The pharmacy industry is highly regulated. In addition to federal requirements, each state requires that pharmacies are licensed before they can legally operate.
Regulations help ensure that pharmacies are not dispensing outdated drugs, drugs that contain dangerous components, drugs manufactured in sub-standard facilities, and so on.
In this article, we explore general state requirements when it comes to pharmacy business licenses, the application process, and related business licenses and permits.
Pharmacy business license requirements smart chart Learn general state requirements when it comes to pharmacy business licensesIf 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 expired licenses held by pharmacists and technicians.
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, wholesaler 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.
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.
As you prepare for your pharmacy license application, you may need to have the following on hand:
In addition to a pharmacy license, you may require the following:
Pharmacists often administer patient healthcare services such as vaccinations, blood pressure testing, wellness screening, and other services delivered in collaboration with a health care provider.
If these services are provided by telehealth or digitally across state lines, pharmacists must abide by the policies and regulations of the state where the patient is located, and many states require pharmacists to hold a license in that “foreign” state.
Note: Patient care services laws vary drastically by state. Consult with the state board of pharmacy before you conduct telehealth consultations with a patient in a state outside your domestic state.
Managing compliance obligations, particularly license renewals, amidst ever-changing regulations should occupy an important part of your company’s day-to-day operations. Keeping track of renewal dates, fees, and necessary documents can be complicated and time-consuming.
CT Corporation can help you navigate the pharmacy industry’s uniquely complex regulatory and licensing challenges.
To learn more about how CT Corporation can help you manage your business license needs, contact a CT Corporation Service Representative.
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