; and (2) on how the Emerging Technology Program of the Food and Drug Administration can help facilitate creating or upgrading existing technologies to address drug shortage challenges and promote modern, reliable manufacturing strategies. 4125. Safe harbor provision (a) In general The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 502 ( 21 U.S.C. 352 ) the following: 502A. Safe harbor provision (a) In general The communication of information, consistent with subsection (b), with respect to the use of a drug or device authorized under section 564 provided or distributed to a health care provider, shall not— (1) be a basis for treating such drug or device as misbranded under subsection (a) or (f) of section 502, or in violation of section 505, 515, or 564 of this Act or subsection (a) or (k) of section 351(a)(1) of the Public Health Service Act, as applicable; or (2) be treated as evidence that such drug or device is misbranded under subsection (a) or (f) of section 502, or in violation of section 505, 513, 515, or 564 of this Act or subsection (a) or (k) of section 351 of the Public Health Service Act, as applicable. (b) Provision of information (1) In general Any information relating to a use of a drug or device authorized under section 564, or for which a submission under section 564 has been submitted, that— (A) is neither false nor misleading, when measured objectively against the information available at the time the statement is made; (B) is accompanied, as required, by an appropriate disclaimer, as described in paragraph (2); and (C) is based on competent and reliable scientific evidence, as described in subsection (c). (2) Disclaimers For purposes of paragraph (1), such information shall be accompanied, as necessary, by an appropriate disclaimer, including— (A) a statement identifying any differences between the information and any labeling of the drug or device; (B) a statement identifying contradictory evidence