On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”...more
On Wednesday, the Food and Drug Administration (FDA) issued a statement granting additional exemptions from its November 27, 2024 deadline for compliance with certain product transaction requirements. The exemptions followed...more
Compliance is a key aspect of operating a successful pharmacy in the United States. This is true for pharmacies that bill federal healthcare benefit programs (i.e. Medicare, Medicaid, and Tricare) and private payors, and it...more
FDA on September 23 issued a Drug Supply Chain Security Act (DSCSA)– related compliance policy stating it will not take enforcement action against wholesalers that do not have systems in place to verify product identifiers of...more