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  • 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...
  • Compounded Products Linked with Potential Deadly Infections, Putting New Pressure on FDA, Congress

    A steady drumbeat of recalls related to potentially non-sterile products manufactured at compounding pharmacies continues, with the US Food and Drug Administration (FDA) issuing announcements this weekend that Specialty Compounding LLC was recalling "all lots of sterile medications within expiry" after at least 15 patients experienced bacterial infections after being given the medication. Background FDA regulates pharmaceutical compounders differently than traditional m...
  • Rare Letter to Compounding Pharmacy Shows FDA Demanding Recall of Potentially Unsterile Products

    Safety recalls are regularly conducted in the healthcare products sector, falling along a three-tiered classification system in which the most serious recalls are referred to as "Class 1" recalls. But despite healthcare professionals often seeing the end result of these recalls-a notice, and usually a "voluntary" recall, as opposed to an agency-ordered one-they rarely get a glimpse into how that recall is ordered. Background On 18 May 2013, FDA issued two notices regar...
  • GAO Report Gives Credence to FDA's Pharmaceutical Compounding Claims

    A new report just published by the Government Accountability Office (GAO) confirms what US Food and Drug Administration (FDA) officials have long argued: They simply don't have sufficient authority to regulate compounding pharmacies with the same level of vigor as they do traditional pharmaceutical manufacturers. Background In the waning months of 2012, a massive outbreak of fungal meningitis was linked to supposedly sterile versions of methylprednisone acetate manufact...
  • Modified Senate Legislation Emerges, Would Reform Compounding Regulation, Track and Trace

    The US Senate's Health, Education, Labor and Pensions (HELP) Committee has released an updated version of legislation meant to enact a track and trace system for pharmaceuticals, as well as new regulations to crack down on deficient pharmaceutical compounding practices that resulted in a massive outbreak of fungal meningitis in late 2012. Background Both the Senate and House of Representatives have been working independently of one another to push forward measures on bo...
  • Pharmacy's Penicillin Manufacturing Problems Relate to Recently-Released Guidance Document

    Guidance documents, as the US Food and Drug Administration (FDA) often reminds industry, are not legally binding entities. Rather, they represent insight into regulators' current best thinking on a particular subject, giving companies the opportunity to make compliant their operations and avoid any regulatory headaches. But just because they're not legally enforceable on their own doesn't mean that FDA isn't interested in taking action in accordance with the regulations ...
  • Spiders, Non-Sterile Practices Lead to Warning for Compounder at Center of Recall

    Several weeks ago, US regulators announced that supposedly sterile products manufactured by a Tennessee compounding pharmacy were contaminated with fungus and bacteria, leading to a recall of the company's products and raising troubling parallels between the case and another one that killed dozens and left hundreds seriously injured. Now the US Food and Drug Administration (FDA) has released the details of its inspection of that compounders' facility, revealing disturbing...
  • FDA Testing Confirms Fungal, Bacterial Contamination of Yet Another Pharmacy's Products

    US Food and Drug Administration (FDA) officials yesterday confirmed what they have feared for more than a week: Products from yet another pharmaceutical compounding pharmacy are contaminated with fungal and bacterial growth. Background Compounding pharmacies have been subject to enhanced scrutiny by FDA in recent months, resulting in a huge number of Warning Letters, Form 483s, recalls and general warnings to consumers and healthcare providers. The root of this enhance...
  • Australia Tackles Compounding Concerns

    Australia's Therapeutic Goods Administration (TGA) has opened a consultation on how best to address concerns that the current regulatory framework for compounding medicines does not provide adequate assurance that they meet acceptable standards of quality and safety. The TGA notes that the expansion of pharmaceutical compound manufacturing in Australia reflects international trends, and that there are concerns locally and overseas regarding the complexity and scale of ...
  • Disturbing Parallels Seen in New Compounding Pharmacy Warning

    US regulators have issued a warning regarding products compounded at a Tennessee pharmacy, saying that it was aware of at least seven adverse events potentially associated with supposedly sterile steroid injectable products manufactured by the company, drawing close parallels to an outbreak that occurred in October 2012. Background Compounding pharmacies have been subject to enhanced scrutiny by FDA in recent months, resulting in a huge number of Warning Letters, Form 4...
  • Senate Advances Compounding, Track and Trace Legislation with an Eye on July Passage

    The US Senate's Health, Education, Labor and Pensions (HELP) Committee has advanced two long-sought-after proposals that would overhaul the framework by which the US Food and Drug Administration (FDA) regulates the compounding, tracking and tracing of pharmaceutical products. Pharmaceutical Compounding Both the House and Senate are concurrently working on two sets of proposals: one to change how pharmaceutical compounders are regulated, and one to shore up the pharma...