Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
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.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility, adhering to the stringent regulations outlined in 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 differentiates us from traditional compounding pharmacies by ensuring our processes, testing, and quality controls meet the highest federal standards for safety and efficacy. We provide these medications for office use by healthcare practitioners, enabling them to have essential drugs readily available for their patients.
The core function of 503B Compounding Pharmacy is the production of medications that are not available commercially or are in shortage. Our facility at 2160 W State Road 434, Longwood, FL 32779 utilizes advanced technology and rigorous sterility testing to prepare injectables, ophthalmics, and other dosage forms. By operating under Section 503B, we provide healthcare professionals with a reliable source for critical medications, ensuring patient needs are met without compromising on quality or safety. Our operations are subject to regular FDA inspections, providing an additional layer of assurance for the medical community we serve.
Healthcare providers in Longwood can rely on 503B Compounding Pharmacy for a consistent supply of high-quality compounded medications. Our location at 2160 W State Road 434 is designed to support local clinics, hospitals, and practices with bulk compounded preparations. We work to alleviate the challenges posed by drug shortages and discontinuations, offering a vital service that directly benefits patient care within our community. The medications produced are intended for administration within a healthcare setting under professional supervision.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical practices. Orders are managed through our dedicated channels, and our team is committed to providing responsive service and support. We encourage healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 to connect with us to discuss their specific needs and how our compounding services can support their practice. For comprehensive information on our available medications and ordering procedures, please visit our website or contact our facility directly.
For further details, please contact 503B Compounding Pharmacy at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/. Our team is ready to assist the medical community at our location on 2160 W State Road 434, Longwood, FL 32779.
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 on a larger scale. This includes current good manufacturing practices (cGMP) and mandatory testing for sterility and potency.
2. Who can order medications from 503B Compounding Pharmacy?
Our medications are prepared for office use and are available for order by licensed healthcare practitioners with prescribing authority. We provide these medications to support clinics and practices at 2160 W State Road 434, Longwood, FL 32779.
3. Can I as a patient directly pick up a medication from your facility?
No. 503B Compounding Pharmacy provides medications for office use to healthcare providers. Patients receive their medications directly from their prescribing physician or healthcare provider at their practice, not from our location.
4. What types of medications does 503B Compounding Pharmacy typically compound?
We specialize in compounding medications that are on shortage or are not commercially available, including sterile injectables and ophthalmics. The specific medications we compound are intended for use within a clinical setting at 2160 W State Road 434, Longwood, FL 32779.
5. How do I place an order for my practice?
Healthcare providers can place orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will guide you through the ordering process and requirements. You can also find more information on our website at https://503bcompoundingpharmacy.com/.