“To provide for digital communication of prescribing information for drugs (including biological products), and for other purposes.”
No CRS summary available for this bill.
This section amends section 502(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)) to permit required prescribing information for prescription drugs (i.e., those subject to section 503(b)(1)) to be provided solely by electronic means, provided the labeling complies with applicable law, manufacturers offer prescribers and dispensers the option to elect or request paper copies at no additional cost with prompt fulfillment, and the term "drug" has the meaning given in section 201(g) (21 U.S.C. 321(g)). The section further (1) directs the Secretary of Health and Human Services to issue final implementing regulations within one year of enactment, including instructions for requesting paper copies and designed to minimize adverse economic impacts on prescribers and dispensers; (2) requires a public workshop with stakeholders within two years of enactment to optimize prescribing information format, accessibility, and usability; and (3) applies the amendment to drugs introduced or delivered for introduction into interstate commerce on or after the sooner of two years post-enactment or the regulations' effective date.