Last week FDA published a notice of public meeting and a request for comments regarding certain aspects of the Drug Supply Chain Security Act (DSCSA). The meeting will take place on October 14, 2016 at the Agency’s campus in White Oak, Maryland. This webpage provides further information for potential attendees. The upcoming event will be the first public meeting convened by FDA to address DSCSA-related issues. The DSCSA requires the Agency to conduct at least 5 such meetings during the lengthy implementation period in order to keep it engaged and communicating with relevant stakeholders.
As we have described previously (see here and here), the goal of the DSCSA is to implement enhanced security and accountability for prescription drugs throughout the U.S. pharmaceutical supply chain. It created phased-in obligations for various “trading partners,” such as manufacturers, distributors, and dispensers, over a 10-year period, beginning with the law’s passage at the end of 2013.
Among many others, one of the impending obligations facing industry is the requirement that manufacturers and repackagers affix or imprint a product identifier, at the package level, to prescription drug products that they introduce into commerce. This product identification step is also referred to as “serialization,” and eventually trading partners will only be allowed to sell and buy serialized drug products. Manufacturers and repackagers must comply with their initial product serialization mandates by November 2017 and November 2018, respectively. Continue Reading FDA Holding its First Public Meeting on Drug Product Identification Requirements in October