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, which includes following current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving our facility meets rigorous testing and quality assurance protocols for strength, purity, and sterility.
The 503B Compounding Pharmacy model is distinct from traditional compounding. Our primary focus is on producing larger batches of compounded medications for office use by healthcare practitioners. This allows physicians, surgeons, and other medical professionals at clinics and hospitals to have immediate access to vital medications that may be in short supply or not commercially available. By serving the medical community from our location at 2160 W State Road 434, Longwood, FL 32779, we provide a critical component of the local healthcare infrastructure, ensuring practitioners have the necessary tools for patient care.
Our services at 2160 W State Road 434, Longwood, FL 32779 are centered on the preparation of a wide array of compounded formulations. This includes sterile preparations like injectables, ophthalmics, and irrigation solutions, which are essential for surgical centers, ophthalmology practices, and other specialized medical fields. We also compound non-sterile medications such as topical creams and oral suspensions. All our processes are conducted under stringent environmental controls and our personnel are rigorously trained in aseptic techniques and cGMP standards.
Quality control is the cornerstone of our operation at 503B Compounding Pharmacy. Every batch of medication produced at our facility undergoes extensive testing to verify its identity, strength, purity, and quality. This commitment to quality, mandated by our 503B status, provides an additional layer of safety and assurance for healthcare providers and their patients. We maintain meticulous records for every batch, ensuring full traceability and accountability for all our preparations.
For healthcare providers seeking a reliable source for high-quality compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is a trusted partner. We encourage you to contact us to discuss your office use needs. You can reach us by phone at (407)993-1381 or visit our website at . Our team is ready to assist the medical community with our compounding services.
Frequently Asked Questions
1. What does it mean that you are a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and operates under Section 503B of the FD&C Act. We follow current Good Manufacturing Practices (cGMP) and produce compounded medications for office use by healthcare practitioners.
2. Can I, as an individual patient, pick up a prescription at your location?
No. 503B Compounding Pharmacy primarily supplies medications for office use to healthcare practitioners. Individual patients should work with their prescribing doctor or a traditional compounding pharmacy that dispenses directly to patients.
3. What types of medications do you compound at your Longwood facility?
At our facility on W State Road 434, we compound both sterile and non-sterile medications. This includes injectables, ophthalmics, irrigation solutions, topical creams, and oral suspensions, all prepared for use by medical professionals.
4. How does the quality control at a 503B facility differ?
As a 503B outsourcing facility, we are required to comply with cGMP standards. This involves rigorous testing of each batch for sterility, potency, and purity, providing a higher level of quality assurance for office-use medications compared to traditional compounding.
5. How can a healthcare provider at a local clinic place an order?
Healthcare providers can contact 503B Compounding Pharmacy directly to place an order for their practice. Please call us at (407)993-1381 or visit our website at to initiate the process.