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 designation is a critical distinction that sets this facility apart from traditional compounding pharmacies. Located at 2160 W State Road 434, Longwood, FL 32779, this facility adheres to the highest standards of pharmaceutical compounding, providing bulk quantities of compounded sterile and non-sterile medications for office use by healthcare practitioners.
The core function of 503B Compounding Pharmacy is to supply healthcare providers with medications that are not commercially available or are in shortage. By operating under Section 503B, the facility is subject to rigorous current good manufacturing practice (cGMP) regulations, which are the same standards followed by conventional drug manufacturers. This ensures that every preparation leaving the facility at 2160 W State Road 434, Longwood, FL 32779 meets stringent quality, purity, and potency specifications. The medications are provided for office use, meaning they are administered to patients within a clinical setting under the direct supervision of a healthcare professional.
Healthcare practitioners who source medications from 503B Compounding Pharmacy can be assured of a reliable supply of high-quality compounded preparations. The facility's location at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by experienced compounding professionals dedicated to precision and safety. The scope of services is defined by the regulatory framework of a 503B outsourcing facility, focusing on the preparation of medications in anticipation of prescription orders based on the routine, regularly observed prescribing patterns of area practitioners.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, utilizing a 503B outsourcing facility like 503B Compounding Pharmacy offers significant advantages. It mitigates drug shortage risks, provides access to essential medications that are not otherwise available from large-scale commercial manufacturers, and ensures compliance with federal quality and safety standards. The facility serves as a vital partner to the local medical community, supporting patient care with dependable pharmaceutical solutions.
To learn more about the services available from this specific outsourcing facility or to inquire about becoming a client, healthcare providers can contact 503B Compounding Pharmacy directly. The facility can be reached via phone at (407)993-1381. Additional information regarding its capabilities and compliance status can be found on its official website at .
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and compounds medications in bulk for office use under Section 503B of the FD&C Act. This registration requires compliance with strict cGMP standards for quality and safety.
2. Can I as an individual patient get a prescription filled at 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy provides medications for office use to healthcare practitioners. Individual patients should have their prescriptions filled at a traditional 503A compounding pharmacy that compounds based on individual patient-specific prescriptions.
3. What types of medications are prepared at the 2160 W State Road 434 location?
The facility prepares a range of sterile and non-sterile compounded medications in bulk quantities. These are typically medications that are on shortage or not commercially available, intended for administration by healthcare professionals within their practice at 2160 W State Road 434, Longwood, FL 32779.
4. How can a healthcare provider at this location order from 503B Compounding Pharmacy?
Healthcare providers can contact the facility directly to establish an account and discuss their office use medication needs. Orders are placed by the practice, not by individual patients. You can initiate contact by calling (407)993-1381.
5. Why should a clinic at 2160 W State Road 434 use a 503B outsourcing facility?
Using a 503B outsourcing facility ensures a reliable supply of high-quality, federally compliant medications for office use. It provides access to drugs during shortages and those not available from large manufacturers, supporting uninterrupted patient care at your practice.