Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
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.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
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 is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. As a 503B outsourcing facility, we produce large batches of compounded sterile and non-sterile preparations for office use by healthcare practitioners, without patient-specific prescriptions. Our operations are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations, ensuring that every preparation leaving our facility meets exacting standards for purity, potency, and sterility.
The services provided by 503B Compounding Pharmacy at our Longwood location are distinct from those of a traditional 503A compounding pharmacy. We serve healthcare providers by supplying them with essential medications for their practice needs. This includes providing medications for office administration, emergency kits, and surgical suites. By working directly with physicians and healthcare facilities, we ensure that medical professionals have immediate access to the critical medications they require to treat their patients effectively and without delay. Our role is to be a reliable, bulk manufacturing partner to the medical community.
Our state-of-the-art facility at 2160 W State Road 434 is designed to uphold the stringent cGMP standards mandated for a 503B outsourcing facility. This encompasses advanced environmental controls, validated sterilization processes, and robust quality control testing. Every batch of medication is meticulously prepared and tested to ensure it is free of contaminants and possesses the precise strength and composition intended. This level of quality assurance provides healthcare practitioners with the confidence that the medications they use in their practice are safe, effective, and of consistent high quality.
Healthcare providers in need of a trusted partner for compounded medications can connect with 503B Compounding Pharmacy directly. We encourage practitioners to discuss their specific office-use medication requirements with our team. For more detailed information about our capabilities and compliance, or to initiate an order, please visit our website at https://503bcompoundingpharmacy.com/ or contact our facility by phone at (407)993-1381. Our team is prepared to provide information and support to the medical community we serve from our location at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
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 adhere to current Good Manufacturing Practices (cGMP) and are subject to regular FDA inspections, which differentiates us from traditional compounding pharmacies and ensures a higher level of regulatory oversight for the bulk compounds we produce.
Who can purchase medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications exclusively to healthcare practitioners and facilities for office use. We do not dispense medications directly to individual patients based on a prescription. Healthcare providers can obtain our medications to administer to patients within their practice located near our facility at 2160 W State Road 434.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we specialize in compounding sterile injectables, ophthalmics, and other preparations in bulk quantities. These are intended for office use by physicians, such as for injections, infusions, or surgical procedures. The specific medications we compound are available for discussion with healthcare providers who contact us.
How does the quality control process work at your facility?
Our quality control process at 2160 W State Road 434 is comprehensive and mandated by cGMP regulations. It includes rigorous testing of raw materials, in-process testing, and finished preparation testing for sterility, potency, and endotoxins. This multi-layered approach guarantees the safety and efficacy of every batch we produce for the local medical community.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can place orders for office-use medications by contacting 503B Compounding Pharmacy directly. You can reach our team by calling (407)993-1381 or by visiting our website at https://503bcompoundingpharmacy.com/ to learn more about our services and initiate the process. All operations are conducted from our location at 2160 W State Road 434, Longwood, FL 32779.