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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, testing, and production, ensuring that healthcare providers at our local address receive medications that are consistently prepared, properly stored, and of the highest possible quality.
The core function of 503B Compounding Pharmacy is to provide bulk compounded pharmaceutical products for office use by healthcare practitioners. This means that physicians, surgeons, veterinarians, and other medical professionals can obtain the specific medications they need to treat their patients directly from our facility at 2160 W State Road 434. By operating under Section 503B, the pharmacy can compound medications without requiring patient-specific prescriptions for these bulk quantities, which is essential for supporting the day-to-day operations of local clinics and practices. This model allows for greater efficiency and readiness, ensuring that vital medications are available when needed for procedures and treatments.
Patients and healthcare providers visiting 503B Compounding Pharmacy at its Longwood location can be assured of a commitment to the highest standards of pharmaceutical science. The facility's operations are strictly regulated, involving environmental monitoring, stringent sterility testing, and stability studies to guarantee the safety, potency, and purity of every preparation. This level of oversight goes beyond traditional compounding, providing an additional layer of confidence for the medical community served directly from 2160 W State Road 434. The team of skilled pharmacists and technicians utilizes advanced technology and follows current good manufacturing practices (cGMP) to fulfill the complex medication needs of the local healthcare ecosystem.
For more information about the services available at this specific facility, or to discuss how 503B Compounding Pharmacy can support your practice, please contact us directly. We are located at 2160 W State Road 434, Longwood, FL 32779. You can reach us by phone at (407)993-1381 or visit our website to learn more at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that this is a 503B outsourcing facility?
It means our facility at 2160 W State Road 434 is registered with the FDA and complies with heightened production and quality control standards outlined in Section 503B of the FD&C Act. We compound medications in larger batches for office use by healthcare practitioners.
Can I as a patient walk in and get a prescription filled at this location?
No. 503B Compounding Pharmacy primarily supplies medications in bulk for "office use" to healthcare providers. Patients with individual prescriptions should have them filled at a traditional 503A compounding pharmacy that handles patient-specific orders.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434 compounds a wide range of sterile and non-sterile medications, including hormonal preparations, sterile injectables, ophthalmics, and other formulations needed by local clinics, hospitals, and veterinary practices for their procedures and treatments.
How do I order compounded medications for my practice from this location?
Healthcare providers can order compounded medications for office use by contacting our facility directly at (407)993-1381. Our team will work with you to understand your needs and provide the necessary medications for pickup or delivery from our location on W State Road 434.
Why should a healthcare provider choose a 503B outsourcing facility?
Choosing our 503B facility ensures the medications you use in your practice meet rigorous federal standards for sterility, potency, and purity. This provides an added layer of safety and consistency for the patients you treat at your practice near our Longwood location.