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 signifies a commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Our facility at 2160 W State Road 434, Longwood, FL 32779 is specifically designed and regulated to produce large volumes of compounded sterile and non-sterile preparations for healthcare providers. We serve a critical role in the medical community by providing essential medications that are not commercially available, ensuring patients receive the specific therapies they need.
The operations at 503B Compounding Pharmacy are distinct from traditional compounding. As a 503B outsourcing facility, our processes are subject to rigorous current good manufacturing practices (cGMP). This includes extensive testing of components, in-process materials, and finished drug products, alongside stringent environmental monitoring and quality control protocols. The medications prepared at our Longwood location are distributed to healthcare providers for office use, supporting physicians, surgeons, and other medical professionals in their practice at 2160 W State Road 434, Longwood, FL 32779.
Our core service is the compounding of prescription medications in a sterile environment. This includes a wide array of dosage forms such as injections, infusions, ophthalmic drops, and nasal sprays. The 503B Compounding Pharmacy facility is equipped with state-of-the-art technology and staffed by highly trained pharmacists and technicians who specialize in aseptic technique. This ensures every preparation leaving our facility meets precise sterility and potency specifications, providing healthcare providers with reliable and effective medications for their patients.
In addition to sterile compounding, 503B Compounding Pharmacy provides non-sterile compounded preparations. These can include topical creams, ointments, gels, and oral suspensions. All processes, from weighing active pharmaceutical ingredients to the final packaging, are conducted with meticulous attention to detail and in full compliance with cGMP regulations. The focus remains on creating medications that fulfill specific needs not met by commercially manufactured drug products, all produced within our facility at 2160 W State Road 434, Longwood, FL 32779.
503B Compounding Pharmacy is dedicated to supporting the local medical community. Healthcare providers can be confident that the medications they receive from our Longwood location are produced under the strict oversight required of an FDA-registered 503B outsourcing facility. For more information about our services or to speak with our team, please contact 503B Compounding Pharmacy directly. Visit our website at https://503bcompoundingpharmacy.com/ or call us 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 operates in compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. This requires us to adhere to current good manufacturing practices (cGMP) for higher standards of quality, testing, and safety compared to a traditional pharmacy.
2. Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications for office use by healthcare providers. Orders are placed by physicians, surgeons, clinics, and other medical practices. We do not dispense medications directly to individual patients from our location at 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy specializes in both sterile and non-sterile compounded preparations. This includes injectables, IV infusions, ophthalmic solutions, and topical formulations. All preparations are made in our facility at 2160 W State Road 434, Longwood, FL 32779 under cGMP standards.
4. How does 503B Compounding Pharmacy ensure the quality of its compounded medications?
Quality is ensured through strict adherence to cGMP protocols. This involves rigorous testing of raw materials, validation of compounding processes, sterility testing, endotoxin testing, and ongoing environmental monitoring within our facility at 2160 W State Road 434, Longwood, FL 32779.
5. How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can initiate orders by contacting 503B Compounding Pharmacy directly. For ordering information and to discuss specific medication needs, please call our facility at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/.