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 operates as an FDA-registered outsourcing facility in strict compliance with 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 preparation of sterile and non-sterile compounded medications. We serve a critical role for healthcare providers by producing medications that are not commercially available, ensuring patients receive the specific formulations they require for their treatment plans.
The operations at our 2160 W State Road 434 location are conducted under the highest standards of quality and safety. As a 503B outsourcing facility, we are subject to rigorous FDA oversight, which includes current Good Manufacturing Practice (cGMP) regulations. This ensures that every preparation leaving our pharmacy meets stringent standards for potency, purity, and sterility. Our team of highly trained pharmacists and technicians utilizes state-of-the-art technology and controlled environments to compound medications with precision and care.
Our core service at the Longwood facility is the large-scale compounding of medications for office use. This means we provide healthcare practitioners with essential medications that they can keep in their offices to administer to patients immediately. This is particularly vital for medications used in specialized treatments, such as hormone replacement therapy, ophthalmology, dermatology, and pain management. By working directly with prescribers at 2160 W State Road 434, we help ensure a seamless and reliable supply of crucial medications.
Patient-specific compounding, while not the primary bulk function of a 503B, is an integral part of our service when coordinated through a prescribing physician. We understand that individual patient needs can be unique, and our capabilities allow us to support personalized healthcare solutions from our location. The entire process, from receiving a prescription to dispensing, is handled with meticulous attention to detail and a commitment to patient safety.
We invite healthcare providers to partner with us for their compounding needs. For more information about our services or to discuss how we can support your practice, please visit our website at or contact us directly at (407)993-1381. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is committed to excellence in pharmaceutical compounding.
Frequently Asked Questions
1. What does it mean that this pharmacy is a 503B outsourcing facility?
It means our facility at 2160 W State Road 434 is registered with the FDA under Section 503B of the FD&C Act. We compound large volumes of medications for office use and are required to comply with stricter federal standards, including current Good Manufacturing Practices (cGMP), which are routinely inspected by the FDA.
2. Can I, as a patient, pick up my compounded medication directly from your location?
Our primary operation is providing compounded medications to healthcare providers for office use. Patient-specific prescriptions are typically dispensed through the prescribing physician's office. Please consult with your healthcare provider regarding the pickup or administration of your medication.
3. What types of medications does 503B Compounding Pharmacy prepare?
At our 2160 W State Road 434 facility, we prepare a wide range of sterile and non-sterile compounded medications. This includes, but is not limited to, formulations for hormone therapy, pain management, dermatology, and ophthalmology, which are not readily available from commercial manufacturers.
4. How does a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can initiate orders by contacting our pharmacy directly at (407)993-1381. Our team will work with you to understand your specific needs and provide information on ordering protocols, formulary, and delivery options to your practice.
5. Why should a provider choose a 503B outsourcing facility over a traditional compounding pharmacy?
Choosing our 503B facility ensures your patients receive medications produced under the highest level of federal oversight. Our adherence to cGMP standards at 2160 W State Road 434 provides an added layer of quality control, sterility assurance, and consistency for medications used in your practice.