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
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 503B compounding pharmacy specializes in the large-scale compounding of sterile medications. As a 503B outsourcing facility, the pharmacy adheres to rigorous federal standards for quality, safety, and production. The primary focus of a 503B compounding pharmacy is to provide hospitals, clinics, and healthcare providers with medications that are not readily available from traditional manufacturers. The operations of this 503B compounding pharmacy are distinct from traditional retail pharmacies, concentrating on non-patient-specific compounding for office use by healthcare practitioners. The team at 503B Compounding Pharmacy is dedicated to ensuring that healthcare facilities have access to essential sterile preparations. The facility at 2160 W State Road 434 is designed to meet the stringent requirements for a 503B outsourcing facility. For more information about the services of this 503B compounding pharmacy, you can visit their website at https://503bcompoundingpharmacy.com/ or contact them by phone 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 large volumes of sterile medications for healthcare facilities. Unlike a traditional pharmacy, a 503B compounding pharmacy follows specific federal regulations for quality and safety.
Who does 503B Compounding Pharmacy serve?
503B Compounding Pharmacy provides medications to healthcare providers and facilities. The services are designed for office use by practitioners, not for direct dispensing to individual patients.
What types of medications does a 503B compounding pharmacy compound?
As a 503B outsourcing facility, this pharmacy compounds sterile preparations, such as injectables and IV solutions, that are essential for hospitals and clinics but may be in short supply from standard manufacturers.
How does the 503B designation ensure quality?
The 503B designation requires compliance with Current Good Manufacturing Practices (cGMP), which are federal standards for sterility, potency, and purity. This ensures medications from a 503B compounding pharmacy meet high-quality benchmarks.
How can I contact 503B Compounding Pharmacy?
You can contact 503B Compounding Pharmacy at their facility located at 2160 W State Road 434, Longwood, FL 32779. For more details, visit their website at https://503bcompoundingpharmacy.com/ or call (407)993-1381.