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. As a 503B outsourcing facility, we produce large batches of compounded sterile and non-sterile preparations for office use by healthcare practitioners, without receiving patient-specific prescriptions. This model allows physicians, surgeons, and other medical professionals to have essential medications readily available for their patients during procedures, treatments, and office visits.
The operations at our Longwood location are distinct from a traditional compounding pharmacy. Our primary focus is on supplying healthcare facilities and practices with medications that are critical for patient care. We adhere to rigorous current good manufacturing practices (cGMP), which are the same standards followed by major pharmaceutical manufacturers. This ensures every preparation that leaves our facility at 2160 W State Road 434, Longwood, FL 32779 is of consistent potency, purity, and quality. Our team of highly trained pharmacists and technicians utilizes state-of-the-art equipment and environmental controls to guarantee the integrity of every product, from sterile injectables to topical formulations.
By serving the medical community from our specific location, 503B Compounding Pharmacy provides a reliable and trusted source for essential medications. Healthcare providers can confidently utilize our products, knowing they are sourced from an FDA-registered and inspected facility that prioritizes patient safety above all else. We are dedicated to supporting the local healthcare ecosystem by ensuring that practitioners have access to the compounded preparations they need to deliver optimal care to their patients.
For more information about our services or to speak with our team, please contact us directly. You can reach us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/. Our facility at 2160 W State Road 434, Longwood, FL 32779 is focused on meeting the specific needs of the medical professionals we serve.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific 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. We are subject to federal oversight and must comply with strict current good manufacturing practices (cGMP) for the compounding of medications, ensuring a higher level of quality control and consistency for office-use products.
Who can order medications from 503B Compounding Pharmacy?
Our services are designed for healthcare practitioners and facilities. We supply medications for office use to physicians, surgeons, hospitals, clinics, and other healthcare providers. We do not fulfill individual patient prescriptions directly; instead, we provide medications to practitioners for administration to their patients within their practice.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we prepare a range of sterile and non-sterile compounded medications. This includes, but is not limited to, sterile injectables, ophthalmics, and other preparations that are essential for procedures and treatments conducted in a clinical setting at our location on 2160 W State Road 434, Longwood, FL 32779.
How does the quality assurance process work at your facility?
Our quality assurance process is rigorous and follows cGMP guidelines. Every batch of medication compounded at our Longwood facility undergoes extensive testing and validation to ensure sterility, potency, and purity. Our controlled environment and standardized procedures are designed to prevent contamination and ensure every product meets our stringent quality standards before it is released.
How can a healthcare practice get started ordering from your facility?
Healthcare practices interested in our services can initiate the process by contacting our facility directly. You can call us at (407)993-1381 to speak with a representative who can discuss your needs, provide information on our available products, and guide you through the account setup and ordering process for our location at 2160 W State Road 434, Longwood, FL 32779.