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 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 preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to current Good Manufacturing Practices (cGMP), which ensures a higher level of safety, quality, and consistency compared to traditional compounding. This regulatory framework allows 503B Compounding Pharmacy to provide medications in larger quantities for office use by healthcare practitioners and for specific patient populations without requiring patient-specific prescriptions for each unit.
The primary distinction of 503B Compounding Pharmacy is our focus on producing medications for healthcare providers with practices in and around Longwood. Physicians, veterinarians, hospitals, and clinics can utilize our services to obtain essential medications for their office stock. This enables practitioners at 2160 W State Road 434, Longwood, FL 32779 to have critical drugs readily available for immediate administration during procedures, emergencies, or for patients with urgent needs. By sourcing from an FDA-registered 503B outsourcing facility, healthcare providers can be assured of the quality and integrity of the medications they use in their practice.
503B Compounding Pharmacy specializes in the compounding of sterile injectable medications. This includes a wide range of solutions, suspensions, and other parenteral medications that are essential for various medical treatments. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is designed with controlled environments to prevent microbial contamination, ensuring every product meets stringent sterility standards. Beyond sterile compounds, 503B Compounding Pharmacy also provides non-sterile compounded preparations, catering to a broader spectrum of therapeutic needs for the local medical community.
Quality control is the cornerstone of our operations at 503B Compounding Pharmacy. Every batch of medication produced undergoes rigorous testing and validation processes. This includes sterility testing, endotoxin testing, and potency verification to guarantee that each product dispensed from our location is safe, potent, and pure. Our commitment to cGMP standards provides an additional layer of safety for patients and assurance for the healthcare professionals who rely on our products at 2160 W State Road 434, Longwood, FL 32779. The 503B model ensures transparency and accountability throughout the compounding process.
503B Compounding Pharmacy serves as a vital resource for the healthcare ecosystem at 2160 W State Road 434, Longwood, FL 32779. In times of drug shortages, which can critically impact patient care, our facility can compound essential medications that are otherwise unavailable from conventional manufacturers. This capability helps ensure continuity of care for patients in the local area. Healthcare providers can confidently partner with 503B Compounding Pharmacy to meet their medication needs, knowing they are working with a compliant, reliable, and quality-focused outsourcing facility dedicated to supporting the local medical community.
Frequently Asked Questions
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 the U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. This requires us to comply with current Good Manufacturing Practices (cGMP), which are rigorous standards for quality control, testing, and production that provide a higher level of assurance regarding the safety and quality of the medications we compound.
2. Can I, as an individual patient, get a prescription filled directly at 503B Compounding Pharmacy?
503B Compounding Pharmacy primarily supplies medications in bulk for "office use" by healthcare practitioners. While we compound medications for patient use, they are typically ordered by a physician, hospital, or clinic from our location at 2160 W State Road 434, Longwood, FL 32779 to be administered within their practice. Patients should consult their healthcare provider about medications compounded for them.
3. What kinds of medications does 503B Compounding Pharmacy produce?
503B Compounding Pharmacy specializes in compounding sterile injectable medications, such as IV bags, injections, and ophthalmics, which are essential for hospitals and clinics. We also compound non-sterile medications. All preparations are made at our facility located at 2160 W State Road 434, Longwood, FL 32779 following strict quality protocols.
4. How does 503B Compounding Pharmacy help during drug shortages?
When commercially manufactured drugs are in short supply, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 can compound those critical medications. This helps ensure that healthcare providers in the area have access to necessary treatments for their patients, thereby preventing interruptions in care caused by national drug shortages.
5. How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from 503B Compounding Pharmacy?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their medication needs. You can reach us by phone at (407)993-1381 to speak with a representative about our available compounds, ordering process, and how we can support your practice from our location at 2160 W State Road 434, Longwood, FL 32779.