Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act, providing large-scale, sterile compounded medications to healthcare systems across the United States. The pharmacy is built to serve hospitals, surgery centers, clinics, and licensed healthcare providers that require consistent, compliant, and scalable access to compounded pharmaceuticals without patient-specific prescriptions. Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy follows current Good Manufacturing Practice (cGMP) standards and is subject to routine FDA inspection. This places it in a fundamentally different category than traditional 503A pharmacies. The focus is not retail compounding or one-off prescriptions. The focus is controlled production, batch consistency, sterility assurance, and regulatory discipline. The facility specializes in sterile injectable and non-sterile compounded medications designed to address drug shortages, support procedural efficiency, and improve supply chain reliability for healthcare providers. All production is performed in ISO-classified cleanroom environments using validated processes, documented quality systems, and lot-level traceability. Each batch undergoes appropriate sterility, endotoxin, and potency testing based on risk level and formulation requirements. 503B Compounding Pharmacy prioritizes transparency and compliance over speed or marketing claims. Products are compounded using USP-grade ingredients sourced from vetted suppliers, with full documentation available for healthcare partners. Beyond production, the pharmacy supports client institutions with regulatory documentation, recall readiness, adverse event reporting protocols, and consistent supply planning. The company exists to solve real operational problems for healthcare organizations. Drug shortages, inconsistent manufacturers, and unreliable distributors create risk for patient care. A properly run 503B facility reduces that risk by acting as a compliant, predictable manufacturing partner rather than a reactive supplier.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation means we adhere to the highest federal standards for quality control, testing, and production, providing healthcare practitioners and patients with medications they can trust for safety, potency, and purity.
The core function of 503B Compounding Pharmacy is the production of medications that are not commercially available. This includes creating specific dosage forms, altering strengths to meet unique patient needs, or excluding certain allergens. Our operations at the 2160 W State Road 434 location are focused on supplying these essential medications to healthcare providers, ensuring they have the necessary tools for patient-specific care. The facility's processes are designed for rigorous quality assurance, with each batch undergoing thorough testing and validation.
By operating as a 503B outsourcing facility, we provide a critical service from our Longwood location. Healthcare providers can source compounded medications with the confidence that comes from FDA-registered oversight. Patients benefit from access to necessary medications that are produced under the most stringent sterile compounding standards. The entire operation at 2160 W State Road 434 is built on a foundation of regulatory compliance and pharmaceutical excellence.
For more detailed information about our compounding services or to speak with our team, we encourage you to visit our website at https://503bcompoundingpharmacy.com/ or contact us directly by phone at (407)993-1381. The team at 503B Compounding Pharmacy is committed to upholding the highest pharmaceutical standards for the community we serve from our facility in Longwood.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with strict federal current Good Manufacturing Practices (cGMP) for drug production, which includes rigorous quality control, testing, and reporting standards beyond those of a traditional 503A pharmacy.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy primarily supplies compounded medications to healthcare providers and facilities. Patients should consult with their healthcare provider to determine if a medication compounded at our Longwood facility is appropriate for their treatment plan.
What types of medications does 503B Compounding Pharmacy produce?
Operating from 2160 W State Road 434, we compound a range of sterile and non-sterile medications that are not commercially available, including specific dosages, strengths, or formulations free of certain inactive ingredients, all produced in accordance with Section 503B standards.
How does the quality assurance process work at your facility?
Our quality assurance process at the Longwood location is comprehensive. It includes stringent environmental monitoring, validation of sterilization processes, and thorough testing of both raw ingredients and finished batches of medication to ensure identity, potency, purity, and sterility before release.
How can a healthcare provider place an order with your pharmacy?
Healthcare providers interested in our services can initiate the process by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide information on ordering protocols, available formulations, and how we can support patient care from our location on W State Road 434.