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  • 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...
  • 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...
  • 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...
  • Compounding Pharmacy Chain Hit with Record Six Form-483s

    Many pharmaceutical companies spend considerable time, resources and energy to ensure that their facilities are in top shape, wary of the potential for US regulators to issue a Form-483 identifying deficiencies at a manufacturing facility and the costs associated with correction or remediation. But if the prospect of just one Form-483 is enough to keep some regulatory affairs professionals awake at night, it's hard not to wonder how much sleep the compliance officials a...
  • Compounding Pharmacy Recalls all Products after FDA Finds Microbial Contamination in Vials

    The US Food and Drug Administration (FDA) has announced that yet another compounding pharmacy has initiated a national recall for all products manufactured at a Florida facility, explaining that an inspection of the facility last month found deficient practices that might have exposed its sterile products to microbial contamination. Background Compounding pharmacies enjoy a relatively unusual regulatory exemption in the US whereby they can compound products without havi...
  • Massachusetts Regulators Discover Widespread Failings at Sterile Manufacturing Sites

    • 05 February 2013
    Crises are rarely ones of regulators' own choosing. So in 2012 when pharmaceutical compounding became the topic de jure after a massive outbreak of fungal meningitis, state and federal regulators seemed blindsided, and were scrambling not only to trace the outbreak to its point of origin, but also to answer a more basic, troubling question: could an outbreak of this scale happen again? A new report just published by the Boston Globe seems to indicate that not only co...
  • Sterility Issues Found at Second Compounder as FDA Anticipates New Drug Shortages

    Officials with the US Food and Drug Administration (FDA) have announced the voluntary recall of all products made by Ameridose, a pharmaceutical compounder whose sister company is linked with a massive outbreak of fungal meningitis , as well as the possibility that the massive recall could lead to new shortages of pharmaceutical products. According to Ameridose , FDA had informed it that it would be, "Seeking improvements in Ameridose's sterility testing process." The ...
  • Troubling Sterility Lapses Found at Compounding Facility

    The US Food and Drug Administration (FDA) has identified a number of troubling lapses in good manufacturing practices at the New England Compounding Center ( NECC ), the Massachusetts-based pharmaceutical compounding facility now linked to a massive outbreak of fungal meningitis, after an inspection revealed widespread and unaddressed sterility problems. Regulators released a Form 483 , a form FDA uses to list potential violations of the Federal Food, Drug and Cosmet...