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 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 specifically designed and regulated to compound large quantities of sterile and non-sterile medications for healthcare providers. This designation means we adhere to the highest federal standards for quality control, sterility assurance, and testing, providing a critical component of the pharmaceutical supply chain for practitioners.
Unlike a traditional 503A compounding pharmacy, which compounds patient-specific prescriptions, our 503B operation produces medications in bulk for office use. This allows healthcare professionals at their practice locations to have essential medications readily available for immediate administration to their patients. Our core mission is to support the local medical community by providing a reliable, high-quality source of compounded medications that are often in short supply or unavailable from conventional pharmaceutical manufacturers.
The services provided by 503B Compounding Pharmacy at our Longwood location are defined by our federal registration. We specialize in the large-scale compounding of injectable medications, including hormones, peptides, vitamins, and other therapeutic agents. Every batch produced within our facility undergoes rigorous testing to ensure potency, purity, and sterility. This process provides an added layer of safety and assurance for both the prescribing providers and their patients who receive these medications.
Our team of highly trained pharmacists and technicians utilizes state-of-the-art equipment within our controlled environment to maintain the integrity of every preparation. We are committed to excellence in every aspect of our operation, from sourcing high-quality ingredients to meticulous documentation and final product release. For healthcare providers seeking a trusted partner for their office-use medication needs, 503B Compounding Pharmacy at 2160 W State Road 434 serves as a vital resource.
To learn more about our available formulations or to discuss how we can support your practice, we encourage you to contact us directly. You can reach our facility by phone at (407)993-1381 or visit our website for additional information at . Our team is dedicated to upholding the stringent standards expected of a 503B outsourcing facility for the benefit of the local healthcare ecosystem.
FAQ
1. What does it mean that you are a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434 is registered with the FDA and complies with strict federal standards for compounding medications in bulk for office use by healthcare providers, including current Good Manufacturing Practices (cGMP).
2. Can I, as an individual patient, get a prescription filled directly at your location?
No. As a 503B outsourcing facility, we provide medications in bulk for office use to licensed healthcare practitioners. Individual patients should contact their provider, who may stock medications compounded at our facility.
3. What types of medications do you compound at your Longwood facility?
Our FDA-registered facility at 2160 W State Road 434 specializes in compounding sterile injectable medications, including but not limited to hormones, peptides, and nutrient-based therapies, for healthcare providers.
4. How do I know the medications from your facility are safe?
Every batch of medication compounded at our location undergoes rigorous testing for potency, sterility, and endotoxins as required by our FDA registration and cGMP standards, ensuring the highest level of quality and safety.
5. How can a healthcare provider at my office order from you?
Healthcare providers can contact our facility directly at (407)993-1381 to establish an account, discuss available medications, and place orders for delivery or pickup at 2160 W State Road 434, Longwood, FL 32779.