Passed in 2013, the Drug Supply Chain Security Act (DSCSA) was enacted as a measure to protect the prescription drug supply chain in the United States against counterfeit, stolen, contaminated, or otherwise harmful products. Under this legislation, Manufacturers, Wholesale Distributors, Dispensers, Repackagers, and Third-Party Logistics Providers are required to gradually implement the new requirements strengthening the FDA’s ability to track and audit their pharmaceutical supply chain over a 10-year timeline.
The next milestone in DSCSA’s timeline is quickly approaching. On November 27, 2020, the FDA will require all Wholesale Distributors to verify the product identifier upon receipt of returned products before further distribution. This will be followed by the interoperability requirement going into effect in 2023, and the states themselves are also reviewing potential changes to license requirements in the wake of the DSCSA uniform national policy licensing standards for Wholesale Distributors and Third-Party Logistics Providers.
Now is the time to ensure you are meeting the current DSCSA requirements and to plan for the additional obligations ahead. All Life Sciences organizations mentioned are required to confirm that their trading partners are Authorized Trading Partners with an FDA Registration or appropriate state license number.
How Can MedPro Systems Help?
MedPro’s suite of healthcare license validation solutions is powered by our robust Healthcare Organization (HCO) database, MedProID. The MedProID database will allow you to verify that all of your trading partners are authorized pursuant to the DSCSA.
Our team has been closely following the FDA’s implementation of the DSCSA requirements and their impact on state licenses and registrations. We can provide HCO license information for Manufacturers, Wholesale Distributors, and Dispensers. We also have state license information for those states that distinctly license Repackagers, Third-Party Logistics Providers, and Reverse Distributors. MedPro can provide you with the license type, status, number, and expiration date, as well as the address when provided by the authoritative state source.
Contact us today, and our team would be happy to discuss how MedPro can assist your organization with DSCSA compliance.