‘‘(VI) a drug that is the listed 
drug referred to in 2 or more abbre-
viated new drug applications under 
which the drug is commercially mar-
keted. 
‘‘(D) OTHER DEFINITIONS.—For purposes 
of this section: 
‘‘(i)(I) The term ‘exporter’ means a 
person that is in the business of exporting 
a drug to individuals in the United States 
from Canada or from a permitted country 
designated by the Secretary under sub-
clause (II), or that, pursuant to submitting 
a registration under subsection (b), seeks 
to be in such business. 
‘‘(II) The Secretary shall designate a 
permitted country under subparagraph (E) 
(other than Canada) as a country from 
which an exporter may export a drug to in-
dividuals in the United States if the Sec-
retary determines that— 
‘‘(aa) the country has statutory 
or regulatory standards that are 
equivalent to the standards in the
United States and Canada with re-
spect to— 
‘‘(AA) the training of phar-
macists; 
‘‘(BB) the practice of phar-
macy; and 
‘‘(CC) the protection of the 
privacy of personal medical infor-
mation; and 
‘‘(bb) the importation of drugs to 
individuals in the United States from 
the country will not adversely affect 
public health. 
‘‘(ii) The term ‘importer’ means a 
pharmacy, a group of pharmacies, or a 
wholesaler that is in the business of im-
porting a drug into the United States or 
that, pursuant to submitting a registration 
under subsection (b), seeks to be in such 
business. 
‘‘(iii) The term ‘pharmacist’ means a 
person licensed by a State to practice 
pharmacy, including the dispensing and 
selling of prescription drugs.
‘‘(iv) The term ‘pharmacy’ means a 
person that— 
‘‘(I) is licensed by a State to en-
gage in the business of selling pre-
scription drugs at retail; and 
‘‘(II) employs 1 or more phar-
macists. 
‘‘(v) The term ‘prescription drug’ means a drug 
that is described in section 503(b)(1). 
‘‘(vi) The term ‘wholesaler’— 
‘‘(I) means a person licensed as a whole-
saler or distributor of prescription drugs in the 
United States under section 503(e)(2)(A); and 
‘‘(II) does not include a person authorized 
to import drugs under section 801(d)(1). 
‘‘(E) PERMITTED COUNTRY.—The term ‘permitted 
country’ means— 
‘‘(i) Australia; 
‘‘(ii) Canada; 
‘‘(iii) a member country of the European 
Union, but does not include a member country with 
respect to which— 
‘‘(I) the country’s Annex to the Treaty of 
Accession to the European Union 2003 includes 
a transitional measure for the regulation of
human pharmaceutical products that has not 
expired; or 
‘‘(II) the Secretary determines that the re-
quirements described in subclauses (I) and (II) 
of clause (vii) will not be met by the date on 
which such transitional measure for the regula-
tion of human pharmaceutial products expires; 
‘‘(iv) Japan; 
‘‘(v) New Zealand; 
‘‘(vi) Switzerland; and 
‘‘(vii) a country in which the Secretary deter-
mines the following requirements are met: 
‘‘(I) The country has statutory or regu-
latory requirements— 
‘‘(aa) that require the review of drugs 
for safety and effectiveness by an entity of 
the government of the country; 
‘‘(bb) that authorize the approval of 
only those drugs that have been deter-
mined to be safe and effective by experts 
employed by or acting on behalf of such 
entity and qualified by scientific training 
and experience to evaluate the safety and 
effectiveness of drugs on the basis of ade-
quate and well-controlled investigations, in-
cluding clinical investigations, conducted 
by experts qualified by scientific training 
and experience to evaluate the safety and 
effectiveness of drugs; 
‘‘(cc) that require the methods used 
in, and the facilities and controls used for 
the manufacture, processing, and packing 
of drugs in the country to be adequate to 
preserve their identity, quality, purity, and 
strength; 
‘‘(dd) for the reporting of adverse re-
actions to drugs and procedures to with-
draw approval and remove drugs found not 
to be safe or effective; and 
‘‘(ee) that require the labeling and 
promotion of drugs to be in accordance 
with the approval of the drug. 
‘‘(II) The valid marketing authorization 
system in the country is equivalent to the sys-
tems in the countries described in clauses (i) 
through (vi). 
‘‘(III) The importation of drugs to the 
United States from the country will not ad-
versely affect public health.