COVID-19 Sparks Compounded Drug Concerns
COVID-19 exacerbated pre-existing compounding concerns throughout hospitals and other healthcare facilities. Compounded medications are not FDA approved and do not undergo safety, effectiveness, or quality checks. The FDA clarified specific topics associated with draft guidance developed to assist with compounded products made in pharmacies not affiliated with outsourcing facilities, addressing concerns about the use of thymosin-alpha 1 and remedesivir during compounding preparations. Read more.

Understanding Proposed Changes to USP 797
The General Chapter 797–Sterile Preparation in Pharmaceutical Compounding was proposed for revision by the United States Pharmacopeia (USP). Category 3 compounded sterile preparations (CSPs) were added to Category 1 and 2 CSPs. Category 3 preparations, which have longer beyond-use dates, also include other specific changes to endotoxin testing, garbing, and cleaning. Currently, the proposed revision is awaiting feedback from pharmacies and other relevant personnel. Read more.

FDA Underscores Unsanitary Compounding Conditions
The FDA recently expressed concern about compounding in medical offices under unsanitary conditions. Under the terms of Section 503A of the Federal Food, Drug and Cosmetic Act, drugs produced under these conditions were considered adulterated. Adverse events have been reported in connection with these products, and case studies were presented in which unsanitary conditions resulted in serious patient illness, hospitalization, and death. Read more.