USP <797> went into effect on November 1, 2023. USP <797> describes the minimum standards to be followed for the preparation of compounded sterile preparations (CSPs) for human and animal drugs. Sterile compounding is defined as combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance to create a sterile preparation.
One area of particular concern that falls under USP <797> is parenteral nutrition (PN) compounding. An Institute for Safe Medication Practices (ISMP) report highlights the risk associated with total parenteral nutrition (TPN) compounding, in which it describes nine suspected deaths due to PN contaminated with Serratia marcescens.
A recent invited review describes the safety issues associated with the complex process of compounding PNs, which include the development of calcium precipitants, mismatch of PN components during the ordering process, and as the ISMP report discusses, microbial contamination of PNs.
The purpose of this review is describing current challenges with the education and training of compounding PNs, identifying compatibility and stability issues with PN admixtures, discussing concerns around the simultaneous administration of nonnutrient medications with PN admixtures, and focusing on specific concerns regarding special populations for whom PN is intended, such as neonates, pediatric patients, and those receiving home care.
The paper describes the gaps that exist in nutrition education and training, as 71% of U.S. medical schools fail to provide the recommended minimum hours of nutrition education for physicians. Further, fewer than one-quarter (23%) received such training during their residency or fellowship training. However, this dearth of nutrition education does not only affect the medical profession. Specific requirements for nutrition education within pharmacy residencies do not exist. Such education is conducted by the clinical specialists within each institution, resulting in gaps in education. The article describes the successful implementation of an institution’s compounding compliance team, which is responsible for educating staff on CSP and best practices. To assist with enhancing pharmacist’s education on PN, the American Society of Parenteral and Enteral Nutrition has developed “Standards of Practice for Nutrition Support Pharmacists.”
The invited review discusses USP <797> regulations and provides a useful table comparing beyond-use dating between previously published USP Chapter <797> guidelines and the revised edition that went into effect in November 2023. Among the differences is that the categorization as low risk in segregated compounding areas, low risk, medium risk, and high risk are no longer used. Instead, the revisions to USP <797> now describe:
• Category 1 CSP, which replaced the low risk in segregated compounding area
• There is no corresponding new category for the old low-risk group
• The medium-risk category is now addressed under the new Category 2 CSP, which describes aseptically process products that do not require sterility testing and include only starting components
• The high-risk group now falls into different categories including:
– Aseptically processed parenteral products with no sterility testing needed and in which >1 nonsterile starting components are used
– Aseptically processed parenteral products that passed sterility testing
– Terminally sterilized (i.e., the process in which a product is sterilized within its sterile barrier field) parenteral products with no sterility testing
– Terminally sterilized parenteral products that have passed sterility testing
– Category 3 CSP
• Aseptically processed parenteral products that are stability tested and that have passed all applicable tests for Category 3 CSPs
• Terminally sterilized parenteral products that had sterility testing performed and have passed all applicable testing for Category 3 CSPs.
The article compares the previous USP <797> beyond-use-dates (BUDs) to the updated BUD in the USP <797>. It provides BUDs for when parenteral products are stored at a controlled room temperature, refrigerated, and/or are frozen.
The paper also addresses PN admixture requirements, which focus on factors that affect stability and instability and safety concerns. To address safety concerns, total nutrient admixtures (formerly called 3-in-1 PN) should be filtered using a 1.2-micron filter. The paper also discusses the use of multichamber bag PNs and their potential safety concerns.
Neonatal and pediatric patients are particularly at risk of PN-associated medication errors given the size of these patients and use of commercially available parenteral products, which are intended for adult use. A particular concern is the precision and accuracy of syringes used in CSPs for this age group.
The article discusses PN compounding and medication compatibility. They describe the stability of calcium-phosphate admixtures in PN and focus on the role that product selection, concentration, presence of other products, the pH of the final admixture, temperature, and the time between compounding and completion of administration have in affecting solubility and stability of the compound.
Lastly, the paper highlights issues with PN compounding during transitions of care, which include avoiding interruption of therapy, reimbursement concerns, and the compounding/administration of home PN.
This article is a must-read for any pharmacist or pharmacy technician involved in the compounding of PNs, whether for inpatient or home use.
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
