Recent observations on DSCSA exemptions and credentialing technology
By now, you’ll probably have heard that FDA has granted a selective enforcement delay for small dispensers with the definition of ‘small’ being broader than in previous guidance. See announcement from June 12, 2024.
Significant take-aways from the subsequent PDG/FDA Joint Public Meeting on June 17 & 18, 2024 were that:
- FDA firmly stands by the originally declared end of the Stabilization Period as being Nov 27, 2024;
- FDA is serious about requiring you to trade only with other Authorized Trading Partners (ATPs);
- EPCIS-related exception handling is still a major pain point for trading partners.
There is some hope amongst some trading partners that Waivers, Exceptions and Exemptions (WEE) will be granted by FDA to alleviate the compliance burden. However, based on other observations we’ve made, the blanket small dispenser exemption and any individual WEEs could cause some confusion due to lack of transparency of who is exempt and to which extent, especially in automated electronic processes.
Regarding the DSCSA requirement for ATP checks, the importance of proper due diligence of your trading partners is underlined by the recent reports on counterfeit drugs (read case study).
Let’s not forget the GS1 Connect 2024 on June 4–6, 2024, where we noticed that credentialing was recognized as being a feasible electronic solution for various use cases. We take this as an encouraging signal that verifiable credentials are now moving from being a novelty to becoming a natural choice when it comes to identity management in the widest sense.
