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, an outsourcing facility like ours is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations and regular FDA inspections. This ensures that every preparation leaving our facility meets stringent quality controls for the healthcare providers and patients we serve at our Longwood location.
The core function of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications that are distributed to healthcare facilities for office use. Our operations at 2160 W State Road 434 are specifically designed to support physicians, surgeons, dermatologists, ophthalmologists, veterinarians, and other healthcare professionals by providing them with a reliable, high-quality source of medications that may be commercially unavailable or in shortage. By preparing these medications in bulk under cGMP standards, we provide a critical service that enhances patient care and practice efficiency for medical professionals utilizing our services from this facility.
Our state-of-the-art facility at 2160 W State Road 434 is equipped with advanced technology and staffed by a team of highly trained pharmacists and technicians. Every step of our process, from sourcing pure, high-quality active pharmaceutical ingredients (APIs) to the final sterility testing and packaging, is meticulously controlled and documented. This unwavering dedication to quality and safety provides peace of mind to the healthcare providers who rely on our compounded preparations for their patients in need. We are a pivotal partner in the local healthcare ecosystem, ensuring that practitioners have access to essential medications.
503B Compounding Pharmacy is dedicated to being a trusted resource for the medical community. We understand the critical nature of the medications we prepare and the importance of reliability. Our team is committed to excellence in every batch we compound, upholding the integrity expected of an FDA-registered outsourcing facility. For more information about our services or to speak with our team, we invite you to contact us directly. Visit our website at https://503bcompoundingpharmacy.com/ or call us at (407)993-1381.
FAQ
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 adhere to current Good Manufacturing Practices (cGMP), which involve rigorous quality control, testing, and reporting standards that exceed those of traditional compounding pharmacies.
Who can receive medications from 503B Compounding Pharmacy?
Our medications are prepared for office use and are distributed to healthcare providers and facilities. Individual patients receive our preparations directly from their doctor, surgeon, or veterinarian during a procedure or appointment, not directly from our facility at 2160 W State Road 434.
What types of medications does 503B Compounding Pharmacy prepare?
We compound a wide range of sterile and non-sterile medications that are often on shortage or are not commercially available. This includes injectables, ophthalmics, topicals, and other formulations essential for various medical and surgical practices serviced from our location at 2160 W State Road 434.
How does a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can initiate orders by contacting our facility directly. For ordering information and to establish an account, please contact our team at (407)993-1381 or through the professional portal on our website at https://503bcompoundingpharmacy.com/.
Why should a practice source medications from your facility in Longwood?
Sourcing from our FDA-registered outsourcing facility at 2160 W State Road 434 ensures your practice receives medications produced under the highest level of quality control and federal oversight. This provides assurance of potency, sterility, and safety for the patients you treat.