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Citing FDA’s slow guidance, the American Pharmacists Association is requesting delay in November 2023 DSCSA enforcement.
The Drug Supply Chain Security Act (DSCSA), passed into federal law in 2013, set up a 10-year implementation schedules with numerous milestones to be met by manufacturers, distributors, and pharmacies, with a goal of a fully interoperable electronic system of data sharing to be in place by November of this year. Manufacturers and then distributors had the initial milestone targets, but now, as the process nears its planned conclusion, the pharmacy sector is looking for more time to comply.
In late January, the American Pharmacists Association (APhA) announced its request for more time, saying that because FDA had its own deadlnes for announcing final guidance, holding public meetings, and assessing pharmacy readiness—and hasn’t met one of them—a delay in enforcement is necessary. “It’s a misnomer to say that pharmacies had 10 years to comply with DSCSA, since it is still waiting for FDA,” Dr Ilise Bernstein, acting CEO of the association, tells Pharmaceutical Commerce. The burdens will fall heaviest on smaller pharmacies; thus, APhA is looking for “enforcement discretion” from FDA, such that the standing regulations would not be enforced until a later date.
FDA has used this enforcement discretion with DSCSA at least twice in the past several years for the benefit of manufacturers and distributors, so there is precedent. Some observers in those industries expect a delay anyway, because there are still knotty problems to be worked out, but as late as last December, when FDA held a public meeting on DSCSA, it is staying firm on the November 2023 deadline.