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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, our facility is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, providing healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with access to critical medications that may be in short supply or unavailable from traditional manufacturers.
The core function of 503B Compounding Pharmacy is to produce compounded medications without receiving patient-specific prescriptions. Our operations are conducted under current Good Manufacturing Practices (cGMP), which are rigorous FDA-enforced standards for drug manufacturing. This ensures that every batch of medication produced at our facility at 2160 W State Road 434, Longwood, FL 32779 meets stringent requirements for potency, purity, and sterility. Healthcare professionals can confidently utilize our services, knowing the medications are prepared in a highly controlled and monitored environment.
Our services are essential for hospitals, clinics, and other healthcare providers at 2160 W State Road 434, Longwood, FL 32779. We specialize in compounding preparations that are on the FDA drug shortage list, ensuring patient care is not interrupted. The 503B Compounding Pharmacy team is comprised of skilled pharmacists and technicians who utilize state-of-the-art technology and equipment to compound a wide range of preparations, including sterile injectables, ophthalmics, and other dosage forms required by the medical community we serve.
By operating as a 503B outsourcing facility, 503B Compounding Pharmacy provides a vital link in the healthcare supply chain for practitioners at 2160 W State Road 434, Longwood, FL 32779. We offer a reliable alternative to conventional drug manufacturers, particularly for essential medications that are vulnerable to shortages. Our commitment is to maintain a consistent supply of high-quality, compounded medications to support the important work of local healthcare providers and ensure positive patient outcomes.
For more information about the services provided by 503B Compounding Pharmacy, please visit our website at or contact us directly by phone at (407)993-1381. Our facility at 2160 W State Road 434, Longwood, FL 32779 is focused on supporting the specific needs of the healthcare community through compliant and reliable compounding practices.
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 the U.S. Food and Drug Administration and complies with Section 503B of the Federal Food, Drug, and Cosmetic Act. We operate under current Good Manufacturing Practices (cGMP), which are the strict quality standards required for drug manufacturers, ensuring the highest level of quality and safety for the medications we compound.
2. Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications to healthcare facilities and practitioners, such as hospitals, clinics, and surgical centers, that are located at 2160 W State Road 434, Longwood, FL 32779. We do not accept orders directly from individual patients, as we compound medications in larger batches for office use by healthcare providers.
3. What types of medications does 503B Compounding Pharmacy produce?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile preparations, including injectables, IV bags, and ophthalmics. We focus on producing medications that are currently on the FDA’s drug shortage list or are otherwise not readily available from standard pharmaceutical manufacturers for the healthcare providers we serve.
4. How does 503B Compounding Pharmacy ensure medication safety and quality?
Safety and quality are paramount at our location. 503B Compounding Pharmacy adheres to rigorous cGMP standards, which include extensive testing of components, in-process testing, and finished product testing. Our sterile compounding is performed in ISO-classified cleanrooms by highly trained staff to ensure every batch meets strict sterility and potency specifications.
5. How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers interested in our services can contact 503B Compounding Pharmacy directly by calling (407)993-1381. Our team will provide information on our current product availability, ordering process, and how we can support the specific medication needs of your practice at 2160 W State Road 434, Longwood, FL 32779.