Sorry everybody....
I've been very tied up at work lately so have not been focusing on the blog. Decided to jump on and post a very, very short bit of info....
So, the Healthcare Distribution Association (HDA) has requested that the DEA move the requirements out more slowly for DSCSA (I.e., a request to delay enforcement requirements for a 2 year time span). Think of the HDA being similar to the ASHP or APhA but for distributors. The reason for the request for delay makes perfect sense. There are many pharmaceutical companies just not ready for November 27, 2023 drop dead date. They are not able to supply the required informations to the wholesalers. So, if DSCSA is fully implemented and wholesalers stop purchasing items from these companies (to follow the full scope of requirements), shortages of products may be a major issue.
Some congressional contacts to the FDA have also occurred. Reps. Troy Balderson (R-OH) and Ann Kuster (D-NH) sent a letter that was co-signed by 29 House legislators requesting delay to help prevent shortages.
Ok another front, American Pharmacist's Association (APhA) has also contacted the FDA to request consideration for compliance in retail settings. They are requesting a 2 year lead in time as well (they are asking to delay until February 2026).
It still remains to be seen if the FDA will agree to any modifications to their processes or evaluations/findings related to DSCSA. Will document on this page if I find out something.
Thanks all!
Jay G
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