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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is a critical distinction that sets this facility apart from traditional compounding pharmacies. Located at 2160 W State Road 434, Longwood, FL 32779, this outsourcing facility adheres to the most rigorous current good manufacturing practices (cGMP) mandated by the FDA for drug manufacturers. This ensures that every preparation leaving the facility meets the highest standards of quality, purity, and potency for the patients and healthcare providers it serves.
The core function of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications that are not available commercially. This includes producing medications that are on the FDA’s drug shortage list, providing a vital service to local hospitals, clinics, and healthcare practitioners who require a reliable source for essential drugs. By operating under Section 503B, the pharmacy can compound medications in advance of receiving a prescription, allowing for a more efficient and responsive supply chain for healthcare entities that depend on these critical preparations.
Patients and prescribers who utilize the services of 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 benefit from the assurance that comes with FDA oversight. The facility undergoes regular FDA inspections, and its processes are designed to minimize the risk of contamination and ensure consistency in every batch. This level of quality control is paramount for sterile injectables, ophthalmics, and other preparations that require an aseptic environment. The pharmacy’s commitment to compliance and patient safety is the foundation of its operation.
Healthcare providers in need of compounded medications for their patients can confidently partner with 503B Compounding Pharmacy. The facility works directly with practitioners, providing them with access to a broad range of medications that may be necessary for specific patient needs but are unavailable from standard commercial manufacturers. This partnership is essential for advancing patient care and ensuring that treatment options are not limited by drug shortages or discontinuations.
For more information about the services provided or to discuss your specific needs, please contact 503B Compounding Pharmacy. You can reach the facility by phone at (407)993-1381 or visit the website at . The team at 2160 W State Road 434, Longwood, FL 32779 is dedicated to supporting the local medical community with high-quality, compliant compounded medications.
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 FDA and complies with strict federal standards for manufacturing, quality control, and testing, similar to those required of major drug manufacturers, to ensure the highest level of patient safety.
2. Can I, as an individual patient, get a prescription filled at 503B Compounding Pharmacy?
503B Compounding Pharmacy primarily provides medications in bulk to healthcare facilities and practitioners. Individual patients should have their healthcare provider contact us directly at (407)993-1381 to discuss availability and ordering.
3. What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434 prepare?
We specialize in compounding sterile injectables and other medications that are on the FDA drug shortage list or are otherwise not available from commercial manufacturers, providing them for use by local hospitals, clinics, and healthcare professionals.
4. How does the 503B outsourcing model benefit our local healthcare providers?
It provides a reliable, local source for high-quality, essential medications that are in short supply or unavailable, ensuring that patient care at facilities using our services is not disrupted due to national drug shortages.
5. How can a healthcare facility or practitioner place an order with 503B Compounding Pharmacy?
Healthcare providers can initiate the process by calling our facility directly at (407)993-1381. Our team will provide information on available medications, ordering procedures, and compliance requirements.