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 precisely located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and consistency in pharmaceutical compounding. Unlike traditional compounding pharmacies, our 503B outsourcing facility adheres to rigorous current good manufacturing practices (cGMP), ensuring that every preparation is produced in a controlled environment with extensive quality control testing. We provide large-scale compounding services for healthcare providers, delivering essential medications that are often in shortage or not commercially available.
The services provided at our Longwood location are dedicated to supplying sterile and non-sterile compounded preparations for office use by medical practitioners. Our core mission is to support the local medical community by offering a reliable source of high-quality, compounded medications that are essential for patient care. By operating as a 503B outsourcing facility, we provide physicians, surgeons, and other healthcare professionals with the assurance that the medications they administer meet stringent federal standards for potency, purity, and sterility. Our team of experienced pharmacists and technicians utilizes state-of-the-art technology and equipment to compound preparations that are critical for a wide range of medical treatments and procedures.
Patients who receive care from providers utilizing our services can have confidence in the medications prepared for them. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 plays a vital role in the local healthcare ecosystem by mitigating drug shortages and providing access to vital medications. We are a pivotal partner for healthcare providers, enabling them to focus on patient care with the assurance that their compounded pharmaceutical needs are being met with the utmost professionalism and quality. For more information about our services or to speak with our team, please contact us via our website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381.
Frequently Asked Questions
What does it mean that you are a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and operates under strict cGMP regulations. This ensures the medications we compound for office use meet the highest federal standards for safety, quality, and purity.
Can I, as a patient, pick up a prescription directly from your location?
No. 503B Compounding Pharmacy provides medications exclusively for office use by healthcare providers. Patients receive their treatments directly from their physician or clinician at a medical facility, not from our location on State Road 434.
What types of medications do you compound at your Longwood facility?
Our FDA-registered facility at 2160 W State Road 434 compounds a wide array of sterile preparations, including injectables, ophthalmics, and other formulations that are often on drug shortage lists, providing a critical supply for local healthcare providers.
How do healthcare providers at my clinic order from your pharmacy?
Healthcare providers and their authorized staff can place orders for compounded preparations by contacting our facility directly at (407)993-1381. We work directly with medical practices to supply the medications they need for their patients.
Why would a doctor use a 503B outsourcing facility instead of a regular pharmacy?
Doctors utilize our services at 2160 W State Road 434 because we provide an added layer of quality assurance through FDA oversight and cGMP compliance. This is especially critical for sterile injectable medications used in clinics and surgical settings, ensuring patient safety and treatment efficacy.