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 medications. The primary focus is on producing larger batches of compounded drugs for healthcare providers and facilities, providing a critical component of the pharmaceutical supply chain.
The services provided by 503B Compounding Pharmacy are distinct from traditional retail pharmacy services. The facility's operations are centered on compounding medications that are not commercially available or are in shortage, ensuring that patients have access to necessary treatments. The pharmacy's status as a 503B outsourcing facility signifies a commitment to meeting the highest standards of pharmaceutical compounding. For more information about the facility and its role in the healthcare system, visit the website at https://503bcompoundingpharmacy.com/ or contact the facility directly at (407)993-1381.
Frequently Asked Questions
What is a 503B compounding pharmacy?
A 503B compounding pharmacy is an FDA-registered outsourcing facility that compounds drugs in accordance with Section 503B of the Federal Food, Drug, and Cosmetic Act. These facilities compound sterile and non-sterile medications, often in larger batches, and are subject to current good manufacturing practice (cGMP) requirements and FDA oversight.
What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy prepares a range of compounded medications, including sterile injectables, ophthalmic solutions, and other formulations that are essential for healthcare providers. The pharmacy focuses on medications that are on shortage or not commercially available from traditional manufacturers.
Who can order from 503B Compounding Pharmacy?
503B Compounding Pharmacy primarily provides compounded medications to healthcare professionals and facilities, such as hospitals, clinics, and physician offices. Patients should consult with their healthcare provider regarding medications compounded at this facility.
How does the 503B outsourcing model benefit healthcare?
The 503B outsourcing model provides a reliable source of high-quality compounded medications, especially during drug shortages. By adhering to strict cGMP standards, 503B Compounding Pharmacy helps ensure patient safety and medication efficacy for healthcare providers at 2160 W State Road 434, Longwood, FL 32779.
How can I learn more about the services at this location?
For detailed information about the services provided by 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, you can visit their website at https://503bcompoundingpharmacy.com/ or call (407)993-1381.