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. Unlike a traditional 503A pharmacy, our 503B status signifies that we adhere to Current Good Manufacturing Practices (cGMP), providing an additional layer of safety, quality, and consistency for the medications we compound.
The core function of 503B Compounding Pharmacy is to provide bulk quantities of compounded medications to physicians, clinics, hospitals, and healthcare facilities. We serve as a critical partner for healthcare providers at our location on State Road 434 by ensuring a reliable supply of essential medications that are often on shortage or are not commercially available from major pharmaceutical manufacturers. Our operations are focused on producing formulations such as sterile injectables, ophthalmics, and other dosage forms that meet the specific needs of the medical community we serve directly from our Longwood facility.
Quality and safety are the foundational principles of everything we do at 503B Compounding Pharmacy. Our state-of-the-art facility at 2160 W State Road 434 incorporates advanced environmental controls, including ISO-classified cleanrooms, to ensure the sterility and potency of every preparation. Every batch of medication undergoes rigorous analytical testing to verify its identity, strength, quality, and purity before it is released. This unwavering commitment to cGMP standards provides healthcare practitioners with the confidence that the medications they receive from our Longwood location are of the highest possible quality.
By operating as a 503B outsourcing facility, we help alleviate critical drug shortages that can impact patient care. Healthcare providers who partner with us at our Longwood facility gain access to a consistent and trustworthy source for vital medications. Our dedicated team of pharmacists, chemists, and quality assurance professionals works diligently to support the local medical community, ensuring that practitioners have the necessary tools to provide optimal patient outcomes. For more information or to discuss your facility's needs, please contact 503B Compounding Pharmacy at our location on State Road 434.
Website: | Phone: (407)993-1381
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an "outsourcing facility"?
An outsourcing facility is an FDA-registered entity, like ours at 2160 W State Road 434, Longwood, FL 32779, that compounds sterile human drugs in accordance with Section 503B of the FD&C Act. This registration requires us to comply with Current Good Manufacturing Practices (cGMP) and to report compounded drug products to the FDA, ensuring a higher level of federal oversight for safety and quality compared to a traditional compounding pharmacy.
2. Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides compounded medications exclusively to healthcare practitioners and facilities. This includes physicians, hospitals, surgery centers, and clinics. We do not provide medications directly to individual patients at our location on State Road 434. Patients receive their medications through their prescribing healthcare provider.
3. What types of medications does 503B Compounding Pharmacy produce?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding large-scale batches of sterile preparations. This includes sterile injectables, intravenous (IV) bags, ophthalmics, and other formulations that are often on a national drug shortage list or are not commercially available for healthcare providers to administer to their patients.
4. How does the quality control process work at your facility?
Quality control is integral to our operation. At our Longwood location, we operate within ISO-classified cleanrooms. Every batch of medication we compound undergoes stringent testing, including sterility testing, endotoxin testing, and potency analysis, to ensure it meets all specifications before being released to a healthcare provider.
5. How can a healthcare facility at this location place an order?
Healthcare providers and facilities can initiate orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will work with you to understand your specific needs and provide information on our available formulations and ordering process directly from our facility at 2160 W State Road 434.