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, a 503B outsourcing facility is subject to rigorous current good manufacturing practices (cGMP) and undergoes regular FDA inspections, ensuring that every preparation meets stringent federal guidelines for strength, quality, and purity.
The services provided by 503B Compounding Pharmacy at our Longwood location are focused on the large-scale compounding of medications for office use by healthcare practitioners. We provide physicians, surgeons, hospitals, and clinics with sterile and non-sterile preparations that are essential for patient care. Our portfolio includes a wide array of preparations such as hormone replacement therapy (HRT) medications, sterile injectables, ophthalmic solutions, and other customized dosage forms that are not commercially available. By operating as a 503B outsourcing facility, we relieve the compounding burden from individual practitioner offices, allowing healthcare providers to focus on patient care while ensuring they have access to reliable, high-quality medications.
Our facility at 2160 W State Road 434 is equipped with state-of-the-art technology and staffed by a dedicated team of licensed pharmacists and quality assurance professionals. Every process, from ingredient sourcing to final product testing, is meticulously controlled and documented. This unwavering dedication to cGMP standards provides healthcare professionals with the confidence that the medications they administer are produced under the most controlled and sterile conditions possible. We are a pivotal resource for the medical community, ensuring patient safety through excellence in compounding.
For healthcare providers seeking a trusted partner for their office-use medication needs, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is the definitive choice. We invite you to learn more about our services and compliance standards. You can reach us 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 operates under Section 503B of the FD&C Act. We adhere to current good manufacturing practices (cGMP), which involve rigorous testing, quality control, and compliance standards that are federally mandated and monitored through regular FDA inspections.
Who can receive medications from 503B Compounding Pharmacy?
Our medications are prepared for office use by healthcare practitioners. We serve physicians, surgeons, hospitals, and clinics. Patients receive our preparations directly from their healthcare provider during office visits or procedures at the provider's facility.
What types of medications does 503B Compounding Pharmacy prepare?
We prepare a wide range of sterile and non-sterile compounded medications for office use. This includes, but is not limited to, sterile injectables, hormone therapy preparations, ophthalmic drops, and other customized formulations that are not readily available from commercial manufacturers.
How does a healthcare provider place an order with your facility?
Healthcare providers can initiate orders by contacting our facility directly at (407)993-1381. Our team will guide you through the process, discuss your specific needs, and provide all necessary information regarding ordering, compliance, and delivery to your practice at 2160 W State Road 434, Longwood, FL 32779.
Why should a healthcare provider choose 503B Compounding Pharmacy?
Choosing our facility ensures you are sourcing medications from an entity that meets the highest federal standards for quality and safety. Our commitment to cGMP provides an unparalleled level of assurance regarding the sterility, potency, and purity of the medications you use in your practice, directly contributing to enhanced patient safety and care.