Pub. L. 115-52, tit. VI, sec. 606 (as amended)
COMMUNICATION PLANS.
SEC. 606. COMMUNICATION PLANS.
Section 505-1(e)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(e)(3)) is amended—
(1) in subparagraph (B), by striking “; or”;
(2) in subparagraph (C), by striking the period and inserting “; or”; and
(3) by adding at the end the following:
“(D) disseminating information to health care providers about drug formulations or properties, including information about the limitations or patient care implications of such formulations or properties, and how such formulations or properties may be related to serious adverse drug events associated with use of the drug.”
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