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 control, utilizing rigorous testing and beyond-use dating to ensure the safety, potency, and purity of every preparation that leaves our pharmacy. Our mission is to provide healthcare providers with access to essential medications that are not commercially available, thereby supporting patient care directly from our location on W State Road 434.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications in anticipation of receiving prescriptions. This operational model allows us to supply healthcare facilities with critical drugs that are often on shortage or are needed in specific formulations not offered by traditional manufacturers. The processes at our Longwood facility are designed to meet the exacting standards set forth by the FDA for outsourcing facilities, which includes current good manufacturing practice (cGMP) regulations. This ensures that every batch of medication is produced in a controlled, monitored environment, providing a reliable source for physicians and clinics.
Patients and healthcare professionals who obtain medications from 503B Compounding Pharmacy at 2160 W State Road 434 can be assured of the integrity of their compounded preparations. Our state-of-the-art facility is equipped to handle complex compounding needs, and our team of skilled pharmacists and technicians is committed to excellence in every step of the process. For more information or to inquire about our services, please contact us via our website at or by phone at (407)993-1381.
Frequently Asked Questions
1. What does it mean that this pharmacy is a 503B outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA under Section 503B. We compound large volumes of sterile and non-sterile drugs for healthcare providers without patient-specific prescriptions and are subject to strict federal quality standards, including cGMP and mandatory FDA inspections.
2. Who can order medications from 503B Compounding Pharmacy?
Medications compounded at our facility are intended for use by healthcare providers in a clinic or office setting. We provide medications to licensed practitioners for office use and for administration to patients within their practice located at 2160 W State Road 434, Longwood, FL 32779.
3. Does 503B Compounding Pharmacy serve individual patients with prescriptions?
No. As a 503B outsourcing facility, our primary function is to supply compounded medications for office use by healthcare providers. We do not typically accept or compound based on individual patient prescriptions. Patients should contact their healthcare provider for information on obtaining our medications.
4. How does the quality assurance at a 503B facility differ from a traditional pharmacy?
503B outsourcing facilities like ours must comply with more rigorous federal standards, including cGMP. This involves extensive environmental monitoring, rigorous potency and sterility testing on batches, stability studies to assign beyond-use dates, and adherence to strict standard operating procedures, all conducted at our location on W State Road 434.
5. How can a healthcare provider at this location place an order?
Healthcare providers interested in our services can initiate the process by contacting our facility directly. We encourage you to visit our website at or call us at (407)993-1381 to speak with a representative about your specific needs and our available compounded preparations.