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, our primary operational focus is on the large-scale production of compounded drugs for office use, which are then distributed to healthcare practitioners for patient administration within their professional practice settings. This model is distinct from traditional compounding, as it adheres to rigorous federal current good manufacturing practices (cGMP) to ensure the highest standards of quality, sterility, and potency in every preparation that leaves our facility.
The 503B Compounding Pharmacy outsourcing facility provides healthcare professionals with a critical resource for obtaining medications that are not commercially available or are in shortage. Physicians, surgeons, veterinarians, and other practitioners serving the community can source essential medications from our location at 2160 W State Road 434, Longwood, FL 32779 with the confidence that comes from FDA oversight and cGMP compliance. Our portfolio includes a wide array of preparations, such as injectables, ophthalmics, and other dosage forms, all produced in batches without patient-specific prescriptions and intended for office stock. This ensures that when a healthcare provider needs a specific medication for a procedure or treatment, it is readily available from a trusted and regulated source.
Quality assurance is the cornerstone of the 503B Compounding Pharmacy operation. Every process within our facility, from ingredient sourcing to final packaging, is governed by stringent protocols. Our personnel are highly trained in aseptic techniques and environmental monitoring, ensuring that all sterile preparations meet the utmost standards for patient safety. We employ state-of-the-art equipment and conduct extensive testing to validate our processes and confirm the identity, strength, purity, and quality of our compounded drugs. This unwavering commitment to quality at our Longwood location minimizes risk for healthcare providers and, ultimately, the patients they treat.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical practices. Healthcare providers can place orders for the compounded medications they require directly with our facility. Our team is available to discuss product availability, provide necessary documentation, including certificates of analysis, and assist with the ordering process. We are committed to being a reliable partner to the local medical community, providing essential medications that support a wide range of treatments and procedures from our facility at 2160 W State Road 434.
For more information or to initiate an order, healthcare providers are encouraged to contact 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or visit our website at . Our team is ready to assist with your office-use compounding needs, ensuring you have access to high-quality, FDA-regulated medications.
FAQ
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 under Section 503B of the FD&C Act. This requires us to comply with stringent current good manufacturing practices (cGMP) for the production of compounded drugs intended for office use by healthcare practitioners.
Who can order compounded medications from 503B Compounding Pharmacy?
Orders are accepted from licensed healthcare practitioners, including physicians, surgeons, veterinarians, and other qualified professionals, for office-use purposes. These medications are administered to patients within the practitioner's care at their practice location and are not dispensed directly to individual patients from our facility.
What types of medications does 503B Compounding Pharmacy prepare?
Our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 specializes in preparing sterile injectables, ophthalmics, and other dosage forms that are often on drug shortage lists or are not commercially available. All preparations are made for office stock, not pursuant to patient-specific prescriptions.
How does 503B Compounding Pharmacy ensure the quality and sterility of its products?
We adhere to rigorous cGMP standards, which include testing raw materials, validating sterile processes, conducting environmental monitoring, and performing sterility testing. This comprehensive quality assurance program is designed to ensure the safety, potency, and purity of every batch produced at our Longwood facility.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can contact our facility directly to discuss their needs and place an order. We can be reached by phone at (407)993-1381. Our team will provide information on product availability, necessary documentation, and order fulfillment from our location at 2160 W State Road 434, Longwood, FL 32779.