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. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the preparation of sterile and non-sterile compounded medications in a large-scale capacity. As a 503B outsourcing facility, we adhere to rigorous current good manufacturing practices (cGMP) set forth by the FDA, ensuring the highest standards of quality, purity, and potency for every preparation that leaves our facility. Our mission is to provide healthcare providers and patients at our location with access to essential medications that are not commercially available, thereby fulfilling a critical need in the local healthcare ecosystem.
The operations at our Longwood facility are distinct from traditional compounding pharmacies. Our 503B status means we compound medications proactively and in larger batches without patient-specific prescriptions, which are then distributed to healthcare providers for office use. This model is essential for hospitals, clinics, and surgical centers in the vicinity of 2160 W State Road 434, allowing medical professionals to have vital medications readily on hand for immediate patient care. Our portfolio includes a wide array of preparations, such as sterile injectables, ophthalmics, and other dosage forms that are crucial for various medical treatments and procedures.
Quality control is the cornerstone of our operation at 2160 W State Road 434. Every step of our compounding process, from sourcing raw ingredients from FDA-registered suppliers to the final packaging and testing, is meticulously controlled and documented. Our sterile compounding suites are designed to meet stringent ISO classifications, and our environmental monitoring program continuously verifies the aseptic conditions. Each batch of medication undergoes rigorous analytical testing to confirm identity, strength, purity, and sterility before it is released, providing healthcare professionals and their patients with unparalleled confidence in the medications they use.
We serve as a vital partner to the medical community in our immediate area. By providing a reliable source of high-quality, compounded medications for office use, we enable physicians, surgeons, and other healthcare providers to focus on patient care without concerns about drug shortages or the availability of specific formulations. Our team of experienced pharmacists and technicians is committed to excellence and reliability, ensuring timely delivery and consistent service for our clients at 2160 W State Road 434, Longwood, FL 32779.
For more information about our services or to discuss your specific needs, please contact us. You can reach our facility by phone at (407)993-1381 or visit our website at . Our team is ready to assist the healthcare providers we serve from our location.
FAQ
1. What does it mean that this facility is a 503B Compounding Pharmacy?
It means our facility at 2160 W State Road 434 is an FDA-registered outsourcing facility. We operate under stricter federal regulations (cGMP) than a traditional pharmacy, allowing us to compound larger batches of medications for office use by healthcare providers without needing patient-specific prescriptions.
2. Who can receive medications from your 503B Compounding Pharmacy?
Our medications are distributed to healthcare providers and facilities for office use. This includes hospitals, clinics, surgical centers, and other medical practices that utilize our medications for their patients within their practice setting at our location.
3. What kinds of medications does your Longwood facility compound?
As a 503B outsourcing facility, we specialize in compounding sterile preparations, including injectables, ophthalmics, and other formulations that are often in short supply or unavailable from conventional manufacturers, all produced at 2160 W State Road 434.
4. How does your 503B operation ensure medication safety and quality?
We adhere to rigorous FDA cGMP standards. This involves stringent environmental controls, validated processes, and comprehensive testing of every batch for sterility, potency, and purity before release from our facility at 2160 W State Road 434.
5. How can a healthcare provider at your location place an order?
Healthcare providers can contact our facility directly to discuss their needs and place orders. We can be reached by phone at (407)993-1381. Our team will provide information on available formulations and ordering procedures for our location.