USP Standards

USP 797: What to Do When the FDA Comes Knocking on the Door of Your Cancer Center

Willis C. Triplett, PharmD; Dawn Holcombe, MBA, FACMPE, ACHE

November 2016, Vol 6, No 11 - USP Standards

Oncology practices are considered producers of sterile drugs, and fall under the standards set forth by the US Pharmacopeial Convention (USP)’s “General Chapter 797 Pharmaceutical Compounding—Sterile Preparations”1 (USP 797). Any regulatory or accreditation entity, including state professional boards, state licensing [ Read More ]