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 safe and precise preparation of compounded medications. As a 503B outsourcing facility, we adhere to the highest current good manufacturing practices (cGMP), ensuring that every preparation meets rigorous standards for sterility, potency, and purity. This designation distinguishes our operations from traditional compounding pharmacies, providing a critical service for healthcare providers seeking bulk, office-use medications without patient-specific prescriptions.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for office use by healthcare practitioners. Our services at 2160 W State Road 434, Longwood, FL 32779 are essential for clinics, hospitals, and surgical centers that require readily available, high-quality medications for procedures and treatments. We provide a vital supply of medications that may be on shortage from conventional manufacturers or that require a specific formulation not commercially available. The 503B Compounding Pharmacy team is comprised of skilled pharmacists and technicians who utilize advanced technology and stringent quality control protocols to ensure every vial, syringe, and bag is prepared with the utmost accuracy and care.
Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 and the immediate vicinity rely on 503B Compounding Pharmacy for a consistent and reliable source of essential medications. Our portfolio includes a wide array of sterile preparations, such as injectables, infusions, ophthalmics, and other critical care solutions. By partnering with 503B Compounding Pharmacy, medical professionals can enhance patient safety, streamline their inventory management, and ensure they have the necessary medications on hand for a variety of treatment scenarios. Our commitment is to support the local medical community with uncompromising quality and dependable service.
For more information on how 503B Compounding Pharmacy can serve your practice, please visit our website at or contact us directly at (407)993-1381. Our team is ready to discuss your specific needs and how our FDA-registered outsourcing facility can provide the compounded sterile preparations required at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
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 complies with strict federal standards for compounding, including current good manufacturing practices (cGMP). This ensures the medications we produce for office use meet heightened requirements for sterility, safety, and quality.
2. Can I, as an individual patient, get a prescription filled at 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy prepares medications in bulk for office use by healthcare providers. We do not compound patient-specific prescriptions. Individual patients should contact a traditional 503A compounding pharmacy for their personal medication needs.
3. What types of medications does 503B Compounding Pharmacy provide?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in producing a broad range of sterile compounded preparations, including injectables, intravenous (IV) bags, ophthalmics, and other solutions used by healthcare professionals in clinical and surgical settings.
4. Who is authorized to order from 503B Compounding Pharmacy?
Orders are accepted from licensed healthcare providers and facilities, such as physicians, surgeons, hospitals, and clinics. These medications are intended for administration to patients within the purchasing provider's practice or facility and not for resale.
5. How can I place an order for my practice at 2160 W State Road 434?
Healthcare providers can place orders by calling 503B Compounding Pharmacy directly at (407)993-1381. Our team will guide you through the ordering process, discuss your specific requirements, and provide information on availability and delivery.