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    • DRUGS AND BIOLOGICS—D.S.D.: 340B contract pharmacy delivery protections not preempted, avoid constitutional limits
    • ANTITRUST—9th Cir.: Stipulated judgment entered on faulty jury instruction reversed because Kodak/Epic factors were inapplicable
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    • LABELING AND PACKAGING (FOOD, DRUGS & MEDICAL DEVICES)—S.D.N.Y.: Case against maker of Enfamil infant formula moves forward
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    Health Law Daily Wrap Up, REGULATION TRACKER—Information on pending or recently adopted regulations and regulation amendments, (Aug 17, 2026)

    By WK Editorial Staff

    This Health Law Regulation Tracker includes a Proposed Rules Comment Calendar and a Table of Final Rule Effective Dates.

    New proposed rules. On August 11, 2026, the FDA issued a proposed rule that would require the submission of generally recognized a ...

    By WK Editorial Staff

    This Health Law Regulation Tracker includes a Proposed Rules Comment Calendar and a Table of Final Rule Effective Dates.

    New proposed rules. On August 11, 2026, the FDA issued a proposed rule that would require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FDC Act).

    See the Regulation Tracker for details.

    New final rules. On August 13, 2026, CMS issued a final rule requiring that a state Medicaid plan must provide that the Medicaid agency will not make payment under the plan for sex-rejecting procedures for children under 18, and prohibits the use of federal Medicaid dollars to fund sex-rejecting procedures for individuals under the age of 18. In addition, this final rule requires that a separate State Children’s Health Insurance Program (CHIP) plan must provide that the CHIP agency will not make payment under the plan for sexrejecting procedures for children under 19, and prohibits the use of Federal CHIP dollars to fund sex-rejecting procedures for individuals under the age of 19. For Medicaid and CHIP beneficiaries who are actively receiving cross-sex hormone therapy, State Medicaid and CHIP agencies may continue to claim Federal Financial Participation for those hormone therapy medications for a period of up to 6 months from the effective date of this final rule.

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