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 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, our facility is dedicated to providing healthcare providers with high-quality, compounded medications that are not commercially available. As a 503B outsourcing facility, we adhere to stringent current good manufacturing practices (cGMP) and are subject to rigorous FDA oversight, ensuring the medications we produce meet the highest standards of safety, identity, strength, quality, and purity.
The core mission of 503B Compounding Pharmacy is to support the medical community by producing large quantities of compounded sterile preparations (CSPs) and non-sterile preparations without receiving patient-specific prescriptions. Our services are essential for hospitals, surgery centers, clinics, and other healthcare providers at 2160 W State Road 434, Longwood, FL 32779, who require bulk compounded medications for office use. This allows healthcare professionals to have critical medications readily available for immediate administration to their patients, facilitating efficient and effective treatment protocols.
Our state-of-the-art facility at 2160 W State Road 434 is designed to operate under the strictest environmental controls. Our compounding processes are performed by highly trained and skilled pharmacists and technicians utilizing advanced technology and equipment. Every step, from sourcing raw materials from FDA-registered suppliers to final product testing and release, is meticulously controlled and documented. This unwavering commitment to cGMP standards differentiates a 503B outsourcing facility from a traditional 503A pharmacy and provides an added layer of assurance for the healthcare providers we serve at this location.
503B Compounding Pharmacy provides a vital service for the healthcare ecosystem at 2160 W State Road 434, Longwood, FL 32779. We compound a range of medications, including hormone replacement therapy (HRT) preparations, ophthalmologic solutions, injectable pain management formulations, and other essential sterile products. By outsourcing their compounding needs to our FDA-registered facility, healthcare providers can be confident they are incorporating safe and reliable medications into their patient care plans, while also saving valuable time and resources.
We invite healthcare providers and medical practices at 2160 W State Road 434, Longwood, FL 32779 to contact 503B Compounding Pharmacy to learn more about our services and how we can support your practice. You can reach us by phone at (407)993-1381 or visit our website at . Our team is committed to being a trusted partner in patient care, providing the highest quality compounded medications from our facility to yours.
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 FD&C Act. We are required to comply with current good manufacturing practices (cGMP) and are subject to routine FDA inspections, which provides an additional level of quality and safety assurance for the bulk compounded medications we produce for healthcare providers.
2. Who can order medications from 503B Compounding Pharmacy at 2160 W State Road 434?
Our services are designed for licensed healthcare providers and institutions, such as physicians, hospitals, clinics, and surgery centers. We provide medications for office use; we do not accept orders directly from individual patients. Healthcare providers can order the medications they need to stock their offices for administration to their patients.
3. What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we specialize in compounding sterile preparations in larger quantities. This includes various injectable medications, such as hormone therapies, pain management solutions, vitamins, and ophthalmologic drops. All medications are compounded at our facility located at 2160 W State Road 434, Longwood, FL 32779.
4. How does the quality control process work at your facility?
Quality control is integral to our operation. We adhere to strict cGMP standards, which involve rigorous testing of raw materials, stringent environmental monitoring of our cleanrooms, validated sterilization processes, and end-product testing. This ensures every batch of medication leaving our facility at 2160 W State Road 434, Longwood, FL 32779 meets specified standards for potency, purity, and sterility.
5. How can a healthcare provider at this location place an order?
Healthcare providers interested in our services can contact 503B Compounding Pharmacy directly to establish an account. You can reach our team by calling (407)993-1381. We will work with you to understand your practice's needs and provide information on our ordering process and available formulations.