118 STAT. 856 PUBLIC LAW 108–276—JULY 21, 2004 ‘‘(B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product; ‘‘(3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition; and ‘‘(4) that such other criteria as the Secretary may by regula tion prescribe are satisfied. ‘‘(d) SCOPE OF AUTHORIZATION.—An authorization of a product under this section shall state— ‘‘(1) each disease or condition that the product may be used to diagnose, prevent, or treat within the scope of the authorization; ‘‘(2) the Secretary’s conclusions, made under subsection (c)(2)(B), that the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condi tion, outweigh the known and potential risks of the product; and ‘‘(3) the Secretary’s conclusions, made under subsection (c), concerning the safety and potential effectiveness of the product in diagnosing, preventing, or treating such diseases or conditions, including an assessment of the available scientific evidence. ‘‘(e) CONDITIONS OF AUTHORIZATION.— ‘‘(1) UNAPPROVED PRODUCT.— ‘‘(A) REQUIRED CONDITIONS.—With respect to the emer gency use of an unapproved product, the Secretary, to the extent practicable given the circumstances of the emer gency, shall, for a person who carries out any activity for which the authorization is issued, establish such condi tions on an authorization under this section as the Sec retary finds necessary or appropriate to protect the public health, including the following: ‘‘(i) Appropriate conditions designed to ensure that health care professionals administering the product are informed— ‘‘(I) that the Secretary has authorized the emergency use of the product; ‘‘(II) of the significant known and potential benefits and risks of the emergency use of the product, and of the extent to which such benefits and risks are unknown; and ‘‘(III) of the alternatives to the product that are available, and of their benefits and risks. ‘‘(ii) Appropriate conditions designed to ensure that individuals to whom the product is administered are informed— ‘‘(I) that the Secretary has authorized the emergency use of the product; ‘‘(II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and ‘‘(III) of the option to accept or refuse adminis tration of the product, of the consequences, if any, of refusing administration of the product, and of
�
