Nonsterile Compounded Medications For Hospitals

Published: February 11, 2021

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Nonsterile compounded medications encompass many different products that providers turn to in treating a wide range of medical issues. Solutions, creams, gels, ointments, suppositories, and capsules are examples of vital nonsterile medications used daily in hospitals and clinics.

Conventional wisdom is that nonsterile products are easier to compound than sterile products, and that safety is not as much of a concern since nonsterile products are not injected. Both of these assumptions are untrue. Nonsterile compounding of vital medications in a 503B Outsourcing Facility is complex and safety-driven, subject to rigorous testing standards. Enforceable USP 795 standards address all aspects of nonsterile compounding, beginning with personnel training, evaluation and requalification, garbing, and hand hygiene. USP 795 standards also include building and facilities requirements, SOPs and record keeping, release testing, establishment of BUDs, handling and transport, and complaint and adverse event reporting.

While hospital pharmacies have increasingly moved to 503B Outsourcing Facilities for many compounded sterile products, the value of securing nonsterile compounded medications from 503Bs may be overlooked. The benefits are numerous: products from these facilities are compounded in full compliance with USP 795 standards and Current Good Manufacturing Practices (CGMPs), mandated rigorous testing in these facilities leads to longer product BUDs, patient-specific prescriptions are not required, and 503Bs are subject to regular FDA inspections.

Edge Pharma produces over twenty nonsterile compounded medication products, and there are more in development. As required, Edge tests all products for bioburden, potency, and container closure integrity. Depending on the product, some are also tested for pH and clarity of the solution. Extensive product development, including rigorous stability studies, determines an accurate beyond use date that can be trusted.

For nonsterile products used daily in hospitals and clinics across the country, quality, consistency, and supply are key, and 503B facilities ensure that these criteria are met. Edge Pharma is committed to this vital area of patient care.