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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is central to the mission of providing high-quality compounded medications for office use by healthcare practitioners. Located at 2160 W State Road 434, Longwood, FL 32779, this facility adheres to the most rigorous federal standards for sterility, quality, and safety, ensuring that every preparation meets exacting specifications.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) that are not available commercially. These medications are essential for physicians, surgeons, veterinarians, and other healthcare providers who require specific formulations for their patients. By operating under Section 503B, the pharmacy is exempt from the new drug approval requirements but is subject to current good manufacturing practice (cGMP) regulations, which are the same standards followed by major pharmaceutical manufacturers. This guarantees a level of consistency and reliability that is paramount for patient care.
Healthcare professionals who source their medications from 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 can be confident in the integrity of their supply. The facility's processes are designed for efficiency and scale, allowing for the provision of essential medications in the quantities needed for clinical practice. The team of highly trained pharmacists and technicians utilizes state-of-the-art technology within a controlled environment to compound a wide array of injectable, ophthalmic, and other sterile preparations.
Choosing a 503B outsourcing facility like 503B Compounding Pharmacy offers significant advantages. It mitigates the risks associated with smaller-scale compounding by enforcing stringent quality control measures at every step, from sourcing raw materials to final product testing. This commitment to excellence ensures that every vial, syringe, or bag dispensed is pure, potent, and sterile. For healthcare providers at clinics, hospitals, and surgical centers, partnering with this local facility means accessing a trusted and compliant source for critical medications.
To learn more about the services and products available, or to discuss your specific needs, you can contact 503B Compounding Pharmacy directly. The team is ready to provide information and support to the medical community. Visit the website at https://503bcompoundingpharmacy.com/ or call the facility at (407)993-1381.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and compounds medications in large volumes for office use by healthcare practitioners. It operates under strict federal current good manufacturing practices (cGMP) for quality and safety.
2. Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications for office use to licensed healthcare professionals, including physicians, surgeons, and veterinarians. Medications are not dispensed directly to individual patients from this location at 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does 503B Compounding Pharmacy prepare?
The facility specializes in compounding sterile preparations (CSPs), which are typically injectable, ophthalmic, and other medications that must be prepared in an aseptic environment to ensure they are free of contaminants.
4. How does the quality assurance process work at this facility?
As a 503B outsourcing facility, it follows rigorous cGMP protocols. This includes testing raw materials, validating processes, conducting environmental monitoring, and performing sterility and potency testing on finished products to ensure the highest quality and safety standards.
5. How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can initiate an order or inquire about available formulations by contacting the facility directly. You can reach the team by phone at (407)993-1381 or find more information on the official website at https://503bcompoundingpharmacy.com/.