top of page
  • jwgilbreath

DSCSA —where are you now?

Updated: Sep 26, 2023

Hello all!!


With the FDA information about stabilization period for DSCSA in mind....


Are you pushing forward with your plans to be fully DSCSA compliant including electronic interoperability? Are you ready or still planning your process to "verify" the items that are being investigated as being suspect?


Has your pharmacy been robbed? You do realize that medications that have been stolen can be placed back into the flow of goods (I.e., a stolen product that you don't know how it was stored may end up in a pharmacy). The highest risk of this of course is if you are purchasing from the grey markets. So, if you are robbed make sure that you report to the FDA via a form 3911 within 24 hours of being robbed.


Definitely consider contracting with a third-party DSCSA compliance tool! These tools can be quite useful for maintenance of compliance!!


Keep moving forward!


Jay G

13 views0 comments

Recent Posts

See All

DSCSA Mid Point

Hello All! We are coming up to the midpoint of the FDAs stabilization period allowed for the industry to prepare for DSCSA compliance. Are you still moving forward? Testing your processes? At the 20

DSCSA—CDER NextGen Portal. Follow up

Hello all! So, as a follow up regarding the CDER NextGen Portal: As I stated in an earlier post, the portal is used as a communication tool especially if the FDA sends you a letter, email, etc request

Comments


bottom of page