“On January 4, CDRH issued its first draft device guidance of the year. The Draft Guidance “Unique Device Identification: Convenience Kits” explains FDA’s position as to what constitutes a convenience kit for purposes of the UDI Rule.”
“HDMA’s 2014-15 Factbook updates member financial, operational performance.
The just-published 2014-15 Factbook, a compilation of HDMA member data as well as relevant industry statistics, gives evidence that full-line wholesalers are running faster—shipping more products each day, while handling a higher daily average of orders. The report also provides a snapshot of what the industry was looking like in 2013 just as the Drug Supply Chain Security Act was passed; presumably, the report from a year from now will show how ready the industry was for the Jan. 1, 2015, deadline coming up for reporting transaction information to customers and FDA, per DSCSA requirements. ”
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 sophisticated in the world, there is a growing network of rogue wholesale drug distributors selling potentially unsafe drugs in the U.S. market.”
“The National Association of Specialty Pharmacy and the Specialty Pharmacy Association of America announced the merger of the two organizations, creating the largest professional and trade association focused on the unique needs in specialty pharmacy.
“This is a historic moment in our industry — one in which our two organizations come together, recognizing the unique strengths each has contributed to specialty pharmacy and the pharmacy industry as a whole, to develop a strong, unified voice representing all specialty stakeholders,” Gary M. Cohen, BSPharm, RPh, CSP, NASP CEO said.”