Clinical Solutions Wholesale is one of the few companies in the Correctional Pharmacy Industry registered with the DEA and licensed as a FDA Repackager and Wholesaler, allowing for the legal distribution of stock medications.

Clinical Solutions Wholesale is currently licensed in 31 states. By holding an FDA repacking license as well as a Wholesale license, Clinical Solutions Wholesale is fully compliant with all Drug Quality and Security Act (DQSA) regulations related to wholesaling and FDA repackaging for stock distribution.

Clinical Solutions Wholesale performs the repackaging of legend drug products for wholesale distribution using Class-A packaging materials received under a Certificate of Conformance from approved suppliers. Clinical Solutions Wholesale takes great pride in its proprietary Quality Management System, which is designed to meet or exceed the FDA requirements for current good manufacturing practice in processing, packing, or holding of drugs and finished pharmaceuticals.

Clinical Solutions Wholesale is FDA audited and compliant to:

• 21 CFR 210/211
• 21 CFR 820
• cGMP and
• GDP

DSCSA COMPLIANT

Drug Supply Chain Security Act (DSCSA) implemented language around how much stock distribution licensed pharmacies can distribute. Clinical Solutions is one of the few companies in this industry licensed as an FDA Repackager and Wholesaler, allowing for the legal distribution of stock medications as required by your facility. In 2013, Clinical Solutions became an FDA Repackager and licensed Wholesaler to distribute stock medication. We are well-versed in good manufacturing practices and maintain a robust set of Standard Operating Procedures for both lines of our business.

Clinical Solutions agrees to fully comply with all pedigree requirements for DSCSA. Clinical Solutions has a dedicated pharmaceutical regulatory division and began implementing phases of the DSCSA in 2013 when the Act was signed. Even though DSCSA has a ten (10) year roll-out requirement for certain deliverables, Clinical Solutions has implemented some of the major milestones such as 2D bar-code reading which is already in use in our Wholesale line of business for product serialization.

Clinical Solutions Wholesale maintains the "3 Ts": transaction information, transaction history, and transaction statements. These transaction documents will be sent via email on the day the order is shipped.

CLINICAL SOLUTIONS WHOLESALE IS LICENSED IN THESE STATES