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 is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations, and provides medications for office use by healthcare practitioners.
The core function of 503B Compounding Pharmacy is the large-scale production of sterile and non-sterile compounded medications. These preparations are distributed to healthcare providers and clinics for office-use, meaning they are administered to patients within a clinical setting and are not typically dispensed directly to individual patients for take-home use. Our operations at 2160 W State Road 434, Longwood, FL 32779 are designed to support the local medical community by providing a reliable, high-quality source of essential medications that may be commercially unavailable or in shortage.
By operating under Section 503B, our facility undergoes regular FDA inspections to ensure our processes, environment, and final products meet exacting standards for sterility, potency, and purity. This provides an additional layer of assurance for healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 who utilize our medications in their practice. We provide a critical service by helping to alleviate drug shortages and by creating necessary formulations that are not otherwise available from commercial manufacturers.
Healthcare professionals seeking a dependable outsourcing partner for their practice can connect with 503B Compounding Pharmacy at our location on 2160 W State Road 434, Longwood, FL 32779. We encourage you to visit our website at https://503bcompoundingpharmacy.com/ or call us directly at (407)993-1381 to learn more about our current product offerings and compliance protocols. Our team is dedicated to supporting the local medical community with the highest quality compounded pharmaceutical preparations.
Frequently Asked Questions
What does it mean that you are a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and operates under Section 503B of the FD&C Act. This subjects us to federal oversight and cGMP regulations, ensuring the highest quality and safety standards for our compounded medications intended for office use.
Can I, as an individual patient, pick up my prescription at your location?
No. 503B Compounding Pharmacy primarily supplies medications for office-use to healthcare practitioners. Individual patients should have their healthcare provider contact us at (407)993-1381 to discuss our services for their practice located at 2160 W State Road 434, Longwood, FL 32779.
What types of medications do you compound at your facility?
Our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 specializes in the large-scale compounding of both sterile and non-sterile preparations. These are provided to healthcare professionals for administration within their practice.
How do I place an order as a healthcare provider?
Healthcare providers can place orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will assist you with the ordering process and any specific requirements for your practice near 2160 W State Road 434, Longwood, FL 32779.
Why should a healthcare provider choose a 503B outsourcing facility?
Choosing our 503B facility at 2160 W State Road 434, Longwood, FL 32779 ensures you are using medications produced under the strictest federal quality controls. This mitigates risk and provides assurance of sterility, potency, and purity for medications used in your practice.