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 central to the identity and operations of the facility located at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, this pharmacy adheres to rigorous federal standards for quality, safety, and production, which are distinct from those of a traditional 503A compounding pharmacy. The primary function of this facility is the large-scale, non-patient-specific compounding of sterile and non-sterile medications that are distributed to healthcare providers for office use.
The services provided at 2160 W State Road 434, Longwood, FL 32779 are defined by its 503B status. This includes the compounding of injectable medications, ophthalmics, and other sterile preparations that are essential for hospitals, clinics, and surgical centers. The facility is equipped with state-of-the-art cleanrooms that meet or exceed ISO classifications to ensure every preparation is free from contaminants. All processes are governed by strict current Good Manufacturing Practices (cGMP), which mandate stringent quality control testing, environmental monitoring, and validation of all equipment and processes. This ensures that every batch of medication produced is of consistent strength, quality, and purity.
For healthcare professionals in need of office-stock medications, the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 provides a critical service. The facility can compound medications that may be in short supply or discontinued by major manufacturers, helping to alleviate drug shortages that impact patient care. By providing these essential medications, the pharmacy supports the local medical community in delivering efficient and effective treatments to their patients. The team at this location comprises qualified pharmacists and technicians who are experts in aseptic technique and quality assurance.
Engaging with the 503B Compounding Pharmacy is a process initiated by healthcare providers. The facility does not dispense medications directly to individual patients based on a prescription. Instead, a healthcare provider's office would order the necessary compounded medications for their practice. The team works directly with these practices to understand their needs and provide compliant, high-quality pharmaceutical solutions. The location at 2160 W State Road 434, Longwood, FL 32779 is the center for all production, quality control, and distribution activities.
To learn more about the specific services available or to initiate an order, healthcare providers can contact the facility directly. The website at provides detailed information, and the team can be reached by phone at (407)993-1381 to discuss specific compounding needs and requirements.
FAQ
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility is an FDA-registered outsourcing facility that compounds large batches of sterile medications without patient-specific prescriptions. It operates under stricter federal cGMP standards compared to traditional pharmacies, focusing on supplying healthcare facilities at 2160 W State Road 434, Longwood, FL 32779.
2. Can I, as an individual patient, get a prescription filled at this location?
No. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 does not dispense medications directly to individual patients. Its services are exclusively for healthcare providers who order medications for office use.
3. What types of medications does this 503B facility compound?
The facility specializes in compounding sterile preparations, including injectables, IV bags, and ophthalmics. These are produced for healthcare providers to have on hand for procedures and treatments at their practices associated with 2160 W State Road 434, Longwood, FL 32779.
4. How does the quality control process work at this location?
Quality control is paramount. The facility at 2160 W State Road 434, Longwood, FL 32779 follows current Good Manufacturing Practices (cGMP), which includes rigorous testing of raw materials, in-process testing, sterility testing, and endotoxin testing on finished products to ensure safety and potency.
5. How can my medical practice place an order with this 503B pharmacy?
Healthcare providers can contact the facility directly to establish an account and place orders. You can reach the team by phone at (407)993-1381 or visit the website at for more information on the ordering process from 2160 W State Road 434, Longwood, FL 32779.