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, an FDA-registered 503B outsourcing facility undergoes rigorous federal oversight, providing an additional layer of assurance for the healthcare providers and patients we serve at our Longwood location.
The core function of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications. Our operations are designed to support the specific needs of healthcare practitioners by providing bulk quantities of medications that are not commercially available or are in shortage. By operating from our facility on W State Road 434, we ensure a reliable and consistent supply of critical medications for our local clientele. Our processes are governed by Current Good Manufacturing Practices (cGMP), which enforce stringent controls on the facility environment, equipment, personnel training, and quality testing.
Our team of highly skilled pharmacists and technicians at the Longwood facility utilizes state-of-the-art technology and validated processes to ensure every preparation meets exacting specifications. We provide essential medications for a wide range of therapeutic areas, including office-use preparations for clinics and hospitals. The medications compounded at 503B Compounding Pharmacy are vital for patient care, often fulfilling needs when standard, mass-produced drugs are not an option due to allergies, dosage requirements, or market unavailability.
We invite healthcare providers and medical facilities to partner with us for their compounding needs. For more information about our services or to discuss how we can support your practice, please contact us directly. You can reach our team at (407)993-1381 or visit our website to learn more: https://503bcompoundingpharmacy.com/. 503B Compounding Pharmacy is dedicated to serving the medical community from our location 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 complies with Section 503B of the FD&C Act. This requires us to adhere to stricter production and quality control standards, known as Current Good Manufacturing Practices (cGMP), providing an elevated level of safety and consistency for compounded medications.
Who can receive medications from 503B Compounding Pharmacy?
As an outsourcing facility, we primarily provide compounded medications in bulk for office use by healthcare practitioners. Healthcare providers at practices and facilities can order these medications for administration to their patients within their clinical settings located near our pharmacy at 2160 W State Road 434.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility on W State Road 434 specializes in the large-scale compounding of both sterile and non-sterile medications. This includes preparations like sterile injectables, ophthalmics, and other formulations that are essential for healthcare providers but may be experiencing a national shortage or are not available from commercial manufacturers.
How does the quality control process work at your Longwood facility?
Quality control is paramount. Our processes at 2160 W State Road 434 include rigorous testing of components, in-process checks, and finished preparation testing. Our compliance with cGMP standards ensures that every batch of medication is compounded in a controlled environment by qualified personnel to guarantee potency, purity, and sterility.
How can a healthcare provider place an order with your pharmacy?
Healthcare providers can contact 503B Compounding Pharmacy directly to place an order or to discuss their specific medication needs. We can be reached by phone at (407)993-1381. Our team is available to provide information and facilitate orders from our location at 2160 W State Road 434, Longwood, FL 32779.