tice in the Federal Register of the intention to 
issue an order temporarily or permanently 
scheduling such drug or substance in schedule 
I of section 202 of the Controlled Substances 
Act, that such article presents an imminent risk 
to the public health; and 
‘‘(2) with respect to which the Attorney General 
has not— 
‘‘(A) scheduled the drug or other substance 
under section 201 of such Act; or 
‘‘(B) notified the Secretary of Health and 
Human Services that the Attorney General has 
made a determination not to schedule the drug 
or other substance under such section.’’. 
(c) INCREASING THE MAXIMUM DOLLAR AMOUNT OF 
DRUGS SUBJECT TO DESTRUCTION.—The sixth sentence 
in section 801(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 381(a)) is amended by striking ‘‘ex-
cept that the Secretary’’ and all that follows through the 
two periods at the end and inserting ‘‘except that the Sec-
retary of Health and Human Services may destroy, with-
out the opportunity for export, any drug refused admission 
under this section, if such drug is valued at an amount 
that is $2,500 or less (or such higher amount as the Sec-
retary of the Treasury may set by regulation pursuant to 
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section 498(a)(1) of the Tariff Act of 1930 or such higher 
amount as the Commissioner of Food and Drugs may set 
based on a finding by the Commissioner that the higher 
amount is in the interest of public health) and was not 
brought into compliance as described under subsection 
(b).’’. 
(d) DESTRUCTION OF ARTICLES OF CONCERN.—The 
sixth sentence of section 801(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381(a)), as amended 
by subsection (c), is further amended by inserting before 
the period at the end the following: ‘‘; and the Secretary 
of Health and Human Services may destroy, without the 
opportunity for export, any article refused admission 
under clause (6) of the third sentence of this subsection.’’. 
(e) TECHNICAL AMENDMENTS.—The seventh, eighth, 
and ninth sentences of section 801(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381(a)) are amend-
ed— 
(1) by striking ‘‘a drug’’ each place it appears 
and inserting ‘‘an article’’; and 
(2) by striking ‘‘the drug’’ each place it appears 
and inserting ‘‘the article’’. 
(f) RULE OF CONSTRUCTION.—The last sentence in 
section 801(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 381(a)) is amended to read as follows: 
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‘‘Clauses (2), (5), and (6) of the third sentence of this 
subsection shall not be construed to prohibit the admission 
of narcotic or nonnarcotic drugs or other substances, the 
importation of which is permitted under the Controlled 
Substances Import and Export Act.’’. 
SEC. 3. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED DRUG 
PRODUCTS. 
(a) PROHIBITED ACTS.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed by adding at the end the following: 
‘‘(eee) The failure to comply with any order issued 
under section 569D.’’. 
(b) NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED DRUGS.—Subchapter 
E of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb et seq.) is amended by adding at 
the end the following: 
‘‘SEC. 569D. NOTIFICATION, NONDISTRIBUTION, AND RE-
CALL OF ADULTERATED OR MISBRANDED 
DRUGS. 
‘‘(a) ORDER TO CEASE DISTRIBUTION.— 
‘‘(1) IN GENERAL.—If the Secretary has reason 
to believe that the use or consumption of, or expo-
sure to, a drug may cause serious adverse health 
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consequences or death to humans, the Secretary may 
issue an order requiring any person who distributes 
such drug to immediately cease distribution of such 
drug. 
‘‘(2) ACTION FOLLOWING ORDER.—Any person 
who is subject to an order under paragraph (1) shall 
immediately cease distribution of such drug and pro-
vide notification as required by such order, and may 
appeal to the Secretary within 24 hours of the 
issuance of such order. Such appeal may include a 
request for an informal hearing and a description of 
any efforts to recall such drug undertaken volun-
tarily by the person, including after a request under 
subsection (b). Except as provided in subsection (c), 
an informal hearing shall be held as soon as prac-
ticable, but not later than 5 calendar days, or less 
as determined by the Secretary, after such an appeal 
is filed, unless the parties jointly agree to an exten-
sion. After affording an opportunity for an informal 
hearing, the Secretary shall determine whether the 
order should be amended to require a recall of such 
drug. If, after providing an opportunity for such a 
hearing, the Secretary determines that inadequate 
grounds exist to support the actions required by the 
order, the Secretary shall vacate the order. 
