USP Chapter 795: a review of changes for non-sterile compounding

The Compounding Center Connections

The Compounding Center's pharmacists Jay Gill and Cheri Garvin discuss the changes prescribers and patients might see with their compounded medications because of the new standards going into effect November 1, 2023. The United States Pharmacopeia (USP) is the organization that sets standards for compounded medications, dietary supplements, and some foods. They have new guidelines going into effect that may cause some changes in compounded formulations and their beyond-use-dates (BUDs). BUD is terminology used in the compounding world, but most people think of it as the compounded preparation's expiration date. Compounded medications are designed to meet each individual's unique needs. For that reason there are hundreds of thousands of formulations. While each ingredient used in compounded medication is from an FDA approved manufacturer, the final preparation may not have gone through stability testing to know it's exact expiration date. For that reason, USP recommends very conservative BUDs. Cheri and Jay review the new beyond-use-dates for oral liquids, solid dosage forms like capsules, and topical creams and ointments. They also discuss options prescribers may want to consider to make the preparation more convenient for their patients. Tune in to learn more!