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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, testing, and production that exceed those of traditional compounding pharmacies, providing a critical component of the pharmaceutical supply chain for healthcare providers.
The core function of 503B Compounding Pharmacy is the production of medications in bulk for office use by healthcare practitioners. This means that physicians, surgeons, dermatologists, and other medical professionals practicing at or near 2160 W State Road 434, Longwood, FL 32779 can source high-quality, compounded medications to have on hand for immediate patient treatment. This eliminates delays in care, as the medications are prepared in advance of patient need, ensuring that when a patient requires a specific compounded formulation, it is readily available during their office visit.
Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy produces a significant volume of medications. These preparations are manufactured under strict aseptic conditions and are subject to stringent potency, sterility, and stability testing. This level of quality assurance is mandated by the FDA for all 503B outsourcing facilities and provides healthcare providers with the confidence that the medications they use meet the highest possible standards for patient safety and efficacy.
The services provided by 503B Compounding Pharmacy are exclusively for healthcare provider offices, hospitals, and clinics. Patients seeking compounded medications for personal use are serviced through a prescribing practitioner who can order from the facility. The team at 2160 W State Road 434, Longwood, FL 32779 works directly with healthcare providers to ensure their specific needs are met, offering a reliable and compliant source for essential medications that may be in short supply or are not available from conventional pharmaceutical manufacturers.
For more information on the services available from this specific outsourcing facility, healthcare providers are encouraged to contact 503B Compounding Pharmacy directly. The team can be reached by phone at (407)993-1381 or through their website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
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 Current Good Manufacturing Practices (cGMP). We compound medications on a large scale for office use by healthcare providers and are subject to federal oversight and rigorous testing standards for sterility, potency, and purity.
2. As a patient, can I pick up my prescription directly from your location?
No. 503B Compounding Pharmacy provides medications for office use by healthcare providers. Your prescribing practitioner at their office near 2160 W State Road 434, Longwood, FL 32779 will administer or dispense the medication to you directly from their supply, which they have sourced from our outsourcing facility.
3. What types of medications does 503B Compounding Pharmacy produce?
Our facility at 2160 W State Road 434, Longwood, FL 32779 compounds a wide range of sterile and non-sterile preparations, including injectables, ophthalmics, topicals, and oral medications. These are often medications that are on drug shortage lists or are needed in specific strengths or formulations not commercially available.
4. How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare providers can initiate orders by contacting our facility directly. We encourage providers to call our dedicated line at (407)993-1381 to speak with a representative or to visit our website at https://503bcompoundingpharmacy.com/ for more information on our ordering process and available formulations.
5. Why would a provider choose a 503B outsourcing facility over a traditional compounding pharmacy?
Healthcare providers choose 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 because of the enhanced level of federal oversight and quality control. The cGMP standards we follow ensure batch consistency, comprehensive testing, and a level of quality assurance that is specifically designed for large-scale production, providing greater confidence in the medications used for patient care.