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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is central to our mission of providing high-quality compounded medications to healthcare providers and their patients. Our facility at 2160 W State Road 434, Longwood, FL 32779 is specifically designed and rigorously maintained to meet the exacting standards set forth by the FDA for 503B outsourcing facilities. This ensures that every preparation leaving our pharmacy meets the highest levels of sterility, potency, and purity.
The core function of 503B Compounding Pharmacy is the large-scale compounding of sterile medications. This process is conducted by our team of expert pharmacists and technicians within our state-of-the-art cleanroom environment at 2160 W State Road 434, Longwood, FL 32779. We utilize advanced technology and stringent quality control protocols to produce batches of medications that are distributed to healthcare settings. Our operations are distinct from traditional retail compounding, focusing on providing a reliable supply of essential drugs that may be in shortage or not commercially available.
Healthcare providers who partner with 503B Compounding Pharmacy can be assured of a consistent and compliant source of medications. Our status as a 503B outsourcing facility means we are subject to federal oversight, including routine FDA inspections, and we must adhere to Current Good Manufacturing Practices (cGMP). This regulatory framework provides an additional layer of safety and quality assurance for the medications we compound and supply from our location at 2160 W State Road 434, Longwood, FL 32779.
Patients ultimately benefit from the work done at 503B Compounding Pharmacy. By providing physicians, hospitals, and clinics with access to critical medications, we help support patient care and treatment plans. The medications prepared at our facility are essential for a wide range of therapeutic areas, ensuring that healthcare professionals have the tools they need. Our commitment is to uphold the strictest quality standards in every vial, syringe, and bag we prepare.
For more information about our services and regulatory compliance, we encourage you to visit our website at https://503bcompoundingpharmacy.com/ or contact our facility directly at (407)993-1381. The team at 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is dedicated to supporting the medical community with reliable, high-quality compounded medications.
FAQ
1. 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. This subjects us to federal oversight, routine inspections, and requires us to comply with Current Good Manufacturing Practices (cGMP) for the compounding of sterile medications.
2. Can I, as a patient, pick up my prescription directly from 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy operates as an outsourcing facility that compounds medications in large batches for healthcare providers and facilities. Patients receive their medications through their prescribing physician, hospital, or clinic, not directly from our location at 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does 503B Compounding Pharmacy produce?
503B Compounding Pharmacy specializes in the compounding of sterile injectable medications. This includes a range of preparations that are essential for healthcare providers, often including those that are on drug shortage lists or are not otherwise available from conventional manufacturers.
4. How does the quality of medication from a 503B outsourcing facility differ?
Medications compounded at our 503B facility at 2160 W State Road 434, Longwood, FL 32779 are produced under cGMP standards, which are the same rigorous quality standards required of large-scale pharmaceutical manufacturers. This includes extensive testing for sterility, potency, and purity, providing a high level of quality assurance.
5. How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers interested in our services can initiate the process by contacting our facility directly at (407)993-1381 or by visiting our website at https://503bcompoundingpharmacy.com/ for more information. Our team will provide details on our ordering procedures and available formulations.