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 sets this facility apart from traditional compounding pharmacies. Located at 2160 W State Road 434, Longwood, FL 32779, this 503B outsourcing facility adheres to the most rigorous current good manufacturing practices (cGMP) mandated by the FDA. This ensures that every preparation leaving the facility meets the highest standards of quality, purity, and potency for the patients and healthcare providers it serves.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) and non-sterile preparations without patient-specific prescriptions. These bulk medications are then distributed to healthcare facilities and practitioners for office use. This model is essential for hospitals, clinics, surgical centers, and other healthcare providers at 2160 W State Road 434, Longwood, FL 32779, ensuring they have immediate access to vital medications that may be in short supply, discontinued by manufacturers, or not commercially available in the required form or dosage.
By operating under Section 503B, this facility provides a layer of safety and reliability. Every batch of medication is produced in a controlled environment with stringent quality control testing, including sterility and endotoxin testing for injectables. Healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 can confidently utilize these medications, knowing they are sourced from an outsourcing facility that is subject to regular and unannounced FDA inspections. This process provides assurance that the medications meet the highest quality benchmarks.
The services provided by 503B Compounding Pharmacy are integral to the local healthcare infrastructure. The availability of compounded medications from this FDA-registered outsourcing facility supports practitioners in providing personalized and effective patient care. For more information on available preparations or to discuss the needs of your practice, you can contact 503B Compounding Pharmacy at their location: 2160 W State Road 434, Longwood, FL 32779. Reach out via their website at or by phone at (407)993-1381.
Frequently Asked Questions
What does it mean that this is a 503B outsourcing facility?
It means this facility is registered with the FDA and complies with strict federal standards for manufacturing, quality control, and testing. This is different from a traditional 503A pharmacy, as we produce medications in larger batches for healthcare providers to have on hand for office use.
Who can receive medications from this 503B Compounding Pharmacy?
Medications are distributed to healthcare practitioners and facilities for office use. This includes hospitals, clinics, and other medical practices that require access to bulk compounded preparations that are not patient-specific.
Can I as an individual patient pick up a prescription here?
No. As an FDA-registered 503B outsourcing facility, we do not fulfill individual patient prescriptions. We supply medications in bulk to licensed healthcare providers and facilities. Patients should contact their healthcare provider or a traditional compounding pharmacy for individual prescriptions.
What types of medications does this facility compound?
We compound both sterile and non-sterile preparations that are often in short supply or unavailable from commercial manufacturers. This includes various injectables, ophthalmics, and other formulations needed by healthcare providers at 2160 W State Road 434, Longwood, FL 32779.
How do I order compounded medications for my practice?
Healthcare providers and facilities can initiate an order or make an inquiry by contacting our facility directly. You can reach us at (407)993-1381 to speak with a representative about your specific needs and our available preparations.