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 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, current good manufacturing practices (cGMP), and rigorous testing protocols to ensure the medications we produce are of exceptional purity, strength, and quality for the patients and healthcare providers we serve at our Longwood location.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are distributed to healthcare facilities for office use. This model allows physicians and practitioners at local clinics and practices to obtain vital medications without the need for patient-specific prescriptions in advance, enabling immediate treatment. The medications prepared at our facility on W State Road 434 are essential for a wide range of treatments, including hormone replacement therapy, ophthalmology, dermatology, and pain management, providing a critical component of the local healthcare infrastructure.
Our state-of-the-art facility at 2160 W State Road 434 is designed to meet the complex demands of modern compounding. We utilize advanced technology and equipment within controlled environments to mitigate the risk of contamination. Every batch of medication is compounded by our team of experienced pharmacists and technicians, who are extensively trained in the precise standards required of a 503B outsourcing facility. This commitment to excellence ensures that every product leaving our pharmacy is safe, effective, and reliable for the practitioners and patients in Longwood.
503B Compounding Pharmacy provides a dependable source for consistent, high-quality compounded medications for the medical community. By operating under the federal 503B guidelines, we offer a level of oversight and quality assurance that goes beyond traditional compounding. Healthcare providers at our location can trust that the medications they administer are produced under a framework of stringent federal regulations, providing peace of mind and allowing them to focus on patient care.
For more information about the services provided directly from our facility, or to speak with our team, please contact 503B Compounding Pharmacy. You can reach us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/. We are located at 2160 W State Road 434, Longwood, FL 32779.
FAQ
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 under Section 503B of the FD&C Act. This requires us to comply with strict federal standards for current good manufacturing practices (cGMP), which include rigorous testing for sterility, potency, and stability on all batches of medication we compound.
2. Can I as an individual patient pick up a prescription directly from your location?
503B Compounding Pharmacy primarily compounds medications for office use by healthcare providers. Medications are typically distributed to local clinics and practices from our facility at 2160 W State Road 434. Patients should consult with their healthcare provider to receive treatments that may utilize medications compounded at our pharmacy.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility compounds a wide array of sterile and non-sterile medications, including but not limited to hormone preparations, ophthalmic solutions, injectable pain management medications, and dermatological creams. All medications are prepared in batches for healthcare providers to have on hand for patient care.
4. How does the quality assurance at a 503B outsourcing facility differ from a traditional pharmacy?
As a 503B outsourcing facility at 2160 W State Road 434, we are subject to federal cGMP standards and ongoing FDA oversight. This involves environmental monitoring, quality control testing on every batch, and adherence to strict standard operating procedures, which provides a higher level of assurance regarding medication consistency, purity, and safety compared to the standards applied to traditional compounding pharmacies.
5. How can a healthcare provider at your location order compounded medications?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs and place orders. You can reach our team by phone at (407)993-1381 or through the contact information available on our website at https://503bcompoundingpharmacy.com/. Our staff will assist with the ordering process and provide information on available medications.