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. This designation signifies our commitment to the highest standards of quality, safety, and consistency in pharmaceutical compounding. Unlike traditional compounding pharmacies, a 503B outsourcing facility undergoes rigorous FDA oversight and manufactures medications on a larger scale without patient-specific prescriptions, supplying these critical drugs to healthcare providers for office use.
The core function of 503B Compounding Pharmacy is the large-scale production of sterile and non-sterile compounded medications. Our services are essential for healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 who require a reliable source of high-quality, compounded preparations for their practice. We provide healthcare professionals with access to medications that may be commercially unavailable, in short supply, or require a specific formulation not offered by mainstream manufacturers. This ensures that practitioners can effectively treat their patients with the precise medications needed.
Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is designed to meet and exceed all federal regulatory requirements. We employ advanced environmental controls, stringent testing protocols, and validated processes to ensure every preparation meets its specified identity, strength, quality, and purity. The team at 503B Compounding Pharmacy consists of highly skilled pharmacists and technicians dedicated to the science of compounding, providing healthcare providers with the confidence that the medications they use are safe, effective, and reliable.
503B Compounding Pharmacy is a vital partner for the medical community at 2160 W State Road 434, Longwood, FL 32779. We empower healthcare providers by ensuring they have immediate access to the necessary compounded medications for their practice, enabling them to deliver the highest standard of care to their patients. Our operational model is focused on supporting other medical professionals, not on direct consumer sales, making us an integral part of the local healthcare infrastructure.
For more information about our services and capabilities, we invite healthcare providers to contact us directly. You can reach 503B Compounding Pharmacy by calling (407)993-1381 or by visiting our website at https://503bcompoundingpharmacy.com/. Our team is ready to discuss how our FDA-registered compounding services can support your practice at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility 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 subjects us to heightened federal oversight, including compliance with Current Good Manufacturing Practices (cGMP), to ensure the medications we compound meet rigorous standards for safety, quality, and purity.
Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications exclusively to healthcare providers for office use. We do not dispense medications directly to individual patients. Healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 can order compounded preparations from us to have on hand for administering to patients in their practice.
What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we specialize in the large-scale compounding of both sterile and non-sterile preparations. This includes medications that are on the FDA drug shortage list, medications that are not commercially available, and specific formulations required by healthcare providers practicing at 2160 W State Road 434, Longwood, FL 32779.
How does 503B Compounding Pharmacy ensure medication quality and sterility?
Our facility at 2160 W State Road 434, Longwood, FL 32779 adheres to strict cGMP protocols. This involves validated sterilization processes, rigorous environmental monitoring of our cleanrooms, and extensive testing of both components and finished preparations through independent laboratories to confirm potency, sterility, and purity before release.
How can a healthcare provider at this location place an order?
Healthcare providers based at 2160 W State Road 434, Longwood, FL 32779 can initiate an order or learn more about our available formulations by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will guide you through the process and provide the necessary information for healthcare professionals.