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. Our facility is precisely located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. As a 503B outsourcing facility, we produce large batches of compounded sterile and non-sterile preparations for office use by healthcare practitioners, without receiving patient-specific prescriptions.
The core function of 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is to provide healthcare professionals with access to high-quality, readily available medications that are often in short supply or unavailable from conventional manufacturers. Our operations are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations, which ensures a level of consistency and quality control that goes beyond traditional compounding. This process involves extensive environmental monitoring, stringent testing of components and finished preparations, and validated processes for sterilization and stability.
Healthcare providers at practices near 2160 W State Road 434, Longwood, FL 32779 can rely on 503B Compounding Pharmacy for a consistent supply of essential medications. Our offerings include a range of sterile preparations, such as injectables, ophthalmics, and irrigations, as well as non-sterile preparations. By sourcing these critical medications from our 503B outsourcing facility, medical professionals can be confident in the integrity, potency, and sterility of the products they administer to their patients, enhancing patient safety and practice efficiency.
Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to supporting the local medical community. We provide a dependable alternative to drug manufacturers for medications that are on shortage or have been discontinued. The team at 503B Compounding Pharmacy is comprised of skilled pharmacists and technicians who utilize advanced technology and adhere to exacting protocols to ensure every preparation meets its specified identity, strength, quality, and purity characteristics.
For healthcare practitioners seeking a trusted source for office-use compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is a pivotal resource. We encourage you to contact us to discuss your practice's specific needs. You can reach our facility directly by phone at (407)993-1381 or visit our website for more information at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
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 complies with strict federal standards, including current Good Manufacturing Practices (cGMP). This ensures the medications we compound for office use meet heightened requirements for quality, sterility, and safety.
Who can order medications from 503B Compounding Pharmacy?
Our services are exclusively for healthcare practitioners and providers. We supply medications for office use to medical practices. We do not accept or compound based on individual patient prescriptions from the general public at our location on 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy provide?
503B Compounding Pharmacy provides compounded sterile preparations, including injectables, ophthalmics, and irrigations, as well as non-sterile preparations. These are often medications that are on national shortage or are not commercially available, providing a critical supply for local healthcare providers.
How does ordering work for a local practice?
Healthcare providers can contact 503B Compounding Pharmacy directly at (407)993-1381 to place an order or discuss available formulations. Our team will coordinate the process to supply your practice with the necessary medications from our facility at 2160 W State Road 434, Longwood, FL 32779.
Why should a practice choose a 503B outsourcing facility over a traditional compounding pharmacy?
Choosing 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 provides assurance of FDA oversight and cGMP compliance. This offers a higher level of quality control, consistency, and sterility assurance for office-use medications, which is crucial for patient safety and practice risk management.