‘‘(ii) a biological product (as defined 
in section 351 of the Public Health Service 
Act (42 U.S.C. 262)); 
‘‘(iii) an infused drug (including a 
peritoneal dialysis solution); 
‘‘(iv) an intravenously injected drug; 
‘‘(v) a drug that is inhaled during sur-
gery; 
‘‘(vi) a parenteral drug; 
‘‘(vii) a drug manufactured through 1 
or more biotechnology processes, includ-
ing— 
‘‘(I) a therapeutic DNA plasmid 
product; 
‘‘(II) 
a 
therapeutic 
synthetic 
peptide product of not more than 40 
amino acids; 
‘‘(III) a monoclonal antibody 
product for in vivo use; and 
‘‘(IV) a therapeutic recombinant 
DNA-derived product; 
‘‘(viii) a drug required to be refrig-
erated at any time during manufacturing, 
packing, processing, or holding; or 
‘‘(ix) a photoreactive drug.
‘‘(6) TREATING PROVIDER.—The term ‘treating 
provider’ means a licensed health care provider 
that— 
‘‘(A)(i) performs a documented patient 
evaluation (including a patient history and 
physical examination) of an individual to estab-
lish the diagnosis for which a prescription drug 
is prescribed; 
‘‘(ii) discusses with the individual the 
treatment options of the individual and the 
risks and benefits of treatment; and 
‘‘(iii) maintains contemporaneous medical 
records concerning the individual; or 
‘‘(B) provides care to an individual as part 
of an on-call or cross-coverage arrangement 
with a health care provider described in sub-
paragraph (A). 
‘‘(7) WHOLESALER.— 
‘‘(A) IN GENERAL.—The term ‘wholesaler’ 
means a person licensed as a wholesaler or dis-
tributor of prescription drugs in the United 
States as described in section 503(e)(2). 
‘‘(B) EXCLUSION.—The term ‘wholesaler’ 
does not include—
‘‘(i) a person authorized to import 
drugs under section 801(d)(1); or 
‘‘(ii) an individual importing a pre-
scription drug under section 812.’’. 
SEC. 3. COMMERCIAL IMPORTATION. 
Subchapter B of chapter VIII of the Federal Food, 
Drug, and Cosmetic Act, as added by section 2 of this 
Act, is amended by adding at the end the following section: 
‘‘SEC. 812. COMMERCIAL IMPORTATION. 
‘‘(a) IN GENERAL.— 
‘‘(1) NO
PRESUMPTION
AGAINST
IMPORTA-
TION.—A drug importation facility, pharmacy, Inter-
net pharmacy, or wholesaler may import a prescrip-
tion drug from Canada or a permitted country into 
the United States for dispensing in the United 
States unless the importation of the prescription 
drug is not in accordance with this subchapter. 
‘‘(2) LIMITATION
TO
CERTAIN
PORTS.—The 
Secretary may limit the ports of entry in the United 
States through which a prescription drug may be 
imported under this section to a reasonable number 
of ports designated by the Secretary. 
‘‘(b) REQUIREMENTS.—Each prescription drug im-
ported under this subchapter shall— 
‘‘(1) be approved under section 505;
‘‘(2) comply with sections 501 and 502; 
‘‘(3) be in a container that bears a label stat-
ing, in prominent and conspicuous type— 
‘‘(A) the lot number of the prescription 
drug; 
‘‘(B) the name, address and phone number 
of the drug importation facility; 
‘‘(C) comply with regulations promulgated 
by the Secretary to require labeling regarding 
the fact that the drug is imported; and 
‘‘(D) a unique identifier code provided by 
the Secretary that modifies the national drug 
code of the prescription drug to indicate that 
the drug has been imported; and 
‘‘(4) comply with any other applicable require-
ment of this Act. 
‘‘(c) APPROVED LABELING.— 
‘‘(1) IN GENERAL.—A drug importation facility 
that offers for importation a prescription drug under 
this subchapter shall submit to the Secretary an ap-
plication for approval that demonstrates that the la-
beling of the prescription drug to be imported into 
the United States complies with the requirements of 
sections 502 and 503.