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 Food, Drug, and Cosmetic Act, providing sterile and non-sterile compounded medications. Located at 2160 W State Road 434, Longwood, FL 32779, our facility is dedicated to serving the specific needs of healthcare providers and their patients with high-quality, personalized pharmaceutical preparations.
As a 503B outsourcing facility, we adhere to rigorous current good manufacturing practices (cGMP) set forth by the FDA. This ensures that every preparation leaving our pharmacy meets the highest standards of quality, purity, and potency. Our team of experienced pharmacists and technicians specializes in creating customized medications that are not commercially available, including specific strengths, dosage forms, or allergen-free formulations. We work directly with prescribers to support unique patient care scenarios, providing essential medications for hospital, clinic, and office use.
Our services at the Longwood location are centered on the large-scale compounding of medications in anticipation of receiving prescriptions, which allows us to provide healthcare institutions with critical drugs that may be in short supply. We are equipped to handle complex compounding needs, including intravenous (IV) medications, ophthalmics, and other sterile preparations. For more information about our services or to speak with our team, please visit our website at https://503bcompoundingpharmacy.com/ or call us at (407)993-1381.
Frequently Asked Questions
What is a 503B compounding pharmacy? A 503B compounding pharmacy is an FDA-registered outsourcing facility that compounds medications in large volumes for healthcare providers to use in their practice. Unlike traditional pharmacies that compound based on individual prescriptions, a 503B facility can compound drugs in advance without a patient-specific prescription, adhering to strict federal manufacturing standards.
What types of medications does 503B Compounding Pharmacy prepare? Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in preparing sterile injectable medications, including IV bags, ophthalmics, and other preparations needed by hospitals and clinics. We focus on producing high-quality compounded drugs that are essential for patient care.
Who can order from 503B Compounding Pharmacy? We provide our compounded medications directly to healthcare providers and facilities, such as hospitals, clinics, and physician offices. Patients should contact their healthcare provider to inquire about medications compounded by our facility.
How does the 503B outsourcing model benefit healthcare providers? The 503B model ensures that healthcare providers at 2160 W State Road 434, Longwood, FL 32779 have access to a reliable supply of critical medications that are compounded under the highest standards of quality and safety, helping to mitigate drug shortages and ensure patient safety.
How can I contact 503B Compounding Pharmacy? You can reach our facility located at 2160 W State Road 434, Longwood, FL 32779 by calling (407)993-1381 or by visiting our website at https://503bcompoundingpharmacy.com/ for more detailed information.