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  • As FDA Begins to Implement DQSA, Questions About Enforcement Discretion go Unanswered

    Significant questions remain about the implementation of certain compounding-related provisions of the Drug Quality and Security Act (DQSA) meant to prohibit the compounding of "copies" of lawfully approved drugs. Background The DQSA , a long-sought piece of legislation intent on reforming the regulation of compounding pharmacies and the pharmaceutical supply chain, was signed by President Barack Obama on 26 November 2013. The law's compounding provisions were ...
  • FDA Prepares Compounding Blacklist of Banned Products

    The US Food and Drug Administration (FDA) is calling for help in compiling a blacklist of sorts of drugs that should not be permitted to be compounded under the terms of the just-passed Drug Quality and Security Act ( DQSA ) of 2013. Among the law's many provisions is one that allows FDA to establish a list of products that no federally regulated compounded pharmacy-also known as "outsourcing facilities"-can manufacture by virtue of their complexity. Edit: Per FD...
  • FDA Releases Trio of Compounding Guidances Just Days After DQSA Signed into Law

    Just days after President Barack Obama signed the Drug Quality and Security Act ( DQSA ) into law, the US Food and Drug Administration (FDA) has released three draft guidance documents intended to interpret its provisions and provide definitional clarity for compounding pharmacies. Background The DQSA contains two sets of measures: One intended to better secure the pharmaceutical supply chain, and the other to more rigorously regulate the compounding pharmacy se...
  • 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...
  • Track and Trace, Compounding Legislation Passes Senate, Awaits President's Signature

    The Senate, after a series of long delays , has finally passed the Drug Quality and Security Act (DQSA) , all but assuring the law's provisions to institute a national track and trace system and new compounding regulations will be signed into law later this month. Background The  DQSA  was prompted by two issues. The first and perhaps most serious problem has been the lack of a uniform "track and trace" system for pharmaceutical products. While Californi...
  • House Passes Compounding and Supply Chain Reform Legislation, Even as Some Groups Cry Foul

    Moving at unusual speed, the House of Representatives on Saturday (28 September 2013) voted to pass the Drug Quality and Security Act (DQSA), a piece of legislation that would overhaul the regulation of pharmaceutical compounding and institute a new track and trace system to better secure the pharmaceutical supply chain. The most recent iteration of the legislation emerged on 25 September 2013, reflecting a bipartisan consensus and a blend of language from previous itera...
  • New Legislative Draft Mixes Congressional Approaches on Compounding, Track and Trace

    US legislators have announced that they have overcome differences in their approaches to reforming the regulation of compounding pharmacies and the pharmaceutical supply chain, clearing a path for potential approval. Background As regular readers of Regulatory Focus know, legislation to reform pharmaceutical compounding and track and trace has been in the works for months. In general, the House of Representatives and Senate have taken different approaches toward refo...
  • Feature ArticlesFeature Articles

    Public Safety Concerns Support FDA Call for Compounding Pharmacy Regulation

    When a contaminated injected steroid that killed more than 63 people and sickened at least 750 in 20 states was traced back to the New England Compounding Center (NECC) in Massachusetts, national attention turned to compounding pharmacies. 1 The public wanted to know what these businesses are and whether they are adequately regulated. Both the US Food and Drug Administration (FDA) and state authorities play a role in regulating compounding pharmacies. Unlike pharmacies t...
  • House Version of Compounding Legislation Emerges, Contrasting Sharply With Senate Approach

    Several prominent members of the House of Representatives' Energy and Commerce (E&C) Committee have released the text of new legislation intended to better regulate the pharmaceutical compounding industry in the wake of a deadly outbreak of fungal meningitis in 2012. Background: Compounding In the waning months of 2012, a massive outbreak of fungal meningitis was linked to supposedly sterile versions of methylprednisone acetate manufactured by the New England Compou...
  • Fallout from Deficient Contract Testing Facility Continues, Prompting Fourth Company to Issue Recall

    Fallout from deficient findings at a contract testing laboratory used by dozens of pharmaceutical compounders continues to upend the compounding industry, with yet another company initiating a nationwide recall after it said it was unable to confirm whether its products are indeed sterile. Background In August 2013, the US Food and Drug Administration issued a  statement  that Loveland, CO-based Front Range Laboratories, Inc. had been observed to be using defi...
  • Fallout from Deficient Testing Contractor Begins as Three Firms Issue Recalls

    US regulators have facilitated three nationwide voluntary recalls for pharmaceutical products manufactured by compounding pharmacies so far this week, the fallout of earlier deficiency findings at a contract testing laboratory that provided sterility assurance testing for hundreds of pharmacies across the US. Background In August 2013, FDA issued a statement that Loveland, CO-based Front Range Laboratories, Inc. had been observed to be using deficient methods to asses...
  • Inspection of Contract Testing Lab Raises Product Quality Questions for Dozens of Companies

    Pharmaceutical compounding operations have gotten something of a bad reputation of late. Thanks to a massive outbreak of meningitis caused by deficient compounding practices and dozens of inspections by the US Food and Drug Administration (FDA) that have found rampant sterility issues, many legislators, insurers and physicians are now taking a close and critical look at the compounding industry. In response, some compounders have instituted (or have long instituted) meas...