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. 
‘‘(8) 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 
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.’’. 
(b) REGULATIONS.—The Federal Trade Commission 
shall promulgate regulations to carry out the enforcement 
program under section 804(l) of the Federal Food, Drug, 
and Cosmetic Act (as added by subsection (a)).
(c) SUSPENSION
AND TERMINATION
OF EXPORT-
ERS.—Section 804(g) of the Federal Food, Drug, and 
Cosmetic Act (as amended by section 4(g)) (21 U.S.C. 
384(g)) is amended by—
(1) striking ‘‘SUSPENSION OF IMPORTATION.—
The Secretary’’ and inserting 
‘‘SUSPENSION OF IMPORTATION.—
‘‘(1) IN GENERAL.—The Secretary’’; and 
(2) adding at the end the following: 
‘‘(2) SUSPENSION AND TERMINATION OF EX-
PORTERS.—
‘‘(A) SUSPENSION.—With respect to the 
effectiveness of a registration submitted under 
subsection (f) by a registered exporter: 
‘‘(i) Subject to clause (ii), if the Sec-
retary determines, after notice and oppor-
tunity for a hearing, that the registered ex-
porter has failed to maintain substantial 
compliance with all registration conditions, 
the Secretary may suspend the registra-
tion. 
‘‘(ii) If the Secretary determines that, 
under color of the registration, the reg-
istered exporter has exported a drug that 
is not a qualifying drug, or a drug that
does not meet the criteria under this sec-
tion, or has exported a qualifying drug to 
an individual in violation of this section, 
the Secretary shall immediately suspend 
the registration. A suspension under the 
preceding sentence is not subject to the 
provision by the Secretary of prior notice, 
and the Secretary shall provide to the reg-
istered exporter involved an opportunity 
for a hearing not later than 10 days after 
the date on which the registration is sus-
pended. 
‘‘(iii) The Secretary may reinstate the 
registration, whether suspended under 
clause (i) or (ii), if the Secretary deter-
mines that the registered exporter has 
demonstrated that further violations of 
registration conditions will not occur. 
‘‘(B) TERMINATION.—The Secretary, after 
notice and opportunity for a hearing, may ter-
minate the registration under subsection (f) of 
a registered exporter if the Secretary deter-
mines that the registered exporter has engaged 
in a pattern or practice of violating 1 or more 
registration conditions, or if on 1 or more occa-
sions the Secretary has under subparagraph 
(A)(ii) suspended the registration of the reg-
istered exporter. The Secretary may make the 
termination permanent, or for a fixed period of 
not less than 1 year. During the period in 
which the registration of a registered exporter 
is terminated, any registration submitted under 
subsection (f) by such exporter or a person who 
is a partner in the export enterprise or a prin-
cipal officer in such enterprise, and any reg-
istration prepared with the assistance of such 
exporter or such a person, has no legal effect 
under this section.’’. 
SEC. 10. AUTHORIZATION OF APPROPRIATIONS. 
There are authorized to be appropriated such sums 
as may be necessary to carry out this Act (and the amend-
ments made by this Act).
Æ