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 dedicated to the preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, including current Good Manufacturing Practices (cGMP), which are more rigorous than the standards applied to traditional compounding pharmacies. This ensures that every preparation leaving our facility meets stringent federal requirements for strength, quality, purity, and identity.
The core function of 503B Compounding Pharmacy is to provide bulk quantities of compounded medications for office use by healthcare practitioners. We serve the medical community at our location on 2160 W State Road 434, Longwood, FL 32779, enabling physicians, surgeons, hospitals, and clinics to have essential medications readily available for their patients. Our services are pivotal during drug shortages, providing a reliable and compliant source for critical drugs that are commercially unavailable. The 503B compounding process allows us to produce large batches of medications, which are then distributed to healthcare providers for administration within their practice settings.
Our facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by highly trained pharmacists and technicians. The environment for sterile compounding includes ISO-classified cleanrooms, which are meticulously controlled to prevent contamination. Every step of the process, from ingredient sourcing to final packaging, is governed by strict protocols and extensive testing to guarantee the integrity of our preparations. The 503B Compounding Pharmacy model is designed for efficiency and scale, ensuring that healthcare providers in our community have consistent access to the compounded medications they require.
503B Compounding Pharmacy provides a vital service to the local healthcare ecosystem. By operating as a 503B outsourcing facility, we assume significant regulatory responsibility, allowing practitioners to focus on patient care with the confidence that their medications are sourced from a fully compliant and audited facility. Our presence at 2160 W State Road 434, Longwood, FL 32779 supports the medical community by mitigating the impact of supply chain disruptions and offering a trusted resource for high-quality compounded preparations.
For more information about our services or to discuss your office use needs, please contact 503B Compounding Pharmacy. You can reach us at our facility located at 2160 W State Road 434, Longwood, FL 32779. Visit our website at or call us at (407)993-1381.
FAQ
1. What does it mean that you are a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA under Section 503B of the FD&C Act. We follow current Good Manufacturing Practices (cGMP) and produce compounded medications in bulk for office use by healthcare practitioners.
2. Can I, as an individual patient, pick up a prescription directly from your location?
No. 503B Compounding Pharmacy provides medications for office use to healthcare providers. Individual patients receive their medications directly from their doctor's office or clinic, which sources the medication from our facility at 2160 W State Road 434, Longwood, FL 32779.
3. How does a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from you?
Healthcare providers can establish an account with 503B Compounding Pharmacy by contacting us directly. Orders can be placed by calling (407)993-1381. We will coordinate with the practice to fulfill their specific medication needs for office use.
4. What kind of quality controls are in place at your facility?
Our facility at 2160 W State Road 434, Longwood, FL 32779 operates under cGMP standards. This includes rigorous environmental monitoring in our cleanrooms, extensive testing of components and finished preparations, and comprehensive standard operating procedures to ensure every product meets strict quality specifications.
5. Do you compound medications that are currently in shortage?
Yes, one of the primary functions of a 503B outsourcing facility is to help alleviate drug shortages. Healthcare providers serving 2160 W State Road 434, Longwood, FL 32779 can contact us at (407)993-1381 to inquire about the availability of medications affected by national shortages.