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…States v. Osborn, No. 3:12-cr-00047. Apothécure was a compounding pharmacy and Mr. Osborn was its owner, president, pharmacist-in-charge, and sole director. The Information alleged that Mr. Osborn was the person…
…539, which was enacted on June 15, 2017. In summary, S.B. 539 places new reporting requirements on pharmaceutical manufacturers and pharmacy benefit managers related to diabetes treatments and health care…
…623-624 (1978). AAM argued that HB 631 violates the dormant Commerce Clause by targeting transactions between pharmaceutical manufacturers and wholesale distributors or retail pharmacy chains with centralized warehouses, none of…
…different customers on the same unit of drug – for example a discount to a pharmacy and a rebate to a third-party payor – when determining best price. In the…
…plan reimburses the pharmacy for the drug, and which may be quite different from the WAC. The second reason why WAC is purportedly relevant is that “plan designs are built…
…January 1, 2018, imposes notification and reporting requirements on pharmaceutical manufacturers for certain price increases on their products sold to state purchasers, insurers, and pharmacy benefit managers in California. In…
…FDA states it will take input from both public comments and its Pharmacy Compounding Advisory Committee (PCAC). It will also continue to review the clinical need determinations for these and…
…bulk substances interim policy… pursuant to which the compounding industry nominated hundreds and hundreds of bulk substances, and after FDA, with the assistance of the Pharmacy Compounding Advisory Committee (PCAC)…
…will hold a meeting of its Pharmacy Compounding Advisory Committee on September 12, 2018, and address six substances that were nominated for use in compounding by 503A facilities: alpha lipoic…
…determination of “clinical need” for outsourcing facilities to compound the product using bulk substances (which, of course, sounds much like FDA’s statements concerning determinations both the Agency and its Pharmacy…
…is sold from one dispenser to another dispenser to “fulfil a specific patient need” (i.e., a sale from one pharmacy to another for dispensing to an individually identified patient). Such…
…source drugs changed to 130% of weighted average of AMPs (§ 1741) AMP definition amended to exclude sales to most non-retail pharmacy entities (§ 1741) Minimum Medicaid Rebate for innovator…
…the pharmacy for the drug. The enrollee and the plan share the remainder of the cost. Before BBA 2018, the enrollee’s cost-sharing amount in the coverage gap, 35% in 2018,…
…Under Section 503A FDA’s Final Guidance for traditional, Section 503A pharmacy compounders does not read that differently from the draft guidance, which we blogged about here. The Final Guidance does,…
…an outsourcing facility can be co-located with a Section 503A pharmacy (we thought the answer was “no” based on earlier draft guidance, here). FDA will also soon issue long awaited…