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 precisely located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, our 503B outsourcing facility adheres to rigorous current good manufacturing practices (cGMP), ensuring that every preparation is produced in a controlled, sterile environment with extensive quality control testing.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for healthcare providers. We serve physicians, hospitals, clinics, and other healthcare entities by providing them with essential medications that are not commercially available or are in shortage. Our operations at 2160 W State Road 434, Longwood, FL 32779 are focused on creating these medications in bulk, which are then distributed to healthcare professionals for office use in treating their patients. This model ensures that practitioners in our community have reliable access to high-quality, critical medications.
Our services are defined by our regulatory status as a 503B outsourcing facility. This includes the compounding of a wide array of sterile injectables, ophthalmics, and other preparations that are vital for patient care. Every batch produced within our facility undergoes stringent testing for potency, sterility, and endotoxins, providing an unparalleled level of assurance for the medical professionals we serve. By centralizing this complex process at our location, we alleviate the burden from individual practitioner offices, allowing them to focus on direct patient care while we ensure the integrity of their medical supplies.
Engaging with 503B Compounding Pharmacy is a direct process for healthcare providers. Orders are managed through our secure systems, and we maintain clear and consistent communication regarding order status and delivery. Our team of highly skilled pharmacists and technicians is dedicated to upholding the strict protocols required of an FDA-registered facility. For more detailed information about our specific capabilities or to initiate an order, healthcare providers are encouraged to contact us directly or visit our website.
To learn more about our compounding services or to place an order, please contact 503B Compounding Pharmacy at our facility. You can reach us by phone at (407)993-1381 or visit our website for comprehensive information at https://503bcompoundingpharmacy.com/.
FAQ
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 operates under Section 503B of the FD&C Act. This requires us to comply with stringent current good manufacturing practices (cGMP) for the production of compounded drugs, including rigorous testing for sterility and potency.
Who can order medications from 503B Compounding Pharmacy?
Our services are designed for healthcare professionals. We provide compounded medications for office use to physicians, hospitals, surgery centers, and other healthcare facilities. Medications are not dispensed directly to individual patients from our location at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we specialize in producing large-scale batches of compounded sterile preparations (CSPs). This includes a range of injectables, IV bags, ophthalmics, and other sterile medications that are often on national shortage or are not available from commercial manufacturers.
How does the ordering process work for healthcare providers?
Healthcare providers can initiate the ordering process by contacting our facility directly at (407)993-1381. Our team will provide information on our available preparations, assist with setting up an account, and guide you through the process for placing and receiving orders from our location.
How can I verify the quality and safety of the compounded medications?
As an FDA-registered 503B outsourcing facility, we are subject to FDA inspection and must adhere to strict cGMP standards. Every batch of medication produced at 2160 W State Road 434, Longwood, FL 32779 undergoes validated testing for sterility, potency, and endotoxins to ensure the highest level of patient safety.