The FDA sent a warning letter to a large drug distributor for violations under the Drug Supply Chain and Security Act, acting on agency authority under this law for the first time since its passage in 2013. The letter alleges that the distributor sent bottles missing pills or with wrong pills to multiple pharmacies. The shipments were originally supposed to be for opioids. This warning letter is an important milestone for the supply chain because it serves as a warning to the industry that all U.S. trading partners, including pharmacies, should ensure they are adhering to their responsibilities under the DSCSA. All pharmacies should have processes in place to identify suspect or illegitimate product at their pharmacy. NCPA has created a downloadable checklist to help community pharmacies understand pharmacy-specific DSCSA requirements.
NCPA
