Key takeaways:
· Manufacturers' exemptions expired on May 27, distributors' on August 27, and dispensers' are set to expire on November 27.
· The exemptions were primarily designed to prevent supply chain disruptions stemming from data exchange failures.
· As it stands, the industry appears ready for full implementation.
The FDA's decision to implement phased exemptions for manufacturers, distributors, and dispensers under the Drug Supply Chain Security Act (DSCSA) is a strategic move to address data exchange issues and ensure smooth compliance. Kala Shankle, the Healthcare Distribution Alliance's (HDA) Vice President of Regulatory Affairs, explains that these exemptions, which began last October, were designed to prevent supply chain disruptions stemming from data exchange failures.
"The FDA aimed to avoid forcing a premature cutover that would've disrupted product movement," she nots. “It was a very welcomed phased exemption period for the supply chain, and it was a balanced approach by the FDA.”
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