
Standard Operating Procedures for Compounding Pharmacies
Standard Operating Procedures (SOPs) are an essential component of quality systems. The United States Pharmacopeia (USP) states that SOPs must be developed for all aspects of the compounding operation. All personnel who conduct or oversee compounding must be trained in the facility's SOPs and are responsible for ensuring the facility’s SOPs are followed. One or more persons must be designated to ensure that SOPs are fully implemented, and the designated person must ensure that follow-up occurs if problems, deviations, or errors are identified.
It's important to review state board of pharmacy laws and regulations, USP chapters, and Food and Drug Administration (FDA) guidelines to determine SOPs for quality systems. The American Society of Health-System Pharmacist Compounding Resource Center provides SOP lists to help pharmacies comply with compounding standards.
USP 1029 Good Documentation Guidelines provide sections typically included in an SOP:
- Purpose and scope
- Instructions and procedure
- Responsibilities and roles
- Materials or equipment, as appropriate
- Definitions or references, as needed
- Review and approval
- Revision History
Additionally, ensure an SOP has a document number, effective date, and an approval signature.
When writing procedures, it’s important to consider the personnel’s perspective. Ensure procedures are clearly written in a step-by-step format. Avoid ambiguity and be careful with important terms. Remember, United States Pharmacopeia defines “should” as a recommendation and “must” as a requirement.
Testing Standard Operating Procedures for compounding SOPs, include but not limited to:
- Media Fill Testing
- Environmental Controls
- Total Airborne Particle Sampling
- Microbiological Air and Surface Monitoring
- Components
- Verifying the effectiveness of cleaning and disinfecting activities
- Verifying the effectiveness of sterilization and depyrogenation methods
- Release Inspections and Testing
- Quality Assurance and Control (out of specifications, complaints, and adverse event reporting)
- Hazardous Drug Testing/Sampling
The state boards of pharmacy and FDA will inspect to ensure that a pharmacy follows written procedures. Having an SOP review schedule and training personnel according to SOPs is essential. Changes to SOPs must be documented and communicated to all personnel involved in the process and procedure with acknowledgment documented.
For additional information on SOPs, access:
- USP 795 Pharmaceutical Compounding Nonsterile Preparations
- USP 797 Pharmaceutical Compounding Sterile Preparations
- USP 800 Hazardous Drugs Handling in Healthcare Settings
- USP 1029 Good Documentation Guidelines
- USP 1163 Quality Assurance in Pharmaceutical Compounding
- USP Compounding Compendium – Access Table of Contents