Secure necessary licenses and permits from your state’s Board of Pharmacy. This includes registration as a pharmacy and licensure for all pharmacists and technicians.
Strictly adhere to state and federal regulations regarding drug storage, handling, and dispensing. Maintain meticulous records of all medications, including inventory, purchases, and dispensing information. Implement a robust inventory management system to prevent drug shortages or expirations. Regularly conduct medication reconciliation to ensure accuracy.
Comply with the Controlled Substances Act (CSA) by registering with the Drug Enforcement Administration (DEA) and following strict procedures for handling controlled substances. Maintain secure storage areas and utilize inventory control systems designed for controlled medications.
Implement robust security measures to protect patient information, including physical security of records and adherence to HIPAA regulations for electronic health information (ePHI). Employee training on data privacy is vital.
Develop and implement standard operating procedures (SOPs) for all pharmacy activities, including ordering, receiving, dispensing, and waste disposal. These SOPs should reflect current regulations and best practices.
Conduct regular internal audits to identify areas of improvement and ensure compliance with all applicable regulations. Document all audit findings and corrective actions.
Stay current on all relevant changes in state and federal pharmacy laws and regulations. Subscribe to professional journals, attend continuing education events, and engage in regular review of updated guidelines.
Partner with legal counsel specializing in healthcare and pharmacy regulation to ensure ongoing compliance and receive guidance on complex legal issues.
Regularly review and update your pharmacy’s policies and procedures to maintain compliance with the latest regulatory requirements and ensure best practices are followed.
