Introduced to prevent counterfeit, stolen, or contaminated prescription drugs from entering the supply chain, the DSCSA is enforced by the Food and Drug Administration FDA and provides regulations for manufacturers, wholesale distributors, dispensers, repackagers, and third-party logistics providers 3PLs. In addition to product labeling and traceability standards, the DSCSA created a framework for credentialing and identifying authorized trading partners ATPs.
This allows supply chain actors to ensure that they are working only with verified and compliant companies. Every member of the supply chain has a responsibility to maintain drug traceability records, thereby promoting public health interests under the DSCSA. Broadly, interoperability means that manufacturers, wholesale distributors, dispensers, repackagers, 3PLs, and other supply chain members can exchange mandated Transaction Information TI and Transaction Statements TS every time a drug changes hands.
And they must do so in a secure, electronic, and interoperable manner. Required product data includes Product Identifiers PIs serial numbers, expiration dates, and lot and batch codes. Pharmaceutical supply chain members are considered to be trading partners if they are involved in the exchange, purchase, or sale of drug products and biologics. If necessary, they have also registered with the appropriate state board of pharmacy. There are also tangible benefits for your business, your trading partners who must also be ATPs, of course , and your patients and customers.
These benefits include:. In turn, this will lead to enhanced trust with consumers and trading partners. Before engaging with any partner, always verify their ATP status.
To verify a trading partner, simply:. Authorized trading partners play a pivotal role in pharmaceutical traceability. At every node of the supply chain, products could be damaged, tainted, or otherwise altered. Instead, they should continue getting their houses in order. So what should you be doing? Additionally, you should explore technology upgrades that will help you comply with forthcoming DSCSA requirements. To learn more about how you can prepare, connect with rfxcel. Our No. Connect with our friendly experts to help answer your questions.
