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 specific designation is a critical component of the pharmaceutical services provided directly from our facility at 2160 W State Road 434, Longwood, FL 32779. The 503B status signifies a commitment to the highest standards of quality, safety, and compliance, distinguishing the operation from traditional compounding pharmacies. The services rendered at this location are built upon a foundation of rigorous FDA oversight, which includes adherence to Current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving the facility meets stringent quality control benchmarks for strength, purity, and stability.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are patient-specific but produced in bulk for distribution to healthcare facilities. The operations conducted at 2160 W State Road 434, Longwood, FL 32779 are integral to supporting the local medical community by providing sterile and non-sterile compounded preparations. These preparations are essential for meeting unique clinical needs that commercially available medications cannot address. The facility's work is dedicated to serving practitioners and their patients by ensuring a reliable supply of high-quality compounded drugs, all produced within a federally regulated environment.
Engaging with 503B Compounding Pharmacy means accessing a service that prioritizes precision and regulatory compliance. The team at this location comprises skilled professionals who specialize in the complex science of pharmaceutical compounding under 503B regulations. Every process, from ingredient sourcing to final product testing, is meticulously documented and controlled. This operational integrity provides assurance to healthcare providers at 2160 W State Road 434, Longwood, FL 32779 that the medications they utilize are produced with an uncompromising focus on patient safety and therapeutic efficacy. The facility stands as a dedicated resource for compounded pharmaceutical needs.
For more detailed information about the specific services and regulatory framework, you are encouraged to visit the official website at https://503bcompoundingpharmacy.com/. Direct inquiries can also be made by calling the facility at (407)993-1381. The team is prepared to provide comprehensive information regarding the 503B compounding services available directly from 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific operation at 2160 W State Road 434, Longwood, FL 32779 is registered with and regulated by the U.S. Food and Drug Administration under Section 503B of the FD&C Act. This requires compliance with Current Good Manufacturing Practices (cGMP) for higher-volume compounding, which includes rigorous testing and quality control standards beyond those of a traditional pharmacy.
What types of compounded medications does 503B Compounding Pharmacy provide?
503B Compounding Pharmacy provides both sterile and non-sterile compounded preparations. These are typically produced in larger batches for healthcare practitioners to administer to patients within their practice or to dispense, addressing needs where a commercially manufactured drug is not suitable or available.
Who can order medications from 503B Compounding Pharmacy?
Medications compounded at our facility at 2160 W State Road 434, Longwood, FL 32779 are provided to healthcare practitioners and facilities. Patients should consult with their healthcare provider to determine if a compounded medication from a 503B outsourcing facility is appropriate for their treatment plan.
How does the 503B model ensure medication safety for patients?
The 503B model ensures safety through mandatory adherence to cGMP standards. This includes validated processes, environmental monitoring, sterility testing, stability studies, and stringent quality assurance protocols that are enforced by the FDA for all operations conducted at this location.
How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 initiate an order?
Healthcare providers can initiate an order or make inquiries by contacting 503B Compounding Pharmacy directly at (407)993-1381. Additional information about our processes and capabilities is available on our website at https://503bcompoundingpharmacy.com/.