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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is central to the operations and services provided at the facility located at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, this pharmacy adheres to rigorous federal standards for quality control, sterility, and safety that exceed those of traditional compounding pharmacies. The primary function of a 503B Compounding Pharmacy is the large-scale compounding of sterile medications, which are then distributed to healthcare providers for office use and administration to patients. The medications produced are essential for a wide range of treatments, including hormone replacement therapy, ophthalmic preparations, injectable antibiotics, and other complex sterile solutions that may be commercially unavailable.
The facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art cleanrooms and environmental monitoring systems to ensure every preparation meets strict sterility assurance levels. The team at 503B Compounding Pharmacy consists of highly trained pharmacists and technicians who specialize in aseptic compounding techniques. This focus on quality and precision ensures that healthcare professionals in the area can confidently source their office-use medications from a trusted, reliable, and federally regulated partner. The 503B model is designed to provide a critical supply chain component for physicians, clinics, and hospitals, offering medications that are often on shortage or not readily available from conventional pharmaceutical manufacturers.
For healthcare providers seeking a dependable source for high-quality compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents a vital resource. The pharmacy's commitment to compliance with FDA regulations provides an added layer of safety and assurance for both practitioners and their patients. To learn more about the specific sterile preparations available or to inquire about services, you can visit the website at https://503bcompoundingpharmacy.com/ or contact the facility directly by phone at (407)993-1381.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means the facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with stringent federal current Good Manufacturing Practices (cGMP) for the large-scale compounding of sterile medications, ensuring a higher level of quality and sterility assurance.
Who can order medications from 503B Compounding Pharmacy?
Medications compounded at 2160 W State Road 434, Longwood, FL 32779 are primarily distributed to healthcare professionals and facilities for office use. Patients should consult their healthcare provider to see if a medication from this 503B outsourcing facility is appropriate for their treatment.
What types of medications does 503B Compounding Pharmacy prepare?
The 503B Compounding Pharmacy specializes in compounding sterile injectable and ophthalmic medications, including hormone replacements, vitamins, electrolytes, and other solutions that may be on national shortage or not commercially available.
How does the 503B Compounding Pharmacy ensure medication sterility?
The facility at 2160 W State Road 434, Longwood, FL 32779 utilizes advanced cleanroom technology, rigorous environmental monitoring, and comprehensive testing protocols as required by the FDA to ensure all compounded preparations meet strict sterility and potency standards.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can initiate orders and discuss their specific medication needs by contacting 503B Compounding Pharmacy directly at (407)993-1381 or by visiting their website at https://503bcompoundingpharmacy.com/ for more information.