Don Puryear, from TurningPoint Systems, recently attended the Healthcare Distributors Alliance (HDA) conference where pharmaceutical manufacturers and pharmaceutical distribution executives met to discuss the upcoming implementation of the Drug Supply Chain Security Act (DSCSA).
“Implementation of the Drug Supply Chain Security Act (DSCSA) continues to transform the pharmaceutical supply chain. Mandatory serialization and traceability technology, as well as FDA compliance with both, is top on the minds of pharmaceutical manufacturers and pharmaceutical distributors. Don’t expect extensions for compliance from the FDA. It is not going to happen again.” – Don Puryear, TurningPoint Systems
Traceability and serialization in the healthcare supply chain were just two of the hot keywords at the conference. Everyone was listening for direction and guidance from the FDA as the DSCSA moves forward to the 2023 full implementation deadline.
What is the Drug Supply Chain Security Act (DSCSA)
The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. This will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.
Additionally, the DSCSA directs FDA to establish national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities report licensure and other information to FDA annually.
Who Does It Impact
The Drug Quality and Security Act (DQSA) will directly impact everyone in the healthcare and drug supply chain, from drug manufacturers to distributors/wholesalers, and ultimately retailers. Full implementation of the law is being phased in over ten year period, but already directly impacts pharmaceutical manufacturers, including relabelers.
About TurningPoint Systems
ProfitPoint/Rx ERP offers Pharmaceutical distributors world-class enterprise resource planning software that will seamlessly manage the flow of ordering, warehousing, inventory, regulatory data, and financial transactions for controlled substances, prescription and over-the-counter products, and more.
Profit Point/Rx provides real time information to track the movement of inventory, order placements, financial transactions, and product delivery. Profit Point/Rx delivers end-to-end technology with track and trace functions and reporting that takes the complexity and expense out of the warehousing for controlled substances and regulated products. Our ERP software is a best-of-class solution that helps you run your company more efficiently and more profitably.
For more information about TurningPoint Systems and how we are helping our customers meet the requirements of the DSCSA law drop us a line using the inquiry form below. We’ll follow-up with you promptly.