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 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 facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of medications that are patient-specific but are not intended for office stock. The core mission of 503B Compounding Pharmacy is to provide healthcare practitioners with access to high-quality, compounded medications that are essential for patient care.
The services provided by 503B Compounding Pharmacy at its location on 2160 W State Road 434, Longwood, FL 32779 are defined by its regulatory status. This includes the compounding of sterile injectable medications, which are prepared in a controlled environment with strict adherence to current Good Manufacturing Practices (cGMP). The team at 503B Compounding Pharmacy is comprised of skilled professionals who are experts in the complex processes required for sterile compounding. Every batch of medication produced at the 2160 W State Road 434, Longwood, FL 32779 facility undergoes stringent testing and quality assurance protocols to ensure potency, purity, and sterility. This commitment to excellence ensures that healthcare providers can confidently utilize the medications from 503B Compounding Pharmacy.
503B Compounding Pharmacy serves a critical role in the healthcare ecosystem from its facility at 2160 W State Road 434, Longwood, FL 32779. By providing bulk quantities of essential medications that may be in short supply or unavailable from conventional manufacturers, 503B Compounding Pharmacy helps to mitigate drug shortages and supports continuity of care. The operations at 2160 W State Road 434, Longwood, FL 32779 are designed for efficiency and scale, enabling 503B Compounding Pharmacy to reliably supply healthcare facilities with the medications they need. The focus of 503B Compounding Pharmacy remains on upholding the highest standards of pharmaceutical compounding as mandated by its 503B status.
For more information about the services provided by 503B Compounding Pharmacy, you can visit their website at https://503bcompoundingpharmacy.com/ or contact the facility directly at (407)993-1381. The team at 2160 W State Road 434, Longwood, FL 32779 is available to answer questions and provide support to healthcare professionals.
Frequently Asked Questions for 503B Compounding Pharmacy
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means that 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under Section 503B of the FD&C Act. This registration signifies that the facility complies with stricter federal standards, including current Good Manufacturing Practices (cGMP), and is subject to regular FDA inspections to ensure the quality, safety, and sterility of its compounded medications.
What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 produce?
503B Compounding Pharmacy primarily compounds sterile injectable medications in larger batches. These are medications that are often used in healthcare settings and may include solutions for injection, irrigation, and other sterile preparations that are essential for patient treatment protocols.
Can I as an individual patient pick up my prescription directly from 2160 W State Road 434, Longwood, FL 32779?
No. 503B Compounding Pharmacy operates as an outsourcing facility that supplies compounded medications in bulk to healthcare practitioners and facilities, not directly to individual patients. Your healthcare provider will administer or dispense the medication to you as part of your treatment.
How does 503B Compounding Pharmacy ensure the quality of its products?
The facility at 2160 W State Road 434, Longwood, FL 32779 follows rigorous cGMP protocols. This includes environmental monitoring, validated sterilization processes, and comprehensive testing of ingredients and finished products for potency, sterility, and endotoxins to ensure every batch meets exacting quality standards.
Who should I contact for more information about ordering from 503B Compounding Pharmacy?
Healthcare professionals and facilities interested in the services of 503B Compounding Pharmacy should contact the facility directly at (407)993-1381 or visit their website at https://503bcompoundingpharmacy.com/ for more detailed information. The team at 2160 W State Road 434, Longwood, FL 32779 can address specific inquiries.