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Cannabis-based product rules continue to vary

Cannabis-based product rules continue to vary

There is a growing public focus on the potential for legitimate pharmacological uses of cannabis. Much of this focus has been directed toward medical marijuana — the use of marijuana in plant form or its basic extracts. Although some states have legalized its use, the Food and Drug Administration has not approved marijuana in plant

The importance of regulatory compliance programs

The importance of regulatory compliance programs

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

Opioid epidemic’s impact on pharmacy sector

Opioid epidemic’s impact on pharmacy sector

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

Controversy over DIR under Medicare Part D heats up

Controversy over DIR under Medicare Part D heats up

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

In Rx, ounce of prevention worth pound of cure

In Rx, ounce of prevention worth pound of cure

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