If your company sells pharmaceutical products – and many
medical-surgical distributors do – there’s an important deadline
looming. The Drug Supply Chain Security Act (DSCSA) requires pharma
manufacturers to add product identifiers to (or “serialize”)
pharmaceutical products by Nov. 27, 2017. Both distributors and
manufacturers have expressed concern about the industry’s readiness for
this deadline. In response to these concerns, the FDA has announced a
one-year enforcement discretion on this portion of the DSCSA.
What this means for distributors
The delay is important, because otherwise distributors could be
penalized for selling non-serialized products. Products that don’t have
the required identifiers by the deadline are considered misbranded, and
manufacturers or distributors that sell them could be subject to fines
or even criminal prosecution. Without the delay, many companies could be
at risk, given that many drug manufacturers don’t appear to be fully
ready for product identification.
However, the guidance that accompanied the delay is complicated. It
states that the FDA will not take action against distributors or
manufacturers who buy or sell non-serialized pharmaceuticals IF those products entered the supply chain between Nov. 27, 2017, and Nov. 26, 2018.
How do you know when the product entered the supply chain? That’s not
clear – in fact, the FDA is seeking public comments on how
manufacturers can indicate the date they introduced a product into the
supply chain and how distributors can determine whether a product
entered the supply chain during the enforcement discretion window.
What didn’t change
Note that the FDA did not change the actual deadline for compliance;
instead it provided companies with a one-year grace period before
penalties will be incurred. That means that the agency fully expects
pharma manufacturers to continue moving quickly to add the required
identifiers to their products.
Also, the enforcement guidance does not apply to the
requirement that manufacturers must begin to provide product transaction
information, transaction history, and transaction statements in
electronic format by November 27, 2017.
And perhaps most important, the law has a strict timeline that
repackagers, wholesale distributors, and dispensers must follow in order
to avoid selling products that do not have the DSCSA product identifier
on them. These requirements have a multi-step timeline that begins
November 27, 2018, and that timeline remains unchanged.
Communication between distributors and manufacturers is vital
As this next phase of DSCSA approaches, it is important for distributors
to stay in touch with their trading partners to understand their
readiness for complying with the law and how they intend to meet data
transmission requirements. This information will help distributors make
decisions about their own systems as well as how to track what they sell
to customers. Additionally, it is important to maintain an ongoing
dialogue with your manufacturing partners as the FDA continues to
release information and updates on how it plans to enforce the DSCSA.
Regularly communicating with your manufacturing partners and
customers can help all parties comply with the law and ensure the
efficient movement pharmaceutical product through the supply chain for
If you would like more information about this law or the FDA’s enforcement discretion, please contact us: HIDAGovAffairs@HIDA.org