After years of development, revised compounding standards from United States Pharmacopeia (USP) became effective on November 1, 2023. USP Chapter <795> focuses on nonsterile compounding, with updates aimed at improving quality, safety, and consistency. These voluntary standards provide clear guidelines on personnel, equipment, training, and documentation, ensuring that patients receive medications that are safe and free from contaminants.
Standards provided in USP Chapter <797> ensure compounded sterile preparations (CSPs) meet necessary standards of safety and quality. These standards provide detailed guidance on maintaining cleanroom environments, proper aseptic technique, sterility assurance, and thorough documentation. This blog post will identify key areas where gaps were identified during Verified Pharmacy Program (VPP®) inspections for the first 10 months since the compounding chapters became compendially applicable.
1. Designated Persons
The updated USP Chapters <795> and <797> include a requirement for a “designated person” who is responsible for overseeing compounding activities and ensuring compliance. While the majority of pharmacies have met this requirement, 21% of nonsterile and 13% of sterile facilities are either unaware of or have yet to assign someone to this role. For patient safety, it is essential for all pharmacies to designate qualified individuals, as this role ensures adherence to protocols and therefore reduces the likelihood of contamination.
2. Training and Competency
Training programs are fundamental for ensuring that staff are knowledgeable about nonsterile and sterile compounding procedures, however, 42% of nonsterile and 16% of sterile pharmacies are still behind in this area. Proper training covers compounding techniques, safety protocols, and documentation, reducing the risk of errors that could impact patient safety. Pharmacies with comprehensive training programs are better equipped to maintain high standards of care. Continuing education is very important to emphasize in pharmacy training programs.
Regulators should continue to emphasize the importance of documented training programs, especially during routine inspections.
3. Documentation and Recordkeeping
Accurate documentation is important for maintaining high standards in compounding. The Master Formulation Record (MFR) and Compounding Record (CR) ensure consistency and accountability, detailing each step of the compounding process. However, 33% of nonsterile and 27% of sterile pharmacies are not fully compliant with MFR requirements, and 29% of nonsterile and 11% of sterile pharmacies are not completing CRs to the standards required by USP. This gap in documentation can lead to inconsistencies, putting patient safety at risk. Pharmacies can improve recordkeeping practices by utilizing templates, internal audits, and educational resources.
4. Certification Reports
Certification reports play a critical role in assessing whether the primary engineering control (PEC) and secondary engineering control (SEC) environments are functioning as required by USP <797>. However, 24% of pharmacies receive incomplete certification reports, which can lead to misunderstandings about the “state of control” in the cleanroom. To ensure CSPs are compounded safely, designated persons must be well-versed in reading these reports and understanding what elements might be missing to fully ensure compliance with compounding standards.
5. Inspection Observations
Live observations during inspections provide critical insights into whether pharmacy personnel are following proper aseptic procedures. Hand hygiene, garbing, and aseptic technique are all vital for maintaining the sterility of CSPs. While most pharmacies meet these standards, there is room for improvement. For example, 23% of pharmacies were observed failing to maintain aseptic technique, potentially compromising the CSP environment.
NABP has adapted its Compounding Pharmacy Accreditation to follow the revised USP standards. Learn more about our Accreditations and how you can show your pharmacy’s alignment to USP Chapters <795> and <797> standards.