‘‘(2) any person that processes, packages, dis-
tributes, receives, holds, or transports a prescription 
drug imported under this subchapter. 
‘‘(b) INSPECTION.—
‘‘(1) IN GENERAL.—If the Secretary has reason 
to believe that a prescription drug imported under 
this subchapter presents a risk to the public health, 
the drug importation facility, pharmacy, Internet 
pharmacy, or wholesaler that imports the prescrip-
tion drug, and each person that processes, packages, 
distributes, receives, holds, or transports the pre-
scription drug shall, at the request of an officer or 
employee duly designated by the Secretary, permit 
the officer or employee, upon presentation of appro-
priate credentials and a written notice to such phar-
macy or person, at reasonable times, within reason-
able limits and in a reasonable manner, to have ac-
cess to and copy all records relating to the prescrip-
tion drug that are needed to enable the Secretary to 
determine whether the prescription drug presents a 
risk to the public health. 
‘‘(2) APPLICABILITY.—Paragraph (1) applies to 
all records maintained by or on behalf of the drug 
importation facility, pharmacy, Internet pharmacy, 
or wholesaler or such other person in any format
(including paper and electronic formats) and at any 
location. 
‘‘(c) PROTECTION OF SENSITIVE INFORMATION.—
The Secretary shall take appropriate measures to ensure 
that there are in effect effective procedures to prevent the 
unauthorized disclosure of any trade secret or confidential 
information that is obtained by the Secretary under this 
section or any commercial or financial information that 
is privileged or confidential. 
‘‘(d) EFFECT OF SECTION.—Nothing in this section 
applies to a prescription drug imported by an individual 
under section 812 or to a commercial transaction con-
ducted between an Internet pharmacy and an individual.’’. 
SEC. 10. ADVANCE NOTICE OF IMPORTED PRESCRIPTION 
DRUG SHIPMENTS. 
(a) IN GENERAL.—Section 801 of the Federal Food, 
Drug, and Cosmetic Act (as amended by section 8(b)) is 
amended by adding at the end the following: 
‘‘(u) ADVANCE NOTICE OF IMPORTED PRESCRIPTION 
DRUG SHIPMENTS.—
‘‘(1) IN GENERAL.—For purposes of enabling 
the Secretary to inspect at ports of entry a prescrip-
tion drug that is being imported or offered for im-
portation into the United States, the person import-
ing or offering for importation the prescription drug
shall, in advance, provide to the Secretary a notice 
that includes—
‘‘(A) the established name (as defined by 
section 502(e)), dosage form, and quantity of 
the prescription drug; 
‘‘(B) the name of the shipper of the pre-
scription drug; 
‘‘(C) the name of the country from which 
the prescription drug originates; 
‘‘(D) the country from which the prescrip-
tion drug is shipped; 
‘‘(E) the name of the port of entry of the 
prescription drug; 
‘‘(F) documentation from the drug impor-
tation facility located in Canada or a permitted 
country specifying—
‘‘(i) the original source of the pre-
scription drug; and 
‘‘(ii) the quantity of each lot of the 
prescription drug originally received by the 
facility from that source; 
‘‘(G) the lot or control number assigned to 
the prescription drug by the manufacturer of 
the prescription drug;