Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
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.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation means we adhere to the highest current good manufacturing practices (cGMP), providing healthcare practitioners and patients with medications that meet rigorous standards for quality, safety, and potency. We serve a critical role in the healthcare ecosystem by preparing medications that are not commercially available, helping to address drug shortages, and creating specific formulations prescribed by healthcare providers for their patients.
The operations at our Longwood location are fundamentally different from a traditional compounding pharmacy. As a 503B outsourcing facility, our processes are industrialized and scalable, subject to FDA oversight and inspection. This allows us to produce larger batches of medications for office use, which are then dispensed by physicians, surgeons, and other healthcare providers directly to patients within their practice settings. Our work supports local clinics, hospitals, and specialist offices by providing them with reliable, high-quality compounded preparations that are essential for patient care.
Our core services at 2160 W State Road 434, Longwood, FL 32779 include the compounding of sterile injectables, ophthalmics, and other dosage forms. We utilize state-of-the-art technology and controlled environments to ensure every product is free from contaminants. The team at 503B Compounding Pharmacy comprises skilled pharmacists and technicians who are experts in the science of compounding, working diligently to fulfill the specific needs of the medical community. We are committed to excellence, from the sourcing of pure ingredients to the final testing and release of each batch.
For healthcare providers seeking a trusted partner for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents a commitment to uncompromising quality and regulatory compliance. We invite you to learn more about our services and how we can support your practice. You can reach us by phone at (407)993-1381 or visit our website to discover more: https://503bcompoundingpharmacy.com/.
FAQ
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with and inspected by the U.S. Food and Drug Administration (FDA) under Section 503B of the FD&C Act. We operate under strict current good manufacturing practices (cGMP), which are more rigorous standards than those applied to traditional compounding pharmacies, ensuring the highest levels of quality, sterility, and safety for the medications we compound.
2. Can I, as a patient, pick up my prescription directly from your location?
No. 503B Compounding Pharmacy primarily supplies medications for office use by healthcare providers. The medications we produce are typically dispensed by your physician, surgeon, or clinic directly to you during your appointment. You should receive your compounded medication from your healthcare provider, not directly from our facility at 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does 503B Compounding Pharmacy produce?
Our facility specializes in the large-scale compounding of sterile preparations, such as injectables, ophthalmics, and other formulations. We produce these medications in batches for healthcare providers to have on hand for patient procedures and treatments. We focus on drugs that are on shortage or are not available from commercial manufacturers.
4. How do I place an order with 503B Compounding Pharmacy?
Orders are placed directly by healthcare providers or their authorized staff. If you are a healthcare provider interested in utilizing our services for your practice, you can initiate the process by contacting our facility at 2160 W State Road 434, Longwood, FL 32779 by phone at (407)993-1381 or through the professional channels outlined on our website.
5. Why would a healthcare provider use a 503B outsourcing facility instead of a traditional pharmacy?
Healthcare providers choose 503B Compounding Pharmacy for the assurance of FDA oversight and cGMP compliance. This provides a higher level of confidence in the sterility, potency, and quality of the medications they use in their practice. Our large-scale batch compounding is also efficient for practices that require consistent supply of specific medications for office-based procedures.