Tennessee Pharmacy License Application

Overview of Pharmacy Licensure in Tennessee

Obtaining a pharmacy license in Tennessee is a structured process governed by the Tennessee Board of Pharmacy. The Board ensures that all pharmacies operating within the state meet the necessary standards to provide safe and effective pharmaceutical care to residents of Tennessee.

This comprehensive guide outlines the types of pharmacy licenses available, the application process, required documentation, fees, and ongoing requirements for maintaining a pharmacy license in Tennessee.

Types of Tennessee Pharmacy Licenses

The Tennessee Board of Pharmacy issues several types of pharmacy permits and licenses, depending on the specific nature of the pharmacy operation:

• Retail Pharmacy License: For community pharmacies that dispense medications directly to the public.
• Hospital Pharmacy License: For pharmacies operating within healthcare facilities that serve inpatients and outpatients.
• Long-Term Care Pharmacy License: For pharmacies primarily serving nursing homes and assisted living facilities.
• Specialty Pharmacy License: For pharmacies focusing on specific therapeutic areas or high-cost medications.
• Compounding Pharmacy License: For pharmacies that prepare customized medications.
• Mail-Order Pharmacy License: For pharmacies that primarily deliver medications by mail.
• Institutional Pharmacy License: For pharmacies serving correctional facilities, hospice centers, or other institutional settings.

Prerequisites for Pharmacy Licensure

Before applying for a pharmacy license in Tennessee, applicants must ensure they meet the following prerequisites:

• A designated pharmacist-in-charge (PIC) who holds a valid, active Tennessee pharmacist license
• A physical location that meets Tennessee's pharmacy facility requirements
• Compliance with local zoning ordinances
• Adequate professional liability insurance
• Application of all relevant federal, state, and local licenses and permits

Tennessee Pharmacy License Application Process

The application process for a Tennessee pharmacy license involves several steps:

1. Complete the Application Form

Begin by completing the official Tennessee Board of Pharmacy Application for Pharmacy Permit form. This form requires information about:

• The pharmacy name and physical address
• Ownership information (individual, partnership, corporation, etc.)
• The designated pharmacist-in-charge
• Hours of operation
• Services to be provided
• Other relevant operational details

2. Submit Required Documentation

Along with the application form, you must submit several supporting documents:

• A floor plan of the pharmacy facility, to scale, indicating all work areas, storage, and security measures
• Proof of ownership or lease of the pharmacy premises
• Copy of the pharmacist-in-charge's Tennessee pharmacist license
• Federal and state tax identification numbers
• Documentation of compliance with DEA requirements
• Professional liability insurance certificate (minimum coverage of $1 million per occurrence)
• Certificate of inspection from the Tennessee Department of Health, if applicable

3. Pay the Application Fee

Submit the required non-refundable application fee. Fees vary by license type but typically range from $200 to $500 for new pharmacy applications.

4. Facility Inspection

Once the application is received and reviewed, the Board will schedule an inspection of the pharmacy facility to ensure it meets all requirements. Areas of inspection include:

• Physical layout and security
• Storage conditions for medications
• Record-keeping systems
• Dispensing procedures
• Quality assurance measures

5. Board Review and Approval

After a successful inspection, the Board will review the complete application at their next scheduled meeting. The pharmacy will be granted a license upon Board approval.

Tennessee Pharmacy License Fees

License fees for pharmacies in Tennessee vary based on the type of pharmacy and other factors. The following table outlines the typical fee structure:

Pharmacy License Renewal

Pharmacy licenses in Tennessee must be renewed annually. The renewal process typically involves:

• Submitting a renewal form with updated pharmacy information
• Paying the annual renewal fee
• Confirming that the pharmacist-in-charge remains actively licensed
• Updating any changes in ownership, location, or services provided
• Attesting to ongoing compliance with Board regulations

Renewal notices are typically sent to pharmacies 60 days before the expiration date. It is the responsibility of the pharmacy to ensure timely renewal regardless of whether a renewal notice is received.

Additional Requirements for Pharmacy Operation

Beyond initial licensure and renewal, Tennessee pharmacies must comply with ongoing requirements:

• Continuing Education: Pharmacy personnel must complete required continuing education credits.
• Record Keeping: Maintain prescription files for at least two years.
• Controlled Substances: Strict adherence to federal and state laws regarding controlled substances.
• Quality Assurance: Implementation of ongoing quality assurance and improvement programs.
• Inspections: Allow unannounced inspections by Board representatives.
• Change Notifications: Report changes in ownership, pharmacist-in-charge, or address to the Board within 10 days.

Special Considerations for Out-of-State Pharmacies

Out-of-state pharmacies that wish to operate in Tennessee must apply for a Nonresident Pharmacy License. This license is required for:

• Mail-order pharmacies supplying Tennessee residents
• Pharmacies with locations in adjacent states serving Tennessee patients
• Specialty pharmacies serving Tennessee healthcare providers

Additional requirements for nonresident pharmacies include:

• Proof of licensure in the home state
• Designation of a registered agent in Tennessee for service of process
• Compliance with Tennessee's prescription monitoring program
• Submission to inspections by the Tennessee Board of Pharmacy

Frequently Asked Questions

How long does the pharmacy licensure process take in Tennessee?

The complete process typically takes 8-12 weeks from application submission to license issuance, depending on the completeness of the application and scheduling of the facility inspection.

Can a pharmacy operate while the application is pending?

No, a pharmacy cannot dispense medications in Tennessee until a license has been issued by the Board.

What happens if a pharmacy fails the initial inspection?

Pharmacies that fail the initial inspection will receive a written report of deficiencies and must address these issues. A reinspection will be scheduled once corrections are made and verified.

Is there a temporary pharmacy license available?

The Tennessee Board of Pharmacy does not issue temporary pharmacy licenses. The full licensing process must be completed before operations may begin.

Can a pharmacy license be transferred to a new owner?

No, pharmacy licenses are not transferable. A new owner must submit a new application and undergo the complete licensing process.

Contact Information

For questions about Tennessee pharmacy licensure or assistance with the application process, contact the Tennessee Board of Pharmacy:

• Address: Tennessee Department of Health, Board of Pharmacy, 710 James Robertson Parkway, 3rd Floor, Nashville, TN 37243
• Phone: (615) 532-5170
• Email: health.pharmacy@tn.gov
• Website: https://www.tn.gov/health/health-program-areas/pharmacy.html