by Rich | Aug 6, 2024 | Compliance, FDA, FDCA, USP
Summary In part one of this two-part article, we talked about how the FDA relies upon FDCA Sections 501(a), 503A, and 503B, and how USP standards are referenced to help set enforceable standards. When compounding, to achieve and maintain full compliance it is critical...
by Rich | Aug 2, 2024 | Compliance, FDA, FDCA, Pharmacy
Summary This two-part article is part of our blog series “Introduction to USP Compliance in Pharmacy: Insights and Best Practices.” This part one explores how United States Pharmacopeia (USP) standards and key provisions of the Federal Food, Drug, and...
by Rich | Apr 2, 2024 | Compliance, Pharmacy, Sterile Compounding, Uncategorized, USP
✔ If you work with complexity (e.g., healthcare) and have not read this book, you should. ✔ If you have not implemented a checklist strategy, you must. “under conditions of complexity, not only are checklists a help, they are required for success. There must always be...
by Rich | Mar 3, 2024 | Compliance, Pharmacy, Uncategorized
Pharmacy technicians have a wide range of critical responsibilities that directly impact patient care and the pharmacy’s compliance with regulations and best practices. It’s no secret that many pharmacies continue to have a difficult time recruiting and retaining...
by Rich | Feb 21, 2024 | Compliance, Pharmacy
Pharmacy managers understand how critical it is to prevent errors and minimize costs. Unfortunately, without complete control, this isn’t always possible. Simply adding more resources, specialized tools, and outside consultants alone will not provide complete control...