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. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the preparation of compounded medications in accordance with the highest standards of quality and safety required for a 503B outsourcing facility. Unlike traditional compounding pharmacies, a 503B Compounding Pharmacy like ours adheres to rigorous current good manufacturing practices (cGMP), ensuring that healthcare providers at 2160 W State Road 434, Longwood, FL 32779 have access to medications produced under strict quality controls.
The primary function of 503B Compounding Pharmacy is to provide bulk quantities of sterile and non-sterile compounded medications for healthcare practitioners. The services provided by 503B Compounding Pharmacy are essential for hospitals, clinics, and other healthcare entities that require ready-to-use medications that are not commercially available. By operating as a 503B outsourcing facility, 503B Compounding Pharmacy can compound medications without receiving patient-specific prescriptions, which allows for a more efficient supply chain for our institutional partners at 2160 W State Road 434, Longwood, FL 32779. The medications prepared by 503B Compounding Pharmacy are intended for office use by healthcare professionals.
Patients receiving care from providers who utilize 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 benefit from the assurance that these medications are produced in an environment subject to FDA oversight. The 503B Compounding Pharmacy model is designed for large-scale production, which helps ensure consistency and reliability for the healthcare providers we serve. The team at 503B Compounding Pharmacy is comprised of skilled professionals dedicated to maintaining the integrity of every preparation that leaves our facility at 2160 W State Road 434, Longwood, FL 32779.
For healthcare providers seeking a reliable source for compounded medications, 503B Compounding Pharmacy represents a critical resource. Our commitment is to support the medical community with high-quality pharmaceutical preparations. We invite healthcare entities to learn more about how 503B Compounding Pharmacy can meet their needs. For more information, please contact 503B Compounding Pharmacy directly. Our website is https://503bcompoundingpharmacy.com/ and our phone number is (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy
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 operates under Section 503B of the FD&C Act. This registration signifies that our facility complies with current good manufacturing practices (cGMP) and is subject to FDA inspection, providing an additional layer of quality and safety oversight for the compounded medications we produce.
2. Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications primarily to healthcare facilities and practitioners for office use. Orders are placed by healthcare entities, not individual patients. Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can utilize our services to obtain necessary medications for their practice.
3. Does 503B Compounding Pharmacy fill individual patient prescriptions?
No. The operational model of a 503B outsourcing facility like 503B Compounding Pharmacy is distinct from a traditional retail or 503A compounding pharmacy. We compound medications in larger batches for healthcare providers, rather than filling individual, patient-specific prescriptions.
4. What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy prepares both sterile and non-sterile compounded medications. These are medications that are not commercially available and are needed by healthcare providers to meet specific clinical needs for their patients at 2160 W State Road 434, Longwood, FL 32779.
5. How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 start ordering from 503B Compounding Pharmacy?
Healthcare providers interested in the services of 503B Compounding Pharmacy should contact us directly to establish an account and discuss their specific needs. You can reach 503B Compounding Pharmacy by phone at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more information.