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  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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    Pharmaceutical and generic drug industry groups are seeking changes to US Food and Drug Administration (FDA) draft guidance on the verification systems that can determine, quarantine and investigate suspect or illegitimate products.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...
  • Regulatory NewsRegulatory News

    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    The US Food and Drug Administration (FDA) on Monday issued draft guidance detailing its policy for when packages and homogenous cases of drugs without a product identifier are grandfathered from certain provisions of the Drug Supply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 ...
  • Regulatory NewsRegulatory News

    FDA Offers Draft Guidance to Further Secure Drug Supply Chain

    The US Food and Drug Administration (FDA) has released draft guidance ahead of the first of a series of public meetings to help companies meet the drug distribution security provisions of the Drug Supply Chain Security Act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...
  • Regulatory NewsRegulatory News

    FDA Details Plans for DSCSA Drug Tracing Pilots, Three Public Meetings

    The US Food and Drug Administration (FDA) on Wednesday announced it plans to launch a pilot program aimed at exploring issues related to the interoperable electronic system for drug tracing required under the Drug Supply Chain Security Act (DSCSA) by 2023. The agency also announced that it will hold a series of public meetings on DSCSA-related issues in August 2017, December 2017 and February 2018. At the meetings, FDA says it plans to discuss issues ranging fr...
  • Regulatory NewsRegulatory News

    FDA Delays Enforcement of Product Identifier Requirements

    In a draft guidance published Friday, the US Food and Drug Administration (FDA) says it does not intend to take action against manufacturers who do not affix or imprint a product identifier to each package and homogenous case of products intended to be introduced in a transaction into commerce before 26 November 2018. "This represents a one year delay in enforcement of the requirement for manufacturers to affix or imprint product identifiers. For the products that ...
  • Regulatory NewsRegulatory News

    Updated: FDA Offers Draft Q&A on Reporting Requirements for Wholesalers, Third-Party Logistics Providers

    The Food and Drug Administration (FDA) on Tuesday released draft question-and-answer guidance, supplementing another draft from 2014, to help drug wholesale distributors and third-party logistics understand their annual reporting requirements. The new draft, entitled "Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers," addresses questions about and clarifies FDA's expectations for annual reporting to ...
  • Regulatory NewsRegulatory News

    FDA Finalizes Drug Supply Chain Guidance, Seeks Comment on New Section

    The US Food and Drug Administration (FDA) on Thursday released final guidance on the implementation of the Drug Supply Chain Security Act (DSCSA), though it’s also seeking comment on a new section describing when manufacturers should notify FDA of a high risk that a product is illegitimate. Under the new section, which FDA says is being distributed “for comment purposes only,” the agency offers its interpretation of Section 582(b)(4)(B)(ii)(II) of the Food, Drugs and ...
  • Regulatory NewsRegulatory News

    Companies Collaborate on DSCSA Guideline as Deadlines Approach

    Beginning next November, pharmaceutical companies will be required to mark their products with a National Drug Code (NDC), serial number, lot number and expiration date in both machine-readable and human-readable format thanks to the Drug Supply Chain Security Act (DSCSA) of 2013. In preparation for that deadline and others over the next seven years, a diverse group of 44 companies – from manufacturers to wholesalers to solution providers – came together to develo...
  • 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

    With Weeks Until Drug Track and Trace System Launches, FDA Issues New Guidance

    With just weeks left until new tracking standards come into effect, the US Food and Drug Administration (FDA) is releasing new recommendations it hopes will better secure the pharmaceutical supply chain from accidents and counterfeiters alike. 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 ...