and inspection for the purpose of carrying out the 
amendments made by the Safe IMPORT Act of 
2004. 
‘‘(B) A contract entered into under subpara-
graph (A) shall—
‘‘(i) ensure adequate training of officers 
and employees to conduct the examinations and 
investigations; and 
‘‘(ii) be effective only with respect to ex-
aminations or inspections of drug importation 
facilities, pharmacies, Internet pharmacies, and 
wholesalers located in the State.’’. 
SEC. 14. USER FEES RELATING TO PRESCRIPTION DRUG 
IMPORTATION. 
Subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 397f et seq.) is 
amended by adding at the end the following: 
‘‘PART 5—FEES RELATING TO PRESCRIPTION 
DRUG IMPORTATION 
‘‘SEC. 740A. FEES RELATING TO PRESCRIPTION DRUG IM-
PORTATION. 
‘‘(a) REGISTRATION FEE.—The Secretary shall es-
tablish a user fee program under which a drug importation 
facility, pharmacy, Internet pharmacy, or wholesaler reg-
istering with the Secretary under section 814 shall be re-
quired to pay a fee to the Secretary. 
‘‘(b) COLLECTION.—
‘‘(1) COLLECTION ON INITIAL REGISTRATION.—
A fee under this section shall be payable for the fis-
cal year in which the drug importation facility, phar-
macy, Internet pharmacy, or wholesaler first reg-
isters under section 814 (or reregisters under that 
section if that person has withdrawn its registration 
and subsequently reregisters). 
‘‘(2) COLLECTION
IN
SUBSEQUENT
YEARS.—
After the fee is paid for that fiscal year, the fee shall 
be payable on or before October 1 of each year. 
‘‘(3) ONE FEE PER FACILITY.—The fee shall be 
paid only once for each drug importation facility, 
pharmacy, Internet pharmacy, or wholesaler reg-
istered for a fiscal year in which the fee is payable. 
‘‘(c) FEE AMOUNT.—The amount of the fee shall be 
determined each year by the Secretary and shall be based 
on the anticipated costs to the Secretary of enforcing the 
amendments made by the Safe IMPORT Act of 2004 in 
the subsequent fiscal year. 
‘‘(d) USE OF FEES.—The fees collected under this 
section shall be used, without further appropriation, to en-
force the amendments made by the Safe IMPORT Act of 
2004. 
‘‘(e) ANNUAL FEE SETTING.—The Secretary shall 
establish, 60 days before the beginning of each fiscal year 
beginning after September 30, 2004, for that fiscal year, 
registration fees. 
‘‘(f) EFFECT OF FAILURE TO PAY FEES.—
‘‘(1) DUE DATE.—A fee payable under this sec-
tion shall be paid by the date that is 30 days after 
the date on which the fee is due. 
‘‘(2) FAILURE TO PAY.—If a registered drug 
importation facility, pharmacy, Internet pharmacy, 
or wholesaler subject to a fee under this section fails 
to pay the fee, the Secretary shall not permit the 
drug importation facility pharmacy, Internet phar-
macy, or wholesaler to engage in importation or of-
fering for importation prescription drugs under this 
Act until all such fees owed by that person are paid. 
‘‘(g) REPORTS.—
‘‘(1) FEE ESTABLISHMENT.—Not later than 60 
days before each fiscal year, the Secretary shall—
‘‘(A) publish user fees under this section 
for that fiscal year; 
‘‘(B) hold a meeting at which the public 
may comment on the recommendations; and
‘‘(C) provide for a period of 30 days for 
the public to provide written comments on the 
recommendations. 
‘‘(2) PERFORMANCE AND FISCAL REPORT.—Be-
ginning with fiscal year 2005, not later than 60 days 
after the end of each fiscal year during which fees 
are collected under this section, the Secretary shall 
submit to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of 
Representatives a report that describes—
‘‘(A) implementation of the user fee au-
thority during the fiscal year; and 
‘‘(B) the use by the Secretary of the fees 
collected during the fiscal year for which the re-
port is made.’’. 
SEC. 15. ANTICOUNTERFEITING PROVISIONS. 
(a) REQUIRED RECORDS.—Section 503(e) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(e)) 
is amended by striking paragraph (1) and inserting the 
following: 
‘‘(1) A distributor of record that is engaged in 
the wholesale distribution of a drug subject to sub-
section (b), shall—