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 503B compounding pharmacy specializes in the large-scale compounding of sterile medications. As a 503B outsourcing facility, the pharmacy adheres to stringent federal quality standards, including current Good Manufacturing Practices (cGMP), which are more rigorous than the standards applied to traditional compounding pharmacies. This ensures that every preparation is consistent, sterile, and of the highest quality for the healthcare providers it serves.
The primary function of a 503B compounding pharmacy is to produce medications in bulk for healthcare facilities, clinics, and practitioners without a patient-specific prescription. This allows medical professionals at 2160 W State Road 434, Longwood, FL 32779, and beyond to have access to essential, ready-to-administer medications. The services provided by 503B Compounding Pharmacy are critical for ensuring a reliable supply of vital drugs, including sterile injectables, ophthalmics, and other preparations that are often in short supply from conventional manufacturers. By operating as a 503B outsourcing facility, the pharmacy provides a crucial link in the healthcare supply chain, supporting patient care with high-quality compounded medications.
For more information about the services offered by this 503B compounding pharmacy, visit their website at https://503bcompoundingpharmacy.com/ or contact them directly at (407)993-1381. 503B Compounding Pharmacy is committed to upholding the highest standards of safety and quality from its location at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
What is a 503B compounding pharmacy?
A 503B compounding pharmacy is an FDA-registered outsourcing facility that compounds sterile medications in large volumes. Unlike traditional pharmacies that compound based on individual prescriptions, a 503B compounding pharmacy at 2160 W State Road 434, Longwood, FL 32779, produces batches of medications for healthcare facilities without requiring patient-specific prescriptions.
What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy specializes in compounding sterile preparations, such as injectable medications, ophthalmic solutions, and other drugs that must be prepared in an aseptic environment. These medications are produced under the strict regulations governing a 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779.
Who can order from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications to healthcare entities, including hospitals, clinics, and surgical centers. Orders are not typically placed by individual patients but by licensed healthcare professionals and institutions that require bulk quantities of compounded sterile preparations from the facility at 2160 W State Road 434, Longwood, FL 32779.
How does the 503B designation ensure medication quality?
The 503B designation means the pharmacy is subject to federal oversight and must comply with Current Good Manufacturing Practices (cGMP). This ensures that all medications compounded at 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, meet rigorous standards for sterility, potency, and purity.
How can I contact 503B Compounding Pharmacy?
You can contact 503B Compounding Pharmacy by visiting their website at https://503bcompoundingpharmacy.com/ or by calling (407)993-1381. The pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.