An important notice to manufacturers and re-packagers of prescription drug products issued recently from the FDA website.
You may recall that in 2017, the FDA introduced a change requiring registered drug establishments to submit a “blanket no-change certification” (in SPL format) for all drug listings that required no updates within that year. This change meant that any drug listings that were not certified as required were subject to removal from publication and risk being considered “misbranded.”
Fast forward to 2018, and these same individuals will need to update their products to include serialization by November 28, 2018 per the *Drug Supply Chain Security Act (DSCSA). The FDA is saying that as a result of this:
Manufacturers and re-packagers of products identified above who have not yet incorporated the new product identifier (serialization) requirements into their labeling should NOT certify that their listings are up-to-date during the registration renewal period. Such a change requires that a new and representative sample of labeling incorporating the new product identifier requirements be submitted as an update to listing.
IMPORTANT: If you are accountable for drug listings that have NOT been certified as required, you will need to update them through a partial conversion.
With less than two months to go before the November 28 deadline, any affected organizations should be reviewing risks with product listings or already be in compliance. If you think your company may be affected and you are worried about missing the deadline, contact the team at Reed Tech. We will be happy to help.
See the FDA’s comprehensive Product Certification Guide for more