Pharmacy Law: Federal Regulations & HIPAA

Course overview

Pharmacy is, by far, the most regulated profession in health care. Pharmacists have a professional obligation to stay current in their knowledge of laws and regulations and their implications to practice and patient care. Federal drug legislation has distinguished between prescription and over-the-counter medications and established that drugs must be both safe and effective, must be properly labeled, and must be manufactured and stored under sanitary conditions. In addition, the Controlled Substances Act (CSA) has expanded regulatory oversight and scheduling of medications to minimize diversion, misuse, and abuse. Federal legislation has been enacted to combat methamphetamine abuse, deter tampering with medications, ensure patient privacy, and mandate patient counseling. It is important to understand the scope of laws and regulations so that we can practice in accordance. Federal and state laws are meant to operate concurrently. If one law is more strict, that is the law we must follow as pharmacists.