On Oct. 7, the Food and Drug Administration (FDA) released revised guidance for industry, “Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” The revised guidance addresses the requirement that compounding be based on the receipt of a valid prescription for an identified patient and the provision concerning compounded drugs that are essentially copies of a commercially available drug. We have developed a draft comment letter based on a series of discussions among a small group of pharmacy personnel from member hospitals. The draft comment letter urges the FDA to recognize the importance of hospital compounding and identifies our concerns with the revised policy. We would greatly appreciate feedback from member hospitals by Nov. 30. The comment period ends Dec. 6.
FDA Hospital and Health System Compounding Guidance Draft Comments
The FDA released revised guidance for industry.
