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 large-scale compounding of sterile and non-sterile medications. This designation means we adhere to the highest current good manufacturing practices (cGMP), providing healthcare practitioners and patients with medications that meet rigorous quality and safety standards. Our mission is to support the local medical community by providing a reliable source of high-quality compounded pharmaceuticals when commercially available options are not suitable.
The operations at our 2160 W State Road 434 location are focused on producing medications for office use, which are then dispensed by physicians and healthcare providers to their patients within their practice settings. This process is vital for treatments such as injectables, infusions, and other preparations that are essential for patient care but may be in short supply or unavailable from traditional manufacturers. By working directly with healthcare providers, 503B Compounding Pharmacy helps ensure that patients receive the specific medications they need without interruption.
As a 503B outsourcing facility, our Longwood location is subject to ongoing FDA inspection and must meet stringent regulatory requirements for sterility, stability, and potency. This level of oversight provides an additional layer of confidence for the healthcare providers we serve. Our team of skilled pharmacists and technicians utilizes state-of-the-art technology and controlled environments to compound medications with precision and consistency. We are committed to upholding the integrity of every preparation that leaves our facility at 2160 W State Road 434.
Healthcare providers seeking a trusted partner for their office-use medication needs will find 503B Compounding Pharmacy to be a dependable resource. Our facility is designed to address drug shortages, provide medications for office stock, and support a wide range of therapeutic areas. We encourage local medical practices to connect with us to learn how our services can enhance patient care. For more information or to initiate an order, please contact us directly.
Website: Phone: (407)993-1381
FAQ
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and compounds medications in accordance with Section 503B of the Federal Food, Drug, and Cosmetic Act. We operate under current good manufacturing practices (cGMP), which are rigorous quality standards enforced by the FDA for drug manufacturers.
2. Can I, as a patient, order medications directly from the 503B Compounding Pharmacy location in Longwood?
No. 503B Compounding Pharmacy provides medications primarily for office use by healthcare providers. Your physician or healthcare provider will order and dispense our compounded medications to you directly within their practice setting at their discretion.
3. What types of medications does the 503B Compounding Pharmacy at 2160 W State Road 434 compound?
Our facility compounds a significant volume of sterile injectables and non-sterile preparations intended for office use by healthcare providers. This includes medications often used in clinics, hospitals, and other healthcare settings that may be on drug shortage lists or are not commercially available.
4. How does the quality assurance at a 503B outsourcing facility differ from a traditional compounding pharmacy?
As a 503B outsourcing facility, our location is subject to mandatory compliance with cGMP standards and regular FDA inspections. This involves extensive testing for sterility, potency, and stability, providing a higher level of regulatory oversight compared to a traditional 503A pharmacy.
5. How can a healthcare provider at a local practice start ordering from your facility?
Healthcare providers can contact 503B Compounding Pharmacy directly at (407)993-1381 to establish an account and discuss their specific medication needs for office use. Our team will guide them through the process for ordering from our location at 2160 W State Road 434, Longwood, FL 32779.