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‘‘(b) EMERGENCY RECALL ORDER.— 
‘‘(1) IN GENERAL.—If the Secretary has cred-
ible evidence or information that a drug subject to 
an order under subsection (a) presents an imminent 
threat of serious adverse health consequences or 
death to humans, the Secretary may issue an order 
requiring any person who distributes such drug— 
‘‘(A) to immediately recall such drug; and 
‘‘(B) to provide for notice, including to in-
dividuals as appropriate, to persons who may be 
affected by the recall. 
‘‘(2) ACTION FOLLOWING ORDER.—Any person 
who is subject to an emergency recall order under 
this subsection shall immediately recall such drug 
and provide notification as required by such order, 
and may appeal to the Secretary within 24 hours 
after issuance of such order. The person subject to 
an emergency recall order shall conduct the recall 
notwithstanding the pendency of any such appeal. 
An informal hearing shall be held as soon as prac-
ticable but not later than 5 calendar days, or less as 
determined by the Secretary, after such an appeal is 
filed, unless the parties jointly agree to an extension. 
After affording an opportunity for an informal hear-
ing, the Secretary shall determine whether the order 
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should be amended pursuant to subsection (d)(1). If, 
after providing an opportunity for such a hearing, 
the Secretary determines that inadequate grounds 
exist to support the actions required by the order, 
the Secretary shall vacate the order. 
‘‘(c) NOTICE TO CONSUMERS AND HEALTH OFFI-
CIALS.—The Secretary shall, as the Secretary determines 
to be necessary, provide notice of a recall order under this 
section to— 
‘‘(1) consumers to whom the drug was, or may 
have been, distributed; and 
‘‘(2) appropriate State and local health officials. 
‘‘(d) ORDER TO RECALL.— 
‘‘(1) AMENDMENT.—Except as provided under 
subsection (e), if after providing an opportunity for 
an informal hearing under subsection (a) or (b), the 
Secretary determines that an order issued under 
subsection (a) or (b) should be amended to include 
a recall of the drug with respect to which the order 
was issued, the Secretary shall amend the order to 
require a recall. 
‘‘(2) CONTENTS.—An amended order under 
paragraph (1) shall— 
‘‘(A) specify a timetable in which the recall 
will occur; 
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‘‘(B) require periodic reports to the Sec-
retary describing the progress of the recall; and 
‘‘(C) provide for notice, including to indi-
viduals as appropriate, to persons who may be 
affected by the recall. 
‘‘(3) ASSISTANCE ALLOWED.—In providing for 
notice under paragraph (2)(C), the Secretary may 
allow for the assistance of health professionals, State 
or local officials, or other individuals designated by 
the Secretary. 
‘‘(4) NONDELEGATION.—An amended order 
under this subsection shall be ordered by the Sec-
retary or an official designated by the Secretary. An 
official may not be so designated under this section 
unless the official is the director of the district in 
which the drug involved is located, or is an official 
senior to such director. 
‘‘(e) SAVINGS CLAUSE.—Nothing contained in this 
section shall be construed as limiting— 
‘‘(1) the authority of the Secretary to issue an 
order to cease distribution of, or to recall, an drug 
under any other provision of this Act or the Public 
Health Service Act; or 
‘‘(2) the ability of the Secretary to request any 
person to perform a voluntary activity related to any 
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drug subject to this Act or the Public Health Service 
Act.’’. 
(c) DRUGS SUBJECT TO REFUSAL.—The third sen-
tence of subsection (a) of section 801 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381), as amended by 
section 2(b)(C), is further amended by inserting ‘‘or (8) 
in the case of a drug, such drug is subject to an order 
under section 568 to cease distribution of or recall the 
drug,’’ before ‘‘then such article shall be refused admis-
sion’’. 
