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 preparations (CSPs) and compounded non-sterile preparations for physician offices and healthcare facilities without patient-specific prescriptions. Our operations are distinct from traditional compounding pharmacies, focusing on supplying medications for office use to meet the needs of healthcare providers at our specific location.
The core function of 503B Compounding Pharmacy at 2160 W State Road 434 is the large-scale compounding of medications. This process is conducted under rigorous quality control measures that meet and often exceed FDA standards. Our state-of-the-art facility features advanced environmental controls, including ISO-classified cleanrooms, to ensure the sterility and potency of every preparation. Every batch we compound undergoes extensive testing and quality assurance review before it is released. Healthcare providers at our location can be confident that the medications they receive from 503B Compounding Pharmacy are produced with an unwavering focus on patient safety and therapeutic efficacy.
Healthcare professionals utilizing the services of 503B Compounding Pharmacy benefit from a reliable source of high-quality medications for office use. Our portfolio includes a range of essential preparations that are critical for various medical procedures and treatments administered within clinical settings. By partnering with us, providers at 2160 W State Road 434 can streamline their inventory management, reduce compounding burdens on their own staff, and mitigate the risks associated with in-office compounding. We serve as a vital support system for the local medical community, ensuring they have access to the necessary medications to provide optimal patient care.
Compliance and safety are the foundational principles of everything we do at 503B Compounding Pharmacy. Our facility is subject to regular and rigorous FDA inspections, and we adhere to current Good Manufacturing Practices (cGMP). This ensures a level of consistency, purity, and quality that is paramount for patient health. Our dedicated team of pharmacists, technicians, and quality assurance professionals works meticulously to uphold these standards with every batch produced. For healthcare providers at our location, this translates to absolute confidence in the medications they use in their practice.
Engaging with 503B Compounding Pharmacy is a straightforward process for healthcare providers at 2160 W State Road 434. We encourage you to explore our available formulations and services through our official website at https://503bcompoundingpharmacy.com/. For specific inquiries, to discuss your facility's needs, or to place an order, our knowledgeable team is available by phone at (407)993-1381. We are dedicated to supporting the local healthcare community with dependable, high-quality compounded medications from our facility at 2160 W State Road 434, Longwood, FL 32779.
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 in compliance with Section 503B of the FD&C Act. This requires us to adhere to strict current Good Manufacturing Practices (cGMP) and undergo regular FDA inspections to ensure the quality, safety, and sterility of our compounded medications for office use.
2. Can individuals get prescriptions filled at 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy does not compound patient-specific prescriptions. Our facility prepares large batches of medications for office use by healthcare providers. These medications are supplied to physician offices and healthcare facilities at 2160 W State Road 434 for use during procedures and treatments within their practice.
3. How does a healthcare provider at this location order from 503B Compounding Pharmacy?
Healthcare providers can place orders for compounded medications by contacting our facility directly at (407)993-1381. Our team will assist with the ordering process. Information about our available products can also be found on our website at https://503bcompoundingpharmacy.com/.
4. What kind of quality control measures are in place at your facility?
Our facility at 2160 W State Road 434 employs rigorous quality control, including environmental monitoring of our ISO-classified cleanrooms, validation of all compounding processes, and thorough testing of finished preparations. We operate under cGMP standards to ensure every batch meets stringent specifications for potency, purity, and sterility before being released.
5. Are the medications from 503B Compounding Pharmacy sterile?
Yes, our facility compounds both sterile and non-sterile preparations. All our compounded sterile preparations (CSPs) are produced in our state-of-the-art cleanrooms to ensure they are free from contaminants. We follow strict aseptic techniques and protocols to guarantee the sterility of these medications for the healthcare providers we serve.