…passed through by the plan sponsor or PBM to the dispensing pharmacy, which would be a major change from the typical practice today. The effective date of the amendments had…

…wholesale drug distributors and pharmacy benefits managers (PBMs). Previously, manufacturers, wholesale drug distributors and PBMs were required to provide “pricing component data” within 60 days of a request from the…

…1032, sets forth reporting requirements applicable to drug manufacturers, pharmacy benefit managers (PBMs), and health insurers. Under the new law, PBMs are required to submit an annual report with information…

…to trigger automatic substitution at the pharmacy level and thus critical to driving competition. Because 505(b)(2) is technically a new drug pathway, the statute does not require FDA to assign…

…here and here), HB 2007 sets forth reporting requirements applicable to health carriers, pharmacy benefit managers (PBMs), wholesale distributors, and manufacturers. Under the new law, health carriers are required to…

…two other therapies. This reduces the likelihood that this free drug program will induce prescribers to use this drug versus other, cheaper options. OIG next determined that the free drug…

…Book with an “A” therapeutic equivalence code because such ratings look only to the drug product itself rather than the approved indications. As a result, a skinny-labeled “A”-rated generic drug…

…the general authority for a pharmacy to deliver a prescription to the “ultimate user.” 85 Fed. Reg. at 78,284. Under the CSA, the ultimate user can be “a person who…

…List I Chemical Registrants, 85 Fed. Reg. 14,810 (Mar. 16, 2020)) and Final Rule, (Registration and Reregistration Fees for Controlled Substance and List I Chemical Registrants, 85 Fed. Reg. 44,710…

…event of an emergency situation as defined in DEA regulations, a practitioner would be able to prescribe, and a pharmacy would be able to dispense, HCPs in accordance with 21…

…knows) and the other factor can be biometric data, a hard token, a “hardware key” stored on a device, etc. Both factors must be entered into the system containing the…

…form, or similar systematic process. Processes should be developed to capture site-level status, site- or vendor-level protocol deviations, and process deviations. COVID-19-related deviations should be summarized in the clinical study…

…Rubidium chloride Sodium dichloroacetat Vanadyl sulfate Vasoactive intestinal peptide (VIP) FDA states that it consulted with both the Pharmacy Compounding Advisory Committee (PCAC) and USP in its evaluation of the…

…bulk substances used in compounding via notice and comment rulemaking after consultation with the Pharmacy Compounding Advisory Committee. Section 503A(d)(1). The straightforward “Q&A” guidance provides no surprises for pharmacies, but…

…drug (thiopental) used in prisoner executions, which we blogged about here, and which was affirmed by the D.C. Circuit Court of Appeals. Beaty v. FDA, 853 F. Supp. 2d 30…