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. Our facility is located at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, we are distinct from traditional compounding pharmacies, focusing on the preparation of large volumes of sterile and non-sterile compounded medications without the need for patient-specific prescriptions. This model is designed to provide healthcare facilities with access to critical medications that may be in shortage or not readily available from conventional manufacturers. The operations at 503B Compounding Pharmacy are conducted under the rigorous oversight of the FDA, ensuring adherence to Current Good Manufacturing Practices (cGMP).
The services provided by 503B Compounding Pharmacy at our Longwood location are integral to supporting the local healthcare infrastructure. We specialize in the compounding of medications that are essential for hospitals, clinics, and other healthcare providers. The compounding processes employed at 2160 W State Road 434 are designed to meet the highest standards of sterility and potency. By functioning as an outsourcing facility, 503B Compounding Pharmacy helps mitigate drug shortages and provides a reliable source of essential medications for the medical community serving patients in Longwood.
Quality assurance is a foundational principle of 503B Compounding Pharmacy. Every batch of medication produced at our facility undergoes stringent testing and validation protocols to ensure patient safety and therapeutic efficacy. The team at 503B Compounding Pharmacy comprises qualified professionals dedicated to maintaining the integrity of the compounding process. Our commitment to compliance with federal regulations positions 503B Compounding Pharmacy as a trusted partner for healthcare providers who require bulk compounded drugs for their practice needs at 2160 W State Road 434, Longwood, FL 32779.
For healthcare entities seeking a dependable source for compounded medications, 503B Compounding Pharmacy offers a critical service. The ability to produce medications on a larger scale, while under FDA oversight, distinguishes our offerings. We encourage local healthcare providers to connect with us to discuss their specific medication needs. The professionals at 503B Compounding Pharmacy are prepared to provide detailed information about our current product offerings and compliance documentation.
Contact 503B Compounding Pharmacy today:
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
Address: 2160 W State Road 434, Longwood, FL 32779
Frequently Asked Questions
1. 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 is registered with the U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. This registration signifies that our facility complies with federal standards for producing compounded drugs in bulk for healthcare facilities without patient-specific prescriptions.
2. What types of medications does 503B Compounding Pharmacy compound?
503B Compounding Pharmacy compounds a range of sterile and non-sterile medications in larger batches. These medications are typically supplied to healthcare providers for office use. The specific formulations available are those that can be produced in compliance with the regulations governing an outsourcing facility at our location on W State Road 434.
3. How does 503B Compounding Pharmacy ensure medication quality and safety?
503B Compounding Pharmacy adheres to Current Good Manufacturing Practices (cGMP). This involves rigorous environmental monitoring, sterility testing, and endotoxin testing for sterile products, along with strict quality control checks throughout the compounding process at our Longwood facility to ensure every batch meets predefined specifications for safety and potency.
4. Can individual patients pick up prescriptions directly from 503B Compounding Pharmacy?
No. As an outsourcing facility, 503B Compounding Pharmacy provides medications primarily to healthcare facilities for office use. Medications are not dispensed directly to individual patients from our location at 2160 W State Road 434. Patients should contact their healthcare provider or a traditional pharmacy for individual prescriptions.
5. How can a healthcare facility at 2160 W State Road 434 order from 503B Compounding Pharmacy?
Healthcare facilities can initiate an order by contacting 503B Compounding Pharmacy directly through our official website, https://503bcompoundingpharmacy.com/, or by calling our main line at (407)993-1381. Our team will provide information on ordering procedures, available products, and necessary documentation for healthcare providers.