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  • Warning Letter Resurrects Issue of Makena and FDA's Use of Enforcement Discretion

    A Warning Letter sent by the US Food and Drug Administration (FDA) this week offers yet another addition in the long and interesting chapter of KV Pharmaceuticals' Makena (17-hydroxyprogesterone  caproate). Background In 2011, FDA approved Makena under an orphan drug designation. While the drug had been used by doctors for years to prevent premature births, KV was the first company to bring Makena through clinical testing. Under the terms of FDA's approval, all...
  • FDA Warns Three Compounding Pharmacies for Unsanitary Conditions

    The US Food and Drug Administration (FDA) may be in the process of moving on from a scandal involving deficient practices by pharmaceutical compounding pharmacies, but as evidenced by three Warning Letters released today, it's not done scrutinizing the industry. Background Unlike more traditional pharmaceutical manufacturers-think Pfizer, for example-compounding pharmacies make custom versions of already-approved pharmaceuticals with the stated purpose of meeting unique...
  • FDA Cites New Authorities in First Warning Letter to Compounding Pharmacy in Six Months

    The issue of pharmaceutical compounding may have dominated much of 2012 and the first half of 2013, but regulators have released few Warning Letters to compounding pharmacies in almost a year, and none since a new trio of compounding guidances came out in December 2013. Now the agency has released its first Warning Letter to a compounding pharmacy in six months, reflecting new authorities and old problems. The 14 January 2014 letter to Triangle Compounding Pharmacy com...
  • FDA Links up With EU Law Enforcement Agency Europol to Combat Fake Pharmaceuticals

    The US Food and Drug Administration (FDA) is stepping up its attempts to go after online pharmacies peddling counterfeit and fake medicines to US consumers, announcing that it is embedding one of its agents with EU's law enforcement agency, Europol. Background: Counterfeiting US regulators have been seeing an influx of counterfeit products in recent years, testing both the limits of the security of the pharmaceutical supply chain and the ability of regulators to stop pr...
  • Hamburg Takes Peer-Pressure Approach in Advocating for Safer Compounding Practices

    When Congress passed the Drug Quality and Security Act (DQSA) into law in November 2013, it did so with the contention that it would prevent the sort of egregious lapses that allowed a pharmaceutical compounder's products to kill dozens and leave hundreds more wounded in 2012. Under the status quo, pharmaceutical compounders were regulated largely by state-level regulators, usually state boards of pharmacy. But under the DQSA , compounders could voluntarily subject th...
  • As Compounding Framework Takes Shape, So Does Influential Advisory Committee

    The US Food and Drug Administration (FDA) has announced the formation of an eagerly awaited advisory committee set to offer critical input in deciding which drug products will no longer be allowed to be compounded under the terms of a recent piece of legislation. Background That legislation, the Drug Quality and Security Act ( DQSA ) , was passed into law on 27 November 2013, and contained numerous provisions intended to regulate pharmaceutical products produced by...
  • 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...
  • 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...
  • 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...
  • With Recall Options Limited in Compounding Case, FDA Turns to Public Shaming to Protect Consumers

    If you wish to see the limits of the US Food and Drug Administration's (FDA) recall authority, look no further than its attempts to recall products from a Texas-based compounding facility whose products were thought to be compromised by sterility concerns. Background On 18 May 2013, FDA issued two notices regarding products manufactured at NuVision Pharmacy, a Dallas, Texas-based compounding pharmacy. The first was a  press statement  announcing that products ...
  • Watchdog Group: FDA Failed to Shut Down Compounder Earlier, at Blame for Outbreak of Infections

    What did government officials know, when did they first know it, and what did they do in response? It's a classic question faced by nearly every agency in the US government, including the US Food and Drug Administration (FDA), which has in recent months been under pressure from legislators regarding its oversight of the pharmaceutical compounding industry. In light of a massive outbreak of fungal meningitis that has since been linked to products manufactured at a Massach...