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FDA extended selected package-level tracing and verification requirements through November 27, 2027, for dispensers owned by companies with 25 or fewer full-time licensed pharmacists or qualified pharmacy technicians. No FDA filing is required, but other DSCSA duties remain.
FDA's August 24 final guidance explains how the agency evaluates therapeutic equivalence and assigns Orange Book codes. It does not itself announce a product-specific TE-code change or create a federal substitution rule; its practical value is a better product-level handoff.
The proposed FFY 2026 survey asks states two yes-or-no questions about steps they take to include drugs dispensed to nursing-facility residents in prospective and retrospective DUR. Comments close October 20; the proposal does not change resident-level monthly drug-regimen review under 42 CFR 483.45(c).
A Japanese claims study found a higher recorded rate of treated severe hypoglycemia in a claims-defined high-vulnerability group. Its useful lesson is to keep the lab date, glucose-lowering regimen, risk history, and resident context together before judging treatment intensity.
A randomized Canadian trial paired medication cleanup with behavioral work and measurement-guided treatment. In adjusted post hoc comparisons, the pathway group's narrow psychotropic-polypharmacy measure was lower at weeks 1 and 3—but not at the prespecified 12-week endpoint, and agitation did not differ between groups.
A pragmatic randomized trial tested a live EHR alert when outpatient clinicians started an antipsychotic for a person with dementia. The cancellation count is worth noticing, but the prespecified pill-days result—and the small number of times the alert actually fired—are the better starting points for a software conversation.
A model study in older outpatients shows why one headline accuracy number is not enough for a software decision. In the held-out test set, the model with the highest accuracy had 46.6% sensitivity and 12.1% precision.
CMS finalized a shorter submission-and-correction window for SNF Quality Reporting Program data beginning with FY 2029. The same rule phases in two other QRP changes on different schedules.