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 from its location at 2160 W State Road 434, Longwood, FL 32779. Functioning under the specific regulatory framework defined by Section 503B of the Federal Food, Drug, and Cosmetic Act, this 503B Compounding Pharmacy provides a critical service for healthcare providers and patients. The designation as a 503B Compounding Pharmacy signifies adherence to the highest standards of pharmaceutical compounding, including Current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving the facility at 2160 W State Road 434, Longwood, FL 32779 meets rigorous standards for potency, purity, and sterility.
The core function of this 503B Compounding Pharmacy is the large-scale production of compounded medications. These medications are prepared for office use by healthcare practitioners, allowing them to have essential drugs readily available for patient administration. The services provided by this 503B Compounding Pharmacy are distinct from traditional compounding, focusing on batch production rather than individual patient-specific prescriptions. This model supports the operational needs of local medical practices, surgical centers, and hospitals by providing them with reliable access to high-quality sterile and non-sterile compounded preparations made under the strict oversight required of a 503B Compounding Pharmacy.
Patients and healthcare providers visiting or utilizing the services of the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 benefit from the assurance of quality that comes with federal oversight. The 503B Compounding Pharmacy facility is subject to regular FDA inspections, providing an additional layer of safety and compliance. For healthcare professionals seeking a trusted outsourcing partner for their practice's pharmaceutical needs, this 503B Compounding Pharmacy serves as a vital resource. The team at this 503B Compounding Pharmacy is dedicated to upholding the principles of quality and safety inherent in its 503B designation.
To learn more about the specific preparations and services available from this 503B Compounding Pharmacy, or to inquire about how it can support your practice, you are encouraged to make direct contact. The 503B Compounding Pharmacy can be reached via phone at (407)993-1381. Detailed information about the operations and compliance standards of this 503B Compounding Pharmacy is also available on its official website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions for 503B Compounding Pharmacy
What does it mean that this is a 503B Compounding Pharmacy?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA as an outsourcing facility under Section 503B. This registration requires us to comply with Current Good Manufacturing Practices (cGMP), which are more rigorous standards than those applied to traditional compounding pharmacies, ensuring a higher level of quality control and sterility assurance for the medications we produce.
Who can order medications from this 503B Compounding Pharmacy?
Our 503B Compounding Pharmacy primarily provides medications for office use by healthcare practitioners. Orders are placed by licensed healthcare providers for administration to patients within their practice at 2160 W State Road 434, Longwood, FL 32779. We do not typically dispense medication directly to individual patients without a provider's order.
What types of medications does this 503B Compounding Pharmacy prepare?
As a 503B Compounding Pharmacy, we specialize in preparing larger batches of both sterile and non-sterile compounded medications. This includes, but is not limited to, sterile injectables, hormone preparations, and other formulations that are in need for healthcare providers serving the local area from our location on State Road 434.
How does the 503B Compounding Pharmacy ensure safety and quality?
Safety and quality are the foundation of our operation as a 503B Compounding Pharmacy. We achieve this through strict adherence to cGMP guidelines, which govern every aspect of our process from ingredient sourcing to environmental monitoring and finished product testing. Our facility at 2160 W State Road 434, Longwood, FL 32779 is designed and maintained to prevent contamination.
How can a healthcare provider start working with your 503B Compounding Pharmacy?
Healthcare providers interested in the services of our 503B Compounding Pharmacy can initiate the process by contacting us directly. The best way to discuss your practice's specific needs and our available preparations is to call our team at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more information.