The Drug Supply Chain Security Act (DSCSA) is a regulation implemented by the U.S. Food and Drug Administration (FDA) to improve the security of the pharmaceutical supply chain and help prevent counterfeit drugs from entering the U.S. market. The regulation sets standards for the identification, tracking, and tracing of prescription drugs as they move through the supply chain from the manufacturer to the patient.
Under the DSCSA guideline, pharmaceutical manufacturers must:
Implement systems and processes to verify the authenticity of drugs and ensure that they are not counterfeit.
Use unique product identifiers (UPIs) to track drugs as they move through the supply chain (forward and reverse).
Report any suspect or illegitimate drugs to the FDA.
Maintain records of all movement transactions for a minimum of six years.
Provide a chain of custody for drugs that can be traced from the manufacturer to the patient or destruction.
The DSCSA regulation also requires wholesalers and pharmacies to perform due diligence when purchasing drugs from other parties and to ensure that they have received drugs from authorized sources.
The goal of the DSCSA is to improve the safety and security of the U.S. drug supply chain and protect patients from the risk of exposure to counterfeit drugs. In regard to the reverse distribution, this regulation and guideline will result in significant reduction of diversion. N3PR is the only solution in the market right now that place the control of this regulation in your hand and not a 3rd party. This regulation is being implemented in stages, with full compliance required to be in in place by November of 2023.
Audit your 3rd party reverse distributor for compliance to this regulation.