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 specialized pharmacy focuses on the large-scale compounding of sterile medications for healthcare providers. As a 503B outsourcing facility, the pharmacy adheres to rigorous federal standards for quality, safety, and production consistency, distinct from traditional compounding pharmacies.
The primary function of a 503B compounding pharmacy is to produce medications in bulk for office use by physicians and healthcare facilities. This ensures that healthcare providers at 2160 W State Road 434, Longwood, FL 32779 have access to essential, high-quality sterile preparations when needed for patient procedures and treatments. The medications compounded are intended for administration within a clinical setting, supporting local medical practices in their delivery of care.
Operating as a 503B outsourcing facility involves compliance with Current Good Manufacturing Practice (cGMP) regulations. This commitment to quality control at 2160 W State Road 434, Longwood, FL 32779 means that every batch of medication undergoes stringent testing and validation processes. The result is a reliable supply of sterile compounded medications that meet the highest standards of purity and strength for the medical community.
For healthcare providers and facilities seeking a trusted source for office-use compounded sterile preparations, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents a critical resource. The pharmacy's registration ensures accountability and transparency, providing peace of mind to medical professionals who rely on these essential medications for their patients.
To learn more about the services available from this FDA-registered outsourcing facility, you can visit their website at https://503bcompoundingpharmacy.com/ or contact them by phone at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
What is a 503B compounding pharmacy? A 503B compounding pharmacy is an FDA-registered outsourcing facility that compounds large volumes of sterile medications for office use by healthcare providers. The facility at 2160 W State Road 434, Longwood, FL 32779 operates under specific federal regulations to ensure medication quality and safety.
Who can order from a 503B outsourcing facility? Only licensed healthcare providers and facilities can order medications from a 503B compounding pharmacy. The medications produced at 2160 W State Road 434, Longwood, FL 32779 are for professional use within a clinical setting and are not dispensed directly to individual patients.
What types of medications does a 503B compounding pharmacy produce? 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile injectable preparations. These are typically medications needed by physicians for procedures, such as anesthetic cocktails, antibiotics, or hormones, prepared in bulk for office use.
How does a 503B outsourcing facility ensure medication quality? As an FDA-registered outsourcing facility, the pharmacy at 2160 W State Road 434, Longwood, FL 32779 complies with Current Good Manufacturing Practice (cGMP) regulations. This includes rigorous environmental monitoring, sterility testing, and endotoxin testing on all batches of compounded sterile preparations.
How can I contact this 503B compounding pharmacy? You can contact 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 by visiting their website at https://503bcompoundingpharmacy.com/ or by calling (407)993-1381.