• As Battle Rages over Semantics of Compounding Pharmacies, Missouri Calls One an Executioner

    Over the last year, US-based compounding pharmacies have been subject to a lengthy debate over the semantics of their operations. Are their operations compounding, or are they really de-facto manufacturers? Should new categories like "outsourcing pharmacy" be created to deal with large-capacity compounders? But now the state of Missouri has raised the semantics state even further, granting one anonymous compounding pharmacy an unusual title: state executioner. The devel...
  • FDA Loses Major Case Testing its Enforcement Discretion Authority

    The US Food and Drug Administration (FDA) has a complicated history with sodium thiopental, a drug notoriously used as part of a multi-drug cocktail administered to prisoners condemned to death. And complicating the history further is a new ruling by the DC Court of Appeals, which today ruled that the agency may not exercise "enforcement discretion" to allow the drug into the country. Background In recent years, death penalty opponents have been using a deep understandi...
  • Judge's Order Banning Enforcement Discretion Appealed by FDA

    The US Food and Drug Administration (FDA) said it has appealed a decision issued in March 2012 by US District Court Judge Richard Leon, who said the agency erred in allowing a drug commonly used in executions into the country without first testing its effectiveness, reports Bloomberg . The drug, sodium thiopental, has been at the center of numerous courtroom skirmishes between proponents and opponents of the death penalty. Opponents hope that by restricting access to th...
  • DOJ Files 'Groundbreaking' Consent Decree Against Ranbaxy, Company Agrees to 'Remedy Deviations'

    The US Department of Justice (DOJ) filed a Consent Decree of Permanent Injunction against Ranbaxy, an Indian generic drug manufacturer, with the US District Court of Maryland on 25 January. The action was taken on behalf of the US Food and Drug Administration (FDA), which had found manufacturing and data integrity deficiencies at numerous Ranbaxy facilities located in India and a US-based Ranbaxy subsidiary's facility in New York. The consent decree requires Ranbaxy to c...
  • Import Regulations Used as Delaying Tactic in Nebraska Execution Case

    The state of Nebraska was the epicenter of a convergence between US Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) import regulations and death penalty politics on 9 January. Attorneys for death row inmate Michael Ryan had sued the state of Nebraska to produce documents proving that the state had legally obtained the execution drug sodium thiopental. Nebraska Attorney General Jon Bruning produced documents Monday showing that Nebraska had ...