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 leaving the facility meets the highest levels of sterility, potency, and purity. The primary focus of 503B Compounding Pharmacy is to provide healthcare facilities with reliable access to essential medications that may be in short supply or unavailable from conventional manufacturers.
The services provided by 503B Compounding Pharmacy are distinct from those of a retail pharmacy. The facility compounds medications in bulk for office use by healthcare providers, rather than for individual patient prescriptions. This model is critical for hospitals, clinics, surgical centers, and other healthcare institutions that require ready-to-administer, sterile preparations. By operating as a 503B outsourcing facility, the pharmacy can proactively compound widely used medications, helping to mitigate drug shortages and ensure that medical professionals have the necessary tools for patient care. The team at 503B Compounding Pharmacy is comprised of skilled pharmacists and technicians who are experts in sterile compounding techniques, quality control, and regulatory compliance.
For healthcare providers seeking a dependable source for high-quality compounded sterile preparations, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents a commitment to safety and reliability. The facility’s registration with the FDA provides an additional layer of oversight and transparency, offering peace of mind to its institutional clients. To learn more about the specific formulations available or to discuss the needs of your healthcare facility, you can visit their website at https://503bcompoundingpharmacy.com/ or contact them directly by phone at (407)993-1381.
Frequently Asked Questions
What does it mean to be a 503B compounding pharmacy?
Being a 503B compounding pharmacy means the facility is registered with the FDA as an outsourcing facility under Section 503B of the FD&C Act. This registration requires compliance with current Good Manufacturing Practices (cGMP) for drug manufacturing, which includes rigorous testing, environmental monitoring, and quality control procedures that exceed the standards for traditional compounding pharmacies.
Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications primarily for healthcare facilities on an office-use basis. This includes hospitals, clinics, ambulatory surgical centers, and other institutional healthcare providers. Medications are not typically dispensed directly to individual patients at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy prepare?
As an outsourcing facility, 503B Compounding Pharmacy specializes in compounding sterile injectable medications. These are often preparations that are essential for patient care but may be experiencing shortages from primary manufacturers. The specific formulations available can be discussed by contacting the pharmacy at (407)993-1381.
How does the quality of a 503B compounded medication compare to an FDA-approved drug?
While 503B compounded medications are not individually approved by the FDA, the outsourcing facility itself is subject to FDA oversight and must comply with cGMP regulations. This ensures a high level of quality, sterility, and strength consistency that is more comparable to commercially manufactured drugs than to medications from a traditional compounding pharmacy.
How can a healthcare facility place an order with 503B Compounding Pharmacy?
Healthcare facilities interested in the services of 503B Compounding Pharmacy can initiate the process by visiting their website at https://503bcompoundingpharmacy.com/ or by calling the facility directly at (407)993-1381. The team can provide detailed information on available products, ordering procedures, and compliance documentation.