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 unwavering commitment to the highest standards of quality, safety, and consistency, surpassing the requirements of traditional compounding. We serve healthcare providers by producing medications that are patient-specific or in bulk for office use, ensuring practitioners at 2160 W State Road 434, Longwood, FL 32779 have access to critical pharmaceutical preparations.
The core function of 503B Compounding Pharmacy is the production of medications that are often in short supply or not commercially available. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with advanced technology and maintained under rigorous environmental controls. Our team of highly skilled pharmacists and technicians adhere to Current Good Manufacturing Practices (cGMP), which mandates extensive testing of components, in-process materials, and finished drug products. This meticulous process provides an additional layer of safety and assurance for the medications dispensed from our location.
Healthcare professionals relying on our services at 2160 W State Road 434, Longwood, FL 32779 benefit from our extensive capabilities. We provide essential medications for a variety of therapeutic areas, including office-use hormones, pain management preparations, and other injectable medications. By partnering with 503B Compounding Pharmacy, providers can mitigate drug shortage issues and access high-quality, reliable compounded pharmaceuticals for their practice needs directly from our Longwood facility.
Patient safety is the paramount principle guiding every operation at 503B Compounding Pharmacy. Our status as a 503B outsourcing facility means we are subject to regular and unannounced inspections by the FDA, ensuring continuous compliance with the most stringent federal regulations. Every batch of medication produced at 2160 W State Road 434, Longwood, FL 32779 is crafted with precision and undergoes validated testing for sterility, potency, and endotoxins. This level of quality control is a fundamental aspect of our service to the local medical community.
To learn more about our services or to place an order, healthcare providers are encouraged to contact 503B Compounding Pharmacy directly. Our knowledgeable staff is available to answer questions and provide support. You can reach us by phone at (407)993-1381 or visit our website for more detailed information at https://503bcompoundingpharmacy.com/. We are located at 2160 W State Road 434, Longwood, FL 32779.
FAQ
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 stricter federal standards outlined in Section 503B of the FD&C Act. This includes adhering to Current Good Manufacturing Practices (cGMP) and undergoing routine FDA inspections to ensure the quality and safety of our compounded medications.
2. Who can order medications from 503B Compounding Pharmacy at 2160 W State Road 434?
503B Compounding Pharmacy provides medications exclusively to licensed healthcare practitioners for office use or for their specific patients. Orders are not dispensed directly to the public. Healthcare providers can order from our facility at 2160 W State Road 434, Longwood, FL 32779 for use in their practice.
3. What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we specialize in compounding a range of medications, including sterile injectables and non-sterile preparations. These are often medications that are on drug shortage lists or are not commercially available from large pharmaceutical manufacturers. All production occurs at our location: 2160 W State Road 434, Longwood, FL 32779.
4. How does the quality control process work at your Longwood facility?
Quality control is integral to our operation at 2160 W State Road 434, Longwood, FL 32779. We perform rigorous testing on raw materials, conduct in-process checks, and require sterility, potency, and endotoxin testing on finished products before they are released. This ensures every batch meets our strict cGMP standards.
5. How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can contact 503B Compounding Pharmacy directly to place an order or discuss their needs. We can be reached by phone at (407)993-1381. Our website, https://503bcompoundingpharmacy.com/, also provides information for initiating the ordering process from our facility.