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 compounding of sterile and non-sterile medications. Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, it prepares medications that are not commercially available, such as those with discontinued ingredients or specific dosage strengths required for individualized patient care. The 503B outsourcing facility provides these medications to healthcare providers for office use and for administration to patients within their care. The stringent cGMP standards govern every aspect of the operation, from environmental monitoring and personnel training to rigorous testing of components and finished preparations.
For healthcare providers and patients associated with 2160 W State Road 434, Longwood, FL 32779, this means access to a reliable source of high-quality compounded medications. The 503B outsourcing facility model is designed for efficiency and scale, enabling the provision of medications that are essential for various medical treatments and procedures. The commitment to compliance with federal regulations provides an added layer of confidence in the medications prepared at this location.
The team at 503B Compounding Pharmacy is comprised of skilled professionals dedicated to the science and safety of compounding. Their expertise, combined with state-of-the-art technology and controlled environments at 2160 W State Road 434, Longwood, FL 32779, forms the foundation of their operation. This dedication ensures that every preparation is consistent and meets its specified identity, strength, quality, and purity characteristics.
To learn more about the services provided by this 503B outsourcing facility, you can visit their website at or contact them directly by phone at (407)993-1381. 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.
FAQ
1. What does it mean that this is a 503B outsourcing facility?
It means this facility is registered with the FDA and operates under strict federal regulations known as current good manufacturing practices (cGMP). This is different from a traditional 503A pharmacy and involves larger-scale production of compounded medications under heightened quality control standards.
2. Who can order medications from 503B Compounding Pharmacy?
Medications are typically distributed to healthcare providers and practitioners for office use or administration to their patients. Healthcare providers can order from this facility located at 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does this 503B outsourcing facility prepare?
The 503B outsourcing facility prepares a range of sterile and non-sterile compounded medications that are not available commercially. This includes medications with specific strengths or formulations that have been discontinued by major manufacturers.
4. How does the 503B designation benefit patients?
The 503B designation and adherence to cGMP standards provide assurance of a consistently high level of quality, safety, and purity in the compounded medications prepared at 2160 W State Road 434, Longwood, FL 32779. This rigorous oversight helps ensure patient safety.
5. How can I get more information about your services?
For more detailed information, you can visit our website at or call us at (407)993-1381. We are located at 2160 W State Road 434, Longwood, FL 32779.