation of a specific 
qualifying insulin or importation by a specific cer-
tified foreign seller or importer pursuant to this sec-
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tion be immediately suspended if the Secretary de-
termines that there is a pattern of importation of 
such specific insulin or by such specific seller or im-
porter that involves counterfeit drugs, drugs that 
have been recalled or withdrawn, or drugs in viola-
tion of any requirement of this section, until an in-
vestigation is completed and the Secretary deter-
mines that importation of such drug or by such sell-
er or importer does not endanger the public health. 
‘‘(2) TEMPORARY SUSPENSION.—The Secretary 
may require that importation of a specific qualifying 
insulin or importation by a specific certified foreign 
seller or importer pursuant to this section be tempo-
rarily suspended if, with respect to such insulin, sell-
er, or importer, there is a violation of any require-
ment of this section or if the Secretary determines 
that importation of such insulin or by such seller or 
importer might endanger the public health. Such 
temporary suspension shall apply until the Secretary 
completes an investigation and determines that im-
portation of such insulin or by such seller or im-
porter does not endanger the public health. 
‘‘(k) SUPPLY CHAIN SECURITY.— 
‘‘(1) PURCHASE FROM REGISTERED FACILITIES 
AND CERTIFIED FOREIGN SELLERS.— 
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‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), certified foreign sellers who 
sell qualifying insulin for importation into the 
United States pursuant to this section may pur-
chase such insulin only from manufacturers or 
entities registered under section 510 or other 
certified foreign sellers. 
‘‘(B) EXCEPTION.—Certified foreign sellers 
who sell qualifying insulin for importation into 
the United States pursuant to this section may 
purchase such insulin from foreign sellers in 
Canada or another permitted country, even if 
such foreign seller is not a manufacturer reg-
istered under section 510 or a certified foreign 
seller, if the Secretary enters into a memo-
randum of understanding or cooperative agree-
ment with Canada, or such other permitted 
country, to ensure compliance, to the extent ap-
propriate and feasible, with subchapter H of 
chapter V. The Secretary shall seek to enter 
into such a memorandum of understanding or 
cooperative agreement with Canada and each 
country from which importation is permitted 
under subsection (e). 
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(b) PENALTIES WITH RESPECT TO ONLINE PHAR-
MACIES.—Section 303 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 333) is amended by adding at 
the end the following: 
‘‘(h) In the case of person operating an internet 
website, whether in the United States or in another coun-
try, that violates section 301(aa) by— 
‘‘(1) selling, by means of the internet, with the 
intent to defraud or mislead or with reckless dis-
regard for safety of the public, an adulterated or 
counterfeit drug to an individual in the United 
States; or 
‘‘(2) dispenses, by means of the internet, a drug 
to an individual in the United States who the person 
knows or has reasonable cause to believe, does not 
possess a valid prescription for that drug, 
such person shall be imprisoned for not more than 10 
years or fined not more than $250,000.’’. 
(c) NO PREEMPTION.—Nothing in this Act, including 
the amendments made by this Act, shall be construed to 
preempt, alter, displace, abridge, or supplant any remedy 
available under any State or Federal law, including com-
mon law, that provides a remedy for civil relief. 
(d) REPORTS.— 
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(1) HHS.—Not later than 1 year after the date 
on which final regulations are promulgated to carry 
out section 804A of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 384), as added by this Act, 
and every 2 years thereafter, the Secretary of 
Health and Human Services, after consultation with 
appropriate Federal agencies, shall submit to Con-
gress and make public a report on the importation 
of insulin into the United States. 
(2) GAO REPORT.—Not later than 18 months 
after the date on which final regulations are promul-
gated to carry out section 804A of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 384), as 
added by this Act, the Comptroller General of the 
United States shall submit to Congress a report con-
taining an analysis of the implementation of the 
amendments made by this Act, including a review of 
drug safety and cost-savings and expenses, including 
cost-savings to consumers in the United States and 
trans-shipment and importation tracing processes, 
resulting from such implementation. 
Æ 
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