(d) APPLICATION.—Sections 301(eee) and 569D of 
the Federal Food, Drug, and Cosmetic Act, as added by 
subsections (a) and (b), shall apply with respect to a drug 
as of such date, not later than 1 year after the date of 
the enactment of this Act, as the Secretary of Health and 
Human Services shall specify. 
SEC. 4. SEIZURE. 
Section 304(b) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 334(b)) is amended by striking the 
first sentence and inserting the following: ‘‘The article, 
equipment, or other thing proceeded against shall be liable 
to seizure by process pursuant to the libel, and the proce-
dure in cases under this section shall conform, as nearly 
as may be, to the procedure in admiralty rather than the 
procedure used for civil asset forfeiture proceedings set 
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forth in section 983 of title 18, United States Code. On 
demand of either party any issue of fact joined in any such 
a case brought under this section shall be tried by jury. 
A seizure brought under this section is not governed by 
Rule G of the Supplemental Rules of Admiralty or Mari-
time Claims and Asset Forfeiture Actions. Exigent cir-
cumstances shall be deemed to exist for all seizures 
brought under this section, and in such cases, the sum-
mons and arrest warrant shall be issued by the clerk of 
the court without court review.’’. 
SEC. 5. SINGLE SOURCE PATTERN OF SHIPMENTS OF ADUL-
TERATED OR MISBRANDED DRUGS. 
Section 801 of the Federal Food, Drug, and Cosmetic 
Act is amended by adding at the end the following: 
‘‘(u) SINGLE SOURCE PATTERN OF SHIPMENTS OF 
ADULTERATED
OR MISBRANDED DRUGS.—If the Sec-
retary identifies a pattern of adulterated or misbranded 
drugs being offered for import from the same manufac-
turer, distributor, or importer, the Secretary may by order 
choose to treat all drugs being offered for import from 
such manufacturer, distributor, or importer as adulterated 
or misbranded unless otherwise demonstrated.’’. 
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SEC. 6. DEBARRING VIOLATIVE INDIVIDUALS OR COMPA-
NIES. 
(a) PROHIBITED ACT.—Section 301(cc) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 331(cc)) 
is amended to read as follows: 
‘‘(cc) The importing or offering for import into the 
United States of an article by, with the assistance of, or 
at the direction of, a person debarred from such activity 
under section 306(b)(3).’’. 
(b) DEBARMENT.—Section 306(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)) is 
amended— 
(1) in paragraph (1)— 
(A) in the matter preceding subparagraph 
(A), by striking ‘‘paragraph (2)’’ and inserting 
‘‘paragraph (2) or (3)’’; 
(B) in subparagraph (B), by striking ‘‘or’’ 
at the end; 
(C) in subparagraph (C), by striking the 
period at the end and inserting ‘‘, or’’; and 
(D) by adding at the end the following: 
‘‘(D) a person from importing or offering 
to import into the United States— 
‘‘(i) a controlled substance as defined 
in section 102(6) of the Controlled Sub-
stances Act; or 
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‘‘(ii) any article that is regulated by 
the Food and Drug Administration that is 
valued at $2500 or less (or such higher 
amount as the Secretary of the Treasury 
may set by regulation pursuant to section 
498(a)(1) of the Tariff Act of 1930).’’; and 
(2) by striking paragraph (3) and inserting the 
following: 
‘‘(3) PERSONS
SUBJECT
TO
PERMISSIVE
DE-
BARMENT; IMPORTATION.— 
‘‘(A) FOOD.—A person is subject to debar-
ment under paragraph (1)(C) if— 
‘‘(i) the person has been convicted of 
a felony for conduct relating to the impor-
tation into the United States of any food; 
or 
‘‘(ii) the person has engaged in a pat-
tern of importing or offering for import 
adulterated food that presents a threat of 
serious adverse health consequences or 
death to humans or animals. 
‘‘(B) IMPORTATION OF DRUGS.—A person 
is subject to debarment under paragraph (1)(D) 
if— 
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