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.
503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
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 specifically designed and regulated to produce large volumes of compounded sterile preparations (CSPs) and non-sterile preparations for healthcare providers and facilities. Unlike a traditional 503A pharmacy, our 503B status signifies that we adhere to Current Good Manufacturing Practices (cGMP), which are the stringent quality and safety standards required of major pharmaceutical manufacturers. This ensures a higher level of assurance in the identity, strength, quality, and purity of the medications we compound and dispense from our Longwood location.
The core function of 503B Compounding Pharmacy is to provide bulk compounded medications for office use. This means we supply medications directly to physicians, clinics, hospitals, and other healthcare entities located within and serving the Longwood community, enabling them to have essential medications on hand for immediate administration to patients during procedures, treatments, or appointments. Our services are integral to supporting the local healthcare infrastructure at 2160 W State Road 434, Longwood, FL 32779, by providing a reliable source of high-quality, compounded medications that are not otherwise commercially available.
Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779, is equipped with advanced environmental controls, including ISO-classified cleanrooms, to ensure the sterility and safety of our injectable medications. Our team of highly trained pharmacists and technicians follows rigorous compounding protocols and conducts extensive testing to validate our processes and final products. For healthcare providers at our location, this translates to confidence and peace of mind, knowing the medications they use are produced under the most exacting standards. We are committed to upholding the highest levels of pharmaceutical care for the medical community from our facility in Longwood.
To learn more about our services or to place an order, healthcare providers can contact 503B Compounding Pharmacy directly. Our team is ready to assist with your compounding needs from our location at 2160 W State Road 434, Longwood, FL 32779.
Website: | Phone: (407)993-1381
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
Being an FDA-registered outsourcing facility means our operation at 2160 W State Road 434, Longwood, FL 32779, is registered with and inspected by the U.S. Food and Drug Administration. We operate under Section 503B of the FD&C Act and are required to comply with Current Good Manufacturing Practices (cGMP), which are rigorous standards for drug manufacturing that ensure product quality, sterility, and safety.
2. Can I as an individual patient pick up a prescription directly from your location?
No, 503B Compounding Pharmacy primarily supplies medications for office use by healthcare providers. Individual patient prescriptions are typically handled by traditional 503A compounding pharmacies. Our facility at 2160 W State Road 434, Longwood, FL 32779, provides medications in bulk to physicians, clinics, and hospitals who then administer them to their patients within their practice.
3. What types of medications does 503B Compounding Pharmacy produce?
From our facility at 2160 W State Road 434, Longwood, FL 32779, we compound a wide range of sterile and non-sterile preparations. This includes injectables, ophthalmics, and other medications that are often used in clinical settings for procedures, hormone therapy, pain management, and other treatments that require medications not readily available from commercial manufacturers.
4. How do healthcare providers at 2160 W State Road 434, Longwood, FL 32779 order from you?
Healthcare providers and facilities can place orders directly with our pharmacy by calling (407)993-1381. Our team will work with you to process your order for office-use compounded medications, which can be shipped or made available for pick-up at our specific location, 2160 W State Road 434, Longwood, FL 32779.
5. Why should a healthcare provider choose a 503B outsourcing facility over other sources?
Choosing a 503B outsourcing facility like ours at 2160 W State Road 434, Longwood, FL 32779, provides an added layer of safety and quality assurance. Our mandatory compliance with cGMP standards, FDA oversight, and rigorous in-house testing protocols means providers can trust the quality, purity, and sterility of the medications they use in their practice, reducing risk and enhancing patient care.