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 specific 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 Compounding Pharmacy 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 sterility. The primary function of this 503B Compounding Pharmacy is the large-scale production of compounded medications for office use, which are then distributed to healthcare practitioners for patient administration within clinical settings.
The services provided at 2160 W State Road 434, Longwood, FL 32779 are exclusively focused on the core function of an outsourcing facility. This 503B Compounding Pharmacy does not typically serve individual walk-in patients seeking a prescription fulfillment. Instead, it partners with physicians, surgeons, veterinarians, hospitals, and clinics in the area. The 503B Compounding Pharmacy at this location provides these healthcare providers with access to a consistent and reliable supply of high-quality compounded sterile preparations (CSPs) and non-sterile preparations that are often unavailable from conventional pharmaceutical manufacturers. This includes essential medications like sterile injectables, ophthalmics, and other formulations necessary for specific medical procedures and treatments.
By operating under Section 503B, this facility is subject to federal oversight, including routine FDA inspections. This provides an additional layer of safety and assurance for the medical community that relies on its products. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by highly trained pharmacists and technicians who specialize in advanced compounding techniques. The commitment of this 503B Compounding Pharmacy is to support local healthcare delivery by ensuring that practitioners have the necessary, quality-assured medications to provide optimal care to their patients.
For more information about the services provided by this 503B Compounding Pharmacy, you can visit their website at or contact them directly by phone at (407)993-1381. The team at 2160 W State Road 434, Longwood, FL 32779 is available to answer questions from healthcare entities regarding their 503B compounding capabilities and processes.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this is a 503B Compounding Pharmacy?
This 503B Compounding Pharmacy is an FDA-registered outsourcing facility. This federal designation means we operate under stricter production standards (cGMP) than a traditional pharmacy, and we primarily compound medications in larger batches for healthcare providers to keep in their offices for patient use.
2. Can I, as an individual patient, come to 2160 W State Road 434 to get a prescription filled?
No. The 503B Compounding Pharmacy at this location provides medications for office use by healthcare professionals. Individual patients should contact a traditional compounding pharmacy or their healthcare provider for prescriptions intended for personal use.
3. What types of healthcare providers does this 503B Compounding Pharmacy serve?
We serve physicians, surgeons, dermatologists, ophthalmologists, veterinarians, hospitals, and clinics that require reliable, high-quality compounded medications for use in their practice at 2160 W State Road 434, Longwood, FL 32779.
4. What are the benefits of using a 503B Compounding Pharmacy for a medical practice?
Practices benefit from access to FDA-regulated, quality-assured medications that are often not commercially available. This ensures a consistent supply of sterile and non-sterile preparations, reducing the compounding burden on the practice itself and enhancing patient safety.
5. How can a medical practice at 2160 W State Road 434 order from your 503B Compounding Pharmacy?
Healthcare providers and their authorized staff can contact our 503B Compounding Pharmacy directly at (407)993-1381 to establish an account, discuss specific medication needs, and place orders for office-use compounded preparations.