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  • Regulatory NewsRegulatory News

    FDA to Texas and Arizona: Destroy or Export Detained Shipments of Execution Drugs

    After a lengthy wait, the US Food and Drug Administration (FDA) has officially told Texas and Arizona that their imported execution drugs cannot be used because they were unlawfully obtained. FDA spokesperson Lyndsay Meyer told Focus via email: “The FDA has notified the Texas Department of Criminal Justice and the Arizona Department of Corrections that their detained shipments of sodium thiopental have been refused on the basis that the detained drugs appear to be...
  • Regulatory NewsRegulatory News

    Florida CMO Recalls All Lots of Liquid Drugs Due to Bacteria Outbreak

    Contract manufacturing organization PharmaTech on Monday announced a voluntary recall of all of its liquid drug formulations made at its Davie, Florida facility over a 10-month period after being linked to a multi-state Burkholderia cepacia outbreak. The recall is an expansion of an earlier recall dated 15 July 2016, in which PharmaTech said it was recalling all lots of Diocto Liquid (docusate sodium), a stool softener, distributed by Rugby Laboratories after the com...
  • Regulatory NewsRegulatory News

    FDA Questions How Company’s ‘Training Products’ Entered US Drug Supply Chain

    The US Food and Drug Administration (FDA) has sent untitled letters to two companies selling a medical product that is intended for training purposes only. The letters were sent more than eight months after recalling the product, which was linked to two deaths. FDA said its investigation of adverse events associated with the use of Wallcur’s “Practi-0.9% Sodium Chloride” product identified several ways in which Florida-based PSS World Medical and Connecticut-based Moore ...
  • 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...
  • As Death Penalty Opponents Target Drug Supply Regulations, States Move to New Methods

    • 11 July 2012
    US states are facing the prospect of losing further access to the execution drug propofol after the UK's business secretary announced his intent to publish new export controls aimed at banning the export of the drug from the country. The Guardian reports Business Secretary Vince Cable is set to publish the details of the proposal on Wednesday, 11 June 2012. "We are clear that the state should never be complicit in judiciary executions through the use of British drugs i...
  • 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...
  • States to FDA: Appeal Enforcement Discretion Decision

    A group of 15 states is calling on the US Department of Justice (DOJ) and the US Food and Drug Administration (FDA) to appeal a Judge's decision in a lawsuit against both FDA and the states' ability to obtain a drug commonly used in the execution of convicted criminals. CNN reports the states, all of which use lethal injection as their preferred method of execution, are having trouble obtaining sodium thiopental-an anesthetic commonly used as part of a multi-drug execu...
  • Nebraska Raises Stakes in Battle With FDA, Won't Surrender Supply of Controversial Drug

    The state of Nebraska, engaged in an ongoing battle with the US Food and Drug Administration (FDA) over its supply of an controversial anesthetic drug used in executions, confirmed it will defy an FDA order to hand over remaining supplies of sodium thiopental, reports The Associated Press. In a statement released 20 April, Nebraska's state attorney general's office said they believed a court order, issued by Federal District Court Judge Richard Leon, was incorrect. Leon...
  • FDA, South Dakota in Tussle Over Regulation of Lethal Injection Drug

    The US Food and Drug Administration (FDA) is currently embroiled in an escalating fight with South Dakota's government over the regulatory quality-and legal status-of a drug intended to be used to put prisoners to death, reports KSFY News . The drug, an anesthetic known as sodium thiopental, is a staple of a three-drug cocktail commonly used to execute prisoners on death row. Anti-death pentalty advocates have increasingly been targeting the drug, which is no longer p...
  • Court Bars FDA from Importing Drug Used in Death Penalty

    A US District Court judge this week barred the US Food and Drug Administration (FDA) from importing an anesthetic drug used in executions, saying FDA's use of enforcement discretion was "callous" and "disappointing," reports Reuters . "The FDA appears to be simply wrapping itself in the flag of law enforcement discretion to justify its authority and masquerade an otherwise seemingly callous indifference to the health consequences of those imminently facing the execution...
  • Inmates Sue Agency to Stop Import of Drugs

    Death row inmates incarcerated in Tennessee, Arizona and California argued on 9 February that the US Food and Drug Administration (FDA) is breaking the law by allowing the importation of sodium thiopental -an anesthetic drug commonly used in a cocktail of execution drugs-after its manufacturer halted domestic production of the drug in 2011. The inmates contend that FDA does not have the authority to allow the drug to be imported because the drug product does not have ma...
  • 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 ...