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
Welcome to 503B Compounding Pharmacy, an FDA-registered outsourcing facility located at 2160 W State Road 434, Longwood, FL 32779. Operating under Section 503B of the Federal Food, Drug, and Cosmetic Act, our pharmacy specializes in the large-scale compounding of sterile medications. As a 503B outsourcing facility, we adhere to rigorous federal quality standards, providing hospitals, clinics, and healthcare practitioners with medications that are not readily available from traditional manufacturers. Our focus is on ensuring a reliable supply of high-quality, compounded sterile preparations to support the critical needs of the healthcare community we serve directly from our Longwood facility.
Our core service is the compounding of sterile injectable medications. This process is conducted in a controlled environment with stringent quality control measures. We provide essential medications that may be in short supply or discontinued by large-scale manufacturers, helping to prevent treatment delays for patients. By working directly with healthcare providers, we contribute to the continuity of care with medications that meet specific clinical requirements. Our operations are dedicated to compliance, safety, and the precise needs of the medical professionals who depend on our products.
For more information about our services or to inquire about working with our facility, please contact us. We are committed to supporting the local healthcare infrastructure from our location at 2160 W State Road 434, Longwood, FL 32779.
Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381
Frequently Asked Questions
What is a 503B compounding pharmacy?
A 503B compounding pharmacy is an FDA-registered outsourcing facility that compounds large volumes of sterile medications in advance of or without receiving a patient-specific prescription. Our facility at 2160 W State Road 434, Longwood, FL 32779, operates under stricter federal regulations than traditional compounding pharmacies to ensure drug quality and safety.
Who can order medications from your pharmacy?
Our services are designed for healthcare entities and practitioners, such as hospitals, clinics, and physicians' offices. We do not typically dispense medications directly to individual patients without a prescription from a collaborating healthcare provider.
What types of medications do you compound?
We specialize in compounding sterile injectable medications. This includes solutions, suspensions, and other preparations that are essential for hospital and clinical use, particularly those that may be on drug shortage lists.
How do you ensure the quality of your compounded drugs?
As an FDA-registered 503B outsourcing facility, we are subject to current Good Manufacturing Practice (cGMP) regulations. This involves rigorous testing, environmental monitoring, and quality control procedures to ensure every medication we produce at our Longwood location meets high standards for potency, purity, and sterility.
How can a healthcare facility start ordering from you?
Healthcare facilities interested in our services should contact us directly to discuss their needs and establish an account. You can reach us by phone at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more information. We serve providers from our facility at 2160 W State Road 434, Longwood, FL 32779.