Which document must sterile compounding pharmacies follow according to regulations?

The requirement for sterile compounding pharmacies to adhere to USP standards is grounded in the fact that the United States Pharmacopeia (USP) sets forth the specific standards for compounding practices to ensure the safety, quality, and efficacy of compounded sterile preparations. These standards, particularly USP Chapter <797>, define the conditions under which sterile compounding must be performed, including facility requirements, equipment, personnel training and competencies, and procedures for maintaining sterility.

Compliance with USP standards is critical for ensuring that compounded products are free from contamination and meet necessary quality benchmarks. While FDA guidelines may also provide important regulatory oversight, the USP standards are specifically designed for the compounding process itself and are recognized by regulatory bodies as the authoritative source in this context. Local health department policies may vary by region and often align with broader guidelines but do not replace the need for adherence to the USP standards. Similarly, state legislature decisions may inform pharmacy operations but do not specifically address the detailed processes for safe sterile compounding.