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, safety, and production, providing healthcare providers with a reliable source for compounded pharmaceutical needs.
The core function of 503B Compounding Pharmacy is the production of medications that are not commercially available or are in shortage. This includes the compounding of sterile injectables, ophthalmic preparations, and other dosage forms in bulk quantities for office use by healthcare practitioners. The facility at 2160 W State Road 434, Longwood, FL 32779 operates under current Good Manufacturing Practices (cGMP), ensuring every preparation meets strict specifications for potency, purity, and sterility. This level of quality control provides assurance to the medical community.
Healthcare professionals seeking a trusted compounding partner will find that 503B Compounding Pharmacy serves their office-use requirements directly from its location at 2160 W State Road 434, Longwood, FL 32779. The facility's operations are distinct from traditional compounding pharmacies, focusing on supplying medications for physicians to have on hand for immediate patient treatment. This model supports local clinics and practices by ensuring vital medications are accessible when needed.
For inquiries regarding services or to place an order, 503B Compounding Pharmacy can be contacted via phone at (407)993-1381. Further information about its capabilities and compliance status is available on its official website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. What does it mean that this facility is a 503B outsourcing facility?
It means 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with heightened production and quality control standards under federal law, specifically Section 503B.
2. Who can order medications from 503B Compounding Pharmacy?
Medications are compounded for office use and are supplied to licensed healthcare practitioners. Orders are placed by medical practices for administration to patients within their care at 2160 W State Road 434, Longwood, FL 32779.
3. Does 503B Compounding Pharmacy serve individual patients directly?
No. As an outsourcing facility, it provides medications in bulk to healthcare providers. Individual patient prescriptions are typically handled by traditional compounding pharmacies, not this 503B facility.
4. What types of medications does the facility compound?
503B Compounding Pharmacy specializes in compounding sterile preparations, including injectables and ophthalmic solutions, that are often on drug shortage lists or are not available from commercial manufacturers.
5. How can a healthcare practice place an order?
Practices can initiate an order by calling 503B Compounding Pharmacy directly at (407)993-1381. The facility is located at 2160 W State Road 434, Longwood, FL 32779.