135 
‘‘(B) in the case of an exporter, at the fa-
cility from which the exporter ships the quali-
fying drug to the United States. 
‘‘(k) DRUG RECALLS.— 
‘‘(1) MANUFACTURERS.—A person that manu-
factures a qualifying drug imported from a per-
mitted country under this section shall promptly in-
form the Secretary— 
‘‘(A) if the drug is recalled or withdrawn 
from the market in a permitted country; 
‘‘(B) how the drug may be identified, in-
cluding lot number; and 
‘‘(C) the reason for the recall or with-
drawal. 
‘‘(2) SECRETARY.—With respect to each per-
mitted country, the Secretary shall— 
‘‘(A) enter into an agreement with the gov-
ernment of the country to receive information 
about recalls and withdrawals of qualifying 
drugs in the country; or 
‘‘(B) monitor recalls and withdrawals of 
qualifying drugs in the country using any infor-
mation that is available to the public in any 
media.
136 
‘‘(3) NOTICE.—The Secretary may notify, as 
appropriate, registered exporters, registered import-
ers, wholesalers, pharmacies, or the public of a recall 
or withdrawal of a qualifying drug in a permitted 
country. 
‘‘(l) DRUG LABELING.—When a qualifying drug that 
is imported into the United States by an importer under 
subsection (a) is dispensed by a pharmacist to an indi-
vidual, the pharmacist shall provide that the packaging 
and labeling of the drug complies with all applicable regu-
lations promulgated under sections 3 and 4 of the Poison 
Prevention Packaging Act of 1970 (15 U.S.C. 1471 et 
seq.) and include with any other labeling provided to the 
individual the following: 
‘‘(1) The lot number assigned by the manufac-
turer. 
‘‘(2) The name and registration number of the 
importer. 
‘‘(3) If the inactive ingredients of the drug are 
different from the inactive ingredients for the U.S. 
label drug— 
‘‘(A) a prominent advisory that persons 
with allergies should check the ingredient list of 
the drug because the ingredients of the drug
137 
differ from the ingredients of the U.S. label 
drug; and 
‘‘(B) a list of the ingredients of the drug 
as would be required under section 502(e). 
‘‘(4) 
If 
required 
under 
paragraph 
(2)(B)(vi)(III) of subsection (g), a prominent advi-
sory that the drug is safe and effective but not bio-
equivalent to the U.S. label drug. 
‘‘(m) 
CHARITABLE
CONTRIBUTIONS.—Notwith-
standing any other provision of this section, this section 
does not authorize the importation into the United States 
of a qualifying drug donated or otherwise supplied for free 
or at nominal cost by the manufacturer of the drug to 
a charitable or humanitarian organization, including the 
United Nations and affiliates, or to a government of a for-
eign country. 
‘‘(n) UNFAIR AND DISCRIMINATORY ACTS AND PRAC-
TICES.— 
‘‘(1) IN GENERAL.—It is unlawful for a manu-
facturer, directly or indirectly (including by being a 
party to a licensing agreement or other agreement), 
to— 
‘‘(A) discriminate by charging a higher 
price for a prescription drug sold to a registered 
exporter or other person in a permitted country
138 
that exports a qualifying drug to the United 
States under this section than the price that is 
charged, inclusive of rebates or other incentives 
to the permitted country or other person, to an-
other person that is in the same country and 
that does not export a qualifying drug into the 
United States under this section; 
‘‘(B) discriminate by charging a higher 
price for a prescription drug sold to a registered 
importer or other person that distributes, sells, 
or uses a qualifying drug imported into the 
United States under this section than the price 
that is charged to another person in the United 
States that does not import a qualifying drug 
under this section, or that does not distribute, 
sell, or use such a drug; 
‘‘(C) discriminate by denying, restricting, 
or delaying supplies of a prescription drug to a 
registered exporter or other person in a per-
mitted country that exports a qualifying drug to 
the United States under this section or to a 
registered importer or other person that distrib-
utes, sells, or uses a qualifying drug imported 
into the United States under this section;
139 
‘‘(D) discriminate by publicly, privately, or 
otherwise refusing to do business with a reg-
istered exporter or other person in a permitted 
country that exports a qualifying drug to the 
United States under this section or with a reg-
istered importer or other person that distrib-
utes, sells, or uses a qualifying drug imported 
into the United States under this section; 
‘‘(E) knowingly fail to submit a notice 
under subsection (g)(2)(B)(i), knowingly fail to 
submit such a notice on or before the date spec-
ified in subsection (g)(2)(B)(v) or as otherwise 
