HIDA Government Affairs Update
Linda Rouse O’Neill
By Linda Rouse O’Neill, Vice President, Government Affairs
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 patients.
If you would like more information about this law or the FDA’s enforcement discretion, please contact us at HIDAGovAffairs@HIDA.org.