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 stringent current Good Manufacturing Practices (cGMP), providing a critical service for healthcare providers by producing high-quality medications that are not commercially available.
The core function of 503B Compounding Pharmacy at its Longwood location is to compound prescription medications for office use. This means the pharmacy prepares medications in bulk for physicians, hospitals, and healthcare clinics, allowing them to have essential drugs on hand for immediate administration to patients. This is distinct from traditional retail compounding, which focuses on patient-specific prescriptions. The medications produced are vital for a wide range of treatments, including hormonal therapies, ophthalmologic solutions, pain management preparations, and other sterile injectables.
Healthcare providers who source their medications from 503B Compounding Pharmacy at 2160 W State Road 434 can be assured of a rigorous quality assurance process. Every batch of medication is compounded in a controlled environment and undergoes thorough testing to ensure potency, purity, and sterility. This commitment to cGMP standards provides a significant level of safety and reliability, which is paramount for patient care. The pharmacy’s operations are subject to regular FDA inspections, further ensuring compliance with the highest regulatory standards.
The team at 503B Compounding Pharmacy comprises skilled pharmacists and technicians who are experts in the science of compounding. Their expertise allows them to work closely with healthcare providers to meet specific clinical needs. By providing access to compounded medications that may be on shortage or are not produced by large pharmaceutical manufacturers, the facility at 2160 W State Road 434 plays an indispensable role in the local healthcare infrastructure, supporting doctors and improving patient outcomes in the community.
For more information about the services provided or to inquire about becoming a client, healthcare providers are encouraged to contact 503B Compounding Pharmacy directly. The facility can be reached by phone at (407)993-1381. Detailed information about its capabilities, compliance status, and the types of medications compounded is available on its official website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
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. We compound medications in large volumes for office use by healthcare providers and must comply with strict current Good Manufacturing Practice (cGMP) regulations, which include rigorous testing and quality control standards beyond those of traditional pharmacies.
Who can order medications from 503B Compounding Pharmacy?
Our services at 2160 W State Road 434 are designed for healthcare providers, including physicians, hospitals, surgical centers, and clinics. We provide medications for office use, meaning a healthcare professional can order and administer them to their patients within their practice. We do not compound medications for individual patients without a prescription from their provider.
What types of medications does 503B Compounding Pharmacy produce?
At our Longwood facility, we specialize in compounding a wide array of sterile and non-sterile preparations. This includes, but is not limited to, hormone replacement therapy (HRT) medications, sterile injectables, ophthalmologic drops, and pain management solutions. These are medications that are often on national shortage or are not commercially available from large pharmaceutical companies.
How does 503B Compounding Pharmacy ensure the quality and safety of its compounded medications?
Quality and safety are paramount at our facility on W State Road 434. We adhere to enforced cGMP standards, which mandate a validated compounding process, environmental monitoring, and extensive testing of both components and finished drug products for sterility, potency, and endotoxins. Our facility and records are also subject to inspection by the FDA.
How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers interested in our services can initiate the process by contacting our facility directly. The best way to begin is to call our dedicated phone line at (407)993-1381 to speak with a representative. You can also visit our website at https://503bcompoundingpharmacy.com/ for more information on our product offerings and compliance documentation.