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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility specializes in the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to stringent current good manufacturing practices (cGMP) to ensure the highest standards of quality, purity, and potency for all compounded preparations. The pharmacy serves healthcare providers and patients by providing medications that are not commercially available, addressing specific patient needs with precision and care.
The services provided at 2160 W State Road 434, Longwood, FL 32779 are distinct from traditional compounding. The 503B model focuses on producing medications in bulk for office use by healthcare practitioners, ensuring they have essential drugs on hand for immediate patient administration. This is critical for medications used in surgeries, emergency care, hormone replacement therapy, ophthalmic procedures, and other clinical treatments. By operating from its facility in Longwood, 503B Compounding Pharmacy provides a reliable, local source for physicians, clinics, and hospitals seeking FDA-registered, cGMP-compliant compounded pharmaceuticals.
Patients and healthcare providers in the area can trust the rigorous quality control processes in place at the Longwood location. Every batch of medication is tested for sterility and potency, and the facility undergoes regular FDA inspections. This commitment to excellence ensures that every product leaving 2160 W State Road 434 meets the highest safety and efficacy standards. For more information or to inquire about services, please contact 503B Compounding Pharmacy via their website at https://503bcompoundingpharmacy.com/ or by phone 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 complies with federal regulations under Section 503B. We operate under current good manufacturing practices (cGMP), which involve rigorous testing, quality control, and adherence to strict production standards for all compounded medications we produce.
2. Can I, as a patient, order medications directly from the 503B Compounding Pharmacy in Longwood?
No. As a 503B outsourcing facility, our primary function is to supply compounded medications in bulk for "office use" to licensed healthcare practitioners. Your physician or healthcare provider at their practice can order from us to have these medications available for your treatment during appointments and procedures.
3. What types of medications does the Longwood 503B facility compound?
503B Compounding Pharmacy at 2160 W State Road 434 compounds a wide range of sterile and non-sterile medications. This includes, but is not limited to, injectables, hormone preparations, ophthalmic solutions, and other formulations that are prescribed by healthcare providers for their patients when commercially manufactured drugs are not suitable or available.
4. How does the 503B Compounding Pharmacy ensure the safety of its products?
Safety is paramount. Our Longwood facility follows strict cGMP protocols, which include environmental monitoring, validated sterilization processes, and comprehensive testing of raw materials and finished products for sterility, potency, and endotoxins. This ensures every medication meets the highest quality and safety standards before it is distributed.
5. How can a healthcare provider at a local clinic place an order with your pharmacy?
Healthcare providers can easily place orders for their practice by contacting 503B Compounding Pharmacy directly. They can initiate the process by calling us at (407)993-1381 or by visiting our website at https://503bcompoundingpharmacy.com/ for more information on our ordering procedures and available formulations.