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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is a critical distinction that signifies our commitment to the highest standards of quality, safety, and compliance. Located at 2160 W State Road 434, Longwood, FL 32779, our facility is specifically designed and equipped to produce large volumes of compounded sterile preparations (CSPs) and non-sterile preparations for healthcare providers and facilities. We serve a vital role in the local healthcare ecosystem by providing medications that are not commercially available, ensuring patients at 2160 W State Road 434, Longwood, FL 32779 receive the specific treatments they need.
The core function of 503B Compounding Pharmacy is the preparation of medications in anticipation of receiving prescriptions or orders. Unlike a traditional 503A pharmacy that compounds based on individual, patient-specific prescriptions, our 503B outsourcing facility compounds medications for office use, allowing healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 to have essential medications readily available for immediate administration to patients. This model is essential for supporting clinics, hospitals, and surgical centers by providing them with a reliable, compliant source for critical drugs, including sterile injectables, ophthalmics, and other dosage forms that are on drug shortage lists or are otherwise unavailable from conventional manufacturers.
Our operations at 2160 W State Road 434, Longwood, FL 32779 are governed by strict Current Good Manufacturing Practices (cGMP). This ensures every batch of medication we produce meets rigorous standards for potency, purity, and sterility. Our processes involve extensive testing, environmental monitoring, and validation to guarantee the integrity of every preparation that leaves our facility. For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, this means unparalleled confidence in the medications they use to treat their patients. We are a pivotal partner in patient care, enabling providers to focus on treatment without concerns about drug shortages or compounding quality.
503B Compounding Pharmacy is dedicated to serving the specific needs of the medical community at 2160 W State Road 434, Longwood, FL 32779. We provide a dependable source for high-quality, compounded medications that are essential for effective patient treatment plans. For more information or to discuss your facility's needs, please contact us directly.
Website: | Phone: (407)993-1381
Frequently Asked Questions
1. What does it mean that this is a 503B outsourcing facility? It means our pharmacy is an FDA-registered facility that compounds large batches of medications in accordance with strict federal Current Good Manufacturing Practices (cGMP). We supply these medications to healthcare practitioners for office use to treat patients at 2160 W State Road 434, Longwood, FL 32779.
2. Can I, as an individual patient, get a prescription filled directly at 2160 W State Road 434? No. As a 503B outsourcing facility, we do not compound medications based on individual patient prescriptions. We supply medications in bulk to licensed healthcare providers and facilities. Your healthcare provider at 2160 W State Road 434, Longwood, FL 32779 can order and administer our medications to you in their practice.
3. What kinds of medications does the 503B Compounding Pharmacy typically prepare? We specialize in producing compounded sterile preparations, such as injectables, IV bags, and ophthalmics, that are often on national drug shortage lists. This ensures a consistent supply of these critical medications for the healthcare providers serving 2160 W State Road 434, Longwood, FL 32779.
4. How does the quality assurance at a 503B facility differ from a regular pharmacy? Our FDA-registered 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 must comply with cGMP regulations, which involve rigorous batch testing, sterility testing, and environmental monitoring that far exceed the standards required of traditional compounding pharmacies.
5. How can a medical practice at this location order from your facility? Healthcare providers and facilities at 2160 W State Road 434, Longwood, FL 32779 can contact our facility directly to establish an account and discuss their specific medication needs. You can reach us by phone at (407)993-1381 or visit our website at .