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. We specialize in the large-scale production of compounded sterile preparations (CSPs) that are distributed for office use by healthcare practitioners. Our core mission is to provide practitioners at 2160 W State Road 434, Longwood, FL 32779 with access to a reliable supply of high-quality medications that are essential for patient care.
The 503B outsourcing facility model under which we operate is distinct from traditional 503A compounding pharmacies. Our operations are subject to rigorous Current Good Manufacturing Practice (cGMP) regulations, which are the same standards required of major pharmaceutical manufacturers. This involves extensive testing of components, stringent environmental monitoring of our cleanrooms, validated sterilization processes, and thorough quality control checks on finished preparations. For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, this translates to an unparalleled level of confidence in the medications they administer to their patients. We provide a critical service by compounding medications that may be on shortage, discontinued, or not commercially available in the required dosage form.
Our service is specifically tailored for healthcare professionals, including physicians, surgeons, oncologists, ophthalmologists, and veterinarians, who practice at or are associated with 2160 W State Road 434, Longwood, FL 32779. We empower these practitioners by ensuring they have the necessary medications to perform procedures and treatments without interruption. By relying on our FDA-registered outsourcing facility, practitioners can be assured of receiving medications produced under a framework designed for maximum patient safety and drug efficacy. Our team of experienced pharmacists and technicians is dedicated to upholding these standards with every preparation that leaves our facility.
To learn more about our services and how we can support your practice, we invite you to contact us directly. You can reach our team by phone at (407)993-1381 for immediate assistance or to speak with a compounding specialist. For comprehensive information about our compliance, available formulations, and the specifics of operating as a 503B outsourcing facility, please visit our official website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that this facility is a 503B outsourcing facility?
It means our operations at 2160 W State Road 434, Longwood, FL 32779 are registered with the FDA and we compound medications in large volumes for office use by healthcare practitioners. We adhere to strict cGMP standards, which involve rigorous testing and quality control processes beyond those of a traditional pharmacy.
Who can order medications from 503B Compounding Pharmacy?
Our services are designed for healthcare practitioners, including physicians and veterinarians, who require compounded medications for office use in treating their patients at 2160 W State Road 434, Longwood, FL 32779. We do not dispense medications directly to individual patients.
How does using a 503B outsourcing facility benefit my practice at this location?
Utilizing our services provides your practice at 2160 W State Road 434, Longwood, FL 32779 with a reliable supply of high-quality, sterile compounded medications. This ensures you have the necessary drugs for procedures, especially those that are commercially unavailable or on national shortage, all while mitigating potential liability through our cGMP compliance.
What types of medications does 503B Compounding Pharmacy prepare?
As an FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779, we specialize in producing a wide range of compounded sterile preparations (CSPs). This includes injectables, infusions, ophthalmics, and other sterile products intended for office administration.
How can I place an order or get more information?
Practitioners can contact our facility directly by calling (407)993-1381. For detailed information about our capabilities and compliance, please visit our website at https://503bcompoundingpharmacy.com/.