required under subsection (e) (3), (4), and (5) 
of section 4 of the Pharmaceutical Market Ac-
cess and Drug Safety Act of 2005, knowingly 
submit such a notice that makes a materially 
false, fictitious, or fraudulent statement, or 
knowingly fail to provide promptly any informa-
tion requested by the Secretary to review such 
a notice; 
‘‘(F) knowingly fail to submit an applica-
tion required under subsection (g)(2)(F), know-
ingly fail to submit such an application on or 
before 
the 
date 
specified 
in 
subsection 
(g)(2)(F)(ii), knowingly submit such an applica-
140 
tion that makes a materially false, fictitious, or 
fraudulent statement, or knowingly fail to pro-
vide promptly any information requested by the 
Secretary to review such an application; 
‘‘(G) cause there to be a difference (includ-
ing a difference in active ingredient, route of 
administration, dosage form, strength, formula-
tion, manufacturing establishment, manufac-
turing process, or person that manufactures the 
drug) between a prescription drug for distribu-
tion in the United States and the drug for dis-
tribution in a permitted country; 
‘‘(H) refuse to allow an inspection author-
ized under this section of an establishment that 
manufactures a qualifying drug that is, or will 
be, introduced for commercial distribution in a 
permitted country; 
‘‘(I) fail to conform to the methods used 
in, or the facilities used for, the manufacturing, 
processing, packing, or holding of a qualifying 
drug that is, or will be, introduced for commer-
cial distribution in a permitted country to good 
manufacturing practice under this Act; 
‘‘(J) become a party to a licensing agree-
ment or other agreement related to a qualifying
141 
drug that fails to provide for compliance with 
all requirements of this section with respect to 
such drug; 
‘‘(K) enter into a contract that restricts, 
prohibits, or delays the importation of a quali-
fying drug under this section; 
‘‘(L) engage in any other action to restrict, 
prohibit, or delay the importation of a quali-
fying drug under this section; or 
‘‘(M) engage in any other action that the 
Federal Trade Commission determines to dis-
criminate against a person that engages or at-
tempts to engage in the importation of a quali-
fying drug under this section. 
‘‘(2) AFFIRMATIVE DEFENSE.— 
‘‘(A) DISCRIMINATION.—It shall be an af-
firmative defense to a charge that a manufac-
turer has discriminated under subparagraph 
(A), (B), (C), (D), or (M) of paragraph (1) that 
the higher price charged for a prescription drug 
sold to a person, the denial, restriction, or delay 
of supplies of a prescription drug to a person, 
the refusal to do business with a person, or 
other discriminatory activity against a person, 
is not based, in whole or in part, on—
142 
‘‘(i) the person exporting or importing 
a qualifying drug into the United States 
under this section; or 
‘‘(ii) the person distributing, selling, 
or using a qualifying drug imported into 
the United States under this section. 
‘‘(B) DRUG DIFFERENCES.—It shall be an 
affirmative defense to a charge that a manufac-
turer has caused there to be a difference de-
scribed in subparagraph (G) of paragraph (1) 
that— 
‘‘(i) the difference was required by the 
country in which the drug is distributed; 
‘‘(ii) the Secretary has determined 
that the difference was necessary to im-
prove the safety or effectiveness of the 
drug; 
‘‘(iii) the person manufacturing the 
drug for distribution in the United States 
has given notice to the Secretary under 
subsection (g)(2)(B)(i) that the drug for 
distribution in the United States is not dif-
ferent from a drug for distribution in per-
mitted countries whose combined popu-
lation represents at least 50 percent of the
143 
total population of all permitted countries; 
or 
‘‘(iv) the difference was not caused, in 
whole or in part, for the purpose of re-
stricting importation of the drug into the 
United States under this section. 
‘‘(3) EFFECT OF SUBSECTION.— 
‘‘(A) SALES IN OTHER COUNTRIES.—This 
subsection applies only to the sale or distribu-
tion of a prescription drug in a country if the 
manufacturer of the drug chooses to sell or dis-
tribute the drug in the country. Nothing in this 
subsection shall be construed to compel the 
manufacturer of a drug to distribute or sell the 
drug in a country. 
‘‘(B) DISCOUNTS TO INSURERS, HEALTH 
PLANS, PHARMACY
BENEFIT
MANAGERS, AND 
COVERED
ENTITIES.—Nothing in this sub-
section shall be construed to— 
‘‘(i) prevent or restrict a manufac-
turer of a prescription drug from providing 
discounts to an insurer, health plan, phar-
macy benefit manager in the United 
States, or covered entity in the drug dis-
count program under section 340B of the
144 
Public Health Service Act (42 U.S.C. 
