How Bare Compounding Maintains USP <795> Compliance
Bare Compounding Pharmacy is committed to the highest standards in pharmaceutical compounding, ensuring patient safety, product quality, and regulatory compliance.
Our nonsterile compounding practices strictly follow USP <795> Pharmaceutical Compounding – Nonsterile Preparations, the nationally recognized standard governing how compounded medications are prepared in the United States.
USP <795> is a chapter published by the United States Pharmacopeia that establishes quality and safety standards for nonsterile compounded medications. It outlines requirements for:
These standards exist to reduce risks such as contamination, incorrect potency, and preparation errors, helping ensure safe outcomes for patients.
All compounding staff at Bare Compounding are thoroughly trained in USP <795> requirements. Personnel follow strict hygiene protocols, including handwashing, proper garbing, and contamination prevention procedures in accordance with updated standards.
Our facility is designed to meet USP <795> specifications:
Routine cleaning and sanitization protocols are documented and performed consistently to maintain compliance.
We use pharmaceutical-grade ingredients sourced from FDA-registered suppliers and ensure all equipment is properly maintained, calibrated, and cleaned to prevent contamination or variability.
Bare Compounding maintains comprehensive SOPs covering:
A designated responsible person oversees compliance, reviews procedures regularly, and implements corrective actions when necessary.
We assign beyond-use dates based on USP <795> guidelines, considering:
This ensures medications remain safe and effective throughout their intended use period.
Every compounded preparation is supported by detailed documentation, including:
Our quality assurance program ensures traceability, consistency, and continuous improvement.
USP <795> compliance is more than a regulatory requirement—it is a commitment to patient safety. By adhering to these standards, Bare Compounding Pharmacy strives to ensure that every customized medication meets rigorous quality expectations.
Contact us today to learn more about how we comply to USP <795> standards.
At Bare Compounding Pharmacy, caring for you is our top priority. We'd love to hear how we did. Share your experience with a Google Review or Like us on Facebook, we appreciate your feedback and we strive to always keep improving!
