Pharmacy Licensing & Reporting

Operating a pharmacy can be a lucrative business, but it’s one of the most heavily regulated industries with many compliance and operational requirements. Pharmacy licensing and reporting requirements can be complex, but Boesen & Snow Law can preserve your ability to operate your pharmacy without the risk of incurring penalties.

Why Choose Us

Boesen & Snow Law has decades of experience helping our clients with various licensing and reporting issues. We are highly experienced with pharmacy law and also have a pharmacist on our team, which makes us a leading choice for legal counsel in the pharmacy industry. We can provide comprehensive legal support to address all licensing and reporting requirements.

There are business-specific licenses for pharmacies in each state, including drug manufacturer licenses, retailer licenses, wholesaler licenses, and repackager licenses. Contact Boesen & Snow Law to discuss your specific licensing requirements.

Change of Ownership (CHOW)

A Change of Ownership (CHOW) for a pharmacy typically requires:

• Notifying the Arizona State Board of Pharmacy, particularly if your pharmacy ownership change is considered to be 30% or more in vested interest with direct operational oversight or voting stocks
• Updating the pharmacy’s permit by submitting a new permit application if the ownership change is significant
• Enrolling as a new owner in the Arizona Health Care Cost Containment System (AHCCS), which involves preparing and submitting an application in the AHCCCS Provider Enrollment Portal (APEP)
• Getting a new NPI (National Provider Identifier) and enrolling the new NPI in NCTracks if your pharmacy plans to bill using Medicare or Medicaid
• Notifying other entities if you’re accredited, including the Accreditation Commission for Health Care (ACHC)
• Ensuring the transfer of patient records and prescriptions is smooth and HIPAA and HITECH compliant

This process can be quite involved and can quickly become overwhelming. Contact our office to work together to craft a successful CHOW application.

Change of Location (CHOL)

A licensed pharmacy seeking to change its physical location must:

• Apply for resident relocation at least 30 days before their planned relocation and include specific documents to pass a final inspection
• Alternatively, they can apply for non-resident relocation, which includes providing a copy of the permit from the pharmacy’s home state. If moving out-of-state, they must prepare and submit a new permit application
• Pay the required fees

The specific requirements and steps for a CHOL process for a pharmacy are determined by each state’s pharmacy board. As a result, it’s worth talking to Boesen & Snow Law, as we can provide assistance tailored to your specific situation.

Preparing for Pharmacy Licensing

Applying for your pharmacy license is a more complex process than you may expect. You must demonstrate you’ve complied with all applicable state and federal regulations. This requires gathering materials, like:

Boesen & Snow Law can help to obtain or transfer your pharmacy license in any state and ensure you are legally able to open for business.

The entire CHOW/CHOL process can quickly become overwhelming. If you need reliable legal assistance or have questions, contact us today.

We can assist you and your business with these types of applications, and we understand the complex federal and state regulations involved in this process. Our goal is to provide you with guidance on how to remain compliant and to provide a smooth application process.

Reporting Requirements for Pharmacies

Along with strict licensing requirements and regulations, pharmacies are also required to complete specific reports to various state and federal oversight agencies. 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. Our team at Boesen & Snow Law can review your reporting requirements to avoid disruptions to your business.

What to Expect from Boesen & Snow Law

When you attempt to manage all your regulatory compliance obligations on your own, it can take up a great deal of your business’s day-to-day operations. Thankfully, we can help:

• Navigate the pharmacy industry’s complex regulatory structure and strict licensing requirements.
• Explain any licensing or reporting issues you currently face or are likely to face in the future
• Resolve complex legal issues
• Provide responsive legal support as you encounter new challenges with your pharmacy business

If you’re looking for assistance with any licensing applications or need clarification on any reporting requirements, contact us today.

FAQs

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.

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. Even if you think you have a firm understanding of pharmacy licensing and reporting requirements, even slight mistakes can be costly, interrupting your business or even leading to criminal penalties and liability for damages.

Q: What Does an Attorney Cost for Pharmacy Licensing and Reporting Assistance?

A: Each attorney sets their own fee schedule based on their experience and the time they may spend on your licensing and reporting matter. Many firms, including ours, can schedule a no-cost initial evaluation to discuss the work we intend to provide and our written fee agreement. Contact us to set up your free evaluation today.

Hire A Pharmacy Lawyer – Call Boesen & Snow Law

Boesen & Snow Law can handle a wide range of complex cases and can ensure you follow applicable licensing and reporting requirements. Our goal is to help you avoid violation penalties, but if violations unintentionally occur, we can help resolve these issues efficiently.

Contact Boesen & Snow Law today to schedule a free consultation.

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