• Regulatory NewsRegulatory News

    Pharma industry making some headway in DSCSA implementation

    The pharmaceutical industry and its trading partners are making “some progress” in implementing the necessary systems to comply with the Drug Supply Chain Security Act (DSCSA), according to a recent survey. Yet industry needs to pick up the pace if the November 2023 deadline is to be met, said an official with the Healthcare Distribution Alliance (HDA), whose group conducted the survey.   The survey found that 75% of manufacturers plan to send 100% of their DSCSA-req...
  • Regulatory NewsRegulatory News

    FDA exempts naloxone distribution from DSCSA tracking requirements

    The US Food and Drug Administration (FDA) announced on Thursday that it will not take enforcement action against distributors of approved naloxone products for treating opioid overdoes under the prescription drug tracking requirements under the Drug Supply Chain Security Act (DSCSA).   The exemption would “help facilitate and expedite the distribution of naloxone to harm reduction programs on the front lines of the opioid overdose crisis, and thus directly aid in add...
  • Regulatory NewsRegulatory News

    Groups weigh in on FDA’s licensing rules for 3PLs and distributors

    Supply chain trading partners expressed broad support for the US Food and Drug Administration’s (FDA) proposed rule on uniform licensing standards for wholesale distributors and third-party logistics providers (3PLs), which are set to replace the current patchwork system of state licensing standards. The standards implement aspects of the Drug Supply Chain Security Act (DSCSA) and are meant to plug holes in the country’s pharmaceutical supply chain.   The generic dru...
  • Regulatory NewsRegulatory News

    Manufacturers that are not testing DSCSA data systems now are in 'big trouble'

    While much progress has been made by trading partners in implementing the pharmaceutical tracking systems called for in the Drug Supply Chain Security Act (DSCSA) more work needs to be done to ensure a smooth transition when these systems go live next November, said experts who recently spoke to Regulatory Focus.   Trading partners, for example, need to start testing and piloting data exchanges now to iron out any glitches early on, and manufacturers in particular ...
  • Regulatory NewsRegulatory News

    FDA publishes two critical DSCSA draft guidances

    The US Food and Drug Administration (FDA) on 5 July issued two draft guidances covering the implementation of the Drug Supply Chain Security Act (DSCSA); one addresses the use of electronic standards for tracing products through the pharmaceutical supply chain, while the other guidance pertains to identifying trading partners that are authorized to track products though the supply chain.   The agency announced that “these documents are critical steps toward implement...
  • This Week at FDAThis Week at FDA

    This Week at FDA: Spring regulatory agenda, upcoming guidances, and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we get a glimpse at FDA’s Spring regulatory agenda and get tips on several upcoming guidances. Plus, we learn about a new 510(k) pilot program for CBER-regulated medical devices.   Next week, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will ...
  • Regulatory NewsRegulatory News

    Industry guidance aims to help manufacturers adhere to bar coding requirements

    The Healthcare Distribution Alliance (HDA) on Monday issued a guide to help the pharmaceutical industry in formatting and placing bar code labels on their products to comply with Drug Supply Chain Security Act (DSCSA) requirements for tracking products through the supply chain.   DSCSA was signed into law in November 2013 and outlines the necessary steps necessary to build and electronic, interoperable system to identify and trace prescription drugs distributed in ...
  • Regulatory NewsRegulatory News

    Pharma trading partners have ‘significant’ work ahead of 2023 DSCSA deadline

    Pharmaceutical manufacturers are lagging behind distributors in testing electronic connections with trading partners as the November 2023 deadline for having these systems in place under the Drug Supply Chain Security Act (DSCSA) approaches, according to a recent survey by the Healthcare Distributors Alliance (HDA).   DSCSA mandates that by November 2023, prescription drug product must be electronically tracked through the supply chain to ward off counterfeiting. In ...
  • Regulatory NewsRegulatory News

    FDA issues long-awaited licensing rules for drug distributors and 3PLs

    The US Food and Drug Administration (FDA) on Thursday issued its widely anticipated proposed rule establishing uniform licensing standards for wholesale distributors and third-party-logistics providers (3PLs). The 2013 Drug Supply Chain Security Act (DSCSA) mandated that these rules be in place before these trading partners take possession of prescription drug products.   The agency announced that “the proposed rule, when finalized, would provide greater assuranc...
  • Regulatory NewsRegulatory News

    FDA urged to endorse EPCIS to spur manufacturers' uptake of DSCSA

    The pharmaceutical industry and other trading partners told the US Food and Drug Administration (FDA) to endorse the use of Electronic Product Code Information Services (EPCIS) for tracing products through the supply chain by finalizing its guidance on standards for the interoperable exchange of product information.   Doing so would help improve industry’s uptake of exchanging product data well ahead of the November 2023 deadline when these systems go live, say trading...
  • Regulatory NewsRegulatory News

    Pandemic has challenged industry’s implementation of DSCSA

    The pharmaceutical industry and its trading partners are showing “uneven readiness” in implementing the serialization systems necessary to comply with the Drug Supply Chain Security Act (DSCSA) by the November 2023 deadline when these exchanges go live.   The pandemic may have prompted this rocky situation as trading partners focus efforts on “core response activities” and not DSCSA compliance, according to a recent survey released 1 November by the Healthcare Distribu...
  • Regulatory NewsRegulatory News

    FDA reiterates support for semi-distributed tracing model under DSCSA

    The US Food and Drug Administration (FDA) recommends that trading partners use the semi-distributed model to trace drug products though the drug distribution chain because of this model’s flexibility and advantages over other data architecture models. The Drug Supply Chain Security Act (DSCSA) requires that trading partners have these systems in place by November 2023.   Connie Jung, acting associate director for policy and compliance in FDA’s Office of Drug Security, ...