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 preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of current good manufacturing practices (cGMP), ensuring that every preparation meets rigorous quality and safety protocols for the healthcare providers and patients we serve.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are distributed to healthcare facilities for office use. The medications prepared at our 2160 W State Road 434, Longwood, FL 32779 location are provided to practitioners for administration to their patients within a clinical setting. This model supports healthcare providers by ensuring they have access to essential medications that may be in shortage or not commercially available, thereby enhancing patient care and treatment outcomes.
Our 503B compounding pharmacy provides a critical service by addressing drug shortages. When pharmaceutical manufacturers have a medication on backorder or discontinue a product, it can disrupt patient treatment plans. Our facility at 2160 W State Road 434, Longwood, FL 32779 can compound these vital medications, providing a reliable alternative for area healthcare providers. This ensures continuity of care for patients who depend on these specific formulations.
The operations at 503B Compounding Pharmacy are defined by an unwavering commitment to quality control. Every batch of medication produced at our Longwood facility undergoes stringent testing and validation processes. This includes environmental monitoring, sterility testing, and endotoxin testing for sterile preparations, as well as potency and stability testing. This meticulous approach guarantees that every preparation leaving our facility is of the highest purity, strength, and quality.
Healthcare providers seeking a dependable source for compounded medications can partner with 503B Compounding Pharmacy. Our team of experienced pharmacists and technicians at 2160 W State Road 434, Longwood, FL 32779 is dedicated to supporting the medical community with high-quality, reliable compounded preparations. We provide a seamless process for ordering and delivery to ensure practitioners receive the medications they need for their patients in a timely manner.
For more information about our services or to place an order, please contact 503B Compounding Pharmacy. You can reach us by phone at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/. Our facility is located at 2160 W State Road 434, Longwood, FL 32779.
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 operates under Section 503B of the FD&C Act. We compound large volumes of medications and are subject to federal current good manufacturing practices (cGMP) and FDA oversight, which includes routine inspections.
Who can order medications from 503B Compounding Pharmacy?
Medications compounded at our 2160 W State Road 434, Longwood, FL 32779 location are distributed to healthcare providers and facilities for office use. This means licensed practitioners can order medications to administer to patients within their practice setting.
Does 503B Compounding Pharmacy serve individual patients directly?
No. As a 503B outsourcing facility, our primary function is to supply compounded medications to healthcare providers and facilities, not directly to individual patients. Patients receive their treatments from their healthcare provider who has sourced the medication from us.
How does the quality control at a 503B outsourcing facility differ?
Our facility at 2160 W State Road 434, Longwood, FL 32779 follows strict cGMP guidelines mandated by the FDA for outsourcing facilities. This involves rigorous batch testing, sterility assurance, environmental monitoring, and process validation that exceeds the standards applied to traditional compounding pharmacies.
How can a healthcare provider place an order with your facility?
Healthcare providers can initiate 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 available preparations, ordering process, and delivery options.