The Drug Quality and Security Act (DQSA) comes into effect November 1st, 2015. Title II of the law, the Drug Supply Chain Security Act (DSCSA), creates tracing, verification and serialization requirements for all drug products across all changes of ownership from manufacturer to dispenser.
Global Pharmacy can share the information in one of two ways which are outlined below.
- Global Pharmacy Web Portal: If you do not currently exchange documents electronically, such as ASNs, you will have access to view the regulatory information by logging into your Global Pharmacy account on glbpharma.com. If you do not have a username and password, contact your sales rep for access. Once logged in, under the Your Account tab, there is the Find a Pedigree option. Here, you will find PDF files containing all the necessary information for compliance.
- B2B Connectivity: If you are EDI capable, you can be integrated with Global so that you can receive this information through your normal electronic transaction.
- A copy of the full law can be found on the U.S. Government Publishing Office site: click here to view.
- A detailed webcast of the DSCSA regulations and business requirements for the supply chain can also be found here.
Global Pharmacy Wholesale looks forward to working with you on this initiative. Should you have any questions, please don’t hesitate to contact us.
DSCSA is Title II of the Drug Quality and Security Act of 2013 (DQSA). Title I of DQSA addresses requirements for compounding.
In order to prepare for the DSCSA deadlines it’s important to review the applicable state’s current traceability laws. DSCSA establishes national traceability
The DSCSA defines a “return” as product going back to the immediate trading partner from which it came. For the first several years, DSCSA will allow returns without traceability data. Beginning six years after implementation, however, the DSCSA will require that the wholesaler verify the transactional information of the returned product.