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 at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation signifies our commitment to the highest standards of quality, safety, and regulatory oversight, providing a critical service for healthcare providers and patients who rely on medications that are not commercially available.
As a 503B outsourcing facility, our primary function is to compound medications in bulk for office use by healthcare practitioners. This enables physicians, surgeons, veterinarians, and other medical professionals to have essential medications readily available for patient care without the need for in-office compounding. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with advanced technology and staffed by highly trained pharmacists and technicians who adhere to rigorous sterile and non-sterile compounding protocols. All processes are conducted under a quality management system that meets and exceeds federal standards, ensuring every preparation is consistent, potent, and pure.
The services provided by 503B Compounding Pharmacy are distinct from traditional compounding. We focus on producing larger batches of medications based on anticipated patient needs, which are then distributed to healthcare settings. This model is essential for providing access to critical drugs, including those on shortage lists, in a timely and reliable manner. Our location at 2160 W State Road 434, Longwood, FL 32779 serves as a centralized hub for this specialized manufacturing and distribution process.
To learn more about the specific medications we compound or to inquire about our services for your practice, we encourage you to contact us directly. You can reach our team by phone at (407)993-1381 or visit our website for comprehensive information at https://503bcompoundingpharmacy.com/.
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 strict federal regulations for compounding medications in larger volumes. This includes adherence to Current Good Manufacturing Practice (CGMP) guidelines, which ensures a higher level of quality control and consistency compared to traditional pharmacy compounding.
Who can order medications from 503B Compounding Pharmacy?
Our medications are intended for office use by licensed healthcare practitioners. This includes physicians, surgeons, dentists, veterinarians, and other qualified medical professionals who administer medications within their practice located near 2160 W State Road 434, Longwood, FL 32779. We do not dispense medications directly to individual patients.
What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we compound a wide range of sterile and non-sterile preparations. This includes injectables, ophthalmics, topicals, and oral medications that are often on national drug shortage lists or are needed in specific strengths and formulations not available from commercial manufacturers. For a detailed list, please contact us at (407)993-1381.
How does the quality assurance process work at your facility?
Our quality assurance process at 2160 W State Road 434, Longwood, FL 32779 is comprehensive. It includes rigorous testing of components, in-process checks, finished preparation testing, environmental monitoring of our cleanrooms, and validation of all equipment and processes to ensure every batch meets its predetermined specifications for safety, identity, strength, quality, and purity.
How can a healthcare provider place an order?
Healthcare providers can initiate an order or make an inquiry by calling our facility directly at (407)993-1381. Our team will guide you through the process, answer any questions about our available formulations, and discuss your specific needs for office-use medications.