Pharmaceutical Site License Requirements – Lexology

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The pharmacy industry is highly regulated. In addition to federal requirements, each state requires pharmacies to be licensed before they can operate legally.

The regulations help ensure that pharmacies do not dispense expired drugs, drugs with unsafe components, drugs manufactured in substandard facilities, etc.

In this article, we explore the general state requirements for pharmacy business licenses, the application process, and the business licenses and permits.

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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 usually issued by the state board of pharmacy.

But the license you need depends on the activity you are carrying out. This may include a drug manufacturer’s license, retailer’s license, wholesaler’s license, importer/exporter’s license and repacker’s 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.

Compound 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 every state where you do business.

Note: Pharmacy employees, such as licensed pharmacists, technicians, and interns, may also need licensure.

Pharmacy License Application Process

First, your business must obtain a state resident or pharmacy license from your state’s licensing agency. The request can be large and usually comes with a fee, 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 Responsible Pharmacist (PIC) or Pharmacy Manager.

Once you have obtained a license in the state and want expand to 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 state application, but you must verify that you have a resident license in your state of residence.

Application Checklist Items and Prerequisites

When preparing your pharmacy license application, you may need to have the following items ready:

  • Embedding (society) or training (SARL) records
  • DBAs Company Name
  • List of leaders and partners
  • Disciplinary and Criminal History for Pharmacy Owners and Officers
  • List of all pharmacists, pharmacy interns, technicians and pharmacy support persons
  • Copy of the deed, lease or assignment of lease
  • Pharmacy master plan or architectural plans
  • Record 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 need the following:

  • Durable Medical Equipment (DME) Permit: This allows you to legally sell or supply EMR or Home Medical Equipment (HME). Some states maintain EMR license exemptions for establishments already licensed as pharmacies or other more regulated establishments. For more information, see Durable Medical Equipment Business License Requirements.
  • General Commercial License: This is a license issued by the city or county in which your business will operate.
  • Zoning and Land Use Permit: Local government zoning laws may prohibit certain business activities in designated areas.
  • Sales Tax Licenses/Vendor Permit/Reseller Permit: The name of this license varies from state to state, but it is required if you intend to sell products or services.
  • Certificate of occupancy

What about licensing requirements for patient care services provided by a pharmacist?

Pharmacists often administer health services to patients such as vaccinations, blood pressure tests, wellness screenings, and other services provided in conjunction with a health care provider.

If these services are provided via telehealth or digitally across state lines, pharmacists must follow the policies and regulations of the state where the patient is located, and many states require pharmacists to be licensed in that state. ” foreign “.

Note: Laws on patient care services vary widely from state to state. Consult the state board of pharmacy before conducting telehealth consultations with a patient in a state outside of your home state.

Conclusion

Managing compliance obligations, especially license renewals, in an ever-changing regulatory environment, should be a big part of your business’ day-to-day operations. Keeping track of renewal dates, fees, and necessary documents can be complicated and time-consuming.

Related article

Durable Medical Equipment Licensing Requirements

Resources

National Association of Boards of Pharmacy

National Association of Community Pharmacists

American Society of Healthcare Pharmacists

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