Non-sterile compounding plays a vital role in hospital pharmacies, enabling the customization of medications to meet the unique needs of patients. The United States Pharmacopeia (USP) General Chapter 795 outlines essential standards for the preparation of non-sterile compounded medications. These requirements ensure the safety, quality, and efficacy of compounded products, while minimizing risks to patients. Below are the key requirements for non-sterile compounding according to USP 795: 

1. Facility and Equipment 

Hospital pharmacies must maintain a dedicated, well-organized, and clean area for non-sterile compounding activities. The compounding area should be free from clutter and distractions to avoid contamination or errors. All equipment used in the compounding process, such as balances, mixers, and grinders, must be appropriate for the tasks performed, regularly cleaned, calibrated, and maintained to ensure consistent performance and product quality. 

2. Personnel Training and Competency 

Pharmacy staff involved in non-sterile compounding must be adequately trained in compounding procedures, equipment usage, and safety protocols. USP 795 requires that personnel understand proper hygiene practices, weighing, measuring, and mixing techniques. To ensure ongoing proficiency, pharmacies should regularly assess and document the competency of staff through testing and observation, ensuring compliance with compounding guidelines. 

3. Formulation and Ingredients 

Non-sterile compounding must follow approved formulations or recipes based on evidence-based sources or pharmacist expertise. Pharmacies must obtain high-quality ingredients from reputable suppliers, ensuring that all components meet required standards for purity and potency. Proper ingredient storage is also crucial, with procedures in place to prevent degradation, contamination, or expiration of materials. 

4. Compounding Process 

The actual compounding process requires strict adherence to documented standard operating procedures (SOPs). Pharmacists and technicians must carefully measure, mix, and prepare medications in line with these SOPs to ensure accuracy and uniformity. This may involve checking ingredient quantities, processing times, and mixing techniques, as well as ensuring the final product meets the prescribed specifications before dispensing. 

5. Beyond-Use Dating (BUD) 

USP 795 mandates the assignment of a beyond-use date (BUD) to all compounded preparations. The BUD indicates the timeframe within which the compounded medication is expected to remain safe and effective. BUD determination is based on factors such as the stability of the individual ingredients, the compounding method, and the intended storage conditions. This ensures that medications are used within their safe and effective shelf life. 

6. Labeling 

Proper labeling of compounded preparations is essential for patient safety. USP 795 requires that labels include critical information such as the name and strength of the medication, the dosage form, the beyond-use date, storage instructions, and any special handling precautions. This ensures that healthcare providers and patients are well-informed about the medication and its proper usage. 

7. Quality Control and Assurance 

Quality control is a cornerstone of USP 795 compliance. Pharmacies must implement quality assurance protocols that verify the accuracy, consistency, and quality of compounded medications. This includes inspections during the compounding process, verification of ingredient quantities, and final product checks, such as visual inspections for consistency and labeling accuracy. Pharmacies should also maintain records of any deviations from established procedures and take corrective actions when necessary. 

8. Documentation and Record-Keeping 

Accurate documentation is critical for ensuring traceability and compliance with USP 795. Pharmacies must maintain detailed records of each compounded preparation, including the formula, ingredient sources, batch numbers, and preparation methods. These records provide accountability and allow for quick responses in the event of product recalls or audits. Good record-keeping also helps track the performance of ingredients and monitor compliance with compounding standards. 

9. Cleaning and Sanitation 

Maintaining a clean and sanitary compounding environment is essential to prevent cross-contamination and ensure product integrity. USP 795 requires pharmacies to follow regular cleaning and disinfection schedules for the compounding area, equipment, and tools. Proper sanitation prevents the buildup of residues that could affect the quality of future preparations. 

Non-sterile compounding in hospital pharmacies must adhere to USP 795 standards to ensure that compounded medications are safe, effective, and of high quality. By maintaining proper facility conditions, training personnel, using quality ingredients, following strict compounding procedures, and implementing robust quality assurance and record-keeping practices, hospital pharmacies can meet these requirements and provide the best care for their patients. 

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