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 compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, our 503B outsourcing facility undergoes rigorous FDA oversight and manufactures medications on a larger scale without patient-specific prescriptions, distributing them to healthcare providers for office use.
The core function of 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is the large-scale production of sterile and non-sterile compounded preparations. These medications are essential for physician offices, hospitals, and clinics, enabling healthcare professionals to have critical drugs readily available for immediate patient care. Our services are pivotal in alleviating drug shortages by providing essential medications that are otherwise unavailable from conventional manufacturers. We adhere to Current Good Manufacturing Practices (cGMP), ensuring every batch meets stringent standards for potency, purity, and sterility.
Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with advanced technology and staffed by a team of highly skilled pharmacists and technicians. This team is dedicated to the precise and accurate preparation of a wide array of compounded formulations. The operational model of 503B Compounding Pharmacy is designed to support the local medical community by providing a reliable source of high-quality, compounded medications for office use, contributing to enhanced patient outcomes and streamlined clinical operations.
For healthcare providers seeking a trusted partner for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a pillar of reliability and quality. We invite you to learn more about our processes and available formulations. Please contact us to discuss how we can support your practice. Reach out via our website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381.
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 federal oversight, routine FDA inspections, and strict adherence to Current Good Manufacturing Practices (cGMP), ensuring the highest level of quality and safety for the compounded medications we produce.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications for office use by healthcare providers. Our products are distributed to physicians, clinics, hospitals, and other healthcare entities that require bulk compounded medications for their practice at 2160 W State Road 434, Longwood, FL 32779. We do not fulfill individual patient prescriptions directly.
What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we specialize in the large-scale preparation of both sterile and non-sterile compounded medications. This includes a range of formulations such as injectables, ophthalmics, and topicals that are commonly used in clinical settings at 2160 W State Road 434, Longwood, FL 32779, particularly those drugs that are currently in shortage.
How does 503B Compounding Pharmacy ensure medication quality and sterility?
Our facility at 2160 W State Road 434, Longwood, FL 32779 employs rigorous quality control protocols mandated by cGMP. This includes environmental monitoring, stringent testing of raw materials, validation of sterilization processes, and thorough end-product testing to verify potency, purity, and sterility before any medication is released for distribution.
How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare providers can initiate an order or inquire about our available medications by contacting 503B Compounding Pharmacy directly. Please call our facility at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more information on our ordering process and product availability.