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 from its location at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act signifies a commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, an outsourcing facility like 503B Compounding Pharmacy is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations and regular FDA inspections. This ensures that every preparation leaving the facility meets stringent quality control benchmarks for sterility, potency, and purity, providing healthcare providers and patients with a superior level of confidence.
The core function of 503B Compounding Pharmacy is the large-scale compounding of sterile medications. This process is conducted in a state-of-the-art cleanroom environment at the 2160 W State Road 434 facility, designed to minimize particulate and microbial contamination. The pharmacy specializes in producing medications that are often in shortage or are not commercially available from traditional pharmaceutical manufacturers. This service is vital for hospitals, surgery centers, clinics, and other healthcare providers in need of reliable access to critical drugs, including sterile injectables, intravenous (IV) bags, ophthalmics, and other parenteral preparations. By providing these essential medications, 503B Compounding Pharmacy plays a crucial role in supporting the local healthcare infrastructure.
Quality assurance is the foundation of every operation at 503B Compounding Pharmacy. Each batch of medication is meticulously prepared and undergoes extensive testing to verify its identity, strength, quality, and purity. The dedicated team of highly trained pharmacists and technicians utilizes advanced technology and follows exacting protocols to ensure every product is consistent and reliable. This unwavering focus on quality control mitigates risk for healthcare providers and, most importantly, ensures patient safety. The pharmacy’s compliance with cGMP standards provides a traceable and auditable manufacturing process from raw materials to the finished product dispensed to providers.
For healthcare entities seeking a trusted partner for their non-patient-specific medication needs, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 offers a dependable source of high-quality compounded preparations. The facility is equipped to handle complex compounding requirements and works diligently to address drug shortage challenges faced by the medical community. To learn more about their services or to initiate an order, healthcare providers can contact the facility directly at (407)993-1381 or visit their website at https://503bcompoundingpharmacy.com/ for comprehensive information.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
This designation means our facility 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. We adhere to current Good Manufacturing Practice (cGMP) regulations, which involve rigorous quality control, testing, and reporting standards that exceed those of traditional compounding pharmacies.
Who can receive medications from 503B Compounding Pharmacy?
As an outsourcing facility, 503B Compounding Pharmacy provides medications for office use and anticipatory compounding. Our preparations are distributed to healthcare providers and facilities, such as hospitals, clinics, and surgery centers, for administration to patients within their practice. We do not compound medications for individual patients based on a prescription.
What types of medications does 503B Compounding Pharmacy prepare?
Our primary focus at our Longwood facility is the compounding of sterile injectable medications. This includes a wide range of preparations such as IV bags, syringes, ophthalmics, and other parenteral medications that are essential for healthcare providers practicing at 2160 W State Road 434, Longwood, FL 32779.
How does 503B Compounding Pharmacy ensure the safety of its products?
Safety is ensured through strict adherence to cGMP protocols. This includes environmental monitoring of our cleanrooms, validation of sterilization processes, and rigorous testing of both raw materials and finished products for sterility, potency, and endotoxins. Every batch is quality-controlled before being released.
How can a healthcare facility at this location place an order?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs and place an order. You may reach us by phone at (407)993-1381. Detailed information about our capabilities and processes is also available on our website at https://503bcompoundingpharmacy.com/.