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 commitment to the highest standards of quality, safety, and regulatory oversight, providing healthcare providers and patients with medications they can trust.
As a 503B outsourcing facility, our primary focus is on producing medications for office use, which are then administered or dispensed by healthcare professionals to their patients within their practice settings. The medications compounded at our Longwood location are prepared in bulk and are not patient-specific, allowing for a readily available supply for physicians, hospitals, and clinics. Our operations are subject to rigorous FDA standards, including current Good Manufacturing Practices (cGMP), which ensures every batch of medication is consistently produced and controlled according to the most stringent quality standards.
The services provided by 503B Compounding Pharmacy at our facility on W State Road 434 are distinct from traditional compounding. We specialize in the production of medications that are often in short supply or unavailable from conventional manufacturers. This includes a range of sterile preparations, such as injectables, ophthalmics, and irrigations, as well as various non-sterile formulations. Our team of highly trained pharmacists and technicians utilizes state-of-the-art equipment and technology to ensure precision, potency, and sterility in every preparation.
Our location at 2160 W State Road 434, Longwood, FL 32779 serves as a critical partner to the local medical community. By providing access to high-quality, compounded medications for office use, we support healthcare providers in delivering optimal patient care. We encourage medical professionals to learn more about our capabilities and current offerings. For detailed information, please visit our website at https://503bcompoundingpharmacy.com/ or contact our facility directly at (407)993-1381 to speak with a representative.
Frequently Asked Questions
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 complies with Section 503B of the FD&C Act. We operate under current Good Manufacturing Practices (cGMP), which are stringent federal regulations for drug manufacturing that ensure the highest levels of quality, purity, and safety for the medications we compound.
2. Can I as a patient directly order medications from the 503B Compounding Pharmacy location in Longwood?
No. 503B outsourcing facilities primarily compound medications for office use. These medications are intended to be purchased by healthcare professionals and administered to patients within their practice. Patients should consult with their healthcare provider to determine if a medication we compound is appropriate for their treatment.
3. What types of medications does the Longwood facility compound?
Our 503B Compounding Pharmacy at 2160 W State Road 434 compounds a broad range of sterile and non-sterile medications in bulk quantities. This includes but is not limited to injectable solutions, ophthalmic drops, and other preparations that are often on drug shortage lists or are not commercially available from standard pharmaceutical manufacturers.
4. How does a healthcare provider place an order with your facility?
Healthcare providers and medical facilities can place orders by contacting our pharmacy directly at (407)993-1381. Our team will provide information on ordering procedures, product availability, and can address any specific questions regarding the medications needed for their practice at our Longwood location.
5. How can I verify the quality and safety standards of your compounded medications?
As an FDA-registered 503B outsourcing facility, we adhere to rigorous cGMP standards. Information about our registration and regulatory compliance is available through the FDA's database. Furthermore, we employ extensive testing and quality control procedures. Detailed quality information can be discussed by calling us at (407)993-1381 or visiting https://503bcompoundingpharmacy.com/.