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, providing healthcare providers with access to critical medications that are not commercially available. Our operations are distinct from traditional compounding pharmacies, as we are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations. This ensures that every preparation leaving our facility meets stringent standards for potency, purity, and sterility.
The primary function of 503B Compounding Pharmacy is to supply compounded medications for office use. Healthcare practitioners at clinics, hospitals, and surgical centers can utilize our services to obtain essential medications for their patients without the need to maintain a large in-house inventory. Our location at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by highly trained pharmacists and technicians who specialize in complex compounding. We provide a reliable source for medications that are often on shortage or are needed in specific formulations not offered by major pharmaceutical manufacturers.
Our services at 2160 W State Road 434, Longwood, FL 32779 are focused on producing batches of medications for healthcare settings. This includes sterile injectables, ophthalmics, and other preparations that are essential for patient care. By operating as a 503B outsourcing facility, we provide an added layer of safety and compliance for the medical community. Healthcare providers can confidently order from 503B Compounding Pharmacy, knowing that our processes are continuously monitored and validated to ensure patient safety. We are committed to supporting the local medical infrastructure by being a dependable partner for compounded pharmaceutical needs.
For more information or to place an order, you can reach 503B Compounding Pharmacy at our facility located at 2160 W State Road 434, Longwood, FL 32779. Contact us via our website at or by phone at (407)993-1381. Our team is ready to assist healthcare professionals with their specific medication requirements.
Frequently Asked Questions for 503B Compounding Pharmacy
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. This registration subjects us to federal oversight and requires compliance with current Good Manufacturing Practices (cGMP), which are the same standards used by conventional drug manufacturers. This ensures a higher level of quality control and consistency for the medications we compound.
2. Can I as an individual patient pick up a prescription directly from your location?
No. 503B Compounding Pharmacy provides medications for office use by healthcare practitioners. We do not compound patient-specific prescriptions that are dispensed directly to the public. Our facility at 2160 W State Road 434, Longwood, FL 32779 supplies medications in bulk to hospitals, clinics, and other healthcare providers who then administer them to their patients within their practice.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile preparations, including injectables, IV bags, and ophthalmics. We also compound non-sterile medications. Our focus is on producing medications that are on the FDA drug shortage list or are needed in a specific strength or formulation that is not commercially available from large pharmaceutical companies.
4. How can a healthcare provider at a local clinic order from you?
Healthcare providers can place orders for office-use medications by contacting 503B Compounding Pharmacy directly. You can reach our facility at 2160 W State Road 434, Longwood, FL 32779 by phone at (407)993-1381 or through our website at . Our team will work with you to process your order and arrange for delivery or pickup.
5. Why should a healthcare provider choose a 503B outsourcing facility over a traditional 503A pharmacy?
Choosing a 503B outsourcing facility like ours at 2160 W State Road 434, Longwood, FL 32779 provides an added assurance of quality and safety. Our compliance with cGMP standards and ongoing FDA oversight means every batch of medication is produced under the most stringent protocols. This is particularly critical for sterile injectables and medications used in vulnerable patient populations, reducing risk for both the provider and the patient.