gage in any other action to restrict, prohibit, or 
delay the importation of a prescription drug under 
this section. 
‘‘(i) ENFORCEMENT DISCRETION AND WAIVER AU-
THORITY FOR IMPORTATION BY INDIVIDUALS.— 
‘‘(1) DECLARATIONS.—Congress declares that 
in the enforcement against individuals of the prohi-
bition of importation of prescription drugs and de-
vices, the Secretary should— 
‘‘(A) focus enforcement on cases in which 
the importation by an individual poses a signifi-
cant threat to public health; and 
‘‘(B) exercise discretion to permit individ-
uals to make such importations in cir-
cumstances in which— 
‘‘(i) the importation is clearly for per-
sonal use; and 
‘‘(ii) the prescription drug or device 
imported does not appear to present an 
unreasonable risk to the individual. 
‘‘(2) WAIVER AUTHORITY.— 
‘‘(A) IN
GENERAL.—The Secretary may 
grant to individuals, by regulation or on a case- 
by-case basis, a waiver of the prohibition of im-
portation of a prescription drug or device or 
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class of prescription drugs or devices, under 
such conditions as the Secretary determines to 
be appropriate. 
‘‘(B) GUIDANCE ON CASE-BY-CASE WAIV-
ERS.—The Secretary shall publish, and update 
as necessary, guidance that accurately describes 
circumstances in which the Secretary will con-
sistently grant waivers on a case-by-case basis 
under subparagraph (A), so that individuals 
may know with the greatest practicable degree 
of certainty whether a particular importation 
for personal use will be permitted. 
‘‘(j) 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. 
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‘‘(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. 
‘‘(k) 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 
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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. 
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. 
‘‘(l) 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, the United Kingdom, a 
member state of the European Union, Switzer-
land, or another permitted country, subject to 
subsection (e), even if such foreign seller is not 
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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 the respective country, 
to ensure compliance, to the extent appropriate 
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, the United Kingdom, 
the European Union, Switzerland, and each 
country from which importation is permitted 
under subsection (e). 
‘‘(2) IMPORTATION TRACING.—Certified foreign 
sellers shall provide importers with the name and 
address of the manufacturer registered under section 
510 of the qualifying prescription drug and the in-
formation 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 informa-
tion to individuals purchasing such drugs, upon re-
quest. 
‘‘(m) REMS.—In the case of an importer that im-
ports a qualifying prescription drug, where the drug with 
the same active ingredient or ingredients (or that is bio-
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similar to an approved biological product), route of admin-
istration, 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. 
‘‘(n) 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 
SALES.—Section 303 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 333) is amended by adding at the 
end the following: 
‘‘(h) In the case of person operating or utilizing an 
internet website, whether in the United States or in an-
other country, 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 
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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.— 
(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-
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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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