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.
503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under 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. As a 503B outsourcing facility, we adhere to rigorous federal standards for quality control, testing, and production, which are distinct from traditional compounding pharmacies. This designation ensures that healthcare providers at our location can access high-quality compounded medications with the assurance of compliance with current good manufacturing practices (cGMP).
The primary function of 503B Compounding Pharmacy is to provide bulk compounded pharmaceutical products for office use by healthcare practitioners. We serve the medical community at our Longwood facility by producing medications that are often in short supply or unavailable from conventional pharmaceutical manufacturers. Our services are essential for hospitals, clinics, and other healthcare entities that require reliable access to specific drug formulations for their patient care protocols. The medications produced are not intended for direct patient purchase but are distributed to authorized healthcare providers for administration within their professional practice.
Our operational model at 2160 W State Road 434 is built on a foundation of quality and safety. Every batch of medication is compounded in our state-of-the-art cleanroom environments by highly trained professionals. We employ stringent sterility testing, analytical testing, and endotoxin testing to verify the potency, purity, and safety of every product we dispense. This meticulous process provides an additional layer of safety for patients and confidence for the healthcare providers who rely on our products at this location.
503B Compounding Pharmacy provides a critical service by compounding medications that are on the FDA drug shortage list. This capability allows healthcare practitioners in our community to continue treatment plans without interruption, ensuring patient care remains consistent and effective. By focusing on these essential medications, we play a vital role in supporting the local healthcare infrastructure directly from our facility on W State Road 434.
For healthcare providers seeking a dependable source for office-use compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a trusted partner. We are committed to upholding the highest standards of pharmaceutical compounding as defined by our 503B status. For more information, please visit our website at or contact us directly at (407)993-1381.
Frequently Asked Questions
1. What does it mean that this is a 503B compounding pharmacy?
Being a 503B compounding pharmacy means our facility at 2160 W State Road 434 is registered with the FDA as an outsourcing facility under Section 503B of the FD&C Act. This requires us to comply with more rigorous federal manufacturing standards, including current Good Manufacturing Practices (cGMP), and to report all of our compounded products to the FDA. This ensures a higher level of quality and safety control for the medications we produce for healthcare providers.
2. Can I, as a patient, directly purchase medications from your location?
No. 503B Compounding Pharmacy at 2160 W State Road 434 provides medications exclusively for office use by healthcare practitioners. Our products are dispensed to hospitals, clinics, and other healthcare entities, not directly to individual patients. You would receive a medication we compounded through your healthcare provider as part of your treatment.
3. What types of medications do you compound at your Longwood facility?
Our facility compounds a wide range of sterile and non-sterile medications that are often on the FDA drug shortage list or are not commercially available. This includes various injectables, ophthalmics, and other formulations required by healthcare providers for their practice. All compounding is done under strict cGMP guidelines at our location on W State Road 434.
4. How does the quality assurance process work at your pharmacy?
Quality assurance is paramount at our 503B facility. Every batch of medication compounded at 2160 W State Road 434 undergoes rigorous testing, including sterility testing, endotoxin testing, and potency analysis, to ensure it meets all specified standards before it is released and dispensed to a healthcare provider.
5. How can a healthcare provider at your location place an order?
Healthcare providers can place orders for office-use compounded medications by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide information on ordering procedures, product availability, and can address any specific questions related to the needs of your practice.