United States Regulatory Updates

This is a compilation of the recent regulatory updates for the United States. Every week, we post an update of what's new, which you can view here.

2018

• November 25: Major industry associations have published their comments on the FDA product identifier Q&A guidance.
• October 28: The FDA published new draft guidance for verification under DSCSA.
• September 30: The FDA published a new decision tree for determining if a product should have a product identifier under the Drug Supply Chain Security Act (DSCSA).
• September 23: The FDA finalized three DSCSA-related guidance documents: A compliance policy for serialized products; a grandfathering policy for non-serialized product; and a general question and answer document along with key questions related to serialized product.
• August 26: The FDA announced an initiative to revise the National Drug Code (NDC). The initial announcement was made for the program along with an invitation for a first public meeting at the FDA, which will be held on 11/5.
• May 13: The FDA published guidance on waivers, exceptions, and exemptions this week for DSCSA compliance.
• April 1: The FDA released the Office of Inspector General report on pharmacy dispenser status with DSCSA compliance.
• March 4: The FDA published two new draft guidance documents for DSCSA on 2/28/18. The internal summary for these documents was prepared and circulated on 3/3/18.
• January 28: The FDA published their 2018 planned guidances for DSCSA.
• January 28: Medical Device: The FDA has published a letter postponing the implementation of UDI requirements for Class 1 by 2 years. The implementation is now slated for 2020 for phase 1 and 2022 for phase 2, which is direct marking.
• January 28: The USAID organization published new standards (requirements, implementation guidelines, and technical guidelines) that support the use of GS1 standards and require the supply of master data via a GDSN provider by the end of 2019. USAID provides these standards as part of its work with developing countries and their governments in enhancing medicine supply chains.