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 standards of quality control, sterility, and testing, which are mandated by federal law. This ensures that healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can confidently prescribe and that patients can reliably receive medications that meet rigorous safety and potency specifications.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for office use. This means we supply medications in bulk to physicians, hospitals, clinics, and other healthcare entities for administration to patients within their practice at 2160 W State Road 434, Longwood, FL 32779. This model is essential for healthcare providers who require immediate access to specific, ready-to-administer medications that are not commercially available or are in short supply. By providing these vital medications, 503B Compounding Pharmacy supports the local medical community in delivering efficient and effective patient care directly from their offices.
Our operations at 2160 W State Road 434, Longwood, FL 32779 are fundamentally different from a traditional retail pharmacy. We do not fulfill individual patient prescriptions that are brought in from the community. Instead, our focus is on producing batches of medications based on the orders from licensed healthcare practitioners and facilities. This distinction is critical, as it allows our 503B compounding pharmacy to specialize in manufacturing-level quality and scale, providing a critical supply chain component for the healthcare providers operating at 2160 W State Road 434, Longwood, FL 32779.
The processes at 503B Compounding Pharmacy are designed to ensure the integrity of every preparation. This includes stringent environmental controls, validated sterility testing, and stability studies. Every batch produced at our facility on W State Road 434 is subject to these rigorous protocols, providing an additional layer of safety and assurance beyond traditional compounding. For healthcare professionals at 2160 W State Road 434, Longwood, FL 32779, this means access to a trusted source for essential medications, from injectables and ophthalmics to other sterile preparations required for their practice.
503B Compounding Pharmacy is committed to serving the specific needs of the healthcare community at 2160 W State Road 434, Longwood, FL 32779. We provide a reliable and compliant source for high-quality compounded medications, enabling local practitioners to enhance their patient services. For more information on how our 503B outsourcing facility can support your practice, please contact us directly.
Website:
Phone: (407)993-1381
Frequently Asked Questions for 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
1. What does it mean that this is a 503B compounding pharmacy?
It means our facility is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. This registration requires us to comply with Current Good Manufacturing Practice (CGMP) regulations, which include rigorous testing for sterility, stability, and potency. This is different from a traditional 503A pharmacy.
2. Can I, as an individual patient, bring my prescription to 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy does not accept individual patient prescriptions. We supply compounded medications in bulk for office use exclusively to licensed healthcare practitioners and facilities. Patients should have their prescribing provider contact us directly.
3. What types of medications does 503B Compounding Pharmacy provide to practices at this location?
We specialize in producing compounded sterile preparations (CSPs), which can include various injectables, ophthalmics, and other sterile solutions. These are provided to healthcare entities at 2160 W State Road 434, Longwood, FL 32779 for administration within their practice.
4. How does a healthcare provider at this address place an order with your 503B compounding pharmacy?
Licensed healthcare providers and facilities can place orders directly with our facility by calling (407)993-1381. Our team will work with you to process your order for office-use medications.
5. Why should a healthcare provider at 2160 W State Road 434 choose a 503B outsourcing facility?
Choosing an FDA-registered 503B outsourcing facility ensures that the medications you use in your practice are produced under the highest federally mandated quality and safety standards. This provides critical assurance regarding sterility, potency, and purity for the medications you administer to your patients.