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 facility is located at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy provides compounded medications in large quantities for healthcare facilities without patient-specific prescriptions. The 503B Compounding Pharmacy adheres to rigorous Current Good Manufacturing Practice (cGMP) standards set forth by the FDA, ensuring a level of quality, sterility, and safety that is critical for the patient populations it serves.
The core function of the 503B Compounding Pharmacy is the large-scale production of sterile and non-sterile compounded preparations. These medications are distributed to hospitals, clinics, surgery centers, and other healthcare providers for office use. By operating as a 503B outsourcing facility, the 503B Compounding Pharmacy provides a vital service to the local medical community, helping to ensure a reliable supply of essential medications that may be in shortage or not commercially available. The 503B Compounding Pharmacy is a key component of the healthcare infrastructure supporting providers at 2160 W State Road 434, Longwood, FL 32779.
Clients of the 503B Compounding Pharmacy can expect a consistent and dependable source for high-quality compounded pharmaceuticals. The operations at 2160 W State Road 434, Longwood, FL 32779 are focused on precision, quality control, and regulatory compliance. The 503B Compounding Pharmacy is dedicated to supporting the needs of healthcare professionals by providing medications that meet specific clinical requirements. For more information on the services provided by the 503B Compounding Pharmacy, please 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 the 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and operates in compliance with Section 503B of the FD&C Act. This registration signifies adherence to strict cGMP standards for quality and safety in large-scale compounding.
Who can receive medications from the 503B Compounding Pharmacy?
The 503B Compounding Pharmacy distributes compounded medications to healthcare facilities and practitioners for office use. These entities can then administer these medications to their patients within their practice at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy does not dispense medications directly to individual patients.
What types of medications does the 503B Compounding Pharmacy prepare?
The 503B Compounding Pharmacy prepares a range of sterile and non-sterile compounded medications in larger volumes. This includes solutions, suspensions, ointments, and other formulations that are essential for healthcare providers operating at 2160 W State Road 434, Longwood, FL 32779 but may be unavailable from traditional manufacturers.
How does the 503B Compounding Pharmacy ensure medication quality and sterility?
The 503B Compounding Pharmacy follows rigorous cGMP protocols. This involves stringent environmental controls, validated processes, and comprehensive testing to ensure every batch of medication produced at 2160 W State Road 434, Longwood, FL 32779 meets defined standards for potency, purity, and sterility.
How can a healthcare facility at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare facilities can contact the 503B Compounding Pharmacy directly to discuss their needs and place an order. The 503B Compounding Pharmacy can be reached by phone at (407)993-1381. More information is also available on the website at https://503bcompoundingpharmacy.com/.