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 coming this fall. The Drug Supply Chain Security Act (DSCSA) requires pharmaceutical manufacturers and repackagers to add product identifiers to (or “serialize”)pharmaceutical products, as of November 27 of last year. The next deadline under this rule, November 27, 2019, is the date after which distributors can only buy, carry, or sell (“transact”) in serialized products and are required to verify serialized product identifiers (PIs) for saleable product returns before they can be resold.
What this means for distributors
Manufacturers and repackagers are now required to begin putting a PI on each package. The packages with the identifier must be the smallest saleable unit (set by manufacturers), and the identifier must be printed with a machine readable (2D) barcode and human readable text. After the 2019 deadline, distributors are not permitted to sell any products that do not contain the necessary PIs.
Now is the time to make sure your trading partners are aware of these requirements. If your company operates a low-unit-of-measure program or a just-in-time program, it is responsible for making sure the smallest saleable unit it delivers possesses a product identifier.
Complying with this requirement could be a challenge for some distributors. For this reason, HIDA and its members have been reaching out to the Food and Drug Administration (FDA) and advocating for measures to make this shift easier. The agency has previously indicated that it is willing to work with the supply chain, and granted enforcement discretion on a portion of the DSCSA in 2017. While the FDA was willing to listen to healthcare suppliers’ input in the past, there is no guarantee that it will be flexible in the future.
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. This information will help distributors make decisions about their own operations as well as how to track what they sell to customers.As the FDA continues to release information and updates on the DSCSA, an open channel between you and your manufacturing partner will ensure no compliance measure is overlooked.
If you would like more information about this law or the FDA’s enforcement discretion, please contact us atHIDAGovAffairs@HIDA.org.