256b) in return for inclusion of the drug 
on a formulary; 
‘‘(ii) require that such discounts be 
made available to other purchasers of the 
prescription drug; or 
‘‘(iii) prevent or restrict any other 
measures taken by an insurer, health plan, 
or pharmacy benefit manager to encourage 
consumption of such prescription drug. 
‘‘(C) 
CHARITABLE
CONTRIBUTIONS.— 
Nothing in this subsection shall be construed 
to— 
‘‘(i) prevent a manufacturer from do-
nating a prescription drug, or supplying a 
prescription drug at nominal cost, to a 
charitable or humanitarian organization, 
including the United Nations and affili-
ates, or to a government of a foreign coun-
try; or 
‘‘(ii) apply to such donations or sup-
plying of a prescription drug. 
‘‘(4) ENFORCEMENT.— 
‘‘(A) UNFAIR OR DECEPTIVE ACT OR PRAC-
TICE.—A violation of this subsection shall be
145 
treated as a violation of a rule defining an un-
fair or deceptive act or practice prescribed 
under section 18(a)(1)(B) of the Federal Trade 
Commission Act (15 U.S.C. 57a(a)(1)(B)). 
‘‘(B) ACTIONS BY THE COMMISSION.—The 
Federal Trade Commission— 
‘‘(i) shall enforce this subsection in 
the same manner, by the same means, and 
with the same jurisdiction, powers, and du-
ties as though all applicable terms and pro-
visions of the Federal Trade Commission 
Act (15 U.S.C. 41 et seq.) were incor-
porated into and made a part of this sec-
tion; and 
‘‘(ii) may seek monetary relief three-
fold the damages sustained, in addition to 
any other remedy available to the Federal 
Trade Commission under the Federal 
Trade Commission Act (15 U.S.C. 41 et 
seq.). 
‘‘(5) ACTIONS BY STATES.— 
‘‘(A) IN GENERAL.— 
‘‘(i) CIVIL ACTIONS.—In any case in 
which the attorney general of a State has 
reason to believe that an interest of the
146 
residents of that State have been adversely 
affected by any manufacturer that violates 
paragraph (1), the attorney general of a 
State may bring a civil action on behalf of 
the residents of the State, and persons 
doing business in the State, in a district 
court of the United States of appropriate 
jurisdiction to— 
‘‘(I) enjoin that practice; 
‘‘(II) enforce compliance with 
this subsection; 
‘‘(III) obtain damages, restitu-
tion, or other compensation on behalf 
of residents of the State and persons 
doing business in the State, including 
threefold the damages; or 
‘‘(IV) obtain such other relief as 
the court may consider to be appro-
priate. 
‘‘(ii) NOTICE.— 
‘‘(I) IN GENERAL.—Before filing 
an action under clause (i), the attor-
ney general of the State involved shall 
provide to the Federal Trade Commis-
sion—
147 
‘‘(aa) written notice of that 
action; and 
‘‘(bb) a copy of the com-
plaint for that action. 
‘‘(II) 
EXEMPTION.—Subclause 
(I) shall not apply with respect to the 
filing of an action by an attorney gen-
eral of a State under this paragraph, 
if the attorney general determines 
that it is not feasible to provide the 
notice described in that subclause be-
fore filing of the action. In such case, 
the attorney general of a State shall 
provide notice and a copy of the com-
plaint to the Federal Trade Commis-
sion at the same time as the attorney 
general files the action. 
‘‘(B) INTERVENTION.— 
‘‘(i) IN GENERAL.—On receiving no-
tice under subparagraph (A)(ii), the Fed-
eral Trade Commission shall have the right 
to intervene in the action that is the sub-
ject of the notice. 
‘‘(ii) EFFECT OF INTERVENTION.—If 
the Federal Trade Commission intervenes
148 
in an action under subparagraph (A), it 
shall have the right— 
‘‘(I) to be heard with respect to 
any matter that arises in that action; 
and 
‘‘(II) to file a petition for appeal. 
‘‘(C) CONSTRUCTION.—For purposes of 
bringing any civil action under subparagraph 
(A), nothing in this subsection shall be con-
strued to prevent an attorney general of a State 
from exercising the powers conferred on the at-
torney general by the laws of that State to— 
‘‘(i) conduct investigations; 
‘‘(ii) administer oaths or affirmations; 
or 
‘‘(iii) compel the attendance of wit-
nesses or the production of documentary 
and other evidence. 
