what is nonsterile drug compounding

USP 795 “Pharmaceutical Compounding ---- Nonsterile Preparations” codifies the rules pharmacists and pharmacy technicians must follow when preparing customized dosage forms meant to be taken orally, inserted rectally or applied topically. The chapter was updated, expanded and republished in May 2011 to emphasize the importance of documenting all compounding procedures, labeling compounded drugs accurately with APIs and beyond use dates, and using purified water for all mixing and cleaning related to nonsterile compounding.

The links in this paragraph provide greater detail on what USP 795 requires, but two facts bear highlighting.

First, as USP Compounding Expert Committee member Patricia Kienle, RPh, MPA, FASHP, told Pharmacy Purchasing & Products, “Even simple processes, such as reconstituting an antibiotic suspension, signify compounding and thus, are covered by this chapter.”

Second, USP 795 carries the force of law. Its provisions can be, and are, enforced by U.S. Food and Drug Administration agents and state board of pharmacy officials. All states have adopted USP 795 as the baseline for safe and legal nonsterile compounding, and some have developed other rules for compounders. In short, adhering to USP 795 standards puts pharmacists and technicians on the right sides of health care practice and the law.