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, where we specialize in the large-scale compounding of sterile and non-sterile medications. This designation differentiates 503B Compounding Pharmacy from traditional compounding pharmacies, as we adhere to more rigorous federal standards for current Good Manufacturing Practices (cGMP). This commitment ensures that healthcare providers at 2160 W State Road 434, Longwood, FL 32779 have access to medications produced under the highest levels of quality and safety control.
The core mission of 503B Compounding Pharmacy is to provide bulk compounded medications for office use by healthcare practitioners. This means that physicians and clinics can obtain essential medications without the need to engage in in-office compounding, thereby enhancing patient safety and practice efficiency. The medications produced by 503B Compounding Pharmacy are intended for administration within professional healthcare settings, ensuring that patients receive consistent, high-quality treatments. Our operations at 2160 W State Road 434, Longwood, FL 32779 are pivotal in supporting the local medical community with reliable pharmaceutical solutions.
As an outsourcing facility, 503B Compounding Pharmacy is subject to regular FDA inspections and must meet stringent testing and quality assurance protocols. Every batch of medication compounded at our facility undergoes rigorous checks for potency, sterility, and stability. This level of oversight provides an additional layer of safety for medications used in patient care at 2160 W State Road 434, Longwood, FL 32779. The team at 503B Compounding Pharmacy is comprised of highly trained pharmacists and technicians who are experts in advanced compounding techniques, ensuring precision and accuracy in every preparation.
503B Compounding Pharmacy plays a critical role in mitigating drug shortages by providing compounded versions of medications that may be in short supply or discontinued. This service is vital for maintaining continuity of care for patients in need of these critical drugs. Healthcare providers relying on our facility at 2160 W State Road 434, Longwood, FL 32779 can be confident that 503B Compounding Pharmacy serves as a dependable source for essential medications, helping to prevent disruptions in treatment plans.
For healthcare providers and facilities seeking a trusted partner for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a leader in quality and compliance. We invite you to learn more about our services and how we can support your practice. You can reach 503B Compounding Pharmacy by visiting our website at https://503bcompoundingpharmacy.com/ or by calling us directly at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under Section 503B of the FD&C Act, adhering to current Good Manufacturing Practices (cGMP) and undergoing regular FDA inspections. This ensures a higher standard of quality and safety for the compounded medications we produce compared to traditional pharmacies.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications for office use by healthcare practitioners. Our services are designed for physicians, clinics, and other healthcare providers at 2160 W State Road 434, Longwood, FL 32779 who need bulk compounded drugs for administration to their patients within a clinical setting.
What types of medications does 503B Compounding Pharmacy compound?
503B Compounding Pharmacy specializes in both sterile and non-sterile compounded medications on a larger scale. This includes preparations like injectables, ophthalmics, and other formulations that are essential for healthcare providers practicing at 2160 W State Road 434, Longwood, FL 32779.
How does 503B Compounding Pharmacy ensure medication quality?
Quality is assured through strict adherence to cGMP standards. Every batch of medication produced by 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 undergoes rigorous testing for sterility, potency, and endotoxins before it is released for distribution.
How can I contact 503B Compounding Pharmacy?
You can contact 503B Compounding Pharmacy located at 2160 W State Road 434, Longwood, FL 32779 through our website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381 for more information or to place an order.