Compliance mandates affect a wide range of pharmacy operations and collectively, they impose significant costs on the nation’s pharmacies. This includes monetary costs as well as the drain on staff resources needed to address compliance requirements.
Mandates come from multiple sources including federal, state, and local legislative bodies; regulatory agencies including the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA); state pharmacy boards and increasingly, from pharmacy benefit managers (PBMs). Regardless of the source, pharmacies are responsible for ensuring complete, accurate and timely implementation.
This includes absorbing the costs associated with compliance, which can include various registration, licensing, and permit fees. Pharmacies also face costs incurred from increasingly common compliance audits. “The average audit,” according to reporting from Pharmacy Times “cost pharmacies $23,978,” during 2020. This was a 35 percent increase over the previous five years.
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