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 control, sterility assurance, and testing that are beyond the requirements of a traditional compounding pharmacy. This ensures that healthcare providers at 2160 W State Road 434, Longwood, FL 32779 have access to a reliable source of high-quality compounded medications for their patients.
The core function of 503B Compounding Pharmacy is the production of medications that are not commercially available. This includes creating formulations without certain allergens like dyes or preservatives, altering the strength or dosage form of a medication to meet specific patient needs, or compounding a drug that is currently on the FDA’s drug shortage list. The team of highly trained pharmacists and technicians at the 2160 W State Road 434, Longwood, FL 32779 location utilizes state-of-the-art equipment and follows strict aseptic techniques to ensure every preparation meets exacting specifications. This commitment to excellence provides a critical component of patient care for the local medical community.
Healthcare professionals seeking a trusted partner for compounded medications can rely on 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779. The facility’s operations are pivotal in supporting hospitals, clinics, and physician practices by providing essential medications that are ready for office use. By focusing on bulk compounding under the highest regulatory standards, 503B Compounding Pharmacy ensures a consistent supply of vital drugs, contributing significantly to the local healthcare infrastructure. For more information or to inquire about services, please contact 503B Compounding Pharmacy directly.
Website: https://503bcompoundingpharmacy.com/ | Phone: (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 Current Good Manufacturing Practices (cGMP). This involves more stringent quality control, testing, and reporting standards compared to a traditional pharmacy, ensuring a higher level of safety and consistency for the medications we compound.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications primarily for healthcare providers and facilities. Orders from our location at 2160 W State Road 434, Longwood, FL 32779 are typically placed by physicians, hospitals, and clinics for office use or administration to patients within their practice.
Can I as a patient pick up a prescription directly from your facility?
503B Compounding Pharmacy operates as an outsourcing facility that supplies medications to healthcare providers, not directly to the public. Your prescribing physician or their clinic at 2160 W State Road 434, Longwood, FL 32779 would order and receive the medication from us for your treatment.
What kinds of medications does 503B Compounding Pharmacy produce?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile injectable medications, including IV bags, syringes, and ophthalmics, as well as non-sterile preparations. We often compound drugs that are on shortage or are needed in specific strengths and formulations not available from commercial manufacturers.
How do I contact 503B Compounding Pharmacy for more information?
You can reach 503B Compounding Pharmacy by calling (407)993-1381 or by visiting our website at https://503bcompoundingpharmacy.com/. Our team at 2160 W State Road 434, Longwood, FL 32779 is available to answer questions from healthcare professionals.