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 safe and precise preparation of compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of current good manufacturing practices (cGMP), ensuring that every preparation is consistent, sterile, and of the utmost quality for the patients and healthcare providers we serve at our Longwood location.
The core function of 503B Compounding Pharmacy is the large-scale compounding of sterile medications. This process is conducted within our controlled environment at 2160 W State Road 434, Longwood, FL 32779 by our team of highly trained pharmacists and technicians. We utilize advanced technology and rigorous testing protocols to produce medications that are often in short supply or unavailable from traditional pharmaceutical manufacturers. Our 503B status means we can provide these essential medications to healthcare facilities, ensuring they have access to the critical drugs needed for patient care.
Healthcare providers in Longwood rely on 503B Compounding Pharmacy for a dependable supply of sterile injectables, ophthalmics, and other preparations. Our location at 2160 W State Road 434, Longwood, FL 32779 is designed to support the local medical community with efficiency and reliability. By working directly with practitioners, 503B Compounding Pharmacy helps to fulfill specific patient needs with medications that are produced under the exacting standards required of an FDA-registered 503B outsourcing facility.
Patients and medical professionals can be assured of the integrity and safety of every product that leaves our facility. The 503B Compounding Pharmacy team is committed to excellence in every aspect of our operation. For more information about our services or to speak with our staff, please contact 503B Compounding Pharmacy directly. Visit our website at https://503bcompoundingpharmacy.com/ or call us at (407)993-1381.
FAQ
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 FDA and complies with strict federal standards for compounding, including current good manufacturing practices (cGMP). This ensures the medications we produce are of consistently high quality and sterility.
Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides compounded medications to healthcare providers and facilities for office use and administration to patients. We work directly with medical professionals serving the community from our location at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we specialize in the large-scale compounding of sterile medications, such as injectables, IV bags, and ophthalmic solutions, which are often used in clinical settings by healthcare providers in Longwood.
How does 503B Compounding Pharmacy ensure medication safety?
Safety is paramount at our facility. We adhere to rigorous cGMP standards, which include environmental monitoring, personnel training, finished product testing, and stringent quality control procedures for all preparations made at 2160 W State Road 434, Longwood, FL 32779.
How can a healthcare provider at 2160 W State Road 434 place an order with 503B Compounding Pharmacy?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs and place an order. You can reach us by phone at (407)993-1381 or find more information on our website at https://503bcompoundingpharmacy.com/.