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
importer or by the manufacturer of the prescription
drug at a qualified laboratory;
‘‘(2) if the tests are conducted by the
importer—
‘‘(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-
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-
ganization (including the United Nations and affiliates)
or to a government of a foreign country.
‘‘(j) 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
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;
‘‘(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.
‘‘(k) 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.
‘‘(l) AUTHORIZATION OF APPROPRIATIONS.—There
are authorized to be appropriated such sums as are nec-
essary to carry out this section.’’.
(b) 
CONFORMING
AMENDMENTS.—The 
Federal
Food, Drug, and Cosmetic Act is amended—
(1) in section 301(aa) (21 U.S.C. 331(aa)), by
striking ‘‘covered product in violation of section
804’’ and inserting ‘‘prescription drug in violation of
section 804’’; and
(2) in section 303(a)(6) (21 U.S.C. 333(a)(6),
by striking ‘‘covered product pursuant to section
804(a)’’ and inserting ‘‘prescription drug under sec-
tion 804(b)’’.
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