Info Collection Extension for PDMA Policies, Requirements

Federal Register notice: FDA has submitted to OMB for approval an information collection extension for “Prescription Drug Marketing Act of 1987 — Administrative Procedures, Policies, and Requirements” (OMB Control Number 0910–0435). This information collection supports FDA regulations implementing the Prescription Drug Marketing Act of 1987 (PDMA). The PDMA is intended to ensure safe and effective drug products and to avoid an unacceptable risk that counterfeit, adulterated, misbranded, subpotent, or expired drugs are sold to consumers. The reporting and recordkeeping requirements are intended to ban the reimportation of prescription drugs produced in the U.S., except when reimported by the manufacturer or under FDA authorization for emergency medical care. They also ban the sale or purchase of prescription drug samples, among other restrictions. To view the notice, click here.