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 at 2160 W State Road 434, Longwood, FL 32779
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 specifically designed and regulated to compound large volumes of sterile and non-sterile medications for office use by healthcare practitioners. As a 503B outsourcing facility, we adhere to rigorous current good manufacturing practices (cGMP), which provides an additional layer of safety and quality assurance for the medications we produce. Our primary mission is to supply healthcare providers with reliable, high-quality compounded pharmaceutical products to support patient care directly from our Longwood location.
The operations at 503B Compounding Pharmacy are distinct from traditional compounding. Our status as a 503B outsourcing facility means we are subject to federal oversight and must meet stringent standards for quality control, sterility testing, and potency verification. This ensures that every batch of medication leaving our facility at 2160 W State Road 434, Longwood, FL 32779 is consistent, reliable, and of the highest pharmaceutical grade. We compound a significant volume of medications, including sterile injectables, ophthalmics, and other preparations that are essential for hospitals, clinics, and surgical centers. Our processes are validated, and our facility undergoes regular FDA inspections to maintain our registered status.
Healthcare practitioners who source their office-use medications from 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 benefit from the assurance of working with an FDA-registered entity. We provide a critical service by compounding medications that may be on shortage or are not commercially available in the specific strength or formulation required for specialized procedures. Our team of licensed pharmacists and skilled technicians utilizes state-of-the-art equipment within our controlled environment to ensure the integrity of every preparation. By focusing on bulk compounding for office use, we enable practitioners to obtain essential medications efficiently and with confidence in their quality and safety.
For healthcare providers at our location, 503B Compounding Pharmacy serves as a vital partner in patient care. The medications compounded at our facility on W State Road 434 are intended for administration within a professional practice setting and are not dispensed directly to individual patients. Our commitment is to support the local medical community with a dependable source of compounded pharmaceuticals that meet exacting standards. We invite healthcare practitioners to learn more about our services and how our 503B status provides a distinct advantage in medication safety and compliance.
Contact 503B Compounding Pharmacy at our facility located at 2160 W State Road 434, Longwood, FL 32779. You can reach us by phone at (407)993-1381 or visit our website at .
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this is a 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779?
It means our pharmacy is registered with the FDA under Section 503B of the FD&C Act. This registration requires our facility at 2160 W State Road 434, Longwood, FL 32779 to comply with stringent current good manufacturing practices (cGMP) for compounding medications in large volumes for office use by healthcare practitioners.
2. Can I, as a patient, pick up my personal prescription at 2160 W State Road 434, Longwood, FL 32779?
No. 503B Compounding Pharmacy compounds medications exclusively for office use by healthcare providers. We do not dispense medications directly to individual patients from our location at 2160 W State Road 434, Longwood, FL 32779. Your healthcare provider will administer any medications we compound within their practice setting.
3. What types of medications does 503B Compounding Pharmacy at this location provide?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile preparations, including injectables, ophthalmics, and other formulations that are often on national shortage or require specific strengths not available from commercial manufacturers, specifically for healthcare practitioner office use.
4. How does the 503B status at this Longwood facility ensure medication quality?
Our 503B status mandates that we operate under cGMP guidelines. This includes rigorous environmental monitoring, extensive testing for sterility and potency, validation of all our processes, and regular inspections by the FDA at our 2160 W State Road 434, Longwood, FL 32779 location to ensure the highest quality and safety standards.
5. How can a healthcare practice at this location order from your 503B facility?
Healthcare practitioners can contact 503B Compounding Pharmacy directly to discuss their office-use medication needs. You can reach our facility at 2160 W State Road 434, Longwood, FL 32779 by calling (407)993-1381 or by visiting our website at . Our team will provide information on ordering and our available formulations.