If you operate an online or mail-order pharmacy, your business must be properly licensed to operate legally in every state where orders are placed. However, the requirements or issuing authority for the appropriate licenses vary by state.
In this article, we explore the process for obtaining an online or mail-order pharmacy license, how non-resident state requirements differ from those of your domestic state, and the consequences of non-compliance.
Any business that dispenses medications and controlled substances is subject to regulations. In whatever state your online or mail-order pharmacy sells to, you are subject to that state’s regulations.
The penalties for non-compliance are strict. If you fail to obtain or renew the appropriate license you may be subject to fines, revocation of a license, or denial of a future license. If you dispense controlled substances without a proper license, you could face criminal prosecution.
To become properly licensed you must first obtain a pharmacy license or permit in the state where your business is domiciled. You must also meet federal licensing requirements and obtain a license in every other state where you do business. Depending on the state, it is known as a non-resident pharmacy license or mail-order pharmacy license. Many states also require a controlled substance license.
These licenses can typically be obtained from the state board of pharmacy or similar public health department and are generally processed within 10 days to three months. The license must also be renewed annually or be subject to annual reporting.
Note: A license in your domestic state is a prerequisite for all non-resident pharmacy licenses.
All states require online or mail-order pharmacies to have a non-resident pharmacy license in the states they are shipping to. The sole exception is Massachusetts which currently does not offer out-of-state licenses, except for outsourcing facilities. (As long as your business is in good standing and has a current pharmacy license, you can ship medications to Massachusetts.)
The process of obtaining a non-resident pharmacy license is similar to the domestic state pharmacy licensing process. One exception to the process is that you may be required to designate a domestic state representative to act as an agent for service of process. This step often requires foreign qualification (aka business registration) in that state. This ensures your business is formally registered in a state other than your formation or domestic state.
All non-resident pharmacy licenses require the pharmacy to be properly licensed in its domestic state.
It’s important to note that non-resident pharmacy license rules vary by state. In certain states, a pharmacist-in-charge (PIC) may need to be licensed through their board of pharmacy. Others require that non-resident pharmacies file reports of controlled substances that are dispensed to residents.
Another challenge is that regulations are always changing, so it’s important to stay current on online and mail-order pharmacy licensing requirements.
Managing compliance obligations, particularly online and mail-order pharmacy license applications and 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.
Contact us today to learn more about how CT Corporation can help you manage your business license needs.
