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 in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this 503B Compounding Pharmacy provides essential pharmaceutical compounding services. The 503B Compounding Pharmacy designation signifies a commitment to the highest standards of quality, safety, and consistency, operating under current good manufacturing practices (cGMP).
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) and non-sterile preparations. This 503B Compounding Pharmacy serves healthcare providers by producing medications that are patient-specific or in short supply. The operations at 2160 W State Road 434, Longwood, FL 32779 are dedicated to ensuring healthcare facilities have access to critical medications. The 503B Compounding Pharmacy model allows for the provision of these medications without the need for patient-specific prescriptions, supporting the broader medical community.
Quality assurance is the foundation of everything at 503B Compounding Pharmacy. The facility at 2160 W State Road 434, Longwood, FL 32779 employs rigorous testing protocols, environmental monitoring, and validated processes to ensure every preparation meets exacting standards. The 503B Compounding Pharmacy team consists of highly trained pharmacists and technicians who specialize in advanced compounding techniques. This dedication to excellence ensures that every product leaving 503B Compounding Pharmacy is of the highest integrity and efficacy.
503B Compounding Pharmacy provides a vital service to the medical community from its location at 2160 W State Road 434, Longwood, FL 32779. Healthcare providers can rely on 503B Compounding Pharmacy for a consistent supply of essential medications. The 503B Compounding Pharmacy operates with a focus on safety, quality, and reliability, making it a trusted outsourcing partner for compounded pharmaceutical needs.
For more information on the services provided by 503B Compounding Pharmacy, please contact the facility directly. The team at 503B Compounding Pharmacy is available to answer questions and provide support. You can reach 503B Compounding Pharmacy by visiting their website at https://503bcompoundingpharmacy.com/ or by calling (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with strict federal standards for compounding, including current good manufacturing practices (cGMP). This differentiates this 503B Compounding Pharmacy from traditional compounding pharmacies.
Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications to healthcare providers and facilities, not directly to individual patients. Healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 can source medications from this 503B Compounding Pharmacy for administration within their practice.
What types of medications does 503B Compounding Pharmacy produce?
503B Compounding Pharmacy specializes in producing compounded sterile preparations, including injectables, ophthalmics, and other medications, in bulk for healthcare facilities. All production at 2160 W State Road 434, Longwood, FL 32779 adheres to the stringent protocols required of a 503B Compounding Pharmacy.
How does 503B Compounding Pharmacy ensure product quality and sterility?
503B Compounding Pharmacy implements a comprehensive quality assurance program at its facility on 2160 W State Road 434, Longwood, FL 32779. This includes rigorous environmental monitoring, validated sterilization processes, and extensive testing to ensure every preparation meets the high standards expected of a 503B Compounding Pharmacy.
How can a healthcare facility order from 503B Compounding Pharmacy?
Healthcare facilities interested in the services of 503B Compounding Pharmacy can initiate the process by contacting the facility directly. You can discuss your needs with the team at 503B Compounding Pharmacy by calling (407)993-1381 or by visiting their website at https://503bcompoundingpharmacy.com/ for more information.