‘‘(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 
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 
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; 
‘‘(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-
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 
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-