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. This designation signifies our commitment to the highest standards of quality, safety, and consistency in pharmaceutical compounding. Unlike traditional compounding pharmacies, our 503B status means we are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations. This ensures that every preparation leaving our facility meets stringent federal quality standards for sterility, potency, and purity.
At our Longwood location, we specialize in the large-scale production of compounded sterile preparations (CSPs) for office use. This model allows healthcare providers at medical practices and hospitals to have immediate access to critical medications without the need for in-house compounding. Our services are essential for physicians who require ready-to-administer medications for procedures, emergency kits, or specific patient needs that cannot be met by commercially available, mass-produced drugs. By centralizing this complex process in our state-of-the-art facility, we provide a reliable and compliant source for these vital medications.
The core of our operation at 2160 W State Road 434 is our unwavering dedication to quality assurance. Our controlled environment includes ISO-classified cleanrooms where our highly trained compounding personnel prepare medications. Every batch undergoes extensive testing and validation processes to ensure it is free of contaminants and possesses exact potency. This level of quality control provides peace of mind to the healthcare professionals we serve, knowing they are administering the safest possible medications to their patients.
We serve as a pivotal support system for the local medical community. Healthcare providers can confidently source their non-patient-specific, office-use medications from our 503B Compounding Pharmacy, allowing them to focus on patient care. Our team works diligently to maintain a robust inventory of commonly needed compounds and can also accommodate specific requests, ensuring that practitioners have the necessary tools to provide optimal treatment.
To learn more about our services or to speak with our team, please contact us. Visit our website at https://503bcompoundingpharmacy.com/ or call us directly at (407)993-1381. 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
What does it mean that this facility is a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434 is registered with the FDA and operates under Section 503B of the FD&C Act. This subjects us to federal oversight and current Good Manufacturing Practices (cGMP), ensuring a higher level of quality control and consistency for sterile compounded medications produced for office use.
Who can order medications from 503B Compounding Pharmacy?
Our services are designed for healthcare providers and institutions. Physicians, surgeons, and medical practices can order non-patient-specific, office-use compounded medications from our facility at 2160 W State Road 434 for use in their treatments and procedures.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we specialize in producing sterile injectable preparations. This includes medications for anesthesia, pain management, hormones, antibiotics, and other solutions needed by healthcare providers for office-based procedures and treatments.
How does the quality assurance process work at your Longwood location?
Our facility at 2160 W State Road 434 adheres to strict cGMP standards. This involves environmental monitoring of our cleanrooms, rigorous testing of components and finished batches, and validation of all our processes and equipment to ensure every preparation meets defined standards for sterility, potency, and purity.
How can a healthcare provider place an order?
Healthcare providers interested in our services can initiate the process by contacting our facility directly. Please call us at (407)993-1381 to speak with a representative. You can also find more information on our website at https://503bcompoundingpharmacy.com/.