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, the 503B Compounding Pharmacy adheres to the most rigorous current good manufacturing practices (cGMP) to ensure the highest standards of quality, purity, and potency in every preparation. The facility specializes in the large-scale compounding of sterile and non-sterile medications that are distributed for office use by healthcare practitioners.
The core function of the 503B Compounding Pharmacy at 2160 W State Road 434 is to provide healthcare providers with access to a reliable supply of high-quality compounded medications. This enables physicians, surgeons, veterinarians, and other medical professionals in Longwood to administer necessary treatments directly to their patients without the burden of in-house compounding. The medications produced are essential for a wide range of applications, including office-based procedures, hospital antidote kits, hormone replacement therapy, and other specialized treatments that may be commercially unavailable.
As an outsourcing facility, the 503B Compounding Pharmacy undergoes regular and rigorous FDA inspections. This ensures that every process, from ingredient sourcing to sterile filtration and final packaging, meets the highest federal standards for safety and quality control. Patients and practitioners utilizing medications from this location can have absolute confidence in the integrity of every vial, capsule, and preparation that leaves the facility at 2160 W State Road 434.
The team at the Longwood facility comprises highly skilled pharmacists and technicians who are experts in advanced compounding techniques. Their dedication to precision and patient safety is the foundation of their operation. The 503B Compounding Pharmacy is committed to supporting the local medical community by providing a vital service that enhances patient care and treatment outcomes.
For more information or to speak with a representative, please contact 503B Compounding Pharmacy directly. You can reach the facility located at 2160 W State Road 434, Longwood, FL 32779 by phone at (407)993-1381 or visit their website at .
Frequently Asked Questions
What does it mean that this is a 503B outsourcing facility?
It means our facility at 2160 W State Road 434 is registered with the FDA and follows strict federal current good manufacturing practices (cGMP). This ensures a higher level of quality control and safety for the sterile and non-sterile medications we compound, compared to a traditional pharmacy.
Who can order medications from this 503B Compounding Pharmacy?
Our medications are distributed for office use by licensed healthcare practitioners. This includes physicians, surgeons, dentists, veterinarians, and other medical professionals who administer medications directly to their patients at their practice.
Can I as a patient pick up my prescription directly from your location?
No. As a 503B outsourcing facility, we do not typically dispense medications directly to individual patients. Your healthcare provider will order the medication from us for use within their practice during your appointment or procedure.
What kinds of medications does the 503B Compounding Pharmacy prepare?
We compound a wide array of medications that are often not commercially available, including sterile injectables, ophthalmics, hormone preparations, and topical pain creams. These are essential for various treatments provided by local healthcare providers.
How do I verify the quality and safety of your compounded preparations?
Our entire operation at 2160 W State Road 434 is built on compliance with FDA cGMP standards. We undergo regular FDA inspections, and our processes include rigorous testing and validation to ensure every preparation meets strict specifications for sterility, potency, and purity.