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 large-scale compounding of sterile and non-sterile medications. This designation signifies our commitment to meeting the highest standards of quality, safety, and purity, providing healthcare practitioners with a reliable source for patient-specific medications that are not commercially available.
The core function of 503B Compounding Pharmacy is the production of medications in larger batches for office use by healthcare providers. Physicians and practitioners serving patients from our local community can utilize our services to obtain essential medications for their practice needs. By operating under Section 503B, our pharmacy adheres to rigorous current good manufacturing practices (cGMP), which includes extensive testing of components, finished products, and environmental controls to ensure every preparation meets stringent quality specifications.
Our location at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by highly trained compounding professionals, including pharmacists and technicians. The facility is designed to maintain the integrity of compounded preparations, particularly critical for sterile injectables, ophthalmics, and other dosage forms requiring an aseptic environment. This allows us to support local clinics, hospitals, and surgical centers with high-quality medications they can trust for their patients.
503B Compounding Pharmacy provides a vital service to the healthcare ecosystem by compounding drugs that are on the FDA’s drug shortage list or are needed in specific strengths or formulations not offered by traditional manufacturers. Healthcare professionals can confidently order from our outsourcing facility, knowing the medications are produced under a framework of heightened regulatory oversight and quality assurance. We serve as a critical partner to prescribers, enabling them to better serve their patient populations with customized medication solutions.
For more information on our available formulations and to understand how 503B Compounding Pharmacy can support your practice, we invite you to contact us directly. You can reach our team by phone at (407)993-1381 or visit our website to learn more about our compliance and quality standards at https://503bcompoundingpharmacy.com/.
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 Section 503B of the Federal Food, Drug, and Cosmetic Act. This requires us to adhere to current good manufacturing practices (cGMP) for higher standards of quality, safety, and reporting compared to traditional compounding pharmacies.
2. Who can order medications from 503B Compounding Pharmacy?
Medications compounded at our facility are intended for office use by healthcare practitioners. Orders are placed by physicians, clinics, hospitals, and other healthcare providers for administration to patients within their practice at 2160 W State Road 434, Longwood, FL 32779. We do not compound medications for individual patients based on a direct prescription.
3. What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we specialize in compounding sterile injectables, ophthalmics, and other non-sterile preparations in larger batches. This often includes medications that are on the FDA drug shortage list or are needed in specific formulations that are not commercially available from pharmaceutical manufacturers.
4. How does the quality control process work at your facility?
Our quality control is rigorous and follows cGMP standards. This involves testing raw materials for purity, potency, and sterility, validating our compounding processes, conducting environmental monitoring of our cleanrooms, and performing stability testing on finished products to ensure they meet all specifications before being released.
5. How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can initiate an order or inquire about our available products by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide information on ordering procedures, product availability, and how we can meet the specific needs of your practice.