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 control, undergoing regular FDA inspections to ensure every preparation meets rigorous testing and safety protocols. This designation differentiates us from traditional compounding pharmacies and underscores our unwavering commitment to providing healthcare providers and patients with medications they can trust.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are not commercially available. This includes creating formulations without certain allergens like dyes or preservatives, adjusting dosages to meet specific patient needs, or producing medications that are currently in shortage. Our work at the 2160 W State Road 434 location is pivotal for hospitals, clinics, and healthcare practitioners who require bulk quantities of reliable, high-quality compounded preparations for their patients. We serve as a critical partner in the local healthcare ecosystem, ensuring essential medications are accessible.
Quality and safety are the foundational principles of everything we do at 503B Compounding Pharmacy. Our state-of-the-art facility on W State Road 434 is designed to prevent contamination, with controlled environments for sterile compounding that meet or exceed USP <797> and USP <800> standards. Every batch of medication is meticulously prepared by our team of expert pharmacists and technicians, and undergoes stringent testing to verify potency, sterility, and purity. This process provides an additional layer of safety and assurance for the healthcare providers who utilize our services at this location.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical professionals. Healthcare providers can initiate orders directly with our facility. Our team is available to discuss specific patient or practice needs, provide information on available formulations, and guide you through the ordering process. We are committed to supporting the medical community at 2160 W State Road 434, Longwood, FL 32779 with dependable service and consistent communication.
For more information or to speak with our team, please contact 503B Compounding Pharmacy. You can reach us by phone at (407)993-1381 or visit our website at . We are here to answer your questions and provide support for your compounding medication requirements.
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 complies with strict federal standards for compounding medications in bulk. We operate under Section 503B of the FD&C Act, which requires adherence to Current Good Manufacturing Practices (cGMP), regular FDA inspections, and specific reporting for adverse events.
2. Who can place an order with 503B Compounding Pharmacy at this location?
Orders are placed by licensed healthcare providers, such as physicians, hospitals, and clinics, for their patients. Patients themselves do not order directly from a 503B outsourcing facility. Your healthcare provider will determine if a compounded medication from our facility is appropriate for your treatment.
3. What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy prepares a wide range of sterile and non-sterile compounded medications, including those used for hormone therapy, pain management, ophthalmology, and medications that are currently in drug shortage. All preparations are made in our facility at 2160 W State Road 434 according to specific formulations and quality controls.
4. How does 503B Compounding Pharmacy ensure the safety of its compounded preparations?
Safety is ensured through a multi-layered approach at our Longwood facility. This includes a controlled cleanroom environment for sterile compounding, rigorous testing of components and finished preparations for sterility and potency, and strict adherence to standardized procedures and cGMP regulations mandated for all 503B outsourcing facilities.
5. How can a healthcare provider get started with your services?
Healthcare providers interested in our services can contact 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide information on our capabilities, discuss specific needs, and outline the process for establishing an account and placing orders from our 2160 W State Road 434 location.