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 specializes in the large-scale compounding of sterile and non-sterile medications that are not available commercially. As a 503B outsourcing facility, 503B Compounding Pharmacy adheres to rigorous federal standards for quality, safety, and production consistency, serving the specific needs of healthcare providers and patients at this location.
The core function of 503B Compounding Pharmacy is to provide medications in bulk for office use by healthcare practitioners. This means that physicians and clinics in the vicinity of 2160 W State Road 434, Longwood, FL 32779 can access essential medications that may be on shortage or are needed in specific formulations not offered by traditional manufacturers. The operations at 503B Compounding Pharmacy are distinct from traditional retail compounding, focusing on supplying healthcare settings with medications prepared under the strictest sterile and quality-controlled conditions.
Patients who receive care from providers utilizing the services of 503B Compounding Pharmacy benefit from the assurance of quality that comes with federal oversight. The medications produced at the facility at 2160 W State Road 434 are compounded in accordance with Current Good Manufacturing Practices (cGMP), which includes extensive testing and environmental monitoring. For healthcare professionals seeking a reliable source for compounded medications for their practice, 503B Compounding Pharmacy represents a critical resource directly accessible from 2160 W State Road 434, Longwood, FL 32779.
The team at 503B Compounding Pharmacy is dedicated to upholding the highest standards set forth for a 503B outsourcing facility. This commitment ensures that every preparation leaving the facility meets precise specifications for potency, purity, and sterility. For more detailed information about the services provided, you can visit the official website at https://503bcompoundingpharmacy.com/ or contact the facility directly by phone at (407)993-1381. 503B Compounding Pharmacy is positioned to serve the healthcare community from its facility at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions for 503B Compounding Pharmacy
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 complies with strict federal standards for compounding medications on a larger scale than a traditional pharmacy, including adherence to Current Good Manufacturing Practices (cGMP).
Can I, as a patient, walk into 503B Compounding Pharmacy to get a prescription filled?
503B Compounding Pharmacy primarily supplies medications in bulk for "office use" by healthcare providers. Patients typically receive medications compounded by 503B Compounding Pharmacy through their physician or clinic, not directly from the facility at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy produce?
503B Compounding Pharmacy compounds sterile and non-sterile medications that are often on national shortage or require specific formulations not available from pharmaceutical manufacturers. These are supplied to healthcare practitioners serving patients from the location at 2160 W State Road 434, Longwood, FL 32779.
How does a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from 503B Compounding Pharmacy?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs and the ordering process. You can reach the facility by phone at (407)993-1381 or find more information on their website at https://503bcompoundingpharmacy.com/.
Why is the quality control at a 503B outsourcing facility important?
The rigorous quality control and testing required of a 503B outsourcing facility like 503B Compounding Pharmacy ensure that medications are sterile, have accurate potency, and are free from contaminants, providing a high level of safety for patients and assurance for healthcare providers at 2160 W State Road 434, Longwood, FL 32779.