Pharmacy business license requirements

Consequences of non-compliance

If you operate a pharmacy without a license or with an expired license, you may be subject to fines or criminal prosecution. States are increasingly cracking down on license violations, including failing to notify the board of a change in the supervising pharmacist or expired licenses held by pharmacists and technicians.

Pharmacy license types

Licenses are typically issued through the state’s board of pharmacy.

But the license you require depends on the activity you conduct. This can include a drug manufacturer license, retailer license, wholesale distributor license, importer/exporter license, and re-packer license.

If you manufacture, distribute, or sell controlled substances, you may also need a controlled substance license or registration administered by the state board of pharmacy.

Compounding pharmacies will also require a compounding license, separate and distinct from the pharmacy license.

If you operate a mail-order or online pharmacy, you will need a pharmacy license in the state where you are domiciled and a non-resident license or mail-order pharmacy license in each state where you do business.

Note: Pharmacy employees — such as registered pharmacists, technicians, and interns — may also need to be licensed.

Pharmacy license application process

As a first step, your business must obtain a resident or in-state pharmacy license from your state’s licensing agency. The application can be extensive and is usually accompanied by fees, a surety bond, proof of insurance, and copies of policies, procedures, or prescription labels. Once approved, the agency will schedule a site inspection.

Depending on your state, you may also need to designate a registered Pharmacist in Charge (PIC) or a Pharmacy Manager

Once you have obtained an in-state license and wish to expand into other states, you can then begin the process of obtaining an out-of-state pharmacy license in that state. The application is similar to the in-state one, but you must verify that you hold a resident license in your domiciled state.