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 rigorous federal standards for quality control, testing, and production that exceed those of traditional compounding pharmacies. This ensures that every preparation leaving our facility meets the highest possible standards for potency, purity, and sterility.
The primary distinction of a 503B compounding pharmacy is our ability to compound medications in advance of receiving a patient-specific prescription. This allows us to supply healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with critical medications that are ready for immediate use. Our operations are subject to current Good Manufacturing Practices (cGMP), which mandates stringent environmental monitoring, validated processes, and thorough quality assurance testing on all batches of compounded drugs. This level of oversight provides an additional layer of safety and reliability for the medical community we serve.
Our services at 2160 W State Road 434, Longwood, FL 32779 are focused on providing bulk quantities of compounded preparations to healthcare facilities and practitioners. This includes hospitals, clinics, surgery centers, and other healthcare providers who require consistent, high-quality medications for their patients. We compound a wide array of preparations, including sterile injectables, ophthalmics, and other dosage forms that are essential for patient care. The team at 503B Compounding Pharmacy is comprised of skilled pharmacists and technicians who utilize state-of-the-art equipment to ensure precision and accuracy in every compound.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, partnering with a 503B outsourcing facility like ours mitigates risk and enhances patient safety. By outsourcing their compounding needs to our FDA-registered facility, practitioners can be confident they are receiving products that have undergone rigorous testing and quality checks. We provide a vital service to the local medical community by ensuring a consistent supply of essential medications that are compounded under the most controlled conditions. Our commitment is to support the healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 with the highest quality pharmaceutical preparations.
To learn more about our services or to place an order, you can contact 503B Compounding Pharmacy directly. Our team is ready to assist the healthcare providers at 2160 W State Road 434, Longwood, FL 32779. Visit us at or call (407)993-1381 for more information.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this facility is a 503B compounding pharmacy?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility. We operate under Section 503B of the Federal Food, Drug, and Cosmetic Act, which requires us to comply with current Good Manufacturing Practices (cGMP) for the large-scale compounding of medications, ensuring the highest standards of quality, sterility, and potency.
2. Who can receive medications from your 503B compounding pharmacy?
Our 503B outsourcing facility provides compounded medications primarily to healthcare practitioners and facilities, such as hospitals, clinics, and surgery centers, for office use. We supply medications to healthcare providers at 2160 W State Road 434, Longwood, FL 32779; we do not typically dispense medications directly to individual patients based on a prescription.
3. What types of medications does your facility at 2160 W State Road 434 compound?
As a 503B compounding pharmacy, we compound a wide range of sterile and non-sterile preparations in larger batches. This includes, but is not limited to, sterile injectables, ophthalmic solutions, and other formulations that are essential for the healthcare providers we serve at this location.
4. How does using a 503B outsourcing facility benefit our practice at 2160 W State Road 434?
Utilizing our 503B compounding pharmacy provides your practice with medications that have undergone rigorous quality testing and are produced under strict cGMP standards. This reduces the risk of compounding errors, ensures consistency between batches, and provides a reliable supply of essential medications for office use, enhancing overall patient safety.
5. How can a healthcare provider at this location place an order?
Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can place an order by contacting our facility directly. You can reach our team by phone at (407)993-1381 to discuss your specific needs and our available preparations. You can also visit our website at for more information.