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 operates as an FDA-registered outsourcing facility in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility provides compounded medications for patient-specific needs. The 503B outsourcing facility designation signifies adherence to rigorous federal standards for quality, safety, and production scale, distinguishing it from traditional compounding pharmacies.
The services at 2160 W State Road 434, Longwood, FL 32779 are designed to support healthcare providers and their patients by producing medications that are not commercially available. This includes creating specific strengths, altering dosage forms for easier administration, or excluding certain allergens. The 503B Compounding Pharmacy prepares these medications in larger batches for office use, ensuring that healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 have access to vital preparations without the lead time of patient-specific compounding.
Quality assurance is a fundamental principle at this location. Every batch produced at the 2160 W State Road 434, Longwood, FL 32779 facility undergoes stringent testing and validation processes. This commitment to quality, governed by current Good Manufacturing Practices (cGMP), ensures that every medication leaving the facility meets precise specifications for potency, purity, and sterility where applicable. The team at 503B Compounding Pharmacy is dedicated to providing reliable pharmaceutical solutions from its facility at 2160 W State Road 434, Longwood, FL 32779.
For more information about the services available or to discuss specific needs, you can contact 503B Compounding Pharmacy directly. The team can be reached by phone at (407)993-1381. Detailed information about their capabilities and compliance is also available on their official website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an outsourcing facility?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA under Section 503B. This registration requires compliance with stricter production standards, including current Good Manufacturing Practices (cGMP), and allows for the larger-scale compounding of medications for office use by healthcare providers.
Who can receive medications from 503B Compounding Pharmacy at 2160 W State Road 434?
Medications compounded at this location are typically distributed to healthcare providers for office use. Patients receive these medications directly from their physician or clinic. Patients with prescriptions for compounded medications should consult their healthcare provider about sourcing.
How does the quality control at 2160 W State Road 434, Longwood, FL 32779 ensure safety?
The 503B Compounding Pharmacy adheres to rigorous cGMP standards. This involves extensive testing of raw materials, validation of all processes and equipment, and thorough testing of finished batches for potency, sterility, and purity to ensure every medication meets exact quality specifications.
Can I pick up a prescription directly from the 2160 W State Road 434 location?
As an outsourcing facility, 503B Compounding Pharmacy primarily supplies medications in bulk to healthcare practices rather than directly to individual patients. Patients should coordinate pick-up or delivery through their prescribing healthcare provider.
How do I contact 503B Compounding Pharmacy for more information?
You can contact the facility directly by calling (407)993-1381. Additional information about their services and regulatory status is available on their website at https://503bcompoundingpharmacy.com/.