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.
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act. This facility is located at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, this pharmacy adheres to rigorous federal standards for quality control, sterility, and potency that exceed those of traditional compounding pharmacies. The services provided from this specific location are dedicated to supplying compounded medications for office use by healthcare practitioners, as well as for specific patient prescriptions when directed.
The core function of 503B Compounding Pharmacy at 2160 W State Road 434 is the large-scale compounding of sterile preparations. This includes the production of injectables, intravenous medications, ophthalmic drops, and other sterile solutions. All processes are conducted within controlled environments by highly trained personnel to ensure the integrity and safety of every preparation. The facility's compliance with current Good Manufacturing Practices (cGMP) is a fundamental aspect of its operation, ensuring that every batch of medication meets strict specifications for identity, strength, quality, and purity.
Healthcare providers in need of reliable, high-quality compounded medications for their practice can source them directly from 503B Compounding Pharmacy at 2160 W State Road 434. The facility provides essential medications that may be in short supply or unavailable from conventional manufacturers. By working with this 503B outsourcing facility, practitioners can be confident they are receiving products that have been created under the highest standards of pharmaceutical compounding.
For more information about the services available from this location, you can visit the website at or contact the facility directly by phone at (407)993-1381. The team at 503B Compounding Pharmacy is committed to supporting the local medical community with dependable pharmaceutical compounding services from its facility at 2160 W State Road 434, Longwood, FL 32779.
FAQ
1. What does it mean that this is a 503B outsourcing facility?
It means this facility at 2160 W State Road 434 is registered with the FDA and complies with stringent federal regulations for sterile compounding, including current Good Manufacturing Practices (cGMP). This ensures a higher level of quality control and consistency for medications compounded here compared to a traditional pharmacy.
2. Can I as a patient pick up my prescription directly from the 2160 W State Road 434 location?
503B Compounding Pharmacy primarily compounds medications for office use by healthcare providers. Patients typically receive their medications through their prescribing doctor's office. You should consult with your healthcare provider regarding the pickup or delivery of your specific prescription.
3. What types of medications are compounded at this facility?
The 503B Compounding Pharmacy at 2160 W State Road 434 specializes in compounding sterile preparations, such as injectable medications, IV bags, hormone therapy solutions, and ophthalmic drops, all produced under strict sterile conditions.
4. How does a healthcare provider order from this 503B Compounding Pharmacy?
Healthcare providers can establish an account and place orders for compounded medications by contacting the facility directly at (407)993-1381. The team will provide information on ordering protocols, available formulations, and delivery options from the Longwood location.
5. Why would a doctor use a 503B outsourcing facility like this one?
Doctors utilize this facility to access high-quality, reliable compounded medications that are essential for their practices, especially for medications that are on shortage or not commercially available. The assurance of FDA-registered, cGMP-compliant production from 2160 W State Road 434 is a significant benefit for patient safety and care.