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 unwavering commitment to the highest standards of quality, safety, and consistency, exceeding the requirements of traditional compounding. We serve healthcare providers by providing them with essential medications that are not commercially available, ensuring patients at 2160 W State Road 434, Longwood, FL 32779 receive the specific treatments they need.
The operations at 503B Compounding Pharmacy are defined by rigorous quality control protocols. Every batch of medication produced within our facility undergoes extensive testing and validation to ensure sterility, potency, and purity. This level of oversight is a fundamental requirement of our 503B status and provides healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 with the confidence that the medications they administer meet the highest pharmaceutical standards. Our state-of-the-art cleanroom environment and highly trained staff are central to maintaining this impeccable quality.
503B Compounding Pharmacy provides healthcare providers with a critical resource for patient-specific care. We compound medications that are on the FDA drug shortage list, helping to alleviate critical gaps in the supply chain for practitioners. Furthermore, we produce medications that are not available from standard commercial manufacturers, allowing for tailored therapeutic solutions. The services provided by 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 are integral to supporting the local medical community and enhancing patient outcomes.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical practices. Healthcare providers can place orders directly with our facility to access a reliable supply of high-quality compounded pharmaceuticals. We encourage medical professionals serving patients from our location to visit our website or contact us to learn more about our current offerings and capabilities. The team at 503B Compounding Pharmacy is ready to support your practice with dependable, FDA-registered compounded medications.
For detailed information about our services and to initiate an order, please contact 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/. Our facility at 2160 W State Road 434, Longwood, FL 32779 is committed to being a trusted partner in healthcare.
FAQ
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 FDA and complies with strict federal standards for compounding, including current Good Manufacturing Practices (cGMP). This ensures a higher level of quality control and oversight for the medications we produce compared to a traditional compounding pharmacy.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications exclusively to healthcare providers and medical facilities. Patients cannot order directly from our facility at 2160 W State Road 434, Longwood, FL 32779. Your healthcare provider must place the order on your behalf.
What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we specialize in producing large batches of compounded sterile preparations and non-sterile medications. This often includes medications that are on the FDA drug shortage list or are not commercially available from pharmaceutical manufacturers, providing essential options for prescribers.
How does a healthcare provider place an order with your facility?
Healthcare providers can place orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team at 2160 W State Road 434, Longwood, FL 32779 will provide information on our formulary, ordering process, and delivery options.
Can patients pick up medications directly from your location?
No. 503B Compounding Pharmacy operates as a wholesale operation that supplies healthcare providers, clinics, and hospitals. Medications are not dispensed directly to patients from our facility at 2160 W State Road 434, Longwood, FL 32779. Patients will receive their medications through their prescribing healthcare provider.