Sec. 8. Electronic labeling
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Section 502(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 352(f) ) is amended by adding at the end the following new sentence: Required labeling (other than immediate container or carton labels) that is intended for use by a physician, a pharmacist, or another health care professional, and that provides directions for human use of a drug subject to section 503(b)(1), may (except as necessary to mitigate a safety risk, as specified by the Secretary in regulation) be made available by electronic means instead of paper form, provided that such labeling complies with all applicable requirements of law, the manufacturer or distributor, as applicable, affords health care professionals and authorized dispensers (as defined in section 581) the opportunity to request the labeling in paper form, and after such a request the manufacturer or distributor promptly provides the requested information without additional cost. .
The Secretary of Health and Human Services shall promulgate regulations implementing the amendment made by subsection (a). The last sentence of section 502(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)), as added by subsection (a), shall apply beginning on the earlier of— the effective date of final regulations promulgated under subsection (b); or the day that is 180 days after the date of enactment of this Act.
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U.S. Code