by Scott Milner | Aug 20, 2024 | ACHC, Compliance, Pharmacy, The Joint Commission, USP
Introduction The pharmacy space in the United States is governed by rigorous standards designed to ensure patient safety, medication efficacy, and overall care quality. Among these standards, those set by the United States Pharmacopeia (USP) play a critical role in...
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 Scott Milner | Jul 24, 2024 | Compliance, Pharmacy, USP
The Vital Role of USP in Pharmacy In recent discussions with industry experts, the importance of compliance with the United States Pharmacopeia (USP) chapters has been a recurring theme. Often regarded as mere “recommendations” or guidelines for best...
by Scott Milner | Jul 2, 2024 | Compliance, Diverson, Pharmacy, Sterile Compounding, Terlumina | Rx, USP
The 90s were a wild time. One summer, while at a scout camp in Kananaskis, Alberta Canada, our troop was invited to try out a zip line. We were the first scouts to zip down a cable tied between two trees, close to 100 feet apart. While the descent felt like three...
by Scott Milner | Jun 15, 2024 | Compliance, Pharmacy, Sterile Compounding, USP
In the realm of hygiene and pharmacy cleanliness standards, terminology can sometimes lead to confusion. Two terms that often cause debate are “unsanitary” and “insanitary.” While both words relate to conditions that are not clean or hygienic,...
