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
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 compounding pharmacy specializes in the preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, the pharmacy adheres to rigorous current good manufacturing practices (cGMP) to ensure the quality, safety, and potency of its preparations for healthcare providers and patients in Longwood.
The primary focus of 503B Compounding Pharmacy is the large-scale compounding of medications that are patient-specific or not commercially available. This includes a range of sterile preparations such as injectables, infusions, and ophthalmic solutions. The pharmacy's status as a 503B facility means it is subject to federal oversight and regular FDA inspections, providing an additional layer of assurance regarding the quality of its compounded drugs. The team at 503B Compounding Pharmacy works directly with physicians and healthcare facilities to provide essential medications that meet specific clinical needs.
For more information about the services provided by 503B Compounding Pharmacy, you can visit their website at https://503bcompoundingpharmacy.com/ or contact them by phone at (407)993-1381. The pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an outsourcing facility?
Being an outsourcing facility under Section 503B means that 503B Compounding Pharmacy is registered with the FDA and complies with current good manufacturing practices (cGMP). This registration signifies a commitment to producing compounded medications under the highest standards of quality and safety, which includes undergoing regular FDA inspections at our facility on W State Road 434 in Longwood.
What types of compounded medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy specializes in the preparation of medications that are not commercially available or need to be tailored for specific patient needs. This includes a significant focus on sterile compounded preparations, such as injectable medications, intravenous (IV) bags, and ophthalmic drops, all produced at our Longwood location.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy primarily supplies compounded medications to healthcare providers and healthcare facilities. Physicians, clinics, and hospitals in need of specific compounded drugs can work with our pharmacy located at 2160 W State Road 434, Longwood, FL 32779.
How does the 503B status benefit healthcare providers in Longwood?
The 503B status provides healthcare providers with the assurance that the compounded medications they receive are produced under strict federal quality standards. This includes testing for sterility, potency, and purity, which is essential for patient safety when using injectable or other high-risk compounded drugs prepared at our facility.
How can I contact 503B Compounding Pharmacy?
You can contact 503B Compounding Pharmacy by visiting our website at https://503bcompoundingpharmacy.com/ or by calling us at (407)993-1381. Our physical location is 2160 W State Road 434, Longwood, FL 32779.