May 4, 2016

Quality & Compliance

ASE Rx has an excellent quality and compliance reputation with regulatory agencies and our customers. ASE Rx is a registered wholesale / distributor in the state of Tennessee and is in compliance with all FDA and DEA rules, regulations and registrations on the state and Federal level. We are also registered and certified for distribution of controlled substances, C2 – C5. ASE Rx complies with all rules and regulations of the Drug Supply Chain Security Act (DSCSA). We are very proud of our DSCSA pedigree tracking software program that can easily integrate with our partners through EDI connectivity, thus creating a streamlined supply chain distribution process.

ASE Rx only partners with companies that comply with all FDA / DEA rules and regulations and must be current on all registrations and licenses. Furthermore, ASE ensures that all partners are cGMP compliant and abide the regulations set forth by the FDA.

cGMP

cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.