Abstract

Abstract

A strong compliance program requires attention, engagement, and active monitoring of pharmacists and pharmacy professionals. Done well, compliance is routine, consistent, even mundane. Yet these very characteristics can create a culture of complacency that pharmacies must actively guard against. This potential risk is only compounded by the wide range of regulatory and contractual rules that bind the practice of pharmacy. Compliance involves tracking everything from state and federal laws—each state’s pharmacy act, the Federal Controlled Substances Act, Stark and anti-kickback statute requirements, to name a few—to USP and accreditation standards, and even to government and commercial payor requirements and restrictions. The sheer scope and complexity of regulatory demands can be overwhelming. While pharmacies are watchful for liability warning signs like false claims, kickbacks, and controlled substance risks, inadequate attention to other regulatory requirements can also result in substantial liability to the pharmacy. This article examines two compliance areas that present unique challenges in compounding: USP <800> and OBRA ’90. It addresses the potential liabilities and risks of noncompliance associated with each; how pharmacies can effectively leverage employees as compliance assets; and what to do if an employee blows the whistle about alleged violations of USP <800> or OBRA ‘90.

Related Keywords

• OBRA '90
• Counseling
• DUR
• UPS <800>
• Compounding pharmacies
• Hazardous drugs
• Compliance programs
• Employee reports
• Exposure and liability due to non-compliance
• Internal reporting
• Whistleblower
• False claims
• Audits and recoupments
• Investigations
• Remediation
• Whistleblower retaliation
• Employee protection laws
• False Claims Act retaliation
• Qui tam
• Risk management
• Compliance training

Related Categories

• BUSINESS
• LEGAL
• UNITED STATES PHARMACOPEIA CONVENTIONS