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  • Regulatory NewsRegulatory News

    Compounding: FDA Details Policy Priorities for 2018, Finalizes Guidance

    The US Food and Drug Administration (FDA) on Thursday released its priorities for addressing compounded drugs in 2018 after years of developing policies to improve its oversight. Background In recent years, FDA has worked to update its policies on compounded drugs in response to a 2012 fungal meningitis outbreak linked to the New England Compounding Center that led to at least 60 deaths and new requirements brought on by the Drug Quality and Security Act (DQSA) of 201...
  • Regulatory NewsRegulatory News

    BIO, PhRMA and Others Urge Further FDA Clarity on Drug Compounding

    The Biotechnology Innovation Organization (BIO), the Pharmaceutical Research and Manufacturers of America (PhRMA), Pew Charitable Trusts and other groups earlier this week sent letters to the House and Senate urging further support for FDA oversight of drug compounders and enforcement of the 2013 Drug Quality and Security Act .  "If FDA is not permitted to maintain that line between traditional compounding and outsourcing facilities, patients are put at risk, sta...
  • Regulatory NewsRegulatory News

    New FDA Guidance for First Responders as Track-and-Trace Requirements Take Effect

    Beginning Tuesday, the delayed implementation of product tracing requirements for pharmacies will take effect, and the US Food and Drug Administration (FDA) on Monday issued final guidance saying it will not take action against first responders who fail to obtain tracing information. Background On 27 November 2013, the Drug Supply Chain Security Act (DSCSA) was signed into law, putting forth new definitions and requirements related to pharmaceutical product tracking and...
  • Regulatory NewsRegulatory News

    FDA Gives Pharmacies Another Four Months to Comply With Track and Trace Requirements

    • 30 June 2015
    • By
    The US Food and Drug Administration (FDA) plans to give drug dispensers—i.e. pharmacies—an additional four months to comply with federal track and trace requirements established under the Drug Supply Chain Security Act (DSCSA) . Background In 2013, the Drug Quality and Security Act (DQSA) was signed into law. While the DQSA is perhaps better known for its extensive pharmaceutical compounding reform provisions, it also contains another major component formally known a...
  • Regulatory NewsRegulatory News

    FDA Guidance: Federal Efforts to Secure Supply Chain Trump State Efforts

    US regulators have released more information regarding an emerging system intended to prevent counterfeit medicines from reaching US consumers. Background In 2013, Congress passed and President Barack Obama signed into law the Drug Quality and Security Act ( DQSA ). While the law is perhaps better known for its extensive pharmaceutical compounding reform provisions, it also contains another major component formally known as the Drug Supply Chain Security Act (DSCSA) ...
  • 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...
  • Regulatory NewsRegulatory News

    Six New FDA Regulations to be Introduced in 2014, Including Major Change in IND Reporting

    The US Food and Drug Administration (FDA) has released an updated list of regulations it is planning to seek in 2014, known as its "Unified Agenda," outlining six new rules it says it intends to propose in 2014. DQSA-Related Rules Several are related to FDA's new authority under the Drug Quality and Security Act (DQSA) of 2013, which contains numerous provisions intended to enhance FDA's ability to regulate compounding pharmacies. For example, FDA plans to issue pro...
  • 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...
  • As GSK Recalls Weight Loss Drug After Tampering, A Focus on Limits of the DQSA

    Did legislators go far enough in their attempts to secure the pharmaceutical supply chain when passing the Drug Quality and Security Act (DQSA) last year? That question is now on the minds of some after pharmaceutical manufacturer GlaxoSmithKline issued a massive recall of all lots of its over-the-counter weight loss drug Alli (orlistat capsules) following a determination that some lots of the drug had been " tampered with ." While the DQSA contains extensive requir...
  • 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...
  • 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...