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 is an FDA-registered outsourcing facility operating under 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 preparation of sterile and non-sterile compounded medications in a regulated environment that adheres to stringent federal quality standards. As a 503B outsourcing facility, our primary focus is on producing large-scale batches of compounded drugs for office use by healthcare practitioners, as well as providing patient-specific medications when prescribed. We serve the specific needs of medical professionals and patients who require medications that are not commercially available or are in shortage.
The operations at our Longwood location are distinct from traditional compounding pharmacies. Our status as a 503B outsourcing facility means we are subject to Current Good Manufacturing Practice (CGMP) regulations, mandatory FDA inspections, and rigorous quality control protocols for every batch we produce. This ensures a higher level of assurance in the identity, strength, quality, and purity of the medications we compound. Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can confidently utilize our services for their office stock, knowing the medications are produced under the highest standards of safety and compliance.
Our services at 2160 W State Road 434, Longwood, FL 32779 include the compounding of various dosage forms, including injectables, ophthalmics, topicals, and other formulations. We address critical drug shortages by providing essential medications to healthcare practitioners, ensuring patient care is not interrupted. For patients with specific medical needs, such as allergies to dyes or preservatives or requiring a different dosage strength, our facility can compound patient-specific medications as prescribed. The team at 503B Compounding Pharmacy is committed to supporting the local medical community with reliable, high-quality compounded pharmaceuticals.
Contact 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 for more information. You can reach us via our website at or by phone at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that you are a 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779?
It means our facility is registered with the FDA under Section 503B of the FD&C Act. We compound medications in large batches for office use by healthcare practitioners and are subject to strict federal standards, including Current Good Manufacturing Practice (CGMP) regulations and routine FDA inspections, which provides an added layer of quality and safety assurance for the medications produced at our location.
2. Can I as a patient directly order medications from your facility at 2160 W State Road 434?
No, 503B outsourcing facilities primarily supply compounded medications for office use by healthcare practitioners. A patient-specific prescription from your doctor is required for any individualized medication prepared for you. Your healthcare provider at 2160 W State Road 434, Longwood, FL 32779 can order from us for their office stock or send us a prescription for your specific needs.
3. What kinds of medications do you compound at your Longwood location?
At our facility at 2160 W State Road 434, Longwood, FL 32779, we compound a range of sterile and non-sterile medications. This includes injectables, ophthalmics, topicals, and other formulations. We often compound medications that are currently in shortage or are not available from commercial manufacturers, providing a critical service to local healthcare providers.
4. How does the quality control at a 503B outsourcing facility differ?
Our 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 operates under CGMP regulations mandated by the FDA. This involves rigorous testing of ingredients (APIs), environmental monitoring, sterility testing, stability studies, and extensive documentation for every batch we produce. This level of quality control is more comparable to that of traditional drug manufacturers than a standard pharmacy.
5. How can a healthcare practitioner at this location order from you?
Healthcare practitioners can order compounded medications for office use from our facility at 2160 W State Road 434, Longwood, FL 32779. They can initiate an order by contacting us directly via phone at (407)993-1381 or through our website at . We will work with them to fulfill their specific compounding needs.