Pharmaceutical traceability is the new regulatory reality. Within the next five years most markets will mandate pharmaceutical serialization at the item-level as a means to enable traceability.
A key enabler of pharmaceutical traceability is the ability of manufacturing, packaging, distribution, dispensing and patient to share information in an interoperable manner.
To minimize the chance of patients receiving an unapproved, counterfeit, unsafe, or ineffective medication, FDA is requesting that the medical practices stop administering drugs purchased from any foreign or unlicensed source.
FDA is using four flyers to educate and alert medical professionals on the risks and liabilities of purchasing medications from unauthorized or unethical wholesalers.