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 is located at 2160 W State Road 434, Longwood, FL 32779, where we provide essential pharmaceutical compounding services. As a 503B outsourcing facility, we adhere to the highest current good manufacturing practice (cGMP) standards, ensuring that every preparation is of the utmost quality, sterility, and potency for the patients and healthcare providers we serve at this location.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are patient-specific yet not commercially available. This includes the production of sterile injectables, hormone replacement therapies, ophthalmics, and other critical preparations. Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can rely on our facility for a consistent and reliable supply of these vital medications, all produced within a robust quality control environment that far exceeds traditional compounding standards. Our registration and compliance with the FDA provide an additional layer of assurance for every prescription dispensed.
Our services are designed to support the specific needs of the medical community operating in and around our facility at 2160 W State Road 434, Longwood, FL 32779. By working directly with physicians, clinics, and hospitals, 503B Compounding Pharmacy helps bridge gaps in the pharmaceutical market, providing access to medications that are on shortage or are not manufactured by large pharmaceutical companies. The team at our Longwood location is dedicated to upholding the integrity of the compounding profession through precision, innovation, and an unwavering commitment to patient safety.
For healthcare providers seeking a trusted partner for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands ready to assist. We encourage you to contact us to discuss your specific needs and how our FDA-registered outsourcing services can support your practice. You can reach us by phone at (407)993-1381 or visit our website to learn more about our capabilities and compliance at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. 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 complies with strict federal standards for compounding, including current good manufacturing practices (cGMP). This ensures a higher level of quality control and oversight for the sterile and non-sterile medications we compound.
2. Who can receive medications from 503B Compounding Pharmacy?
As an outsourcing facility, 503B Compounding Pharmacy primarily provides medications to healthcare providers and institutions. Physicians and other practitioners at 2160 W State Road 434, Longwood, FL 32779 can prescribe our compounded preparations for their patients, which are then dispensed pursuant to a prescription order.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility focuses on compounding medications that are not commercially available or are on drug shortage lists. This includes a significant volume of sterile injectables, hormone therapies, ophthalmics, and other customized preparations to meet the specific needs of the local medical community we serve.
4. How does the quality assurance at a 503B outsourcing facility differ?
503B Compounding Pharmacy operates under rigorous cGMP standards mandated by the FDA. This involves extensive testing of ingredients, validation of sterilization processes, environmental monitoring of our cleanrooms, and thorough documentation for every batch produced at our Longwood location, providing a demonstrable chain of quality and safety.
5. How can a healthcare provider at your location place an order?
Healthcare providers serving patients from our location can initiate orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will guide you through the process. You can also find more information about our services and capabilities on our website at https://503bcompoundingpharmacy.com/.