FDA’s Delay Issuing DSCSA Grandfathering Guidance Creating Problems For Manufacturers
US agency's delay in issuing guidance for how it intends to handle un-serialized 'grandfathered' drug products is creating headaches for manufacturers and other parties in the pharmaceutical distribution chain.
You may also be interested in...
Pharmaceutical manufacturers should have already begun serializing products and verifying saleable returns to comply with DSCSA, says FDA official who also asserted that licensing standards for wholesale distributors and third-party logistics providers will be forthcoming. This rule is already six years overdue under a DSCSA mandated timeline.
Highly anticipated proposed rulemaking from the FDA on licensing standards for wholesale distributors and third-party logistics providers has been repeatedly delayed, and the reasons for the delay are unclear. The rule is five years overdue under a DSCSA mandated timeline.
As supply chain partners drill down into implementing the last phase of Drug Supply Chain Security Act serialization, they ask FDA for more clarity, and some relief, on exception handling for products with no serial numbers after full track-and-trace goes into effect.