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.
503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, producing medications in bulk for healthcare providers to administer to their patients within their practice settings. Our operations are distinct from traditional retail pharmacies, as we supply physician offices, hospitals, and clinics with the essential medications they require.
The 503B compounding pharmacy model ensures that every preparation leaving our facility at 2160 W State Road 434, Longwood, FL 32779 is produced under a framework of rigorous quality control. This includes compliance with Current Good Manufacturing Practices (cGMP), which mandates strict protocols for sterility testing, potency verification, and environmental monitoring. For healthcare professionals, this provides a critical level of assurance regarding the medications they use, reducing the risk of contamination and ensuring patient safety. Our commitment is to provide reliable, high-quality compounded pharmaceuticals to support the medical community.
Our service at 2160 W State Road 434, Longwood, FL 32779 focuses on providing healthcare providers with access to medications that may be in short supply or not readily available from conventional manufacturers. By compounding these essential drugs, 503B Compounding Pharmacy helps to mitigate drug shortages and ensures that patient care is not interrupted. The medications produced are not intended for individual patient prescriptions to be taken home but are instead supplied in larger quantities for office use. This operational focus is the core of our service to the medical community.
Healthcare providers who utilize the services of 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 can expect a partnership built on reliability and quality. Our facility is designed to handle complex compounding processes, ensuring that every product meets precise specifications. We operate with transparency and are subject to regular FDA inspections, providing an additional layer of trust and verification for our clients. Our goal is to be a dependable source for compounded medications, allowing healthcare providers to focus on delivering exceptional patient care with confidence in the tools they use.
For more information about our services and how we can support your practice, please contact 503B Compounding Pharmacy. You can reach us at our facility located at 2160 W State Road 434, Longwood, FL 32779. Visit our website at or call us at (407)993-1381.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and operates under Section 503B of the Federal Food, Drug, and Cosmetic Act. This registration signifies that we comply with Current Good Manufacturing Practices (cGMP) and are subject to regular FDA inspections, ensuring the highest standards of quality and safety for the medications we compound.
2. Can I as an individual patient get a prescription filled at 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is an outsourcing facility that compounds medications in bulk for healthcare providers. We supply physician offices, hospitals, and clinics directly. Individual patients should have their prescriptions filled at a traditional 503A compounding pharmacy.
3. What types of medications does 503B Compounding Pharmacy produce?
Our facility at 2160 W State Road 434, Longwood, FL 32779 compounds a wide range of sterile and non-sterile medications, often focusing on drugs that are currently in shortage or are not commercially available. These medications are prepared for office use by healthcare providers to administer to patients within their practice.
4. How does a healthcare provider place an order with your facility?
Healthcare providers can place orders by contacting 503B Compounding Pharmacy directly at our location, 2160 W State Road 434, Longwood, FL 32779. You can initiate an order by calling us at (407)993-1381 or by visiting our website at . Our team will guide you through the process.
5. Why should a healthcare provider choose 503B Compounding Pharmacy?
Choosing our facility at 2160 W State Road 434, Longwood, FL 32779 provides assurance of quality and compliance. As a 503B outsourcing facility, our processes are held to the rigorous cGMP standards, which include extensive testing for sterility and potency. This reduces risk for healthcare providers and ensures the highest level of patient safety.