How to Acquire a Pharmacy License
The process of becoming a licensed pharmacy can be complex even if you have experience, as every state has different documentation requirements. Pharmacies must obtain all the necessary licenses to meet the necessary professional standards before they can legally begin operation.
Before pharmacies begin the permit application process, they are usually required to form a business entity. This involves completing the necessary application forms and obtaining professional certifications from state-accredited programs. Consulting with a CPA and attorney can help pharmacists through the certification process and develop the best business structure for their needs. They must also register their business name with the state and register for state and federal taxes. This registration process includes applying for an Employer Identification Number (EIN) from the Internal Revenue Service.
Questions to Expect on the Pharmacy Permit Application
When applying for a permit, application questions vary from one state to another. Here are some typical requirements you may expect to see on a permit application:
- Name, address, and contact information of the pharmacy
- Business structure and entity information
- Names and license numbers of staff pharmacists
- Physician information
- Pharmacy type (retail, internet, hospital, infusion, sterile compounding, nuclear, etc.)
- Officer and owner information
- Accreditation information
- Articles of incorporation/formation
- Disciplinary and criminal history for owners and officers of the pharmacy
- A list of non-pharmacist personnel who will operate the pharmacy
- Pharmacy hours of operation
- Lease agreements
- Types of drugs to be handled at the facility
- Application and license fees
- Methods of delivery
Next Steps After Your Permit is Approved
Before your pharmacy opens for business, you must follow several more steps in addition to your permit application.
Your pharmacy must be inspected for compliance with state and federal regulations. If it passes, the pharmacy will receive a permit. The pharmacy will also need a controlled substance registration if it distributes controlled substances, which is available by application from the relevant authorities. Depending on your state and type of pharmacy, you may also need to apply for supplemental licenses for specific services you offer.
Multi-State Licensure
If you plan to conduct pharmaceutical operations across state lines and jurisdictions, you will likely face additional requirements from each state. This is particularly important for internet and mail-order pharmacies and pharmacies close to state lines. The pharmacists on your staff may need to complete additional training and maintain active licensure in each state.
Additional requirements for multi-state licensure may include:
- Registering your pharmacy within all the states where it operates, including qualifying your business in the states where your business is not located but may operate
- Submitting your inspection reports and licensures through the Verified Pharmacy Program (VPP)
- Registering your business entity for state taxes in the states where you’ll be doing business, including corporate, withholding, and unemployment insurance taxes
- Enrolling as a Medicaid provider in all states where you intend to receive Medicaid reimbursement
How to Maintain Compliance with Current Licensure
Once you’ve received all the necessary permits and licenses, it’s important to consistently maintain them so they stay active and in good standing. Here’s a breakdown of the key actions to take in maintaining your permits and licenses:
Track Permit Expiration Dates
- Check the expiration date of your pharmacy permit. Terms can vary by state:
- Some permits expire annually
- Others may have longer terms
- Submit a renewal application and payment before the expiration date
Manage Multiple Licenses
- If you have multiple locations or handle controlled substances, track renewals for multiple licenses.
- Operating in multiple states adds complexity:
- Renew pharmacy permits in each state
- Submit required documentation or reports to each state’s secretary
- Maintain special licenses (e.g., controlled substances) for each state
Notify State Boards of Changes
- Inform the state board about any significant changes in:
- Ownership
- Services
- Locations
- Business structure
- Pharmacist-in-charge (ensure they complete annual self-inspection reports)
To simplify the process of tracking licensure, Verisys offers a comprehensive solution that continuously monitors healthcare licensure across all U.S. states, territories, and jurisdictions. Our real-time license verifications and healthcare compliance monitoring ensure your pharmacy remains compliant by alerting you to any changes or requirements, helping you avoid fines and exposure. Verisys actively tracks regulations to keep you informed and mitigate compliance risks.
Learn more about how Verisys can assist your HCOs in meeting all government healthcare credentialing and regulatory standards.
