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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is central to our mission at our specific location: 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, we are held to the highest standards of pharmaceutical compounding, adhering to rigorous Current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving our facility is of the utmost quality, purity, and potency. Our primary focus is on the non-sterile and sterile compounding of medications in larger batches for office use by healthcare practitioners, serving a critical need within the medical community at our Longwood address.
The core function of 503B Compounding Pharmacy is to provide healthcare professionals with access to medications that may be commercially unavailable or in short supply. Physicians, surgeons, veterinarians, and other practitioners who utilize our services at 2160 W State Road 434 can be confident in the integrity of the products they administer to their patients. Our operations are distinct from traditional 503A compounding pharmacies, as we are authorized to compound medications without patient-specific prescriptions for office stock, which allows for greater efficiency and readiness in clinical settings. This model supports local healthcare providers by ensuring they have essential medications on hand when needed.
Quality assurance is the foundation of everything we do at our Longwood facility. Our state-of-the-art cleanrooms are designed to meet or exceed FDA standards for both non-sterile and sterile compounding environments. Every batch of medication is subjected to stringent testing and quality control protocols. This includes stability testing, potency verification, and sterility testing for injectable products. Our commitment to cGMP means our processes are meticulously documented and reproducible, providing an unparalleled level of traceability and safety for the healthcare providers we serve at 2160 W State Road 434.
By choosing 503B Compounding Pharmacy at 2160 W State Road 434, healthcare practitioners are partnering with a facility that prioritizes regulatory compliance and patient safety above all else. We provide a reliable source for high-quality compounded medications, helping to mitigate drug shortages and support effective patient care strategies. For more information about our services or to discuss your office use needs, we encourage you to contact us directly. Visit our website at https://503bcompoundingpharmacy.com/ or call our facility at (407)993-1381.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and operates in compliance with Section 503B of the FD&C Act. This requires us to adhere to strict Current Good Manufacturing Practices (cGMP) for the compounding of both sterile and non-sterile medications, ensuring a higher level of quality control and consistency compared to traditional pharmacies.
Who can receive medications from 503B Compounding Pharmacy at 2160 W State Road 434?
As a 503B outsourcing facility, we compound medications for office use by healthcare practitioners. These medications are supplied to physicians, hospitals, clinics, and other healthcare entities for administration to patients within their practice. We do not dispense medications directly to individual patients from this location without a specific agreement or protocol.
What types of medications does 503B Compounding Pharmacy in Longwood prepare?
Our facility at 2160 W State Road 434 compounds a wide range of non-sterile and sterile preparations in batches. This includes, but is not limited to, hormone replacement therapy (HRT) preparations, sterile injectables, ophthalmics, and other formulations that are often on drug shortage lists or are not otherwise commercially available for healthcare providers to keep in stock.
How does the quality control process work at your Longwood location?
Quality control is integral to our operation at 2160 W State Road 434. Every batch of medication undergoes rigorous testing, which includes analytical testing to verify potency, sterility testing for injectables, and endotoxin testing. Our processes are fully documented under cGMP guidelines to ensure every product meets its specified identity, strength, quality, and purity characteristics before it is released.
How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers interested in our services can initiate the process by contacting our facility directly. We encourage you to visit our website at https://503bcompoundingpharmacy.com/ to learn more about our capabilities or to call us at (407)993-1381 to speak with a representative who can discuss your specific needs and our ordering procedures.