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 operates as an FDA-registered outsourcing facility in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility is precisely located at 2160 W State Road 434, Longwood, FL 32779. This designation is a critical differentiator in the field of pharmaceutical compounding, signifying a commitment to the highest standards of quality, safety, and regulatory oversight. Unlike traditional compounding pharmacies, an outsourcing facility like 503B Compounding Pharmacy compounds medications in larger batches without requiring patient-specific prescriptions. These medications are intended for office use by healthcare practitioners, providing a vital link in the supply chain for hospitals, clinics, and surgical centers.
The operations at our Longwood location are governed by Current Good Manufacturing Practices (cGMP), which are rigorous FDA-enforced standards. This ensures that every preparation leaving our facility at 2160 W State Road 434 meets stringent criteria for sterility, potency, and purity. Our dedicated team of pharmacists and technicians utilizes advanced technology and controlled environments to compound sterile injectables, including IV bags, ophthalmics, and other critical care medications. The focus of 503B Compounding Pharmacy is on producing medications that are often in short supply or unavailable from conventional manufacturers, thereby supporting the local healthcare infrastructure.
By choosing 503B Compounding Pharmacy at 2160 W State Road 434, healthcare providers can be assured of a reliable source for high-quality compounded preparations. Our FDA-registered status provides an additional layer of confidence, as our facility is subject to regular FDA inspections. We serve as a strategic partner to medical professionals, enabling them to focus on patient care with the assurance that their pharmaceutical needs are met by a trusted, compliant, and local outsourcing facility. The entire operation is dedicated to upholding the principles of quality and safety inherent in the 503B compounding pharmacy model.
For healthcare entities seeking a dependable partner for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands ready to assist. We encourage you to reach out to discuss how our services can integrate with your practice. You can contact us via our website at https://503bcompoundingpharmacy.com/ or by telephone at (407)993-1381.
Frequently Asked Questions
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 specific federal standards under Section 503B. This includes adhering to Current Good Manufacturing Practices (cGMP) for higher-volume compounding of sterile preparations intended for office use by healthcare practitioners.
What types of medications does 503B Compounding Pharmacy compound?
503B Compounding Pharmacy specializes in compounding sterile preparations, such as injectables and IV medications, that are commonly used in clinical settings. These are produced for healthcare providers and are not dispensed directly to individual patients from our location at 2160 W State Road 434.
Can individual patients get prescriptions filled at 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy operates as an outsourcing facility that compounds medications for healthcare facilities and practitioners for office use. Individual patients should contact a traditional 503A compounding pharmacy for their personal prescription needs.
How does the 503B model benefit healthcare providers at 2160 W State Road 434?
Healthcare providers benefit from access to high-quality, batch-compounded medications that undergo rigorous testing and quality control. This model provides a reliable supply of essential drugs, often mitigating shortages, and ensures compliance with federal safety standards for medications administered in their practice.
How can I contact 503B Compounding Pharmacy?
You can contact 503B Compounding Pharmacy at our location, 2160 W State Road 434, Longwood, FL 32779, through our website at https://503bcompoundingpharmacy.com/ or by calling (407)993-1381.