126 
from the inactive ingredients for the 
U.S. label drug, include— 
‘‘(aa) a prominent notice 
that the ingredients of the quali-
fying drug differ from the ingre-
dients of the U.S. label drug and 
that the qualifying drug must be 
dispensed with an advisory to 
people with allergies about this 
difference and a list of ingredi-
ents; and 
‘‘(bb) a list of the ingredi-
ents of the qualifying drug as 
would be required under section 
502(e). 
‘‘(B) IMPORTATION BY INDIVIDUAL.— 
‘‘(i) IN GENERAL.—In the case of a 
qualifying drug that is imported or offered 
for import by a registered exporter to an 
individual, such drug shall be considered to 
be in compliance with section 502 and the 
labeling requirements under the approved 
application for the U.S. label drug if the 
packaging and labeling of the qualifying 
drug complies with all applicable regula-
127 
tions promulgated under sections 3 and 4 
of the Poison Prevention Packaging Act of 
1970 (15 U.S.C. 1471 et seq.) and the la-
beling of the qualifying drug includes— 
‘‘(I) directions for use by the 
consumer; 
‘‘(II) the lot number assigned by 
the manufacturer; 
‘‘(III) the name and registration 
number of the exporter; 
‘‘(IV) if required under para-
graph (2)(B)(vi)(III), a prominent ad-
visory that the drug is safe and effec-
tive but not bioequivalent to the U.S. 
label drug; 
‘‘(V) if the inactive ingredients of 
the drug are different from the inac-
tive ingredients for the U.S. label 
drug— 
‘‘(aa) a prominent advisory 
that persons with an allergy 
should check the ingredient list 
of the drug because the ingredi-
ents of the drug differ from the
128 
ingredients of the U.S. label 
drug; and 
‘‘(bb) a list of the ingredi-
ents of the drug as would be re-
quired under section 502(e); and 
‘‘(VI) a copy of any special label-
ing that would be required by the Sec-
retary had the U.S. label drug been 
dispensed by a pharmacist in the 
United States, without regard to 
whether the special labeling bears any 
trademark involved. 
‘‘(ii) REQUEST FOR COPY OF SPECIAL 
LABELING
AND
INGREDIENT
LIST.—The 
Secretary shall provide to the registered 
exporter involved a copy of the special la-
beling, the advisory, and the ingredient list 
of the drug, upon request of the exporter. 
‘‘(iii) REQUESTED LABELING AND IN-
GREDIENT LIST.—The labeling and ingre-
dient list provided by the Secretary under 
clause (ii) shall— 
‘‘(I) 
include 
the 
established 
name, as defined in section 502(e)(3),
129 
for each active ingredient in the drug; 
and 
‘‘(II) not include the proprietary 
name of the U.S. label drug or any 
active ingredient thereof. 
‘‘(4) SECTION 501; ADULTERATION.—A quali-
fying drug that is imported or offered for import 
under subsection (a) shall be considered to be in 
compliance with section 501 if the drug is in compli-
ance with subsection (c). 
‘‘(5) STANDARDS FOR REFUSING ADMISSION.— 
A drug exported under subsection (a) from a reg-
istered exporter or imported by a registered importer 
may be refused admission into the United States if 
1 or more of the following applies: 
‘‘(A) The drug is not a qualifying drug. 
‘‘(B) A notice for the drug required under 
paragraph (2)(B) has not been submitted to the 
Secretary. 
‘‘(C) The Secretary has ordered that im-
portation of the drug from the permitted coun-
try cease under paragraph (2) (C) or (D). 
‘‘(D) The drug does not comply with para-
graph (3) or (4).
130 
‘‘(E) The shipping container appears dam-
aged in a way that may affect the strength, 
quality, or purity of the drug. 
‘‘(F) The Secretary becomes aware that— 
‘‘(i) the drug may be counterfeit; 
‘‘(ii) the drug may have been pre-
pared, packed, or held under insanitary 
conditions; or 
‘‘(iii) the methods used in, or the fa-
cilities or controls used for, the manufac-
turing, processing, packing, or holding of 
the drug do not conform to good manufac-
turing practice. 
‘‘(G) The Secretary has obtained an in-
junction under section 302 that prohibits the 
distribution of the drug in interstate commerce. 
