Pharmacies should be aware of the following changes regarding the Drug Supply Chain Security Act (DSCSA) effective November 2023:
Serialized Product Verification: Starting November 27, 2023, pharmacies must verify the serialized product identifiers (including unique serial numbers) of certain prescription drugs before dispensing them to patients. This step aims to enhance product authentication and prevent the distribution of counterfeit or illegitimate drugs.
Suspect Product Investigation: Pharmacies are required to investigate and quarantine any suspect products, including those with questionable packaging, labeling, or authenticity. Maintaining accurate records and promptly reporting suspicious activities to the appropriate authorities is crucial.
Enhanced Verification and Notification: The DSCSA mandates that pharmacies should be more vigilant in verifying and validating the legitimacy of the drugs they receive from suppliers. Additionally, they must notify trading partners and the FDA in case of suspect or illegitimate products.
Grandfathering Provisions: Certain product packages that were manufactured and labeled before November 27, 2023, may be exempt from the serialized product verification requirements. However, pharmacies must comply with the DSCSA requirements for any subsequent repackaging or relabeling activities.
Interoperable Electronic Systems: The DSCSA encourages the use of interoperable electronic systems to facilitate secure and efficient product tracing throughout the supply chain. Pharmacies should consider adopting or upgrading their systems to support these capabilities.
It is important for pharmacies to familiarize themselves with these DSCSA changes, implement necessary procedures and technologies, and stay updated with any additional guidance provided by regulatory authorities to ensure compliance and maintain the integrity of the drug supply chain.
With PharmCAP, you gain access to powerful tools that safeguard your pharmacy and ensure compliance, providing you with the peace of mind you deserve. Our comprehensive platform, backed by a dedicated staff and strategic partnerships, is designed to assist you in navigating the time-consuming and personnel-intensive tasks of staying current with shifting regulations and evolving laws.
Trust PharmCAP to empower your pharmacy with the necessary resources and expertise, so you can focus on what matters most: delivering quality care to your patients.