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 from its location at 2160 W State Road 434, Longwood, FL 32779. Operating in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act, this 503B outsourcing facility distinguishes itself through its commitment to producing large-scale compounded medications. The 503B designation signifies adherence to the highest current good manufacturing practices (cGMP), ensuring that every batch of medication produced meets rigorous standards for sterility, potency, and purity. This is fundamentally different from a traditional 503A compounding pharmacy, as the 503B model is designed for bulk production without patient-specific prescriptions, supplying crucial medications to healthcare providers and facilities.
The core service of 503B Compounding Pharmacy at 2160 W State Road 434 is the production of sterile and non-sterile compounded medications in large volumes. This includes a significant focus on injectable medications, which are essential for hospitals, surgical centers, clinics, and other healthcare providers in need of a reliable, quality-assured supply. By functioning as a 503B outsourcing facility, the pharmacy provides these entities with access to medications that may be in short supply or unavailable from conventional pharmaceutical manufacturers. Every product from this 503B Compounding Pharmacy is created under a stringent quality control environment, which is routinely inspected by the FDA to verify ongoing compliance with all federal regulations.
For healthcare professionals seeking a trusted partner for compounded pharmaceutical needs, 503B Compounding Pharmacy offers a critical service. The team at the Longwood location is dedicated to upholding the integrity of the 503B standards, providing consistent, high-quality medications that healthcare providers can administer with confidence. The facility's operations are a direct response to drug shortages and specific clinical needs, ensuring patient care is not interrupted. Engaging with this 503B outsourcing facility means partnering with a provider that prioritizes safety, regulatory compliance, and reliability above all else.
To learn more about the services provided or to discuss your facility's needs, you can contact 503B Compounding Pharmacy directly. The team is available to answer questions and provide detailed information about their capabilities as an FDA-registered 503B outsourcing facility.
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
Address: 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. This requires us to comply with strict current good manufacturing practices (cGMP) for pharmaceuticals, which includes rigorous testing for sterility, potency, and purity on every batch of medication we compound.
Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides compounded medications to healthcare professionals and facilities, such as hospitals, clinics, and surgical centers. We do not compound medications for individual patients based on a prescription; instead, we supply medications in bulk for office use by healthcare providers at their practice location.
What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we specialize in compounding large batches of both sterile and non-sterile medications. This includes a significant number of injectable medications that are often on drug shortage lists, providing a critical supply chain solution for healthcare providers at 2160 W State Road 434, Longwood, FL 32779.
How does the quality assurance process work at your facility?
Our quality assurance process is comprehensive and mandated by federal law. It involves environmental monitoring, validated processes, and extensive testing of raw materials and finished products. Every batch is tested to ensure it meets its specified identity, strength, quality, and purity characteristics before it is released from our facility.
How can a healthcare facility place an order with 503B Compounding Pharmacy?
Healthcare facilities interested in our services can contact us directly to establish a relationship. You can reach our team at 2160 W State Road 434, Longwood, FL 32779 by calling (407)993-1381 or by visiting our website at https://503bcompoundingpharmacy.com/ to initiate a conversation about your specific medication needs.