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 pharmaceutical preparations for healthcare providers. The status as a 503B outsourcing facility signifies a commitment to the highest standards of quality, safety, and compliance, producing medications in larger batches for office use by physicians and healthcare facilities.
The operations at 2160 W State Road 434, Longwood, FL 32779 are distinct from traditional compounding. As a 503B Compounding Pharmacy, the facility adheres to Current Good Manufacturing Practices (cGMP), which are rigorous standards enforced by the FDA. This ensures that every preparation leaving the facility at 2160 W State Road 434, Longwood, FL 32779 meets stringent quality control specifications for potency, purity, and sterility. The 503B Compounding Pharmacy model is designed to provide healthcare professionals with reliable access to medications that may be in shortage or are not commercially available.
Healthcare providers who partner with 503B Compounding Pharmacy benefit from a dependable source for critical medications. The services provided at the facility located at 2160 W State Road 434, Longwood, FL 32779 are integral to supporting local clinical practice. By supplying sterile and non-sterile compounded preparations for office use, 503B Compounding Pharmacy enables efficient patient care. The focus of this 503B Compounding Pharmacy is on the consistent and scalable production of these important pharmaceutical products.
The team at 503B Compounding Pharmacy comprises skilled professionals dedicated to the precise science of compounding within the 503B framework. Every process at the Longwood location is meticulously controlled and documented, from ingredient sourcing to final product testing. This operational discipline is a hallmark of a true 503B outsourcing facility. For healthcare providers, this translates to confidence in the medications they administer to their patients, knowing they are sourced from a fully compliant 503B Compounding Pharmacy.
To learn more about the services available from this specific facility, visit the website at https://503bcompoundingpharmacy.com/ or contact 503B Compounding Pharmacy directly by phone at (407)993-1381. The team at 2160 W State Road 434, Longwood, FL 32779 is prepared to provide information regarding the capabilities and compliance standards of this 503B Compounding Pharmacy.
FAQ
What does it mean that this is a 503B Compounding Pharmacy?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility that complies with Section 503B of the FD&C Act. This 503B Compounding Pharmacy follows Current Good Manufacturing Practices (cGMP) for higher-volume production of compounded medications for office use by healthcare providers.
Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications for office use to healthcare providers and healthcare facilities. The preparations from this 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 are intended for administration in a clinical setting, not for individual patient prescriptions to be taken at home.
What types of medications does this 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, this pharmacy produces a range of sterile and non-sterile compounded preparations. These often include medications that are on shortage or are not available from commercial manufacturers, all produced under strict quality controls at the Longwood location.
How does the 503B model benefit healthcare providers at this location?
The 503B model ensures that medications supplied from 2160 W State Road 434, Longwood, FL 32779 are produced under rigorous FDA-enforced standards. This provides healthcare providers with a reliable and compliant source for essential medications, supporting patient care in their practice.
How can I contact this specific 503B Compounding Pharmacy?
You can contact 503B Compounding Pharmacy at its location, 2160 W State Road 434, Longwood, FL 32779, by visiting the website https://503bcompoundingpharmacy.com/ or by calling (407)993-1381.