It can be exciting to start your own business in an independent pharmacy. You find a pharmacy location, buy or rent the real estate… and then what? The next step is the licensing process.
What's the licensing process for an independent pharmacy?
The licensing process for an independent pharmacy differs from state to state. However, it's likely to be something similar to this:
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Begin with your state Board of Pharmacy
You will need to get your pharmacist's license from your state board of pharmacy before you can get the other licenses you need. If you are going to receive your products via wholesale, is also likely that you need to show your pharmacist's license to do that.
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Submit an application for and receive a pharmacy permit
You will have to pay a fee when you submit your pharmacy permit to the appropriate authorities.
The pharmacy permit generally requires that you have a qualifying inspection by a Board of Pharmacy compliance officer, to ensure that you meet certain pharmacy requirements.
For example, you may be required to show that:
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The pharmacy structure is a stationary and a permanent location
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You have appropriate security measures in place to secure controlled substances and other theft-prone merchandise in the pharmacy, and to secure your pharmacy after hours from unauthorized entry
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You have appropriate ventilation and lighting
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The pharmacy is clean and sanitary
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The pharmacy has an appropriate sink with both hot and cold running water, refrigeration if necessary, and appropriate sewage disposal/piping
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You have secured any equipment, facilities, fixtures, etc., that the state board deems necessary for you to operate as a pharmacy.
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Make sure you meet sterility requirements for pharmacies
Since you will be preparing sterile pharmaceutical medications, you will need to show that you have a clean room or other sterile environment to prepare them. This environment should:
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Be restricted to authorized personnel only
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Be in a completely separate room or in a separate space in a larger room that is not a stock room setting or warehouse
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Have no dust and dirt in it
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Hold stock supplies that are necessary to maintain the area for still preparation of products as required by law.
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Keep a current copy of OSHA requirements for the of hazardous drugs
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Agree to participate in your state's prescription monitoring program
These programs are designed to cut down on the abuse of prescription drugs, including controlled substances, into an online database. This does two things: Provides important information to law enforcement as necessary for investigation; and keeps patient information up-to-date for healthcare professionals.
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NPLEx: PSE and Ephedrine Reporting Requirements
If you sell nonprescription ephedrine or pseudoephedrine directly to your customers, you likely must report these sales to your state.
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Obtain a National Provider Identifier
Because of the Health Insurance Portability and Accountability Act of 1996, the government Department Of Health And Human Services requires you as a pharmacist to use the National Provider Identifier, a unique identifier for all healthcare providers, including pharmacists. This 10 digit number is used nationally and replaces all previous legacy numbers.
Questions about the process
An independent pharmacy won't necessarily have the structure of authority (or an established protocol) for set up that a retail pharmacy might, so if you have any questions about the process, make sure to contact your state Board of Pharmacy so that you are directed to the appropriate personnel.
When you know that you are in complete compliance and have all the licensing and permits necessary to open, you won't have to worry about delays; you can open on time, ready to serve your community – and succeed in your own business.
