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 specializes in the large-scale compounding of sterile and non-sterile medications that are distributed for office use by healthcare practitioners. As a 503B outsourcing facility, it adheres to rigorous federal standards for current good manufacturing practices (cGMP), providing an elevated level of quality control, sterility assurance, and consistency that is critical for patient safety.
The core function of 503B Compounding Pharmacy at its Longwood location is to support local medical practices by providing them with a reliable, compliant source of compounded medications. This allows physicians, veterinarians, and other healthcare providers in the area to access essential drugs, including those that may be in short supply or discontinued, without undertaking the complex compounding process in their own offices. By centralizing this specialized production at its 2160 W State Road 434 facility, 503B Compounding Pharmacy ensures that practitioners can focus on patient care with the confidence that the medications they administer meet the highest standards of pharmaceutical quality.
Patients who receive treatments at a local clinic or doctor's office may benefit from the work of 503B Compounding Pharmacy without ever visiting the facility directly. The medications produced are intended for administration under professional supervision, ensuring that individuals in the community have access to a broader range of necessary therapeutic options. For any questions regarding the services or to learn how your practice can partner with this facility, please contact 503B Compounding Pharmacy directly via their website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381.
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 strict federal standards for drug compounding, including current Good Manufacturing Practices (cGMP). This ensures the medications we produce for local healthcare providers meet rigorous quality and safety protocols.
2. As a patient, can I walk into the 503B Compounding Pharmacy location to get a prescription filled?
No. 503B Compounding Pharmacy operates as an outsourcing facility that provides compounded medications for office use by licensed healthcare practitioners. Patients do not visit our location at 2160 W State Road 434 for individual prescriptions; instead, you would receive medications that we produced directly from your doctor during an office visit or procedure.
3. How do healthcare providers at local practices order from your facility?
Healthcare providers serving the community can place orders for compounded medications directly with 503B Compounding Pharmacy. They can initiate this process by contacting our facility at (407)993-1381 or through the professional portal on our website at https://503bcompoundingpharmacy.com/.
4. What types of medications does the Longwood 503B facility compound?
Our FDA-registered outsourcing facility at 2160 W State Road 434 compounds a wide array of sterile and non-sterile medications, including hormone replacements, ophthalmics, injectables, and other preparations that are often used by physicians and veterinarians in a clinical setting for their patients.
5. Why would a doctor at a local clinic use a 503B outsourcing facility?
Doctors use our services to ensure the medications they administer are prepared under the highest quality controls. This is especially important for drugs that are on shortage or are not commercially available. It allows them to offer necessary treatments to their patients at 2160 W State Road 434 with confidence in the product's safety and efficacy.