1.Notification,
nondistribution, and recall of adulterated or misbranded drugs
(a)Section 301 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331) is amended by adding at the end the following:
(uu)The failure to
comply with—
(1)the notification
requirement under section 568(a);
(2)an order issued
under paragraph (1) of section 568(c), following a hearing, if requested, under
paragraph (2)(C) of such section;
(3)an order amended under paragraph (2) or
paragraph (3) of section 568(c); or
(4)an emergency order
issued under section
568(d).
.
(b)Nondistribution
and Recall of Adulterated or Misbranded DrugsSubchapter 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:
568.Notification,
nondistribution, and recall of certain adulterated or misbranded drugs
(a)Notification
regarding certain adulterated or misbranded Drugs
(1)Any person required to register under section 510 shall,
as soon as practicable, notify the Secretary of the identity and location of a
drug, if such person has reason to believe—
(A)that such drug,
when introduced into or while in interstate commerce, or while held for sale
(regardless of whether the first sale) after shipment in interstate commerce,
is adulterated or misbranded; and
(B)there is a
reasonable probability that the use or consumption of, or exposure to, the drug
(or an ingredient or component used in any such drug) will cause a threat of
serious adverse health consequences or death to humans or animals.
(2)Notification under
paragraph (1) shall be made in such
manner and by such means as the Secretary may require by regulation or
guidance.
(b)The Secretary may request that any person who distributes
a drug that the Secretary has reason to believe is adulterated, misbranded, or
otherwise in violation of this Act voluntarily—
(1)recall such drug;
and
(2)provide for
notice, including to individuals as appropriate, to persons who may be affected
by the recall.
(c)Order To cease
distribution and recall drug and related procedures
(1)If the Secretary has reason to believe that the use or
consumption of, or exposure to, a drug (or an ingredient or component used in
any such drug) may cause serious adverse health consequences or death to humans
or animals, the Secretary shall have the authority to issue an order requiring
any person who distributes such drug—
(A)to immediately
cease distribution of such drug; and
(B)to provide for
notice, including to individuals as appropriate, to persons who may be affected
by such cessation of distribution.
(2)
(A)Cease
distribution and notificationAny person who is subject to an
order under
paragraph (1) shall immediately cease
distribution of such drug and provide notification as required by such
order.
(B)Any person who is subject to an order under
paragraph (1) may appeal within 24
hours of issuance 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).
(C)Except as provided in
subsection (d), if an appeal made under
subparagraph (B) contains a request
for an informal hearing, such 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 parties jointly agree to an
extension.
(D)After
affording an opportunity for an informal hearing, the Secretary shall
determine—
(i)whether—
(I)the order under
paragraph (1) should be amended to
require a recall of such drug; or
(II)inadequate
grounds exist to support the actions required by the order; or
(ii)that the order
under
paragraph (1) was appropriate as
issued.
(E)Amendment or
vacation of order
(i)In the case of a determination made under
subparagraph (D)(i)(I), the
Secretary shall amend the order made under
paragraph (1) accordingly.
(ii)In the case of a determination made under
subparagraph (D)(i)(II), the
Secretary shall vacate the order made under
paragraph (1).
(3)
(A)Except
as provided under
subsection (d), if after providing an
opportunity for an informal hearing under
paragraph (2)(C), the Secretary
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.
(B)An
amended order under
subparagraph (A) shall—
(i)specify a
timetable in which the recall will occur;
(ii)require periodic
reports to the Secretary describing the progress of the recall; and
(iii)provide for
notice, including to individuals as appropriate, to persons who may be affected
by the recall.
In
providing for such notice, the Secretary may allow for the assistance of health
professionals, State or local officials, or other individuals designated by the
Secretary.(C)An
amended order under this paragraph shall be ordered by the Secretary or an
official designated by the Secretary. An official may not be so designated
unless the official is the director of the district under this Act in which the
drug involved is located, or is an official senior to such director.
(d)
(1)If the Secretary has credible evidence or information
that a drug subject to an order under
subsection (c)(1) 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 individuals as appropriate, to persons who may be affected
by the recall.
(2)
(A)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.
(B)
(i)Any
person who is subject to an emergency recall order under this subsection may
appeal within 24 hours after issuance such order to the Secretary.
(ii)The person subject to an emergency recall order shall
conduct the recall notwithstanding the pendency of any appeal of such
order.
(C)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 an appeal under
subparagraph (B) is filed, unless
the parties jointly agree to an extension.
(D)After
affording an opportunity for an informal hearing, the Secretary shall
determine—
(i)whether—
(I)the order under
paragraph (1) should be amended to
require a recall of such drug; or
(II)inadequate
grounds exist to support the actions required by the order; or
(ii)that the order
under
paragraph (1) was appropriate as
issued.
(E)Amendment or
vacation of order
(i)In the case of a determination made under
subparagraph (D)(i)(I), the
Secretary shall amend the order made under
paragraph (1) accordingly.
(ii)In the case of a determination made under
subparagraph (D)(i)(II), the
Secretary shall vacate the order made under
paragraph (1).
(3)An
order under this subsection shall be issued by the Commissioner of Food and
Drugs, the Principal Deputy Commissioner, or the Associate Commissioner for
Regulatory Affairs of the Food and Drug Administration.
(e)Notice to
Consumers and Health OfficialsThe 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.
(f)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)The amendments made by this section shall take effect one
year period after the date of the enactment of this
Act.