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 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 preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, including current Good Manufacturing Practices (cGMP), which are more rigorous than the standards applied to traditional compounding pharmacies. This ensures that every preparation leaving our facility meets stringent federal requirements for strength, quality, and purity.
The core function of 503B Compounding Pharmacy is to provide bulk quantities of compounded medications for office use by healthcare practitioners. We serve the medical community at our location on 2160 W State Road 434, Longwood, FL 32779, enabling physicians, surgeons, hospitals, and clinics to have essential medications readily available for their patients. Our services are pivotal during drug shortages, when a commercially manufactured drug is unavailable, or when a specific formulation is needed that is not otherwise on the market. The medications produced at our Longwood facility are prepared in advance of receiving a prescription and are held in inventory for when a healthcare provider requires them for patient care.
Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is designed to support a wide range of compounding needs. We specialize in both sterile and non-sterile preparations. Sterile compounding involves creating medications that must be free from microbial contamination, such as injectables, ophthalmics, and irrigations. This process is conducted in ISO-classified cleanrooms by our highly trained staff. Non-sterile compounding includes the preparation of capsules, creams, ointments, and other topical formulations. Every step of our process, from sourcing ingredients to final packaging, is meticulously controlled and documented to ensure patient safety and medication efficacy.
503B Compounding Pharmacy is committed to supporting the local healthcare infrastructure from our location at 2160 W State Road 434, Longwood, FL 32779. We work directly with healthcare providers to ensure they have access to the critical medications their patients need. Our role is to be a reliable partner to the medical community, providing consistent, high-quality compounded preparations. For more information about our services or to discuss your office use needs, please contact us via our website at or by phone at (407)993-1381.
Frequently Asked Questions
1. 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 Section 503B of the FD&C Act. We operate under current Good Manufacturing Practices (cGMP), which are federal quality standards for drug manufacturing. This differentiates us from traditional 503A compounding pharmacies and ensures a higher level of regulatory oversight for the medications we compound.
2. Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications for office use to healthcare practitioners. This includes physicians, surgeons, dentists, and other licensed medical professionals, as well as hospitals and clinics. We serve these providers directly from our location at 2160 W State Road 434, Longwood, FL 32779. Medications are not dispensed directly to individual patients without a prescription from their provider.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 prepares a broad spectrum of sterile and non-sterile compounded medications. This includes injectables, ophthalmics, nasal sprays, oral solutions, capsules, topical creams, and ointments. These preparations are made for office use by healthcare providers, particularly to address patient needs when a commercial drug is unavailable or during a drug shortage.
4. How does the quality control process work at your facility?
Quality control is integral to our operation at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, we follow strict cGMP protocols. This includes rigorous testing of incoming ingredients, environmental monitoring of our cleanrooms, validated sterilization processes, and thorough testing of finished preparations for potency, sterility, and endotoxins. Extensive documentation is maintained for every batch we compound.
5. How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare providers interested in our services can initiate an order or request more information by contacting 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or through our website at . Our team will guide you through the process and requirements for ordering compounded medications for office use from our facility.