‘‘(D) ACTIONS BY THE COMMISSION.—In 
any case in which an action is instituted by or 
on behalf of the Federal Trade Commission for 
a violation of paragraph (1), a State may not, 
during the pendency of that action, institute an 
action under subparagraph (A) for the same
149 
violation against any defendant named in the 
complaint in that action. 
‘‘(E) VENUE.—Any action brought under 
subparagraph (A) may be brought in the dis-
trict court of the United States that meets ap-
plicable requirements relating to venue under 
section 1391 of title 28, United States Code. 
‘‘(F) SERVICE OF PROCESS.—In an action 
brought under subparagraph (A), process may 
be served in any district in which the defend-
ant— 
‘‘(i) is an inhabitant; or 
‘‘(ii) may be found. 
‘‘(G) MEASUREMENT
OF
DAMAGES.—In 
any action under this paragraph to enforce a 
cause of action under this subsection in which 
there has been a determination that a defend-
ant has violated a provision of this subsection, 
damages may be proved and assessed in the ag-
gregate by statistical or sampling methods, by 
the computation of illegal overcharges or by 
such other reasonable system of estimating ag-
gregate damages as the court in its discretion 
may permit without the necessity of separately 
proving the individual claim of, or amount of
150 
damage to, persons on whose behalf the suit 
was brought. 
‘‘(H) EXCLUSION
ON
DUPLICATIVE
RE-
LIEF.—The district court shall exclude from the 
amount of monetary relief awarded in an action 
under this paragraph brought by the attorney 
general of a State any amount of monetary re-
lief which duplicates amounts which have been 
awarded for the same injury. 
‘‘(6) EFFECT ON ANTITRUST LAWS.—Nothing 
in this subsection shall be construed to modify, im-
pair, or supersede the operation of the antitrust 
laws. For the purpose of this subsection, the term 
‘antitrust laws’ has the meaning given it in the first 
section of the Clayton Act, except that it includes 
section 5 of the Federal Trade Commission Act to 
the extent that such section 5 applies to unfair 
methods of competition. 
‘‘(7) MANUFACTURER.—In this subsection, the 
term ‘manufacturer’ means any entity, including any 
affiliate or licensee of that entity, that is engaged 
in— 
‘‘(A) the production, preparation, propaga-
tion, compounding, conversion, or processing of 
a prescription drug, either directly or indirectly
151 
by extraction from substances of natural origin, 
or independently by means of chemical syn-
thesis, or by a combination of extraction and 
chemical synthesis; or 
‘‘(B) the packaging, repackaging, labeling, 
relabeling, or distribution of a prescription 
drug.’’. 
(2) PROHIBITED
ACTS.—The Federal Food, 
Drug, and Cosmetic Act is amended— 
(A) in section 301 (21 U.S.C. 331), by 
striking paragraph (aa) and inserting the fol-
lowing: 
‘‘(aa)(1) The sale or trade by a pharmacist, or by 
a business organization of which the pharmacist is a part, 
of a qualifying drug that under section 804(a)(2)(A) was 
imported by the pharmacist, other than— 
‘‘(A) a sale at retail made pursuant to dis-
pensing the drug to a customer of the pharmacist or 
organization; or 
‘‘(B) a sale or trade of the drug to a pharmacy 
or a wholesaler registered to import drugs under sec-
tion 804. 
‘‘(2) The sale or trade by an individual of a qualifying 
drug that under section 804(a)(2)(B) was imported by the 
individual.
152 
‘‘(3) The making of a materially false, fictitious, or 
fraudulent statement or representation, or a material 
omission, in a notice under clause (i) of section 
804(g)(2)(B) or in an application required under section 
804(g)(2)(F), or the failure to submit such a notice or 
application. 
‘‘(4) The importation of a drug in violation of a reg-
istration condition or other requirement under section 
804, the falsification of any record required to be main-
tained, or provided to the Secretary, under such section, 
or the violation of any registration condition or other re-
quirement under such section.’’; and 
(B) in section 303(a) (21 U.S.C. 333(a)), 
by striking paragraph (6) and inserting the fol-
lowing: 
‘‘(6) Notwithstanding subsection (a), any person that 
knowingly violates section 301(i) (2) or (3) or section 
301(aa)(4) shall be imprisoned not more than 10 years, 
or fined in accordance with title 18, United States Code, 
or both.’’. 
(3) AMENDMENT OF CERTAIN PROVISIONS.— 
(A) IN GENERAL.—Section 801 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
381) is amended by striking subsection (g) and 
inserting the following: