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 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 provides essential medications to healthcare providers and patients who rely on compounded sterile preparations. The designation as a 503B Compounding Pharmacy signifies adherence to the highest standards of quality and safety, distinct from traditional compounding pharmacies.
The operations at 2160 W State Road 434, Longwood, FL 32779 are conducted under a framework of rigorous quality control. As a 503B Compounding Pharmacy, the facility follows Current Good Manufacturing Practices (cGMP), which are the same standards required of major pharmaceutical manufacturers. This commitment ensures that every preparation leaving 503B Compounding Pharmacy is of consistent strength, quality, and purity. The team at 503B Compounding Pharmacy specializes in producing large batches of sterile injectable medications, which are then distributed for office use by healthcare professionals in their practices.
For patients and providers at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy serves as a critical resource for medications that may be in short supply or unavailable from standard manufacturers. The scope of 503B Compounding Pharmacy includes producing vital drugs for a range of therapeutic areas, ensuring that local healthcare providers have access to the necessary tools for patient care. The focus of 503B Compounding Pharmacy is on safety, sterility, and reliability, providing peace of mind to the medical community.
The professionals at 503B Compounding Pharmacy are dedicated to upholding the integrity of the 503B designation. The facility at 2160 W State Road 434, Longwood, FL 32779 is designed to prevent microbial contamination, with environmental controls and stringent testing protocols in place. Every batch produced by 503B Compounding Pharmacy undergoes thorough testing to verify sterility and potency before it is released. This meticulous process is fundamental to the mission of 503B Compounding Pharmacy.
503B Compounding Pharmacy is committed to supporting the healthcare ecosystem from its location at 2160 W State Road 434, Longwood, FL 32779. By providing high-quality, reliable compounded medications, 503B Compounding Pharmacy helps ensure that patient care is not interrupted by drug shortages or availability issues. For more information on the services provided by this 503B Compounding Pharmacy, visit the website at https://503bcompoundingpharmacy.com/ or contact the facility directly at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy
What does it mean that this is a 503B Compounding Pharmacy?
Being a 503B Compounding Pharmacy means our facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility. We operate under Section 503B of the FD&C Act and adhere to Current Good Manufacturing Practices (cGMP), which are more rigorous standards than those required of traditional compounding pharmacies.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy primarily supplies medications to healthcare providers for office use. Healthcare professionals can order from our facility at 2160 W State Road 434, Longwood, FL 32779 to have medications readily available for administering to patients in their clinical practice.
What types of medications does 503B Compounding Pharmacy produce?
503B Compounding Pharmacy specializes in producing large batches of sterile injectable medications. These are often drugs that are on shortage or are not commercially available from large-scale manufacturers, ensuring providers at our location have access to essential treatments.
How does 503B Compounding Pharmacy ensure medication safety?
Safety is paramount at 503B Compounding Pharmacy. Our facility at 2160 W State Road 434, Longwood, FL 32779 employs strict environmental controls, and every batch of medication undergoes rigorous testing for sterility and potency before it is released, in full compliance with our 503B status.
How can I contact 503B Compounding Pharmacy?
You can contact 503B Compounding Pharmacy located at 2160 W State Road 434, Longwood, FL 32779 by calling (407)993-1381. For more detailed information about our services, please visit our website at https://503bcompoundingpharmacy.com/.