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 at 2160 W State Road 434, Longwood, FL 32779
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 specifically designed and regulated to produce large volumes of compounded sterile and non-sterile medications without patient-specific prescriptions. This designation signifies our commitment to the highest standards of quality, safety, and consistency in pharmaceutical compounding. We serve healthcare providers and facilities by providing them with essential medications that are often in short supply or unavailable from conventional manufacturers.
The operations at our Longwood location are distinct from traditional compounding pharmacies. As a 503B outsourcing facility, we adhere to Current Good Manufacturing Practices (cGMP), which are the same rigorous quality standards required of major pharmaceutical manufacturers. This involves extensive environmental monitoring, stringent testing of raw materials and finished products, and comprehensive validation of all our processes and equipment. The medications produced at 2160 W State Road 434 are prepared for office use by healthcare practitioners, ensuring they have the necessary supplies to treat their patients effectively and without interruption.
Our services at this facility are critical for healthcare providers in the area who require access to reliable, high-quality compounded medications. We specialize in producing a range of preparations, including sterile injectables, ophthalmics, and other dosage forms that are essential for various medical treatments and procedures. By focusing on bulk compounding under Section 503B, we help alleviate drug shortages and provide a trusted source for medications that meet precise specifications. The team at 503B Compounding Pharmacy is dedicated to upholding the integrity of the pharmaceutical supply chain from our location at 2160 W State Road 434, Longwood, FL 32779.
For more information on our available formulations or to discuss your facility's needs, you can contact us directly. We provide our services exclusively from our FDA-registered outsourcing facility at this address.
Website: | Phone: (407)993-1381
Frequently Asked Questions
1. What does it mean that this facility is a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA under Section 503B. We compound large quantities of medications for office use by healthcare practitioners and must comply with stringent Current Good Manufacturing Practices (cGMP) for quality and safety.
2. Can I, as an individual patient, get a prescription filled at this location?
No. 503B Compounding Pharmacy at 2160 W State Road 434 operates as an outsourcing facility that provides medications in bulk for healthcare providers. Individual patients must have their prescriptions filled by a traditional pharmacy that compounds per patient-specific prescriptions.
3. What types of medications are compounded at your Longwood facility?
Our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile preparations, such as injectables, ophthalmics, and other formulations that are often on drug shortage lists, for use by local healthcare professionals in their practices.
4. How does the quality control at a 503B facility differ from a regular pharmacy?
As a 503B outsourcing facility, our location on W State Road 434 adheres to Current Good Manufacturing Practices (cGMP). This involves a higher level of environmental monitoring, sterility testing, and process validation than is required of a traditional compounding pharmacy, ensuring batch-level consistency and quality.
5. How can a healthcare facility or provider order from your pharmacy?
Healthcare providers and facilities can contact 503B Compounding Pharmacy directly to discuss their needs and place orders for office-use medications. All operations and distribution are conducted from our facility at 2160 W State Road 434, Longwood, FL 32779. Contact us at or by phone at (407)993-1381.