Running a pharmacy involves more than filling prescriptions—it requires rigorous pharmacy compliance to meet federal and state regulations. Whether you operate a community pharmacy or a large chain location, strong pharmacy regulatory compliance systems protect your license, your staff, and your patients.
Use this checklist to build pharmacy audit readiness and reduce compliance risk across your operation.
Why Pharmacy Compliance Matters
Pharmacies are closely monitored by boards of pharmacy, the DEA, and state regulators. Noncompliance can result in fines, license suspension, or loss of DEA registration. A proactive compliance program safeguards public health and preserves your organization’s reputation.
Staffing and Training Requirements
- Defined competencies: Train all team members on ID verification, recognizing red flags, and robbery response.
- Scheduling and handoffs: Implement fatigue-aware schedules and formal shift-change checklists to reduce errors.
- Role-based education: Provide structured pharmacy staff training for pharmacists, technicians, delivery drivers, and support staff.
Physical Security and Inventory Controls
- Secure storage: Restrict access to controlled substances and pseudoephedrine as part of your pharmacy security protocols.
- Accurate inventory: Use perpetual or frequent cycle counts, including blind counts at shift change.
- Automated monitoring: Deploy tools that flag discrepancies for stronger pharmacy inventory control.
Dispensing Safeguards and SOPs
- PDMP checks: Verify controlled prescriptions through your state Prescription Drug Monitoring Program.
- Prescriber validation: Confirm telemedicine and out-of-area prescribers are licensed and appropriate.
- Standard operating procedures: Maintain clear pharmacy SOPs for refusal-to-fill, documentation, and communication.
Enhancing the Customer Experience
- Accessible signage: Display operating hours and multilingual signs (e.g. “pharmacy cerca de mí”).
- Secure layout: Provide controlled entry and private counseling areas.
- Transparency: Post expected wait times and language access options.
How PCG Supports Your Pharmacy Compliance Program
PCG helps align pharmacy operations with pharmacy operational compliance best practices—protecting your license, your staff, and your patients while supporting safe, compliant care.
Please contact us for more information solutions@pcgrx.com