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 operates as an FDA-registered outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act. This 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy designation signifies a commitment to the highest standards of quality, safety, and compliance, producing large-scale compounded medications for healthcare providers. The 503B Compounding Pharmacy at this location adheres to rigorous Current Good Manufacturing Practices (cGMP), ensuring every preparation meets stringent federal quality and sterility standards.
The services provided by this 503B Compounding Pharmacy are distinct from traditional compounding. As a 503B outsourcing facility, this 503B Compounding Pharmacy prepares medications in advance of receiving a prescription, based on orders from licensed practitioners. The medications produced by this 503B Compounding Pharmacy are intended for office use by physicians, hospitals, and clinics, enabling healthcare professionals to have essential medications readily available for patient care. The 503B Compounding Pharmacy facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with advanced technology and staffed by expert compounding professionals dedicated to precision and quality.
Patients and practitioners visiting or sending orders to 2160 W State Road 434, Longwood, FL 32779 can be assured of the integrity of the medications provided by this 503B Compounding Pharmacy. The 503B Compounding Pharmacy model focuses on producing batches of sterile and non-sterile preparations that are vital for patient treatment plans. The operations at this 503B Compounding Pharmacy are subject to regular FDA inspections, providing an additional layer of oversight and confidence in the medications dispensed. For more information or to place an order, contact this 503B Compounding Pharmacy via their website at or by phone at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this is a 503B Compounding Pharmacy?
This 503B Compounding Pharmacy is an FDA-registered outsourcing facility. This means our operations at 2160 W State Road 434, Longwood, FL 32779 comply with stricter federal standards, including Current Good Manufacturing Practices (cGMP), for the large-scale compounding of medications intended for office use by healthcare practitioners.
2. Can I, as a patient, get a prescription filled directly at this 503B Compounding Pharmacy?
No. As a 503B Compounding Pharmacy, we primarily supply medications to healthcare providers for office use. Your physician or hospital at 2160 W State Road 434, Longwood, FL 32779 may administer medications we compound directly to you during your treatment, but individual patient prescriptions are typically handled by traditional 503A pharmacies.
3. How does a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from your 503B Compounding Pharmacy?
Licensed practitioners and healthcare facilities can place orders directly with our 503B Compounding Pharmacy. They can contact us via our website at or by calling our dedicated line at (407)993-1381 to discuss their medication needs and place bulk orders for office-use compounds.
4. What are the benefits of using a 503B Compounding Pharmacy for a medical practice?
Using our 503B Compounding Pharmacy ensures practitioners receive medications produced under the highest level of quality control. Our location at 2160 W State Road 434, Longwood, FL 32779 provides reliable access to consistently formulated, high-quality compounded preparations, which is crucial for patient safety and effective treatment outcomes.
5. Is the 503B Compounding Pharmacy at this location inspected?
Yes. Our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and is subject to routine and for-cause inspections to ensure ongoing compliance with all applicable federal regulations governing 503B outsourcing facilities.