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. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, we adhere to rigorous federal standards for quality control, testing, and production, which are distinct from traditional compounding pharmacies. Our primary mission is to provide healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with access to high-quality, compounded medications that are essential for patient care but may be commercially unavailable or in shortage.
The operations at our location at 2160 W State Road 434, Longwood, FL 32779 are focused on producing medications in bulk for office use by healthcare practitioners. This means we supply medications directly to physicians, surgeons, veterinarians, and other healthcare professionals for administration to their patients within their practice settings. The 503B compounding pharmacy model ensures that every batch of medication produced is subject to stringent testing for potency, sterility, and endotoxins, providing an added layer of safety and reliability for practitioners at 2160 W State Road 434, Longwood, FL 32779.
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in sterile compounding. This includes the preparation of injectables, intravenous (IV) bags, ophthalmics, and other medications that must be free of microbial contamination. The cleanroom environment at our 503B compounding pharmacy is meticulously controlled and continuously monitored to meet the exacting standards required by the FDA for an outsourcing facility. This allows us to serve the specific and critical needs of local healthcare providers who require these sterile preparations for their procedures and treatments.
In addition to sterile preparations, the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 also compounds non-sterile medications. This includes topical creams, ointments, capsules, and oral suspensions. All products, whether sterile or non-sterile, are created following Current Good Manufacturing Practices (cGMP) as mandated for all 503B outsourcing facilities. This commitment to quality at every step of the process differentiates our services and provides assurance to the medical community we serve directly from 2160 W State Road 434, Longwood, FL 32779.
The 503B Compounding Pharmacy is a vital resource for mitigating drug shortages. When a commercially manufactured drug is on allocation or unavailable, healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can rely on our outsourcing facility to provide a compliant and quality-assured alternative. Our team of licensed pharmacists and trained technicians works diligently to ensure that the medications needed for patient care are accessible. For more information or to inquire about our services, please contact 503B Compounding Pharmacy at our facility: Website: | Phone: (407)993-1381.
FAQ
1. What does it mean that this is a 503B compounding pharmacy?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility that compounds medications in large volumes. We operate under stricter federal regulations than traditional compounding pharmacies, including compliance with Current Good Manufacturing Practices (cGMP) and mandatory testing of compounded batches for sterility, potency, and endotoxins.
2. Can I, as a patient, pick up my prescription directly from your location?
No. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 supplies medications for office use by healthcare practitioners. Patients receive their medications directly from their doctor, surgeon, or veterinarian, who orders and administers our compounded preparations within their practice.
3. What types of medications does this 503B compounding pharmacy produce?
Our facility at 2160 W State Road 434, Longwood, FL 32779 produces both sterile and non-sterile medications. Sterile preparations include injectables and IV bags, while non-sterile preparations include topical creams and oral suspensions. All are made for healthcare providers to use in their practice.
4. How does a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can initiate orders by contacting our 503B compounding pharmacy directly. They can reach our facility at 2160 W State Road 434, Longwood, FL 32779 by phone at (407)993-1381 to discuss their specific medication needs and our ordering process.
5. Why should a practitioner choose a 503B outsourcing facility?
Choosing our 503B compounding pharmacy at 2160 W State Road 434, Longwood, FL 32779 provides assurance of quality and compliance. Our FDA-registered status and adherence to cGMP standards mean practitioners receive medications that have undergone rigorous quality control testing, which is critical for patient safety and effective treatment outcomes.