Pharmacy Licensing and Reporting Requirements

Operating a pharmacy can be a lucrative business, but you operate in one of the most heavily regulated industries and face many compliance requirements you must meet to continue operations. Pharmacy licensing and reporting requirements can be very complex, but the right attorney can assist you in preserving your ability to operate your pharmacy without the risk of incurring penalties for noncompliance.

Helping Pharmacy Owners with Licensing and Reporting Requirements

The team at Boesen & Snow Law has more than 45 years of combined experience helping our clients in the healthcare sector with various licensing and reporting issues. Our team is not only highly experienced with pharmacy law but also has professional medical experience that positions us as a leading choice for legal counsel in the pharmacy industry. We can help meet your licensing and reporting requirements with confidence.

If you operate a pharmacy with an expired license or without a license, you may face criminal prosecution along with the closure of your business. If you fail to meet applicable reporting requirements to any oversight agency, you risk the same. Our team can provide comprehensive legal support that helps you fully address all licensing and reporting requirements you face so you can operate your pharmacy with peace of mind.

Licensing Requirements for Pharmacists

There are business-specific licenses for pharmacies in the state, including drug manufacturer licenses, retailer licenses, wholesaler licenses, and repackager licenses.

If a business manufactures, distributes, or sells any controlled substances, the business will need the appropriate controlled substance registration and may be subject to specific reporting requirements with the Drug Enforcement Agency (DEA) as well as the state Board of Pharmacy. Compounding pharmacies may require specific compounding licenses, which are entirely distinct from standard pharmacy licenses.

If a business operates any type of mail-order or online pharmacy, the business owner will need a license in the state in which they are physically located and non-resident licenses and/or mail-order pharmacy licenses in almost every state where they do business. Depending on the breadth of this type of operation, the licensing requirements can be substantial.

Preparing for Pharmacy Licensing

Applying for your pharmacy license is a more complex process than you may expect. You must demonstrate that your business complies with all applicable state and federal regulations. This will require gathering various materials, such as:

• The “doing business as” name of your pharmacy.
• Incorporation documents for your corporation or formation documents for your corporation or LLC. You may need a professional corporation or PLLC.
• Your Federal Employment Identification Number (FEIN).
• A complete list of all your company’s officers and partners.
• A list of every pharmacist, pharmacy intern, technician, and support personnel employed in your business.
• A copy of the deed or lease to your commercial property.
• A blueprint or the architectural plans of your pharmacy.
• A statement of your intended hours of operation.
• Your licensing fee and other license and permit requirements as dictated by the applicable State Board of Pharmacy.
• If applicable, your license to sell durable medical equipment (DME) or home medical equipment (HME) if you intend to sell any such products.
• A general business license issued by the city or county in which you intend to operate your pharmacy.
• Copies of your zoning and land use permits.
• Sales tax licenses, sellers permits, and resellers permits applicable for the products and services you intend to sell.
• Your certificate of occupancy.

The experienced legal team at Boesen & Snow Law can not only assist you with obtaining or transferring your pharmacy license in the state but also help ensure you are legally able to open for business. In addition to these services, you can also rely on our team for contract development with vendors and healthcare organizations in your community, and we are ready to provide guidance with any contract disputes you might encounter in the future.

Reporting Requirements for Pharmacists

Along with strict licensing requirements and regulations, pharmacies are also required to complete specific reports to various state and federal oversight agencies. For example, if a pharmacy dispenses any controlled substance from Schedule II to V, they need to report daily dispensing reports to the state Board of Pharmacy’s PDMP program. This applies to every outpatient pharmacy with an active DEA number and a valid Arizona pharmacy permit.

Compliance with the state Prescription Drug Monitoring Program (PDMP) and various other reporting regulations is vital for every pharmacy. Failure to meet reporting requirements can potentially lead to fines and other penalties, and repeat violations are likely to lead to an audit from an oversight agency. An experienced attorney can review your reporting requirements with you to avoid these disruptions to your business.

