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 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 specializes in 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 primary function of 503B Compounding Pharmacy is to produce medications in bulk for office use by healthcare practitioners. This means physicians, surgeons, veterinarians, and other medical professionals in Longwood can obtain essential medications for their practice directly from this location. The medications are prepared in a controlled environment that meets current Good Manufacturing Practices (cGMP), ensuring each batch is consistent, high-quality, and free from contaminants. This is distinct from traditional compounding, as the 503B model allows for anticipatory compounding without patient-specific prescriptions, enabling clinics and hospitals to have vital drugs on hand for immediate patient care.
Services at the 2160 W State Road 434 location are centered on this bulk compounding model. The facility produces a wide array of preparations, including sterile injectables, ophthalmics, inhalants, and topical formulations. These medications are critical in various medical settings, from hospital operating rooms and surgical centers to outpatient clinics and veterinary offices. By sourcing from this local 503B outsourcing facility, healthcare providers at 2160 W State Road 434 can be confident they are receiving medications produced under the highest standards of pharmaceutical safety and compliance.
For more information about the services provided, you can visit the facility's website at or contact them directly by phone at (407)993-1381. The team at 503B Compounding Pharmacy is dedicated to supporting the local medical community with dependable, high-quality compounded medications.
FAQ
1. What does it mean that this is a 503B outsourcing facility?
Being a 503B outsourcing facility means our pharmacy at 2160 W State Road 434 is registered with the FDA and operates under strict federal regulations. We compound large batches of medications for office use by healthcare practitioners, adhering to current Good Manufacturing Practices (cGMP) for superior quality and safety.
2. Who can purchase medications from this 503B Compounding Pharmacy location?
Medications compounded at our facility at 2160 W State Road 434 are intended for healthcare providers, including physicians, surgeons, and veterinarians, for use within their practice. These are not medications for direct dispensing to individual patients without a prescription.
3. What types of medications does this location compound?
Our 503B outsourcing facility at 2160 W State Road 434 specializes in compounding a variety of sterile and non-sterile medications, including injectables, ophthalmics, inhalants, and topical creams and gels, all prepared for office use by medical professionals.
4. How does the quality control at a 503B facility differ?
As an FDA-registered 503B outsourcing facility, we are required to follow cGMP guidelines. This includes rigorous testing of raw ingredients, environmental monitoring, and end-product testing to ensure every batch of medication produced at 2160 W State Road 434 meets stringent standards for potency, purity, and sterility.
5. How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can place an order by contacting our facility directly at (407)993-1381. Our team will provide information on available medications, ordering procedures, and delivery options specific to our location at 2160 W State Road 434.