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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is central to our mission of providing high-quality compounded medications to healthcare providers and their patients. Our facility at 2160 W State Road 434, Longwood, FL 32779 is specifically designed and rigorously maintained to meet the exacting standards set forth by the FDA for 503B outsourcing facilities. This ensures that every preparation leaving our pharmacy meets the highest levels of safety, potency, and quality.
The core function of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications. Unlike traditional compounding, our 503B status means we produce medications in bulk for office use by healthcare practitioners. This allows physicians, surgeons, dermatologists, and other medical professionals in Longwood to have immediate access to critical medications without the need for in-house compounding. Our processes are governed by strict Current Good Manufacturing Practices (cGMP), which include extensive testing of components, rigorous environmental monitoring, and validated processes to ensure consistency and sterility in every batch.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, partnering with a 503B outsourcing facility like ours offers significant advantages. It mitigates risk by transferring the complex responsibility of compounding to a specialized facility with dedicated quality control systems. It also enhances efficiency, as providers can order reliable, ready-to-use medications, saving valuable time and resources. Patients ultimately benefit from receiving medications that are consistently prepared under the most stringent quality controls available.
Our commitment extends beyond mere compliance. The team at 503B Compounding Pharmacy is dedicated to supporting the local medical community with a reliable supply of essential medications. We encourage healthcare practitioners to learn more about the 503B difference and how our services can integrate seamlessly into their practice to improve patient care. We are located at 2160 W State Road 434, Longwood, FL 32779 and are ready to serve your compounding needs.
To discover more about our services or to speak with our team, please contact us. Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381
Frequently Asked Questions
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 U.S. Food and Drug Administration and complies with strict federal standards for compounding medications in large volumes. We operate under Section 503B of the FD&C Act, which requires adherence to Current Good Manufacturing Practices (cGMP) for heightened quality control and patient safety.
Who can order medications from 503B Compounding Pharmacy?
Our medications are prepared for office use and are distributed to licensed healthcare practitioners. We serve physicians, clinics, hospitals, and other healthcare providers who require bulk compounded pharmaceuticals for their practice at 2160 W State Road 434, Longwood, FL 32779.
Can patients directly purchase medications from your facility?
No. As a 503B outsourcing facility, we compound medications in bulk for healthcare providers, not for individual patient-specific prescriptions. Patients should receive their medications directly from their prescribing physician or healthcare provider who has sourced the medication from us.
What types of medications does 503B Compounding Pharmacy prepare?
We specialize in the large-scale compounding of both sterile and non-sterile dosage forms. This includes preparations like injectables, ophthalmics, topicals, and other formulations that are commonly used by healthcare providers in a clinical setting at 2160 W State Road 434, Longwood, FL 32779.
How do I, as a healthcare provider, place an order with 503B Compounding Pharmacy?
Healthcare providers can initiate an order or inquire about our available formulations by contacting our facility directly. You can reach us by phone at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more information on our ordering process and services.