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FDA Affirms Office-Use Compounding Restrictions In Letter To Lawmakers

FDA affirms that traditional compounders must obtain patient-specific prescriptions, laying out the policy in a Sept. 15 letter responding to lawmakers' questions about whether the agency would allow compounding for physicians to use in their practice without having patient-specific prescriptions.

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Reps. Michael Burgess (R-TX) and Allyson Schwartz (D-PA) introduced bipartisan legislation Friday (Sept. 19) that would exempt indirect payments that drug and device manufacturers offer to continuing medical education providers from sunshine reporting requirements, legislation that if enacted would reverse CMS' plan to do away with the exemption.

Post-acute care legislation designed to lay the foundation for payment reforms is headed to the president's desk.

Employer groups are ramping up their efforts to revise the ACA's 30-hour full-time employee definition in hopes of getting it changed before the employer mandate kicks in for some large employers next year.

Public Citizen Friday (Sept. 19) came out against pending legislation that would allow limited population antibiotic approvals, saying the bill would compromise the FDA approval process.

As FDA establishes a protocol for how the agency will handle drug shortage notifications, the International Society for Pharmaceutical Engineering (ISPE) is pushing initiatives to better address shortage situations, such as building business continuity plans and internally tracking the quality of products.

FDA Friday (Sept. 19) released four re-proposed food safety rules with several revisions, including a tiered approach to the water quality standards, removal of the nine-month time interval between the application of manure and harvesting, exemption of brewers from implementing additional good manufacturing practices, and a hybrid approach for importers to ensure the safety of products they bring into the country.

CMS projects that Medicare Advantage enrollment will hit an all-time high next year, but MA plans will face new financial pressures next year as they lose bonuses and face further pay cuts.

Presidential advisors Thursday (Sept. 18) recommended that the federal government create incentives for antibiotic drug development, including possible changes to reimbursement and patent buyouts -- a request that will be further evaluated by a new interagency task force created by an executive order.