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‘‘(H) The lot or control number assigned 
to the prescription drug by the manufacturer of 
the prescription drug. 
‘‘(I) The name, address, telephone number, 
and professional license number (if any) of the 
importer. 
‘‘(J)(i) Documentation demonstrating that 
the prescription drug was received by the recipi-
ent from the manufacturer and subsequently 
shipped by the first foreign recipient to the im-
porter. 
‘‘(ii) Documentation of the quantity of 
each lot of the prescription drug received by the 
first foreign recipient demonstrating that the 
quantity being imported into the United States 
is not more than the quantity that was received 
by the first foreign recipient. 
‘‘(iii) In the case of an initial imported 
shipment, documentation demonstrating that 
each batch of the prescription drug in the ship-
ment was statistically sampled and tested for 
authenticity and degradation. 
‘‘(K) Certification from the importer or 
manufacturer of the prescription drug that the 
prescription drug—
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‘‘(i) is approved for marketing in the 
United States and is not adulterated or 
misbranded; and 
‘‘(ii) meets all labeling requirements 
under this Act. 
‘‘(L) Laboratory records, including com-
plete data derived from all tests necessary to 
ensure that the prescription drug is in compli-
ance with established specifications and stand-
ards. 
‘‘(M) Documentation demonstrating that 
the testing required by subparagraphs (J) and 
(L) was conducted at a qualifying laboratory. 
‘‘(N) Any other information that the Sec-
retary determines is necessary to ensure the 
protection of the public health. 
‘‘(2) MAINTENANCE BY THE SECRETARY.—The 
Secretary shall maintain information and docu-
mentation submitted under paragraph (1) for such 
period of time as the Secretary determines to be nec-
essary. 
‘‘(e) TESTING.—The regulations under subsection (b) 
shall require—
‘‘(1) that testing described in subparagraphs 
(J) and (L) of subsection (d)(1) be conducted by the
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importer or by the manufacturer of the prescription 
drug at a qualified laboratory; 
‘‘(2) if the tests are conducted by the im-
porter—
‘‘(A) that information needed to—
‘‘(i) authenticate the prescription drug 
being tested; and 
‘‘(ii) confirm that the labeling of the 
prescription drug complies with labeling re-
quirements under this Act; 
be supplied by the manufacturer of the pre-
scription drug to the pharmacist or wholesaler; 
and 
‘‘(B) that the information supplied under 
subparagraph (A) be kept in strict confidence 
and used only for purposes of testing under this 
section; and 
‘‘(3) may include such additional provisions as 
the Secretary determines to be appropriate to pro-
vide for the protection of trade secrets and commer-
cial or financial information that is privileged or 
confidential. 
‘‘(f) REGISTRATION OF FOREIGN SELLERS.—Any es-
tablishment within Canada engaged in the distribution of 
a prescription drug that is imported or offered for impor-
687
tation into the United States shall register with the Sec-
retary the name and place of business of the establishment 
and the name of the United States agent for the establish-
ment. 
‘‘(g) SUSPENSION OF IMPORTATION.—The Secretary 
shall require that importations of a specific prescription 
drug or importations by a specific importer under sub-
section (b) be immediately suspended on discovery of a 
pattern of importation of that specific prescription drug 
or by that specific importer of drugs that are counterfeit 
or in violation of any requirement under this section, until 
an investigation is completed and the Secretary deter-
mines that the public is adequately protected from coun-
terfeit and violative prescription drugs being imported 
under subsection (b). 
‘‘(h) APPROVED LABELING.—The manufacturer of a 
prescription drug shall provide an importer written au-
thorization for the importer to use, at no cost, the ap-
proved labeling for the prescription drug. 
‘‘(i) 
CHARITABLE
CONTRIBUTIONS.—Notwith-
standing any other provision of this section, section 
801(d)(1) continues to apply to a prescription drug that 
is donated or otherwise supplied at no charge by the man-
ufacturer of the drug to a charitable or humanitarian or-
688
ganization (including the United Nations and affiliates) 
or to a government of a foreign country. 
‘‘(j) WAIVER AUTHORITY FOR IMPORTATION BY IN-
DIVIDUALS.—The Secretary may, for drugs being im-
ported from a licensed Canadian pharmacy, grant to indi-
viduals, by regulation or on a case-by-case basis, a waiver 
of the prohibition of importation of a prescription drug 
or device or class of prescription drugs or devices, under 
such conditions as the Secretary determines to be appro-
priate. Such conditions shall include conditions that such 
drug or device be—
‘‘(1) in the possession of an individual when the 
individual enters the United States; 
‘‘(2) imported by such individual from a li-
censed pharmacy for personal use by the individual, 
not for resale, in quantities that do not exceed a 90-
day supply, which individual will use the drug or de-
vice (or for a family member of such individual); 
‘‘(3) accompanied by a copy of a valid prescrip-
tion; 
‘‘(4) imported from Canada, from a seller reg-
istered with the Secretary; 
‘‘(5) a prescription drug approved by the Sec-
retary under chapter V that is not adulterated or 
misbranded;