‘‘(H) The Secretary has under section 
505(e) withdrawn approval of the drug. 
‘‘(I) The manufacturer of the drug has in-
stituted a recall of the drug. 
‘‘(J) If the drug is imported or offered for 
import by a registered importer without submis-
sion of a notice in accordance with subsection 
(d)(4).
131 
‘‘(K) If the drug is imported or offered for 
import from a registered exporter to an indi-
vidual and 1 or more of the following applies: 
‘‘(i) The shipping container for such 
drug does not bear the markings required 
under subsection (d)(2). 
‘‘(ii) The markings on the shipping 
container appear to be counterfeit. 
‘‘(iii) The shipping container or mark-
ings appear to have been tampered with. 
‘‘(h) LICENSING
AS PHARMACIST.—A registration 
condition is that the exporter involved agrees that a quali-
fying drug will be exported to an individual only if the 
Secretary has verified that— 
‘‘(1) the exporter is authorized under the law of 
the permitted country in which the exporter is lo-
cated to dispense prescription drugs; and 
‘‘(2) the exporter employs persons that are li-
censed under the law of the permitted country in 
which the exporter is located to dispense prescription 
drugs in sufficient number to dispense safely the 
drugs exported by the exporter to individuals, and 
the exporter assigns to those persons responsibility 
for dispensing such drugs to individuals.
132 
‘‘(i) INDIVIDUALS; CONDITIONS
FOR
IMPORTA-
TION.— 
‘‘(1) IN GENERAL.—For purposes of subsection 
(a)(2)(B), the importation of a qualifying drug by 
an individual is in accordance with this subsection if 
the following conditions are met: 
‘‘(A) The drug is accompanied by a copy of 
a prescription for the drug, which prescrip-
tion— 
‘‘(i) is valid under applicable Federal 
and State laws; and 
‘‘(ii) was issued by a practitioner who, 
under the law of a State of which the indi-
vidual is a resident, or in which the indi-
vidual receives care from the practitioner 
who issues the prescription, is authorized 
to administer prescription drugs. 
‘‘(B) The drug is accompanied by a copy 
of the documentation that was required under 
the law or regulations of the permitted country 
in which the exporter is located, as a condition 
of dispensing the drug to the individual. 
‘‘(C) The copies referred to in subpara-
graphs (A)(i) and (B) are marked in a manner 
sufficient—
133 
‘‘(i) to indicate that the prescription, 
and the equivalent document in the per-
mitted country in which the exporter is lo-
cated, have been filled; and 
‘‘(ii) to prevent a duplicative filling by 
another pharmacist. 
‘‘(D) The individual has provided to the 
registered exporter a complete list of all drugs 
used by the individual for review by the individ-
uals who dispense the drug. 
‘‘(E) The quantity of the drug does not ex-
ceed a 90-day supply. 
‘‘(F) The drug is not an ineligible subpart 
H drug. For purposes of this section, a pre-
scription drug is an ‘ineligible subpart H drug’ 
if the drug was approved by the Secretary 
under subpart H of part 314 of title 21, Code 
of Federal Regulations (relating to accelerated 
approval), with restrictions under section 520 of 
such part to assure safe use, and the Secretary 
has published in the Federal Register a notice 
that the Secretary has determined that good 
cause exists to prohibit the drug from being im-
ported pursuant to this subsection.
134 
‘‘(2) NOTICE REGARDING DRUG REFUSED AD-
MISSION.—If a registered exporter ships a drug to 
an individual pursuant to subsection (a)(2)(B) and 
the drug is refused admission to the United States, 
a written notice shall be sent to the individual and 
to the exporter that informs the individual and the 
exporter of such refusal and the reason for the re-
fusal. 
‘‘(j) MAINTENANCE OF RECORDS AND SAMPLES.— 
‘‘(1) IN GENERAL.—A registration condition is 
that the importer or exporter involved shall— 
‘‘(A) maintain records required under this 
section for not less than 2 years; and 
‘‘(B) maintain samples of each lot of a 
qualifying drug required under this section for 
not less than 2 years. 
‘‘(2) PLACE OF RECORD MAINTENANCE.—The 
records described under paragraph (1) shall be 
maintained— 
‘‘(A) in the case of an importer, at the 
place of business of the importer at which the 
importer initially receives the qualifying drug 
after importation; or