• 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, ...
  • Regulatory NewsRegulatory News

    Pharmaceutical trading partners lagging in exchanging electronic product information

    Pharmaceutical trading partners are behind the curve in exchanging electronic product information with each other under a mandate established by the Drug Supply Chain Security Act (DSCSA) that requires these exchanges go live by 27 November 2023.   Roughly half of manufacturers and distributors say they are currently exchanging EPICIS Electronic Product Code Information Services (EPICIS) data with each other, while these data are not being exchanged at all between dist...
  • Regulatory NewsRegulatory News

    Industry calls for withdrawal of FDA electronic tracing guidance

    Pharmaceutical distributors urge the US Food and Drug Administration (FDA) to immediately withdraw its guidance setting parameters for establishing electronic systems to trace products through the supply chain. A trade association for distributors claims the agency overreached its statutory authority in seeking access to private electronic tracing information among trading partners.   The guidance, published in June, laid the groundwork for the data architecture system...
  • Regulatory NewsRegulatory News

    FDA official: Agency will not extend 2023 DSCSA interoperability deadline

    The US Food and Drug Administration is working “full tilt” towards implementing requirements calling for manufacturers and trading partners to have full interoperable electronic track and trace systems in place by the November 2023 deadline set by the Drug Supply Chain Security Act (DSCSA), with no plans to extend the deadline for manufacturers to comply with these requirements.   So asserted Leigh Verbois, director of FDA’s Office of Drug Security, Integrity and Res...
  • Regulatory NewsRegulatory News

    Updated: FDA grants industry 30-day extension to comment on track and trace guidance

    Editor's note: This story has been updated to include the US Food and Drug Administration's notice extending the deadline to comment on its track and trace guidance. The US Food and Drug Administration (FDA) has agreed to give the pharmaceutical industry more time to comment on a draft guidance calling for the establishment of electronic systems to track products through the supply chain. Prior to Monday's announcement of the extension, two groups representing phar...
  • Regulatory NewsRegulatory News

    Industry consortium releases blueprint for DSCSA tracking systems

    An industry consortium has recently released the first chapter of a blueprint to help guide the pharmaceutical industry in setting up electronic systems to track their products through the supply chain.   The PDG Blueprint was released by the Partnership for DSCSA Governance (PDG), a consortium of more than 60 pharmaceutical supply chain members that was chosen by FDA to pilot data architecture systems for tracking products. The Drug Supply Chain Security Act (DSCSA)...