and experience to evaluate the safety and effec-
tiveness of drugs; 
‘‘(C) requires the methods used in, and the 
facilities and controls used for, the manufac-
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) requires the reporting of adverse re-
actions to drugs and establish procedures to re-
call, and withdraw approval of, drugs found not 
to be safe or effective. 
‘‘(f) LABELING.—Any qualifying prescription drug 
imported that meets the labeling requirements described 
in subsection (b)(5)(A)(iv) is deemed not misbranded for 
purposes of section 502. 
‘‘(g) DRUG
TESTING
LABORATORIES.—The Sec-
retary may approve one or more laboratories to conduct 
random testing of prescription drugs sold by certified for-
eign sellers to assess the chemical authenticity of such 
drugs. 
‘‘(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)— 
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‘‘(1) to discriminate by charging a higher price 
for a prescription drug sold to a certified foreign 
seller that sells such drug to an importer in accord-
ance with this section than the price that is charged, 
inclusive of rebates or other incentives to the coun-
try from which the drug is exported, to another per-
son that is in the same country and that does not 
import such a drug into the United States in accord-
ance with this section; 
‘‘(2) except with respect to a prescription drug 
on the drug shortage list under section 506E, dis-
criminate by denying, restricting, or delaying sup-
plies of a prescription drug to a certified foreign sell-
er, on account of such seller’s status as a certified 
foreign seller, that sells such drug to an importer in 
accordance with this section, or by publicly, pri-
vately, or otherwise refusing to do business with 
such a certified foreign seller on account of such 
seller’s status as a certified foreign 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 drug) between a prescrip-
tion drug for distribution in the United States and 
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the drug 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 a prescription drug 
on the drug shortage list under section 506E, en-
gage in any other action to restrict, prohibit, or 
delay the importation of a prescription drug 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 prescription drug im-
ported into the United States— 
‘‘(A) the unique facility identifier of the 
manufacturer of the drug, described in section 
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 
drug. 
‘‘(2) MAINTENANCE
OF
RECORDS
BY
SEC-
RETARY.—The Secretary shall maintain information 
and documentation submitted under paragraph (1) 
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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 prescription drug or importation by a spe-
cific certified foreign seller or importer pursuant to 
this section be immediately suspended if the Sec-
retary determines that there is a pattern of importa-
tion of such specific drug or by such specific seller 
or importer that involves counterfeit drugs, drugs 
that have been recalled or withdrawn, or drugs in 
violation of any requirement of this section, until an 
investigation 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 
prescription drug or importation by a specific cer-
tified foreign seller or importer pursuant to this sec-
tion be temporarily suspended if, with respect to 
such drug, seller, or importer, there is a violation of 
any requirement of this section or if the Secretary 
determines that importation of such drug or by such 
seller or importer might endanger the public health. 
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Such temporary suspension shall apply until the Sec-
retary completes an investigation and determines 
that importation of such drug or by such seller or 
importer does not endanger the public health. 
‘‘(k) SUPPLY CHAIN SECURITY.— 
‘‘(1) PURCHASE FROM REGISTERED FACILITIES 
AND CERTIFIED FOREIGN SELLERS.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), certified foreign sellers who 
sell qualifying prescription drugs for importa-
tion into the United States pursuant to this 
section may purchase such drugs only from 
manufacturers or entities registered under sec-
tion 510 or other certified foreign sellers. 
‘‘(B) EXCEPTION.—Certified foreign sellers 
who sell qualifying prescription drugs for im-
portation into the United States pursuant to 
this section may purchase such drugs from for-
eign sellers in Canada or another permitted 
country, even if such foreign seller is not a 
manufacturer registered under section 510 or a 
certified foreign seller, if the Secretary enters 
into a memorandum of understanding or coop-
erative agreement with Canada, or such other 
permitted country, to ensure compliance, to the 
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extent appropriate and feasible, with subchapter 
H of chapter V. The Secretary shall seek to 
enter into such a memorandum of under-
standing or cooperative agreement with Canada 
and each country from which importation is 
permitted under subsection (e). 
‘‘(2) IMPORTATION TRACING.—Certified foreign 
sellers shall provide importers with the unique facil-
ity identifier associated with the manufacturer reg-
istered under section 510 of the qualifying prescrip-
tion drug and the information under paragraph 
(25), paragraph (26) (other than subparagraph (C)), 
and subparagraphs (D), (F), and (G) of paragraph 
(27) of section 581. Certified foreign sellers shall 
provide such information to individuals purchasing 
such drugs, upon request. 
‘‘(l) REMS.—In the case of an importer that imports 
a qualifying prescription drug, where the drug with the 
same active ingredient or ingredients (or that is biosimilar 
to an approved biological product), route of administra-
tion, and strength that is approved under chapter V or 
section 351 of the Public Health Service Act is subject 
to elements to assure safe use under section 505–1, such 
importer shall be subject to such elements to assure safe 
use, as applicable and appropriate. 
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‘‘(m) CONSTRUCTION.—Nothing in this section limits 
the authority of the Secretary relating to the importation 
of prescription drugs, other than with respect to section 
801(d)(1) as provided in this section.’’. 
(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 
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available under any State or Federal law, including com-
mon law, that provides a remedy for civil relief. 
(d) REPORTS.— 
(1) HHS.—Not later than 1 year after the date 
on which final regulations are promulgated to carry 
out section 804 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 384), as amended 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 drugs 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 804 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 384), as amend-
ed 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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