REMS Compliance

REMS Compliance refers to adhering to Risk Evaluation and Mitigation Strategies, which are plans required by the FDA to ensure that certain medications are used safely. These strategies include specific training, certifications, or monitoring to minimize risks like side effects or misuse. Healthcare providers and pharmacies must follow these steps exactly to maintain safe use, and regular reporting confirms that the safety measures are being properly implemented. In essence, REMS Compliance ensures that both patients and providers follow the safety protocols designed to protect health while benefiting from the medication.