“Beware of Rogue Wholesale Drug Distributors Wholesale drug distributors are a link between manufacturers and health care professionals. Their role is to ensure prescription medications are delivered safely and efficiently to thousands of health care practitioners and pharmacies nationwide every day. While the U.S. health care supply chain is one of the most secure and […]
Month: September 2014
Industry groups take issue with guidance on outsourcing facilities
“GPhA says compounders and outsourcing facilities should abide by the same inspection criteria as other drug manufacturers. “Drug manufacturers with U.S-based facilities are required to be inspected by FDA at least every 24 months,” GPhA says. “Compounders producing sterile products should be held to similar standards.” Similarly, BIO disagrees with FDA’s proposed alternative approaches for […]
HDMA – Issues in Distribution: Pharmaceutical Traceability and the Drug Supply Chain Security Act
“The Drug Supply Chain Security Act (DSCSA, or Title II of the Drug Quality and Security Act) was enacted on November 27, 2013. The act replaces a 50-state patchwork of pedigree requirements with one federal traceability solution for prescription medicines, and raises licensure standards across the U.S. The law will transform how the domestic supply […]