716
‘‘(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 or other-
wise complying with this Act; 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-
tation into the United States shall register with the Sec-
717
retary the name and place of business of 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) PROHIBITION OF DISCRIMINATION.—
‘‘(1) IN GENERAL.—It shall be unlawful for a 
manufacturer of a prescription drug to discriminate 
against, or cause any other person to discriminate 
against, a pharmacist or wholesaler that purchases 
or offers to purchase a prescription drug from the 
manufacturer or from any person that distributes a
718
prescription drug manufactured by the drug manu-
facturer. 
‘‘(2) DISCRIMINATION.—For the purposes of 
paragraph (1), a manufacturer of a prescription 
drug shall be considered to discriminate against a 
pharmacist or wholesaler if the manufacturer enters 
into a contract for sale of a prescription drug, places 
a limit on supply, or employs any other measure, 
that has the effect of—
‘‘(A) providing pharmacists or wholesalers 
access to prescription drugs on terms or condi-
tions that are less favorable than the terms or 
conditions provided to a foreign purchaser 
(other than a charitable or humanitarian orga-
nization) of the prescription drug; or 
‘‘(B) restricting the access of pharmacists 
or wholesalers to a prescription drug that is 
permitted to be imported into the United States 
under this section. 
‘‘(j) 
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-
719
ganization (including the United Nations and affiliates) 
or to a government of a foreign country. 
‘‘(k) WAIVER AUTHORITY FOR IMPORTATION BY IN-
DIVIDUALS.—
‘‘(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 
class of prescription drugs or devices, under
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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. 
‘‘(3) DRUGS
IMPORTED
FROM
CANADA.—In 
particular, the Secretary shall by regulation grant 
individuals a waiver to permit individuals to import 
into the United States a prescription drug that—
‘‘(A) is imported from a licensed pharmacy 
for personal use by an individual, not for resale, 
in quantities that do not exceed a 90-day sup-
ply; 
‘‘(B) is accompanied by a copy of a valid 
prescription; 
‘‘(C) is imported from Canada, from a sell-
er registered with the Secretary; 
‘‘(D) is a prescription drug approved by 
the Secretary under chapter V;
721
‘‘(E) is in the form of a final finished dos-
age that was manufactured in an establishment 
registered under section 510; and 
‘‘(F) is imported under such other condi-
tions as the Secretary determines to be nec-
essary to ensure public safety. 
‘‘(l) STUDIES; REPORTS.—
‘‘(1) BY THE INSTITUTE OF MEDICINE OF THE 
NATIONAL ACADEMY OF SCIENCES.—
‘‘(A) STUDY.—
‘‘(i) IN
GENERAL.—The Secretary 
shall request that the Institute of Medicine 
of the National Academy of Sciences con-
duct a study of—
‘‘(I) importations of prescription 
drugs made under the regulations 
under subsection (b); and 
‘‘(II) 
information 
and 
docu-
mentation submitted under subsection 
(d). 
‘‘(ii) REQUIREMENTS.—In conducting 
the study, the Institute of Medicine shall—
‘‘(I) evaluate the compliance of 
importers with the regulations under 
subsection (b);