…separate waiver arises from a difference in the preferred distribution chain, indicating that the use of a specialty pharmacy may be more restrictive than necessary; however, given that three other…

…facility Athenex Pharmacy Solutions LLC filed a lawsuit pursuant to the Administrative Procedures Act against FDA and others challenging FDA’s bulks determination (on the same day as FDA’s Federal Register…

By Alan M. Kirschenbaum – Today the Office of Pharmacy Affairs (“OPA”) of the Health Resources Services Administration (“HRSA”) published in the Federal Register its first proposed regulation under the…

…Fees for Three-Year Cycle Registrants Registrant Category Current Three-Year Fee Proposed Three Year Fee Increase Per Year Pharmacy; Hospital/Clinic; Practitioner; Teaching Institution; Mid-Level Practitioner     $551     $732…

…Before the Health Information Technology for Economic and Clinical Health Act (HITECH Act), which became law on February 17, 2009, pharmaceutical companies could hire pharmacies and pharmacy chains to remind…

…privacy in information held by a third party (here, the pharmacy or PDMP).  Distinguishing other third party doctrine cases dealing with bank and telephone records, the Oregon court held that…

On April 17, 2008, U.S. Representatives Steve Buyer (R-IN) and Jim Matheson (D-UT) introduced H.R. 5839, the “Safeguarding America’s Pharmaceuticals Act,” which would substantially expand federal drug pedigree requirements.  Among…

…when the physician, pharmacy, distributor, wholesaler or other DEA registrant has taken a “belt and suspenders” approach and filed challenges in both the district court and court of appeals.  In…

The Academy of Managed Care Pharmacy (AMCP)’s Format Executive Committee is excited to let you know that after two years of work, version 5.0 of the Format for Formulary Submissions…

…material to a false or fraudulent claim . . . . [31 U.S.C. § 3729(a)(1)(A)-(B).] A Look Back At Franklin Some courts have broadly construed the FCA to include statements…

…as consumers of these products, we are thankful for that.   FDA inspected the NIH Pharmaceutical Development Section and Clinical Center Pharmacy for five days between May 19 and May 29,…

…Prohibiting possession or receipt of unfinished dextromethorphan by any person not registered, licensed or approved under federal or state law to practice pharmacy, engage in “pharmaceutical production,” or manufacture or…

…responsibilities E.         Contract pharmacy arrangements F.         Manufacturer responsibilities G.        Rebate option for AIDS Drug Assistance Programs H.        HHS audits of Covered Entities and manufacturers, and manufacturer audits of Covered Entities…

…or risks, of a medical product derived from analysis of RWD.” RWD can be collected from a wide range of sources, such as electronic health records, registries, administrative claims, pharmacy…

…cost reimbursement, but will instead use the National Average Drug Acquisition Cost (NADAC) published monthly by CMS based on actual pharmacy invoice surveys.  (See TAC 355.8541(a)(1))  The preamble explains (at…