Protect Your Pharmacy And Ensure Its Compliance For Continued Success
The continued business of your pharmacy depends on its compliance with the regulations and laws that govern pharmacists and business. If your pharmacy is under suspicion of noncompliance or is at risk of being sued, you want to contact an attorney as soon as possible.
The attorneys at Boesen & Snow Law in Arizona have experience in pharmacy law and business law. They will assess your case and help you understand how to identify the solutions to your problem.
The Potential Risks To Your Pharmacy’s Monetary Growth
Many pharmacies incorporate pharmacy benefit managers into their business operations. PBMs are beneficial to your pharmacy until they begin charging insurance companies for more than they are reimbursing you. In addition, they may impose direct and indirect remuneration fees. This would result in a costly loss for your pharmacy.
Most PBMs own their own specialty pharmacies and may prevent you from joining an exclusive network. Our attorneys will fight for your access into these exclusive pharmacy networks.
Incorporating Outsourcing Facilities
The guidelines of 503B outsourcing facilities are strict. An outsourcing facility can be a risk to your business if they are not compliant with certain FDA regulations.
It is important to refrain from improperly inducing the dispensing of prescriptions to patients. Beneficiary inducements for government third-party-payors and for all patients in so-called “All Payor States” can lead to a risk for receiving a civil monetary penalty (CMP) or criminal charges. The penalties range from $2,000 to $100,000 depending on type of fraud or abuse and whether the government can prove intent to defraud.
Consult with a lawyer to determine how to construct and monitor the facility and design compliance of your pharmacy.
Pharmacy Regulatory Compliance
Your pharmacy and pharmacists must comply with all laws that regulate the dispensing of controlled substances. Two specific basic requirements include:
- Labeling the prescription
- Knowing the regulations for dispensing legend drugs and controlled substances to patients.
Noncompliance can result in fines and the suspension or revocation of your pharmacy license. If your pharmacy has been suspected of noncompliance with:
- The 340B drug program
- 503B outsourcing facilities
- Fraud, waste and abuse compliance
- Pharmacy or specialty pharmacy regulation