117 STAT. 1688
PUBLIC LAW 108–136—NOV. 24, 2003 chooses to act under this clause, an authorization under this section regarding the emergency use shall, to the extent practicable given the circumstances of the emergency, authorize such person to provide appropriate information with respect to such product in addition to the labeling provided by the manufacturer, subject to compliance with clause (i). While the authorization under this section is effective, such additional information shall not be considered labeling for purposes of section 502. ‘‘(C) The Secretary may establish with respect to the distribution and administration of the product for the unapproved use conditions no more restrictive than those established by the Secretary with respect to the distribution and administration of the product for the approved use. ‘‘(3) GOOD MANUFACTURING PRACTICE.—With respect to the emergency use of a product for which an authorization under this section is issued (whether an unapproved product or an unapproved use of an approved product), the Secretary may waive or limit, to the extent appropriate given the circumstances of the emergency, requirements regarding current good manufacturing practice otherwise applicable to the manufacture, processing, packing, or holding of products subject to regulation under this Act, including such requirements established under section 501. ‘‘(4) ADVERTISING.—The Secretary may establish conditions on advertisements and other promotional descriptive printed matter that relate to the emergency use of a product for which an authorization under this section is issued (whether an unapproved product or an unapproved use of an approved product), including, as appropriate— ‘‘(A) with respect to drugs and biological products, requirements applicable to prescription drugs pursuant to section 502(n); or ‘‘(B) with respect to devices, requirements applicable to restricted devices pursuant to section 502(r). ‘‘(f) DURATION OF AUTHORIZATION.— ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), an authorization under this section shall be effective until the earlier of the termination of the declaration under subsection (b) or a revocation under subsection (g). ‘‘(2) CONTINUED USE AFTER END OF EFFECTIVE PERIOD.— Notwithstanding the termination of the declaration under subsection (b) or a revocation under subsection (g), an authorization shall continue to be effective to provide for continued use of an unapproved product with respect to a patient to whom it was administered during the period described by paragraph (1), to the extent found necessary by such patient’s attending physician. ‘‘(g) REVOCATION OF AUTHORIZATION.— ‘‘(1) REVIEW.—The Secretary shall periodically review the circumstances and the appropriateness of an authorization under this section. ‘‘(2) REVOCATION.—The Secretary may revoke an authorization under this section if the criteria under subsection (c) for issuance of such authorization are no longer met or other circumstances make such revocation appropriate to protect the public health or safety.
VerDate 11-MAY-2000
10:15 Aug 27, 2004
Jkt 019194
PO 00000
Frm 00640
Fmt 6580
Sfmt 6581
D:\STATUTES\2003\19194PT2.001
APPS10
PsN: 19194PT2
�
