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 not available commercially. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, sterility testing, and beyond-use dating, providing a critical service for healthcare providers and patients at its specific location.
The core function of 503B Compounding Pharmacy is to produce medications in larger batches for office use by healthcare practitioners. This means that physicians, surgeons, dermatologists, and other medical professionals practicing at or near 2160 W State Road 434, Longwood, FL 32779 can source high-quality, compounded medications directly for their practice needs. This service is essential for procedures and treatments that require specific drug formulations, strengths, or delivery systems that are not offered by traditional pharmaceutical manufacturers. The pharmacy's operations are strictly confined to its registered address, ensuring all compounded preparations are produced and controlled within its state-of-the-art facility.
Patients who receive treatments from local medical practices that utilize 503B Compounding Pharmacy benefit from access to a broader range of medication options. The pharmacy's commitment to operating under the highest regulatory standards provides assurance regarding the safety, potency, and purity of every preparation that leaves its location. For any inquiries regarding the services available directly from 2160 W State Road 434, Longwood, FL 32779, please contact 503B Compounding Pharmacy at (407)993-1381 or visit their website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that you are a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with Current Good Manufacturing Practices (cGMP). This ensures the medications we compound meet stringent federal standards for quality, sterility, and strength.
Can I, as a patient, order medication directly from your pharmacy?
No, 503B Compounding Pharmacy provides medications for office use by healthcare practitioners. Your local doctor, clinic, or hospital near 2160 W State Road 434, Longwood, FL 32779 can order from us to administer to you during your appointment or procedure.
What types of medications do you compound at your location?
At our facility at 2160 W State Road 434, Longwood, FL 32779, we compound a range of sterile and non-sterile preparations, including injectables, ophthalmics, and topicals, that are prescribed by healthcare providers for their patients.
How does a healthcare provider at your location place an order?
Healthcare providers serving the community can place orders for their practice by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will assist with the ordering process and requirements.
Why would a doctor use a 503B outsourcing facility instead of a regular pharmacy?
Doctors use our services at 2160 W State Road 434, Longwood, FL 32779 to access FDA-regulated compounded medications for office stock that are not commercially available, ensuring they have the specific formulations needed for specialized treatments with guaranteed quality and consistency.