Licensing and Registration (Legal Requirements of a Drug Store)
Pharmacy License: Obtain from state board or relevant authority; requires applications, fees, and documents.
Pharmacist-in-Charge (PIC): Designate and register a licensed pharmacist responsible for operations.
Business Registration: Register with local/state authorities; obtain business permits and tax IDs.
Controlled Substances Registration: Register with agencies (e.g., DEA) for controlled substances, meeting storage, record-keeping, and reporting requirements.
Facility Requirements
Premises Approval: Meet standards for size, cleanliness, and suitability; inspection required.
Equipment and Resources: Maintain equipment for dispensing and storage; access to current pharmaceutical references.
Storage Conditions: Ensure proper storage for medication integrity, with designated areas for various products.
Staffing Requirements
Qualified Personnel: Employ licensed pharmacists; technicians may need certification.
Continuing Education: Pharmacists must complete ongoing education for license renewal; regular staff training on regulations.
Operational Standards
Standard Operating Procedures (SOPs): Develop and update SOPs for pharmacy operations.
Quality Assurance Programs: Implement systems for quality control and error reduction.
Regulatory Compliance: Adhere to laws on prescriptions, confidentiality, and advertising.
Insurance and Liability
Professional Liability Insurance: Coverage for malpractice or negligence.
Business Insurance: Protects property, inventory, and general liability.
these all are Legal Requirements of a Drug Store