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 at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act signifies a commitment to the highest standards of quality, safety, and compliance in pharmaceutical compounding. Unlike traditional compounding pharmacies, an outsourcing facility like 503B Compounding Pharmacy prepares large volumes of sterile and non-sterile compounded medications without patient-specific prescriptions, supplying these critical drugs to healthcare providers for office use.
The core function of 503B Compounding Pharmacy is the anticipatory compounding of medications. This process involves preparing medications in advance of receiving a prescription, based on the established needs of the medical practices it serves at 2160 W State Road 434, Longwood, FL 32779. This model is essential for healthcare providers who require immediate access to specific compounded preparations for procedures, treatments, or emergency kits. All products are created in a state-of-the-art facility adhering to rigorous Current Good Manufacturing Practices (cGMP), which are enforced by the FDA to ensure sterility, potency, and purity.
Healthcare professionals in Longwood can rely on 503B Compounding Pharmacy for a consistent supply of high-quality medications. The scope of services includes the compounding of sterile injectables, ophthalmics, and other dosage forms that are often in short supply from conventional manufacturers. By operating from its facility at 2160 W State Road 434, 503B Compounding Pharmacy provides a vital link in the local healthcare chain, ensuring that practitioners have the necessary tools to provide optimal patient care without the delays associated with traditional prescription fulfillment.
The operations at 2160 W State Road 434, Longwood, FL 32779 are defined by a culture of quality assurance. Every batch of medication is subjected to stringent testing and quality control protocols. This includes testing for sterility, endotoxins, potency, and stability. The facility undergoes regular FDA inspections to maintain its registered outsourcing facility status, providing an additional layer of trust and reliability for the healthcare providers it serves. This focus on uncompromising quality is the foundation of the service provided by 503B Compounding Pharmacy.
For healthcare providers seeking a dependable source for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents a partner in patient care. The facility is dedicated to supporting the local medical community with FDA-registered, cGMP-compliant pharmaceutical solutions. To learn more about its services or to discuss your practice's needs, you can contact 503B Compounding Pharmacy via their website at or by phone at (407)993-1381.
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. We comply with stricter Current Good Manufacturing Practices (cGMP) and are subject to regular FDA inspections, ensuring a higher level of quality control for our compounded medications compared to traditional pharmacies.
2. Can I, as an individual patient, get a prescription filled at 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy operates as an outsourcing facility that supplies compounded medications to healthcare providers for office use. Individual patients must have their prescriptions filled by a traditional pharmacy that dispenses based on a patient-specific prescription. Our services are exclusively for healthcare practitioners.
3. What types of medications does 503B Compounding Pharmacy prepare at its Longwood location?
At our facility on 2160 W State Road 434, we specialize in compounding sterile preparations, including injectables, ophthalmics, and other formulations that are often on drug shortage lists. These are prepared in batches for healthcare providers to have on hand for procedures and treatments in their practices.
4. How does the quality assurance process work at your facility?
Quality assurance is paramount. Every batch of medication compounded at 2160 W State Road 434, Longwood, FL 32779 undergoes rigorous testing for sterility, potency, and purity. Our processes are designed to meet or exceed FDA cGMP standards, and we maintain extensive documentation for every product we compound.
5. How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can initiate orders by contacting 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 to speak with a representative about your practice's specific needs and our available compounded preparations. Our website also provides information for prospective clients.