Third-party logistics providers (3PLs) must report licensure information to FDA annually
Manufacturers must print lot numbers on packaging
Manufacturers must serialize and verify products
Repackagers must serialize products
FDA delays enforcement of saleable returns requirement for wholesalers
Wholesalers/distributors can only receive and distribute serialized products
FDA announces extended stabilization period, postponing enforcement for one year
Full interoperable electronic unit-level traceability for all stakeholders
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