Compliance With Oversight Agencies

It’s vital to remember that a pharmacy has many state and federal regulatory compliance requirements that must be met; otherwise, the business may be shut down, fined, or the business owner could face criminal prosecution:

• The DEA is the federal agency responsible for enforcement of the country’s licit and illicit controlled substance policies. Many pharmacies are required to have active DEA numbers that allow them to dispense controlled substances by prescription, and they are required to file daily reports to the state Board of Pharmacy. The DEA may investigate any pharmacy suspected of violations.
• The Food and Drug Administration (FDA) is responsible for various aspects of drug product regulation throughout the United States.
• The Environmental Protection Agency (EPA) regulates many industries concerning their impact on the environment. When it comes to the pharmacy industry, reporting requirements generally concern the disposal of hazardous wastes and expired medications.
• The State Board of Pharmacy is the primary state-level agency responsible for pharmacy licensing. Almost all your state licensing activities will unfold under the purview of the state board, including applying for a new license, transferring a license from another jurisdiction, or renewing a license.

Compliance with oversight agencies is a strict requirement for any pharmacy. The team at Boesen & Snow Law has the experience needed to handle a wide range of complex cases and can help meet all applicable licensing and reporting requirements. Our goal is to help you avoid penalties for violations, but if violations unintentionally occur, we can assist you in resolving these issues as efficiently as possible.

What to Expect from the Team at Boesen & Snow Law

When you attempt to manage all your regulatory compliance obligations on your own, address license renewals, and monitor the constantly changing regulatory environment of the pharmacy industry on your own, it can take up a great deal of your business’s day-to-day operations. You must also keep track of license renewal dates, pay associated fees, and maintain meticulous records to ensure you meet all reporting requirements.

The team at Boesen & Snow Law can help manage these affairs more efficiently, assisting you in navigating the pharmacy industry’s very complex regulatory structure and strict licensing requirements. During your initial consultation with our team, we can help you understand any licensing or reporting issues you currently face or are likely to face in the future. We are skilled at resolving complex legal issues in the pharmacy industry.

You can rely on Boesen & Snow Law for responsive legal support as you encounter new challenges with your pharmacy business in Arizona. Our team not only has extensive professional legal experience but also practical experience in the medical field, allowing us to provide a unique level of legal representation in the fields of healthcare law and pharmacy law.

Regulatory compliance is one of the most important issues you face when attempting to run a healthcare business or pharmacy of any kind. With our team’s help, you can open your business with confidence and continue operating with the peace of mind that comes with knowing you have a legal advocate ready to help resolve any pharmacy licensing or reporting requirements you must fulfill.

Reach out to our team as soon as possible if you plan to apply for a pharmacy license in the state, need to renew your license, or if you are unsure how to approach your reporting requirements to any state or federal agency. We can provide comprehensive legal representation for any such legal issues you encounter with your pharmacy business.

FAQs

Q: How Do I Get My Pharmacist License?

A: To qualify for your pharmacist license, you must hold a degree from a qualified university Doctor of Pharmacy degree program, pass the NAPLEX, pass the MPJE, and complete the appropriate application process. Once the state Board of Pharmacy reviews your exam score and application, they will issue the appropriate license if you are approved. Whether you are applying for a license for the first time or transferring from another state, the MPJE may be required.

Q: Who Regulates Pharmacies?

A: Every pharmacy in the state is subject to regulation from the state Board of Pharmacy and various federal agencies. It is vital for a pharmacy to maintain full compliance with all applicable regulations; otherwise, the business may be forced to shut down, and the business owner could face severe legal penalties. Your attorney can help you more clearly understand all your regulatory compliance requirements.

Q: Why Should I Hire an Attorney for Pharmacy Licensing and Reporting Requirements?

A: Trustworthy legal oversight is an invaluable asset for any business, especially one in a heavily regulated industry such as a pharmacy. Even if you think you have a firm understanding of pharmacy licensing and reporting requirements, even slight mistakes can cost you dearly, interrupting your business or even leading to criminal penalties and liability for damages. Your attorney can help prevent such issues by guiding you through licensing and reporting.

The team at Boesen & Snow Law has years of experience helping pharmacists operate with confidence, and we excel at assisting our clients with complex licensing and reporting requirements. If you need legal counsel you can trust to assist you with any such issues, we are ready to help. Contact Boesen & Snow Law today to schedule a free consultation with our team and learn more about the legal services we provide.