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. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to producing high-quality compounded medications in large batches for healthcare providers. As a 503B Compounding Pharmacy, we adhere to rigorous current good manufacturing practices (cGMP) to ensure the safety, potency, and sterility of our preparations.
The 503B Compounding Pharmacy model is distinct from traditional compounding. Our primary focus at our Longwood location is on non-patient-specific, office-use medications. This means we supply healthcare practitioners with essential medications they need to have on hand for immediate use in their practices located at 2160 W State Road 434, Longwood, FL 32779. These medications are produced in advance, based on historical need and anticipated demand, allowing for timely administration to patients during office visits, procedures, or treatments.
Healthcare providers who utilize the services of 503B Compounding Pharmacy benefit from the assurance of working with an FDA-registered facility. This registration signifies a commitment to the highest standards of quality control, environmental monitoring, and product testing. The medications produced at our facility undergo stringent quality checks to verify their identity, strength, quality, and purity. For practitioners at 2160 W State Road 434, Longwood, FL 32779, this translates to a reliable and trusted source for critical drugs, reducing the compounding burden on their own practices and enhancing patient safety.
The scope of services provided by 503B Compounding Pharmacy includes the compounding of sterile injectables, such as IV bags, ophthalmics, and other parenteral medications. Our team of highly trained pharmacists and technicians utilizes state-of-the-art equipment within our controlled environment to produce these sterile preparations. By centralizing this complex process, 503B Compounding Pharmacy helps mitigate the risks associated with in-office compounding, providing a safer alternative for both practitioners and their patients.
Accessing the services of 503B Compounding Pharmacy is straightforward for healthcare providers. Our facility is designed to be a seamless extension of a medical practice's supply chain. We encourage practitioners at 2160 W State Road 434, Longwood, FL 32779 to connect with us to discuss their specific medication needs. To learn more about our available formulations and to initiate an order, please contact 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or visit our website for comprehensive information at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions for 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with strict federal standards known as current good manufacturing practices (cGMP). This ensures the medications we produce meet high benchmarks for quality, sterility, and strength.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy supplies medications exclusively to healthcare providers for office use. Our services are intended for physicians, clinics, and other healthcare entities that require pre-made, non-patient-specific medications for administration within their practice at 2160 W State Road 434, Longwood, FL 32779. We do not dispense medications directly to individual patients.
What types of medications does 503B Compounding Pharmacy produce?
503B Compounding Pharmacy specializes in compounding sterile injectable medications. This includes a range of preparations such as intravenous (IV) bags, ophthalmic solutions, and other injectable drugs that are essential for various medical treatments and procedures performed in clinical settings.
How does using 503B Compounding Pharmacy benefit a healthcare practice?
Utilizing 503B Compounding Pharmacy allows healthcare providers to source high-quality, ready-to-use medications without the need for in-office compounding. This saves time, reduces the risk of compounding errors, and provides assurance that the drugs meet rigorous federal safety and quality standards, thereby enhancing overall patient care.
How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers interested in our services should contact 503B Compounding Pharmacy directly to discuss their needs and establish an account. You can reach our facility by calling (407)993-1381. Detailed information about our capabilities is also available on our website at https://503bcompoundingpharmacy.com/.