503A Compounding

A 503A pharmacy (like Advanced Scripts) compounds patient-specific medications based on individual prescriptions from licensed practitioners. We create customized formulations for specific patients with unique needs. In contrast, 503B facilities (outsourcing facilities) produce larger batches of compounded medications without patient-specific prescriptions, often for office use or hospital settings. As a 503A pharmacy, we focus on individualized care and work directly with providers to create tailored solutions for their patients.

Our sterile compounding capabilities include injectable medications, ophthalmic preparations (eye drops and solutions), and other specialized sterile products. All sterile compounds are prepared in compliance with USP <797> standards in our dedicated clean room environment. We maintain rigorous testing and quality control protocols for all sterile preparations to ensure safety and efficacy.

We implement multiple quality assurance measures, including: using only pharmaceutical-grade ingredients with certificates of analysis; following USP guidelines for both non-sterile (<795>) and sterile (<797>) compounding; maintaining strict environmental monitoring in compounding areas; performing regular testing of equipment and processes; conducting end-product testing when appropriate; and providing comprehensive staff training and certification.

For optimal compounding, we need: complete patient information; detailed prescription specifications (active ingredients, concentrations, delivery method); relevant allergies or sensitivities; quantity and directions for use; and any specific instructions or preferences. For complex formulations, information about the patient’s condition and treatment goals can help us recommend appropriate options. We’re always available to consult on formulation possibilities.

We have specialized storage facilities for temperature-sensitive medications, light-sensitive compounds, and controlled substances. Our pharmacy maintains appropriate refrigeration, freezing capabilities, and controlled environmental conditions for all sensitive preparations. We also provide clear storage instructions for patients and can recommend appropriate packaging and handling based on the specific requirements of each compounded medication.

Yes, one of the valuable services we provide is compounding alternatives for medications that are on backorder, discontinued, or experiencing supply chain disruptions. When a commercial medication becomes unavailable, we can often compound a similar formulation with the same active ingredients. This service helps maintain continuity of care for patients who depend on specific medications for their health management.