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 Compounding Pharmacy adheres to the highest standards of pharmaceutical compounding, following Current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving the facility meets stringent quality control and testing protocols for sterility, potency, and purity.
The services provided at 2160 W State Road 434, Longwood, FL 32779 are focused on the large-scale production of compounded sterile preparations (CSPs) for office use. This 503B Compounding Pharmacy primarily serves healthcare providers and facilities, supplying them with essential medications that are often in shortage or not commercially available. The team of highly trained pharmacists and technicians at this location utilizes state-of-the-art technology and cleanroom environments to compound a range of preparations, including hormone replacement therapy (HRT), ophthalmic solutions, injectable medications, and other sterile products.
By operating under Section 503B, this facility provides healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 with a reliable and compliant source for critical medications. This allows physicians and clinics to focus on patient care with the confidence that the medications they administer are produced under the most rigorous quality and safety standards. The 503B Compounding Pharmacy model is designed to enhance patient safety and support the local medical community with consistent, high-quality pharmaceutical products.
For more information about the services available from this specific 503B Compounding Pharmacy, you can visit their website at or contact them directly by phone at (407)993-1381. The dedicated staff is available to assist healthcare providers with their compounding needs.
Frequently Asked Questions
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility that compounds large volumes of sterile medications for office use. It operates under stricter federal regulations, including Current Good Manufacturing Practices (cGMP), which require rigorous testing for sterility, potency, and purity.
2. Who can order from this 503B Compounding Pharmacy?
This 503B Compounding Pharmacy primarily serves healthcare providers, physicians, and medical facilities. Medications are compounded for office use and are not typically dispensed directly to individual patients without a prescription from their provider.
3. What types of medications does this location compound?
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 specializes in compounded sterile preparations (CSPs). This includes injectables, hormone replacement therapies, ophthalmic solutions, and other medications that are often on national drug shortage lists.
4. How does the quality control process work at this facility?
As an FDA-registered 503B outsourcing facility, this location follows mandatory cGMP guidelines. Every batch of medication undergoes extensive quality control testing, including sterility testing, endotoxin testing, and potency analysis, to ensure the highest level of patient safety.
5. How can a healthcare provider place an order?
Healthcare providers interested in the services of this 503B Compounding Pharmacy can initiate the process by calling (407)993-1381. The staff will provide information on ordering protocols, available formulations, and how to establish an account.