The returned pharmaceuticals provisions of the Food & Drug Administration’s (FDA’s) Drug Supply Chain Security Act (DSCSA) require pharmaceutical products that are returned in saleable condition to be verified as legitimate and safe before they are placed back in the supply chain for resale. These requirements will help battle the rising tide of counterfeit drugs, which the World Health Organization (WHO) defines as “products deliberately produced and mislabeled with respect to identity and/or source.”
Although it is hard to judge the extent of drug counterfeiting, since this crime is often detected only when the perpetrators are caught, the WHO estimates that 10% of global pharmaceutical products are counterfeit. The risks of counterfeit drugs are serious: they include drugs with no Active Pharmaceutical Ingredient (API) or the wrong API, contaminated drugs or expired products. These products can be toxic or fatal, or in the case of drugs with no API, they can mislead consumers into believing they are being treated when they are not. Follow-on effects can include the erosion of public confidence in the healthcare industry and pharmaceutical providers, the emergence of drug-resistant organisms and mistrust of drug regulatory bodies.
By combatting the distribution of counterfeit pharmaceuticals, the DSCSA improves patient safety and strengthens the supply chain. These laws provide a single source of truth and clarity, helping identify illegitimate pharmaceuticals. The DSCSA benefits pharmaceutical manufacturers and wholesalers as well, helping to protect their brands and reputations, reducing litigation and lost sales, as well as preventing the costs associated with disposing of counterfeit products.
The DSCSA requires manufacturers, wholesalers and other stakeholders in the pharmaceutical supply chain to track, trace and verify prescription drugs. Manufacturers and repackagers must serialize products with a set of identifying information. Supply chain stakeholders must be able to verify that a product is legitimate and must be able to notify their trading partners quickly if an illegitimate product is suspected.
According to the upcoming saleable returns verification requirement, wholesale distributors must verify the serialized product identifiers of any pharmaceuticals returned in saleable condition before they can be resold. The wholesaler initiates a verification request to the manufacturer, who must respond within 24 hours with a verification response that indicates whether the product identifier is correct and true. Many wholesalers currently rely on manual processes or point-to-point solutions, resulting in process disruptions and delays.
With Movilitas.Cloud, compliance is greatly simplified, making it easy for wholesalers to properly handle returned products with confidence. Wholesalers can save time and improve efficiency with Movilitas.Cloud’s mobile scanning and verification app:
No major investment or infrastructure management is required: just register and start verifying. With real-time feedback after each scan, you know immediately whether products are legitimate. A complete history of scans is available to help you identify trends and patterns to optimize your operations.
