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, located at 2160 W State Road 434, Longwood, FL 32779, is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. We are dedicated to providing high-quality, sterile compounded medications to meet the specific needs of healthcare providers and their patients within the Longwood community. Our state-of-the-art facility adheres to stringent quality control measures and cGMP guidelines to ensure the safety, efficacy, and consistency of every preparation. We specialize in producing bulk, non-patient-specific compounded sterile drug preparations for administration by licensed practitioners. Our commitment is to deliver reliable and customized pharmaceutical solutions, supporting the critical care requirements of medical professionals right here in Longwood. For inquiries or to learn more about our services, please visit our website at https://503bcompoundingpharmacy.com/ or call us at (407)993-1381.
Q1: What types of compounded medications does 503B Compounding Pharmacy offer at this Longwood location?
A1: At our 2160 W State Road 434, Longwood, FL 32779 facility, we specialize in sterile compounded drug preparations for administration by licensed practitioners. This includes a range of bulk, non-patient-specific medications.
Q2: Is 503B Compounding Pharmacy registered with the FDA?
A2: Yes, 503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act, ensuring compliance with federal standards.
Q3: How can healthcare providers in Longwood, FL, order compounded medications from your facility?
A3: Healthcare providers can learn more about our services and place orders by visiting our website at https://503bcompoundingpharmacy.com/ or by calling us directly at (407)993-1381.
Q4: What quality standards does your Longwood compounding pharmacy follow?
A4: Our facility at 2160 W State Road 434, Longwood, FL 32779, adheres to strict quality control measures and current Good Manufacturing Practices (cGMP) to ensure the safety and efficacy of our compounded preparations.
Q5: Are your compounded medications prepared for individual patients?
A5: Our 503B outsourcing facility focuses on producing bulk, non-patient-specific compounded sterile drug preparations intended for administration by licensed practitioners.