‘‘(i) IN
GENERAL.—The Secretary 
shall disapprove a registration, and notify 
the registrant of such disapproval, if the 
Secretary has reason to believe that such 
registrant is not in compliance with a reg-
istration condition. 
‘‘(ii) SUBSEQUENT
APPROVAL.—The 
Secretary may subsequently approve a reg-
istration that was denied under clause (i) 
if the Secretary finds that the registrant is 
in compliance with all registration condi-
tions. 
‘‘(3) LIST.—The Secretary shall— 
‘‘(A) maintain an up-to-date list of reg-
istered exporters (including qualifying Internet 
pharmacies that sell qualifying drugs to individ-
uals); 
‘‘(B) make such list available to the public 
on the Internet site of the Food and Drug Ad-
ministration and via a toll-free telephone num-
ber; and 
‘‘(C) update such list promptly after the 
approval of a registration under this subsection. 
‘‘(4) EDUCATION
OF
CONSUMERS.—The Sec-
retary shall carry out activities, by use of the Inter-
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net website and toll-free telephone number under 
paragraph (3), that educate consumers with regard 
to the availability of qualifying drugs for import for 
personal use under this section, including informa-
tion on how to verify whether an exporter is reg-
istered. 
‘‘(5) INSPECTION
OF
IMPORTERS
AND
REG-
ISTERED EXPORTERS.—The Secretary shall inspect 
the warehouses, other facilities, and records of im-
porters and registered exporters as often as the Sec-
retary determines necessary to ensure that such im-
porters and registered exporters are in compliance 
with this section.’’. 
(g) SUSPENSION OF IMPORTATION.—Section 804(g) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
384(g)) is amended by— 
(1) striking ‘‘and the Secretary determines that 
the public is adequately protected from counterfeit 
and violative prescription drugs being imported 
under subsection (b)’’; and 
(2) by adding after the period at the end the 
following: ‘‘The Secretary shall reinstate the impor-
tation by a specific importer upon a determination 
by the Secretary that the violation has been cor-
rected and that the importer has demonstrated that 
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further violations will not occur. This subsection 
shall not apply to a prescription drug imported by 
an individual, or to a prescription drug shipped to 
an individual by a qualifying Internet pharmacy.’’. 
(h) WAIVER AUTHORITY FOR INDIVIDUALS.—Section 
804(j) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 384(j)) is amended to read as follows: 
‘‘(j) IMPORTATION BY INDIVIDUALS.— 
‘‘(1) IN GENERAL.—Not later than 180 days 
after the enactment of the Pharmaceutical Market 
Access Act of 2006, the Secretary shall by regula-
tion permit an individual to import a drug from a 
permitted country to the United States if the drug 
is— 
‘‘(A) a qualifying drug; 
‘‘(B) imported from a licensed pharmacy 
or qualifying Internet pharmacy; 
‘‘(C) for personal use by an individual, or 
family member of the individual, not for resale; 
‘‘(D) in a quantity that does not exceed a 
90-day supply during any 90-day period; and 
‘‘(E) accompanied by a copy of a prescrip-
tion for the drug, which— 
‘‘(i) is valid under applicable Federal 
and State laws; and 
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‘‘(ii) was issued by a practitioner who 
is authorized to administer prescription 
drugs. 
‘‘(2) DRUGS DISPENSED OUTSIDE THE UNITED 
STATES.—An individual may import a drug from a 
country that is not a permitted country if— 
‘‘(A) the drug was dispensed to the indi-
vidual while the individual was in such country, 
and the drug was dispensed in accordance with 
the laws and regulations of such country; 
‘‘(B) the individual is entering the United 
States and the drug accompanies the individual 
at the time of entry; 
‘‘(C) the drug is approved for commercial 
distribution in the country in which the drug 
was obtained; 
‘‘(D) the drug does not appear to be adul-
terated; and 
‘‘(E) the quantity of the drug does not ex-
ceed a 14-day supply.’’. 
(i) REPEAL OF CERTAIN PROVISIONS.—Section 804 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
384) is amended by striking subsections (l) and (m). 
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SEC. 205. REGISTRATION FEES. 
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 registration fee program under which a reg-
istered exporter under section 804 shall be required to pay 
an annual fee to the Secretary in accordance with this sub-
section. 
‘‘(b) COLLECTION.— 
‘‘(1) COLLECTION ON INITIAL REGISTRATION.— 
A fee under this section shall be payable for the fis-
cal year in which the registered exporter first sub-
mits a registration under section 804 (or reregisters 
under that section if that person has withdrawn its 
registration and subsequently reregisters) in a 
amount of $10,000, due on the date the exporter 
first submits a registration to the Secretary under 
section 804. 
‘‘(2) COLLECTION
IN
SUBSEQUENT
YEARS.— 
After the fee is paid for the first fiscal year, the fee 
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described under this subsection 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 registered exporter for a fis-
cal year in which the fee is payable. 
