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 at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act signifies a commitment to the highest standards of quality, safety, and compliance in pharmaceutical compounding. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous current good manufacturing practices (cGMP) and undergoes regular FDA inspections. This ensures that every preparation leaving our facility meets stringent federal requirements for strength, quality, purity, and identity.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications for office use by healthcare practitioners. Our location at 2160 W State Road 434, Longwood, FL 32779 is a production hub, manufacturing medications that are dispensed to patients by their physicians, surgeons, veterinarians, and other qualified healthcare providers. We provide these practitioners with access to a reliable supply of sterile and non-sterile compounded preparations that may be commercially unavailable or experiencing a shortage. This service is vital for enabling healthcare professionals to provide tailored treatments for their patients.
Our services at 2160 W State Road 434, Longwood, FL 32779 are defined by our 503B status. We specialize in the production of sterile injectables, ophthalmics, and other complex formulations that require an aseptic processing environment. Our facility is equipped with state-of-the-art technology and staffed by a team of expert pharmacists and technicians dedicated to precision and accuracy. Every batch is meticulously prepared and undergoes extensive testing to ensure patient safety and therapeutic efficacy. The operations at this location are focused on supporting the local medical community with bulk, office-use medications.
For healthcare providers seeking a trusted partner for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents a source of unparalleled quality and reliability. We operate with transparency and a patient-first philosophy, understanding that the medications we produce are critical for positive health outcomes. To learn more about our capabilities or to inquire about our services, please contact us directly. Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381
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 standards for drug manufacturing, known as current good manufacturing practices (cGMP). This ensures a higher level of oversight and quality control for the medications we compound compared to a traditional pharmacy.
Can I, as a patient, pick up my prescription directly from your location at 2160 W State Road 434?
No. 503B Compounding Pharmacy primarily compounds medications for office use by healthcare providers. Your physician or healthcare provider will order the medication from us and then dispense it to you directly in their office. We do not typically dispense medications directly to individual patients from this facility.
What types of medications does 503B Compounding Pharmacy produce at its Longwood facility?
Our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile preparations, including injectables, IV bags, and ophthalmics. We also compound non-sterile preparations. All products are made in larger batches for healthcare practitioners to have on hand for patient care.
How can my medical practice at 2160 W State Road 434 start ordering from 503B Compounding Pharmacy?
Healthcare practices can initiate orders by contacting our facility directly. We will guide you through the setup process, which includes establishing an account. You can reach us for more information at (407)993-1381 or through our website at https://503bcompoundingpharmacy.com/.
Why would a healthcare provider choose 503B Compounding Pharmacy over other suppliers?
Healthcare providers choose our services at 2160 W State Road 434, Longwood, FL 32779 because of our unwavering commitment to cGMP quality, our reliability during drug shortages, and our ability to provide formulations that may not be commercially available. Our FDA oversight provides an additional layer of confidence in the medications they administer to patients.