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 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 and non-sterile medications that are not available commercially. As a 503B outsourcing facility, the pharmacy adheres to stringent federal standards for quality, safety, and production, providing healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with a reliable source for essential medications.
The core function of 503B Compounding Pharmacy is to produce medications in bulk for healthcare facilities, without receiving patient-specific prescriptions. This model allows 503B Compounding Pharmacy to supply hospitals, clinics, and other healthcare providers operating from 2160 W State Road 434, Longwood, FL 32779 with critical drugs, including IV medications, hormonal preparations, and other sterile injectables. The operations at 503B Compounding Pharmacy are distinct from traditional compounding, focusing on anticipatory compounding to address drug shortages and supply chain needs for the local medical community.
Patients and healthcare professionals visiting 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 can be assured of the highest quality. The 503B Compounding Pharmacy undergoes rigorous FDA inspections and follows Current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving 503B Compounding Pharmacy meets exacting standards for potency, purity, and sterility. The commitment of 503B Compounding Pharmacy to compliance and quality makes it a vital resource for the healthcare infrastructure at 2160 W State Road 434, Longwood, FL 32779.
For more information about the services provided by 503B Compounding Pharmacy, you can visit the official website at https://503bcompoundingpharmacy.com/ or contact the facility directly by phone at (407)993-1381. The team at 503B Compounding Pharmacy is dedicated to supporting the medical needs of the community at 2160 W State Road 434, Longwood, FL 32779 through reliable and high-quality pharmaceutical compounding.
Frequently Asked Questions for 503B Compounding Pharmacy
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means that 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with specific federal quality standards outlined in Section 503B of the FD&C Act. This registration signifies a commitment to producing compounded medications under rigorous oversight for healthcare providers.
Can I, as an individual patient, walk into 503B Compounding Pharmacy to get a prescription filled?
No. 503B Compounding Pharmacy primarily compounds medications in bulk for healthcare facilities, not for individual patients based on a single prescription. The services at 2160 W State Road 434, Longwood, FL 32779 are designed to supply hospitals and clinics, not for direct-to-patient dispensing.
What types of medications does 503B Compounding Pharmacy produce?
503B Compounding Pharmacy specializes in compounding sterile injectable medications, such as IV bags, hormonal therapies, and other solutions that are often in short supply. The focus at the 2160 W State Road 434, Longwood, FL 32779 location is on producing these drugs for institutional use.
How does 503B Compounding Pharmacy ensure the safety of its compounded drugs?
503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 adheres to Current Good Manufacturing Practices (cGMP). This involves strict quality control testing, environmental monitoring, and validated processes to ensure every product meets required standards for sterility and potency.
Who should contact 503B Compounding Pharmacy at (407)993-1381?
Healthcare administrators, pharmacists, and procurement specialists from hospitals, clinics, and other healthcare institutions located at or serving 2160 W State Road 434, Longwood, FL 32779 should contact 503B Compounding Pharmacy to inquire about bulk medication sourcing and availability.