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. Located at 2160 W State Road 434, Longwood, FL 32779, this facility specializes in the large-scale compounding of sterile and non-sterile medications that are not available commercially. The 503B Compounding Pharmacy provides these medications for office use by healthcare practitioners, ensuring a reliable and compliant source for patient-specific needs.
The core function of 503B Compounding Pharmacy is to serve as a critical partner to local medical practices and hospitals. By operating from its facility at 2160 W State Road 434, Longwood, FL 32779, the 503B Compounding Pharmacy adheres to stringent FDA standards for quality, safety, and production. This includes rigorous testing, beyond-use-date assignment, and current good manufacturing practices (cGMP) that exceed those of traditional 503A compounding pharmacies. The 503B Compounding Pharmacy is dedicated to providing healthcare providers with access to essential medications that are often in short supply or discontinued by major manufacturers.
Healthcare professionals in the area utilize the services of 503B Compounding Pharmacy to obtain medications for their office inventory. This allows for immediate administration to patients during office visits, procedures, or treatments. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 compounds a wide array of preparations, including hormone replacement therapy injections, intravenous medications, ophthalmologic solutions, and other sterile preparations required for patient care. The focus remains on quality, consistency, and regulatory compliance in every batch produced.
Patients benefit indirectly from the services of 503B Compounding Pharmacy through the care provided by their local doctors, clinics, and surgical centers. The medications supplied by the 503B Compounding Pharmacy enable healthcare providers to offer treatments and therapies that might otherwise be inaccessible. The operations at 2160 W State Road 434, Longwood, FL 32779 are central to supporting the local medical community's ability to deliver comprehensive and effective care.
For more information about the services provided or to inquire about becoming a client, you can contact 503B Compounding Pharmacy directly. The team at 2160 W State Road 434, Longwood, FL 32779 is available to answer questions from healthcare entities. Reach out via their website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381.
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 complies with federal current good manufacturing practices (cGMP) for drug production, which includes stricter quality control and testing standards than traditional compounding pharmacies.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications for office use by licensed healthcare practitioners. Our services at 2160 W State Road 434, Longwood, FL 32779 are designed for medical practices, hospitals, and clinics to maintain an inventory of medications for patient administration within their facility.
Can I, as a patient, pick up a prescription directly from 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy does not typically dispense medications directly to individual patients. We supply medications in bulk to healthcare providers at their place of practice. Your treating physician or clinic located at 2160 W State Road 434, Longwood, FL 32779 would administer the medication we compound to you during your appointment.
What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434 produce?
503B Compounding Pharmacy specializes in compounding sterile injectable and intravenous medications, including hormone therapies, vitamins, and other solutions for office-based procedures. All products are compounded under cGMP standards at our Longwood facility.
How can a healthcare practice start ordering from 503B Compounding Pharmacy?
Healthcare practices interested in our services can initiate the process by contacting our facility directly. You can reach the 503B Compounding Pharmacy team at our location, 2160 W State Road 434, Longwood, FL 32779, via phone at (407)993-1381 or through our website at https://503bcompoundingpharmacy.com/ to establish an account and discuss specific medication needs.