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 expired licenses held by pharmacists and technicians.
Pharmacy license types
Licenses are typically issued through the state’s board of pharmacy.
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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.
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.
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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.
Application checklist items and prerequisites
As you prepare for your pharmacy license application, you may need to have the following on hand:
- Incorporation (corporation) or formation (LLC) documents
- DBA name of the business
- FEIN
- List of officers and partners
- Disciplinary and criminal history for owners and officers of the pharmacy
- List of all pharmacists, pharmacist interns, technicians, and pharmacy support persons
- Copy of deed, lease, or assignment of lease
- Blueprint or architectural plans of the pharmacy
- Statement of pharmacy hours
- Federal DEA registration (mainly when controlled substances are sold)
- License fee
Other license and permit requirements
In addition to a pharmacy license, you may require the following:
- Durable medical equipment (DME) license: This allows you to legally sell or provide DME or home medical equipment (HME). Some states maintain exemptions for DME licensing for facilities that are already licensed as pharmacies or other more regulated facilities. For more information, see Durable medical equipment business license requirements.
- General business license: This is a license issued by the city or county in which your business will operate.
- Zoning and land use permits: Local government zoning laws may prohibit certain business activity in designated areas.
- Sales tax licenses/sellers permit/resellers permit: The name of this permit varies by state but is required if you intend to sell any products or services.
- Certificate of occupancy
What about license requirements for patient care services provided by a pharmacist?
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.
Conclusion
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.
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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 or call (844) 878-1800.
Related articles
Durable medical equipment licensing requirements
Online and mail-order pharmacy license requirements
Resources
National Association of Boards of Pharmacy
National Community Pharmacists Association
American Society of Health-System Pharmacists
Source: https://t-tees.com
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