The rapid spread of the COVID-19 virus has placed an enormous strain on the U.S. health care system, and we can expect that the pandemic will continue to impact retail pharmacies for the foreseeable future. In addition to the wide range of operational challenges facing retail pharmacies, the COVID-19 virus has sparked a number of
In the current regulatory environment, it is imperative that a pharmacy maintain a robust regulatory compliance program in order to avoid the potentially significant legal and regulatory pitfalls. Because state boards of pharmacy act as a pharmacy’s primary regulator, the state pharmacy laws and pharmacy board rules are the regulatory requirements that pharmacy staff and
The United States is battling what the Centers for Disease Control and Prevention (CDC) has labeled an epidemic of prescription drug abuse. According to CDC data, drug overdose deaths more than doubled between 2002 and 2015 (the latest year for which information is available). In 2015, drug overdose deaths exceeded 50,000 — which is more
Direct and indirect remuneration (DIR) is one component of the complex Medicare Part D payment system. In the past several months, the issue of DIR increasingly has become a source of contention between various players in the Part D program. Pharmacies, the Centers for Medicare and Medicaid Services (CMS), and members of Congress have expressed
A regulatory inspection by the Drug Enforcement Administration or a state board of pharmacy can be a high stakes event. Penalties for violations of the federal Controlled Substances Act may include criminal penalties, significant civil monetary fines and administrative action up to and including a “show cause” proceeding to suspend or revoke a pharmacy’s controlled
