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  • Regulatory NewsRegulatory News

    FDA Considers Compounding Restrictions on Four Drugs, Including Acetaminophen

    The US Food and Drug Administration (FDA) is preparing to ask one of its newest advisory committees to decide if some compounding pharmacies should be allowed to make four drugs, including the widely used painkiller acetaminophen. Background The advisory committee, known as the Pharmacy Compounding Advisory Committee (PCAC) , was re-created under a piece of 2013 legislation known as the  Drug Quality and Security Act (DQSA) . The law, passed in the wake of a major drug...
  • Regulatory NewsRegulatory News

    FDA Releases Long-Awaited Policies on Regulation of Pharmaceutical Compounders

    The US Food and Drug Administration (FDA) has announced the release of four guidance documents intended to help increase regulatory oversight of the pharmaceutical compounding industry. Background The documents come nearly three years after an outbreak of fungal meningitis was linked back to drug products compounded by the New England Compounding Center (NECC). In the aftermath of that outbreak, legislators passed the Drug Quality and Safety Act (DQSA) , which clarif...
  • Regulatory NewsRegulatory News

    FDA Committee Prepares to Decide if Six Drugs Can be Made by Compounding Pharmacies

    The US Food and Drug Administration (FDA) has announced it will soon hold the first meeting of a new and influential advisory committee that is set to make recommendations about which drugs will not be allowed to be made by compounding pharmacies in the US. Background The advisory committee, known as the Pharmacy Compounding Advisory Committee (PCAC), was re-created under a piece of 2013 legislation known as the Drug Quality and Security Act (DQSA) . The law, passed in...
  • Regulatory NewsRegulatory News

    FDA Appoints Members to New, Influential Advisory Committee

    Almost a year after announcing the re-creation of its Pharmacy Compounding Advisory Committee (PCAC), the US Food and Drug Administration (FDA) has announced that it has selected 12 experts who will serve on the influential committee as it considers how best to regulate the pharmaceutical compounding sector. Background The re-creation of the PCAC was called for under the Drug Quality and Security Act (DQSA) , which sought to update the way in which FDA regulated p...
  • Regulatory NewsRegulatory News

    In FDA Effort to Strengthen Regulation of Compounded Drugs, Protections and Profits Intersect

    A new law meant to protect consumers from unsafe pharmaceutical compounding practices is drawing interest from pharmaceutical companies, who are petitioning the US Food and Drug Administration (FDA) to add some of their products to a new list of restricted drugs that could protect patients from deficient drugs—and likely companies from compounded competition as well. Background The Drug Quality and Security Act (DQSA) of 2013 was passed into law in the wake of a massi...
  • DHHS Signs Over (a Little Bit of) Compounding Oversight Authority to FDA

    The US Food and Drug Administration (FDA) is getting some new, though not unexpected, authority this week by way of its parent organization, the US Department of Health and Human Services (DHHS). The new authority pertains to a new law passed in 2013 known as the Drug Quality and Security Act (DQSA) , which was passed in the wake of a deadly scandal involving pharmaceutical products compounded using deficient practices. Part of the law permitted FDA to more tightly r...
  • FDA Guidance Sets up User Fee System for Pharmaceutical Compounders

    The US Food and Drug Administration (FDA) has published a new guidance document intended to establish user fees to fund its inspections of a new category of compounding pharmacy established under the Drug Quality and Security Act (DQSA) of 2013. Background In late 2012, a massive outbreak of fungal meningitis was traced to deficient manufacturing at a Massachusetts compounding pharmacy. In the wake of the outbreak, which killed more than 60 and left hundreds more inju...
  • FDA Hits Two Compounders for Making J&J Drug That Lacked US Approval

    Two compounding pharmacies are the latest recipients of Warning Letters from the US Food and Drug Administration (FDA), part of a recent surge of letters reflecting the agency's new authority under the Drug Quality and Security Act (DQSA) . Background: Compounding Pharmacies and the DQSA Unlike more traditional pharmaceutical manufacturers-think Pfizer, for example-compounding pharmacies make custom versions of already-approved pharmaceuticals with the stated purpose o...
  • 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...
  • 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...