We want to engage a third-party logistics company (3PL) to store and transport our medicines. What compliance requirements apply?

Outsourcing pharmaceutical-product storage and transport to a third-party logistics company (3PL) is permitted, but this does not mean you can outsource your compliance responsibilities as well. As a licensed wholesaler, you remain ultimately responsible. When selecting and using a 3PL, the following compliance requirements must be met: 1. Due diligence: you must rigorously audit the 3PL to ensure its facilities, equipment, personnel and procedures meet GDP requirements. 2. Technical agreement: you must enter into a detailed Technical Agreement with the 3PL, clearly defining each party's responsibilities and obligations at every stage of pharmaceutical-product handling, including receipt, storage, temperature monitoring, picking, packing, transport, record retention, and complaint and recall handling. 3. Audit rights: you must retain the right to audit the 3PL regularly to ensure ongoing compliance. 4. Department of Health notification: you must notify the Department of Health of the 3PL engaged and the address where it stores your pharmaceutical products.