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»  Posts By   July 2013 

Sterile Compounder Agrees to Cease Operations in Consent Decree with FDA, Highlighting Need for FDA Inspection Standard Operating Procedures

A New Jersey-based sterile compounding pharmacy recently entered into a Consent Decree with the Food and Drug Administration (FDA) following an investigation by the Agency in which the pharmacy was cited for unsanitary conditions and violations of good manufacturing practice requirements.  The pharmacy was also cited for producing and distributing numerous drug products without receiving patient-specific prescriptions and without having an approved new drug application or approved abbreviated new drug...

Oregon Enacts Fair Audit Practices Act, Aimed at Preventing PBM Abuses

By Jesse C. Dresser, Esq. and Jonathan E. Levitt, Esq. Earlier this month, Oregon Governor John Kitzhaber signed H.B. 2123 into law, which provides for sweeping oversight of pharmacy benefits mangers (PBMs) in the Oregon. H.B. 2123 implements fair audit standards that apply when PBMs conduct audits of community pharmacies. For example, the law provides an 18-month look-back period for audits, and limits audits to no more than 200 claims at...

PBM Increases Attacks on Florida Pharmacies Providing Diabetic Testing Supplies

In recent weeks and months, OptumRx, the in house pharmacy benefits manager (PBM) for UnitedHealthcare has engaged in a new course of action challenging Florida pharmacies that provide diabetic testing supplies through mail order. Contending that mail order is not permitted under the contract, OptumRx has begun sending cease and desist letters to Florida pharmacies and threatening network termination. OptumRx often sends these letters in connection with pending or uncompleted...