Patient counseling is not just a professional best practice but a legal requirement governed by a framework of federal and state laws. The landmark Omnibus Budget Reconciliation Act of 1990 (OBRA ’90) established the federal foundation for counseling, which has since been expanded upon by nearly every state. This topic is a cornerstone of the … Read more
The practice of pharmacy in the United States is primarily regulated at the state level by Boards of Pharmacy to protect public health. Achieving licensure requires not only clinical competence, as assessed by the NAPLEX, but also a deep understanding of federal and state-specific laws, tested by the Multistate Pharmacy Jurisprudence Examination (MPJE). The Principles … Read more
The “closed system” is the cornerstone of controlled substance regulation in the United States, established by the Controlled Substances Act (CSA) and enforced by the Drug Enforcement Administration (DEA). This framework is designed to track high-risk medications from manufacture to dispensing to prevent diversion. A deep understanding of these regulations, a core component of the … Read more
Compounding is a cornerstone of pharmacy practice, allowing pharmacists to create customized medications for individual patient needs based on a practitioner’s prescription. This practice is governed by strict standards to ensure product quality and patient safety, a topic covered in depth in the dedicated Sterile Compounding course and reinforced in the experiential education curriculum, “. … Read more
Prescription drug labeling is a critical component of medication safety, governed by a complex framework of federal and state regulations. From interpreting the detailed manufacturer’s package insert to creating a clear and accurate label for the patient’s vial, pharmacists are the key guardians of this information. This skill draws on foundational knowledge from the Principles … Read more
Pharmaceutical advertising is a powerful and highly regulated industry in the United States, overseen by both the FDA and FTC. Pharmacists, as trusted medication experts, must be able to critically evaluate the claims made in drug advertisements and understand the legal framework that governs them, a key topic in the Principles of Pharmacy Law and … Read more
All clinical research involving human participants is built upon a strict ethical framework designed to protect their rights and welfare. For pharmacists, who are both critical consumers of and sometimes participants in research, understanding these principles is a core professional obligation. As covered in courses like Principles of Evidence-Based Practice and Pharmacy Law and Ethics, … Read more
The marketing and promotion of drugs in the United States is a highly regulated process overseen by the FDA to protect public health. A cornerstone of this regulation, a key topic in the Principles of Pharmacy Law and Ethics course “, is the strict prohibition against manufacturers marketing unapproved drugs or unapproved (“off-label”) uses of … Read more
The journey of a new drug from laboratory discovery to the pharmacy shelf is a long, complex, and highly regulated process overseen by the U.S. Food and Drug Administration (FDA). Understanding this new drug approval process, a key topic in the Principles of Medicinal Chemistry and Pharmacology I course, is essential for pharmacists to critically … Read more
