Systech blog
Solve your compliance, authentication and traceability challenges with industry insights on the latest packaging and supply chain advancements.
The EU Falsified Medicines Directive Regulation Explained
Here's a deep dive into the details of the European Falsified Medicines Directive regulation and requirements for pharma manufacturers and non-manufacturers.
The EU Falsified Medicines Directive (FMD) Compliance Revisited
With the United States being far and away the largest pharmaceutical market in the world, complying with necessary regulations is critical for the industry.
NABP Pulse and Systech – A winning DSCSA platform combination for
Systech announced recently that it joined the National Association of Boards of Pharmacy (NABP) Interoperable Partner Program, Pulse by NABP. This is important news as both Systech and NABP want to ensure that pharmacies and dispensers are ready for DSCSA (Drug Supply Chain Security Act) compliance this November. Though a stabilization period has been granted by the FDA, the November 27, 2023 date is still the legal target for the industry.
DSCSA 2023 Guidelines from HDA Conference & FDA Stabilization
This extension is pivotal in addressing evolving challenges and further fortifying the integrity of the pharmaceutical supply chain.
DSCSA deadline 2023… there is NO extension
Don’t misconstrue that the DSCSA implementation is being delayed—it isn’t.
DSCSA exception management for dispensers: Is your process ready?
As part of the FDA’s Drug Quality and Security Act, one key rationale for the Drug Supply Security Act (DSCSA) was to protect US patients from receiving counterfeit or illegitimate medications. Everything the industry is doing to connect manufacturers, wholesalers and dispensers to create an interoperable supply chain is all about patient safety.
For pharmacies, DSCSA compliance starts with Authorized Trading
In the rapidly evolving landscape of pharmaceuticals, maintaining regulatory compliance is paramount for pharmacies. The Drug Supply Chain Security Act (DSCSA) aims to enhance patient safety by establishing a secure supply chain for prescription drugs.
Is your pharmacy ready for DSCSA exception handling?
The receiving process for totes at pharmacies from wholesalers hasn’t changed much over the past 25 or more years.… Physical packages reconciled to a printed manifest/order. Quantities checked. Verification that nothing is damaged. Inspection to see if anything is already expired. Data entry into a pharmacy inventory system. Even if there are some issues, the medicines get put into stock.
For pharmacies, DSCSA compliance is about data connections
Even if we do get a Drug Supply Chain Security Act (DSCSA) enforcement delay from the FDA, pharmacies are still on the hook for compliance. And compliance means connections.
