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 is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, testing, and production, providing a critical service for healthcare providers and patients who require medications that are not commercially available.
The core function of 503B Compounding Pharmacy is the preparation of compounded medications in bulk for office use by healthcare practitioners. This means that physicians, surgeons, veterinarians, and other medical professionals serving the community can obtain essential, high-quality medications for their practice directly from this Longwood location. The pharmacy compounds a significant volume of medications without receiving patient-specific prescriptions, which are then administered or dispensed within clinical settings. This model ensures that local healthcare providers have immediate access to vital drugs, including sterile injectables, ophthalmics, and other formulations that are often in short supply or discontinued by major manufacturers.
Operating from its facility on W State Road 434, 503B Compounding Pharmacy employs state-of-the-art technology and strict environmental controls to ensure every preparation meets exacting standards of potency, purity, and sterility. The processes are governed by Current Good Manufacturing Practices (cGMP), which are enforced by the FDA. This includes rigorous testing of components, in-process materials, and finished drug products, alongside comprehensive staff training and meticulous documentation. For healthcare providers in Longwood, this translates to a trusted, local source for reliable medications that are essential for patient care, from hospital settings to private clinics.
503B Compounding Pharmacy provides a vital link in the healthcare supply chain for practitioners based at or near 2160 W State Road 434. By focusing on bulk compounding for office use, the facility helps ensure that patients in the local area receive the treatments they need without delay. For more information on available formulations or to inquire about services, you can contact 503B Compounding Pharmacy directly. Visit their website at https://503bcompoundingpharmacy.com/ or call the 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 the U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. This registration signifies we comply with federal standards for compounding medications in bulk for office use, including adherence to Current Good Manufacturing Practices (cGMP) for quality and safety.
Who can order medications from 503B Compounding Pharmacy?
Medications are compounded for office use and are available for order by licensed healthcare practitioners, including physicians, surgeons, and veterinarians, for administration or dispensing within their practice. We serve practitioners who utilize our specific location at 2160 W State Road 434 for their medication needs.
Does 503B Compounding Pharmacy fill individual patient prescriptions?
No. As a 503B outsourcing facility, our primary function is the large-scale compounding of medications for office use by healthcare providers. We do not compound medications based on individual patient prescriptions, which is typically the role of a traditional 503A compounding pharmacy.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility on W State Road 434 specializes in compounding a wide array of sterile and non-sterile medications in bulk quantities. This includes, but is not limited to, sterile injectables, ophthalmics, and other formulations that are often on drug shortage lists or are no longer available from commercial manufacturers.
How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs and place an order. You can reach our facility by calling (407)993-1381. Detailed information about our services and capabilities is also available on our website at https://503bcompoundingpharmacy.com/.