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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the preparation of compounded sterile medications in a stringent, controlled environment. As a 503B outsourcing facility, the pharmacy adheres to rigorous current good manufacturing practices (cGMP), which are enforced by the FDA. This ensures that every preparation leaving the facility meets the highest standards of quality, sterility, and potency for the patients and healthcare providers it serves at its Longwood location.
The core function of 503B Compounding Pharmacy is the large-scale production of medications that are not commercially available or are in shortage. This is a critical service for hospitals, surgery centers, clinics, and other healthcare providers who rely on a consistent and reliable supply of essential sterile preparations. By operating under Section 503B, the facility can compound medications without patient-specific prescriptions, distributing them to healthcare practitioners for office use. This model provides a vital link in the healthcare supply chain, ensuring that medical professionals at facilities near 2160 W State Road 434 have immediate access to the medications they need for procedures and patient treatments.
Patients and providers visiting or utilizing the services of 503B Compounding Pharmacy at 2160 W State Road 434 can be assured of the integrity of every product. The facility’s commitment to cGMP standards means that every step of the compounding process—from ingredient sourcing and environmental monitoring to sterile technique and final product testing—is meticulously documented and controlled. This level of oversight provides a significant layer of safety and consistency that goes beyond traditional compounding, offering peace of mind to the local medical community.
For healthcare entities in need of compounded sterile preparations, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, stands as a trusted partner. To inquire about services or to place an order, you can contact them via their website at or by phone at (407)993-1381.
Frequently Asked Questions
1. What does it mean to be a 503B outsourcing facility?
Being a 503B outsourcing facility means we are registered with the FDA and operate under Section 503B of the Federal Food, Drug, and Cosmetic Act. This requires us to comply with stringent current good manufacturing practices (cGMP) for the production of compounded sterile medications, ensuring a higher level of regulatory oversight for quality and safety compared to traditional compounding pharmacies.
2. Who can receive medications from your facility at 2160 W State Road 434?
Our medications are primarily distributed to healthcare providers and facilities for "office use." This means we supply hospitals, clinics, and other practitioner offices with compounded preparations that they can keep on hand to administer to patients as needed. We do not typically dispense medications directly to individual patients without a specific provider relationship.
3. What types of medications does 503B Compounding Pharmacy prepare?
We specialize in compounding sterile injectable medications, including IV bags, syringes, and other parenteral preparations. These often include medications that are currently in shortage from major manufacturers or specific formulations that are not commercially available, providing a critical supply for healthcare providers at our location.
4. How does the quality control process work at your facility?
Our quality control is governed by enforced cGMP standards. This involves rigorous testing of ingredients (APIs), continuous environmental monitoring of our cleanrooms, validation of sterile processes, and thorough testing of finished products for sterility, potency, and endotoxins before they are released for distribution from our Longwood facility.
5. How can a healthcare provider place an order with your pharmacy?
Healthcare providers and facilities can place orders by contacting our team directly. You can reach us by phone at (407)993-1381 to speak with a representative about your specific needs and our available preparations. Our website at also provides a point of contact for service inquiries.