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 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 the preparation of compounded medications. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations, which ensures that every preparation leaving our facility meets stringent federal quality standards.
The services provided by 503B Compounding Pharmacy at our Longwood location are specifically designed for healthcare providers. We work directly with physicians, hospitals, and clinics to produce large batches of sterile and non-sterile compounded medications that are patient-specific or for office use. Our state-of-the-art facility at 2160 W State Road 434 is equipped with advanced technology and maintained under strict environmental controls to ensure the integrity and sterility of all our preparations. The team at 503B Compounding Pharmacy consists of highly skilled pharmacists and technicians who are experts in the science of compounding, dedicated to supporting the medical community with reliable pharmaceutical solutions.
By focusing on the specific needs of healthcare professionals serving patients from our local facility, 503B Compounding Pharmacy acts as a critical partner in the delivery of specialized care. Our operations are centralized at 2160 W State Road 434, Longwood, FL 32779, allowing us to maintain a singular focus on quality and consistency for every preparation. For more information on how 503B Compounding Pharmacy can support your practice, or to place an order, please contact us directly. We encourage you to visit our website at https://503bcompoundingpharmacy.com/ or call our facility at (407)993-1381.
Frequently Asked Questions
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 and inspected by the U.S. Food and Drug Administration. We operate under Section 503B and adhere to current Good Manufacturing Practices (cGMP), which are stricter standards than those applied to traditional compounding pharmacies, ensuring a higher level of quality control and consistency in our preparations.
Who can place an order with 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications exclusively to healthcare providers. Orders can be placed by physicians, hospitals, clinics, and other healthcare institutions. We do not dispense medications directly to individual patients from our location at 2160 W State Road 434.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility specializes in preparing large-scale batches of both sterile and non-sterile compounded medications for office use. This includes, but is not limited to, injectables, ophthalmics, and topical preparations, all produced under the stringent cGMP standards required of a 503B outsourcing facility.
How does the quality assurance process work at your facility?
Quality assurance is integral to our operation at 2160 W State Road 434. Every batch of medication undergoes rigorous testing, including sterility testing, endotoxin testing, and potency analysis, as required by cGMP regulations. Our processes are designed to ensure that every preparation meets its specified identity, strength, quality, and purity characteristics before it is released.
How can a healthcare provider start ordering from 503B Compounding Pharmacy?
Healthcare providers interested in our services can initiate the process by contacting our facility directly. You can reach our team by phone at (407)993-1381 to set up an account and discuss your specific needs. Detailed information about our capabilities and compliance is also available on our website at https://503bcompoundingpharmacy.com/.