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 is precisely located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in pharmaceutical compounding. We specialize in the large-scale production of compounded sterile preparations (CSPs) for office use, which are then distributed to healthcare providers for patient administration within their practice settings.
The core function of 503B Compounding Pharmacy is to provide healthcare practitioners with access to essential medications that are not commercially available or are experiencing a shortage. By operating as a 503B outsourcing facility, we adhere to rigorous current good manufacturing practices (cGMP), which are more robust than the standards applied to traditional 503A compounding pharmacies. This ensures that every preparation leaving our facility at 2160 W State Road 434, Longwood, FL 32779 meets stringent federal requirements for sterility, potency, and purity. Our processes are designed to provide practitioners with a reliable and consistent supply of high-quality medications.
Our services are exclusively tailored for healthcare providers and medical practices. The medications prepared at our Longwood facility are intended for office-based administration and are not dispensed directly to individual patients. We work closely with practitioners to support their clinical needs, offering a range of sterile preparations that are vital for various treatments and procedures. The assurance of quality that comes with our 503B status allows healthcare professionals to focus on patient care with confidence in the medications they use.
For more information about our services or to initiate an order, healthcare providers are encouraged to contact 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or visit our website to learn more about our compliance and capabilities 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 operates under Section 503B of the FD&C Act. We follow current good manufacturing practices (cGMP) for the large-scale production of compounded sterile preparations, which are subject to federal oversight and FDA inspection.
2. Can I, as a patient, pick up my prescription directly from the 503B Compounding Pharmacy location?
No. 503B Compounding Pharmacy provides medications for office use by healthcare providers. We do not compound patient-specific prescriptions or dispense medications directly to the public from our facility at 2160 W State Road 434, Longwood, FL 32779. Your healthcare provider will administer the medication in their office.
3. How do I, as a healthcare provider, order from 503B Compounding Pharmacy?
Healthcare providers can place orders for office-use compounded medications by contacting our facility directly. Please call us at (407)993-1381 to speak with a representative and discuss your practice's specific needs and our ordering process.
4. What kind of quality controls are in place at your Longwood facility?
Our 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 adheres to strict cGMP standards. This includes rigorous environmental monitoring, validated sterilization processes, extensive testing of components and finished preparations, and comprehensive documentation to ensure the safety, sterility, and potency of every product we compound.
5. Where can I find more information about your available preparations?
For a comprehensive overview of our services and capabilities, healthcare providers are invited to visit our official website at https://503bcompoundingpharmacy.com/. For specific inquiries, calling (407)993-1381 is the most direct method to get detailed information.