‘‘(c) FEE AMOUNT.— 
‘‘(1) IN
GENERAL.—Subject to subsection 
(b)(1), 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 Pharmaceutical Market 
Access Act of 2006 in the subsequent fiscal year. 
‘‘(2) LIMITATION.— 
‘‘(A) IN GENERAL.—The aggregate total of 
fees collected under this section shall not exceed 
1 percent of the total price of drugs exported 
annually to the United States by registered ex-
porters under this section. 
‘‘(B) REASONABLE ESTIMATE.—Subject to 
the limitation described in subparagraph (A), a 
fee under this subsection for an exporter shall 
be an amount that is a reasonable estimate by 
the Secretary of the annual share of the ex-
porter of the volume of drugs exported by ex-
porters under this section. 
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‘‘(d) USE OF FEES.—The fees collected under this 
section shall be used for the sole purpose of administering 
this section with respect to registered exporters, including 
the costs associated with— 
‘‘(1) inspecting the facilities of registered ex-
porters, and of other entities in the chain of custody 
of a qualifying drug; 
‘‘(2) developing, implementing, and maintaining 
a system to determine registered exporters’ compli-
ance with the registration conditions the Pharma-
ceutical Market Access Act of 2006, including when 
shipments of qualifying drugs are offered for import 
into the United States; and 
‘‘(3) inspecting such shipments, as necessary, 
when offered for import into the United States to 
determine if any such shipment should be refused 
admission. 
‘‘(e) ANNUAL FEE SETTING.—The Secretary shall 
establish, 60 days before the beginning of each fiscal year 
beginning after September 30, 2006, 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. 
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‘‘(2) FAILURE TO PAY.—If a registered exporter 
subject to a fee under this section fails to pay the 
fee, the Secretary shall not permit the registered ex-
porter to engage in exportation to the United States 
or offering for exportation 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 the beginning of each fiscal year, the 
Secretary shall— 
‘‘(A) publish registration 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 2006, 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-
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mittee on Energy and Commerce of the House of 
Representatives a report that describes— 
‘‘(A) implementation of the registration fee 
authority 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. 206. COUNTERFEIT-RESISTANT TECHNOLOGY. 
(a) MISBRANDING.—Section 502 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352; deeming 
drugs and devices to be misbranded) is amended by adding 
at the end the following: 
‘‘(x) If it is a drug subject to section 503(b), unless 
the packaging of such drug complies with the require-
ments of section 505C for counterfeit-resistant tech-
nologies.’’. 
(b) REQUIREMENTS.—Chapter V of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) 
is amended by inserting after section 505B the following: 
‘‘SEC. 505C. COUNTERFEIT-RESISTANT TECHNOLOGIES. 
‘‘(a) INCORPORATION OF COUNTERFEIT-RESISTANT 
TECHNOLOGIES
INTO
PRESCRIPTION
DRUG
PACK-
AGING.—The Secretary shall require that the packaging 
of any drug subject to section 503(b) incorporate— 
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‘‘(1) overt optically variable counterfeit-resist-
ant technologies that are described in subsection (b) 
and comply with the standards of subsection (c); or 
‘‘(2) technologies that have an equivalent func-
tion of security, as determined by the Secretary. 
‘‘(b) ELIGIBLE TECHNOLOGIES.—Technologies de-
scribed in this subsection— 
‘‘(1) shall be visible to the naked eye, providing 
for visual identification of product authenticity with-
out the need for readers, microscopes, lighting de-
vices, or scanners; 
‘‘(2) shall be similar to that used by the Bureau 
of Engraving and Printing to secure United States 
currency; 
‘‘(3) shall be manufactured and distributed in a 
highly secure, tightly controlled environment; and 
‘‘(4) should incorporate additional layers of 
non-visible covert security features up to and includ-
ing forensic capability. 
‘‘(c) STANDARDS FOR PACKAGING.— 
‘‘(1) MULTIPLE ELEMENTS.—For the purpose 
of making it more difficult to counterfeit the pack-
aging of drugs subject to section 503(b), manufac-
turers of the drugs shall incorporate the technologies 
described in subsection (b) into multiple elements of 
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the physical packaging of the drugs, including blister 
packs, shrink wrap, package labels, package seals, 
bottles, and boxes. 
‘‘(2) LABELING
OF
SHIPPING
CONTAINER.— 
Shipments of drugs described in subsection (a) shall 
include a label on the shipping container that incor-
porates the technologies described in subsection (b), 
so that officials inspecting the packages will be able 
to determine the authenticity of the shipment. Chain 
of custody procedures shall apply to such labels and 
shall include procedures applicable to contractual 
agreements for the use and distribution of the labels, 
methods to audit the use of the labels, and database 
access for the relevant governmental agencies for 
audit or verification of the use and distribution of 
the labels. 
‘‘(d) EFFECTIVE DATE.—This section shall take ef-
fect 180 days after the date of enactment of the Pharma-
ceutical Market Access Act of 2006.’’. 
SEC. 207. PROHIBITED ACTS. 
Section 301 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 331) is amended by inserting after sub-
section (k) the following: 
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