‘‘(1) IN GENERAL.—A person required, with re-
spect to drugs, to register under section 510, 801(r), 
or 801(s) that has reason to believe that— 
‘‘(A) a drug when introduced into or while 
in interstate commerce, or while held for sale 
(regardless of whether the first sale) after ship-
ment in interstate commerce, is adulterated or 
misbranded, and 
‘‘(B) as a result, the use or consumption 
of, or exposure to, the drug (or an ingredient 
or component used in any such drug) may re-
sult in illness or injury to humans or animals, 
shall, as soon as practicable, notify the Secretary of 
the identity and location of the drug. 
‘‘(2) MANNER OF NOTIFICATION.—Notification 
under paragraph (1) shall be made in such manner 
and by such means as the Secretary may require by 
regulation. 
‘‘(b) VOLUNTARY RECALL.—The Secretary may re-
quest that any person who distributes a drug that the Sec-
retary has reason to believe is adulterated, misbranded, 
or otherwise in violation of this Act voluntarily— 
‘‘(1) recall such drug; and 
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‘‘(2) provide for notice, including to individuals 
as appropriate, to persons who may be affected by 
the recall. 
‘‘(c) ORDER TO CEASE DISTRIBUTION.—If the Sec-
retary has reason to believe that the use or consumption 
of, or exposure to, a drug may result in illness or injury 
to humans or animals, the Secretary shall have the author-
ity to issue an order requiring any person who distributes 
such drug to immediately cease distribution of such drug. 
‘‘(d) ACTION FOLLOWING ORDER.—Any person who 
is subject to an order under subsection (c) shall imme-
diately cease distribution of such drug and provide notifi-
cation as required by such order, and may appeal within 
24 hours of issuance of such order to the Secretary. Such 
appeal may include a request for an informal hearing and 
a description of any efforts to recall such drug undertaken 
voluntarily by the person, including after a request under 
subsection (b). Except as provided in subsection (f), an 
informal hearing shall be held as soon as practicable, but 
not later than 5 calendar days, or less as determined by 
the Secretary, after such an appeal is filed, unless the par-
ties jointly agree to an extension. After affording an op-
portunity for an informal hearing, the Secretary shall de-
termine whether the order should be amended to require 
a recall of such drug. If, after providing an opportunity 
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for such a hearing, the Secretary determines that inad-
equate grounds exist to support the actions required by 
the order, the Secretary shall vacate the order. 
‘‘(e) ORDER TO RECALL.— 
‘‘(1) AMENDMENT.—Except as provided under 
subsection (f), if after providing an opportunity for 
an informal hearing under subsection (d), the Sec-
retary determines that the order 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; 
‘‘(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. In providing for such no-
tice, the Secretary may allow for the assistance 
of health professionals, State or local officials, 
or other individuals designated by the Sec-
retary. 
‘‘(f) EMERGENCY RECALL ORDER.— 
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‘‘(1) IN GENERAL.—If the Secretary has cred-
ible evidence or information that a drug subject to 
an order under subsection (c) presents an imminent 
threat of serious adverse health consequences or 
death to humans or animals, 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 within 24 hours after issuance such 
order to the Secretary. The person subject to an 
emergency recall order shall conduct the recall not-
withstanding the pendency of any such appeal. An 
informal hearing shall be held as soon as practicable 
but not later than 5 calendar days, or less as deter-
mined 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 (e)(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. 
‘‘(g) 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 consumers to whom the drug was, or may have 
been, distributed and to appropriate State and local health 
officials. 
‘‘(h) 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, a 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 
drug subject to this Act or the Public Health Service 
Act.’’. 
(c) ARTICLES SUBJECT
TO REFUSAL.—The third 
sentence of subsection (a) of section 801 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amend-
ed by inserting ‘‘or (4) in the case of a drug, such article 
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