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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, testing, and production, providing healthcare providers with a reliable source for compounded medications that are not commercially available. The operations at 2160 W State Road 434 are distinct from traditional compounding, focusing on producing medications for office use by physicians and healthcare facilities.
The core function of 503B Compounding Pharmacy at its Longwood location is the production of medications in larger volumes without receiving patient-specific prescriptions. This model supports local clinics, hospitals, and healthcare practices by supplying them with essential medications ready for immediate administration to patients. The facility's commitment to compliance with current Good Manufacturing Practices (cGMP) ensures that every product leaving 2160 W State Road 434 meets strict specifications for potency, purity, and sterility. This level of quality assurance is a fundamental aspect of the 503B compounding designation and is central to the pharmacy's operations in Longwood.
Healthcare professionals seeking a trusted source for compounded medications can rely on the services provided at 2160 W State Road 434. The facility's portfolio includes a range of preparations, from sterile injectables to topical formulations, all produced under a robust quality management system. By operating as a 503B outsourcing facility, this pharmacy provides a critical service to the medical community, ensuring access to high-quality medications that are essential for various treatment protocols. The team at 503B Compounding Pharmacy is dedicated to upholding the highest standards of pharmaceutical compounding at its location on W State Road 434.
For more information on the services available or to discuss your facility's needs, you can contact 503B Compounding Pharmacy directly. The team can be reached by phone at (407)993-1381. Additional details about the facility's capabilities and compliance status are available on the official website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA under Section 503B. We compound medications in larger volumes for office use by healthcare providers, adhering to strict federal manufacturing standards, including current Good Manufacturing Practices (cGMP).
Can I, as an individual patient, get a prescription filled at 2160 W State Road 434?
No. 503B Compounding Pharmacy does not compound medications based on individual patient prescriptions. Our facility supplies medications in bulk to licensed healthcare providers for use in their practices. Patients should contact their healthcare provider for information on obtaining compounded medications.
What types of medications does the Longwood facility compound?
Our facility at 2160 W State Road 434 compounds a range of sterile and non-sterile medications. This includes various injectable, ophthalmic, and topical preparations that are supplied to healthcare facilities for administration to patients within their care.
How does the quality assurance at 503B Compounding Pharmacy work?
As an FDA-registered 503B outsourcing facility, we operate under a comprehensive quality management system that complies with cGMP. Every batch of medication produced at our Longwood location undergoes rigorous testing to ensure it meets specified standards for identity, strength, quality, and purity before it is released.
How can a healthcare facility at 2160 W State Road 434 place an order?
Healthcare facilities and providers can contact 503B Compounding Pharmacy directly to discuss their needs and place an order. You can reach us by phone at (407)993-1381. More information is also available on our website at https://503bcompoundingpharmacy.com/.