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 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 large-scale compounding of sterile and non-sterile medications. This designation signifies our unwavering commitment to the highest standards of quality, safety, and regulatory oversight, exceeding the requirements of a traditional compounding pharmacy.
As a 503B outsourcing facility, our primary mission is to provide bulk quantities of compounded medications for physician offices, hospitals, and healthcare clinics. The medications produced at our Longwood location are prepared without patient-specific prescriptions and are intended for office use by medical professionals. This allows healthcare providers at 2160 W State Road 434, Longwood, FL 32779 to have essential medications readily available for their patients during procedures, treatments, and appointments.
The operational protocols at 503B Compounding Pharmacy are rigorous. Our state-of-the-art facility incorporates advanced environmental controls, including ISO-classified cleanrooms, to ensure the sterility and potency of every preparation. Every lot of medication is subjected to stringent testing and quality assurance procedures before it is released. This meticulous process provides healthcare practitioners with the confidence that the medications they use from our 2160 W State Road 434, Longwood, FL 32779 facility are of the utmost quality and reliability.
Healthcare providers seeking a trusted source for high-quality, office-use compounded medications will find a reliable partner in 503B Compounding Pharmacy. We encourage medical professionals to contact us to discuss their specific needs and to learn more about our comprehensive list of available medications. You can reach us directly at (407)993-1381 or visit our website for more detailed information at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. What does it mean that you are a 503B outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with Current Good Manufacturing Practices (cGMP). We compound medications on a larger scale for office use by healthcare practitioners, adhering to more rigorous federal standards than a traditional pharmacy.
2. Can I, as an individual patient, get a prescription filled at your location?
No. 503B Compounding Pharmacy provides medications for office use to healthcare providers, not directly to individual patients. Your healthcare provider at their practice may use medications compounded at our facility located at 2160 W State Road 434, Longwood, FL 32779 during your treatment.
3. How do I, as a healthcare provider, order from your facility?
Healthcare providers can place orders for office-use compounded medications by contacting our facility directly. We are located at 2160 W State Road 434, Longwood, FL 32779 and can be reached by phone at (407)993-1381 to establish an account and discuss your specific compounding needs.
4. What kind of quality control measures are in place at your facility?
Our 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 operates under cGMP guidelines. This includes rigorous environmental monitoring, validated processes, and independent testing of compounded medications for sterility, potency, and endotoxins to ensure patient safety.
5. Where is your 503B facility physically located?
Our FDA-registered outsourcing facility is located exclusively at 2160 W State Road 434, Longwood, FL 32779. This is the only location where our 503B compounding activities are performed.