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    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...
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    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...
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    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 The US Food and Drug Administration (FDA) has agreed to give the pharmaceutical industry more time to comment on a draft guidance calling for the establishment of electronic systems to track products through the supply chain.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...
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    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)...
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    FDA details plans for DSCSA implementation in four guidances

    The US Food and Drug Administration (FDA) on 3 June released four guidances on its plans for implementing the Drug Supply Chain Security Act (DSCSA), setting the agency’s expectations for how pharmaceutical manufacturers should comply with new product tracing requirements.   They address situations that can increase the risk of suspect products entering the supply chain, expectations for product identifiers, interoperable electronic tracing of products and definition...
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    Four FDA guidances related to DSCSA awaiting OMB sign-off

    The Office of Management and Budget (OMB) on 11 May began reviewing a set of guidances related to the US Food and Drug Administration’s (FDA) implementation of the Drug Supply Chain Security Act (DSCSA) .  They address suspect products, product identifiers and interoperable electronic tracing of products.   Under the Paperwork Reduction Act of 1995, federal agencies must regularly submit to the OMB guidance document and regulations for review to ensure their cost-e...
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    Panelists: Sluggish pace of DSCSA testing is worrisome

    In a recent traceability forum, the pharmaceutical industry and other trading partners were told to start testing their data systems now to ensure that any glitches are ironed out before prescription drug products must be electronically tracked through the supply chain to ward off counterfeiting. The Drug Supply Chain Security Act (DSCSA) mandates that these systems go live in November 2023.   To ensure readiness, panelists participating in the 29 April Healthcare Dist...
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    FDA delays enforcement of some DSCSA provisions by three years

    The US Food and Drug Administration (FDA) last week announced it will again delay enforcement of a provision of the Drug Supply Chain Security Act (DSCSA) that would require wholesalers to verify saleable returned drugs they intend to further distribute.   “FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2023, verify the product identifier prior to further distributing returned product as required under section 582(...
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    Drugmakers Make Significant Headway in Track-and-Trace Compliance

    A new GS1 Healthcare report on the progress made in meeting the serialization requirements of the Drug Supply Chain Security Act (DSCSA) found significant progress, especially in comparison to reports from 2017 and 2018. Part of the reason for the progress can be attributed to a US Food and Drug Administration (FDA)  deadline extension  to November 2018 for certain product identifiers. “Of course, the compliance deadline really drove suppliers’ actions toward seria...
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    PhRMA, AAM Seek Tweaks to FDA’s Verification Guidance

    Pharmaceutical and generic drug industry groups are seeking changes to US Food and Drug Administration (FDA) draft guidance on the verification systems that can determine, quarantine and investigate suspect or illegitimate products. The 11-page draft, released last October, lays out how FDA recommends that trading partners submit cleared product notifications (ie. that a product is not illegitimate) and the statutory requirements for verification, including verificati...
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    FDA Issues Delayed DSCSA Grandfathering Guidance

    The US Food and Drug Administration (FDA) on Monday issued draft guidance detailing its policy for when packages and homogenous cases of drugs without a product identifier are grandfathered from certain provisions of the Drug Supply Chain Security Act (DSCSA). While the guidance comes two years after the deadline set by the DSCSA and on the same day that requirements for manufacturers to begin affixing or imprinting product identifiers on packages and homogenous cases ...
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    FDA Offers Draft Guidance to Further Secure Drug Supply Chain

    The US Food and Drug Administration (FDA) has released draft guidance ahead of the first of a series of public meetings to help companies meet the drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) of 2013. Background The DSCSA outlines the path to better secure the US drug supply chain via an electronic, interoperable system by 2023 to track and trace certain prescription drugs as they are distributed. The law helps FDA ensur...