The U.S. Food and Drug Administration issued a Feb. 2015 Guidance for Industry titled, “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities,” that is being distributed for comment purposes only.
Although there are differences between the medical device Unique Device Identification (UDI) regulation and the Pharmaceutical Drug Supply Chain Security Act (DSCSA), Videojet Technologies’ Tim Kearns finds many common aspects across both.
Will packaging and other machines be easier and more cost-effective to purchase and install in the future? More than 100 consumer packaged goods companies and 25 of their vendors are working with AIOE on new guidelines that could help make it happen.
Kevin O’Donnell, Senior Partner, Exelsius, is a noted authority in supply chain integrity. In this Q&A he lends his “big-picture” insights regarding distribution practices for time and temperature-sensitive pharmaceutical/biological products.