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 at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of quality control, undergoing rigorous FDA inspections to ensure the safety, potency, and purity of every preparation that leaves our pharmacy. This distinguishes our services from traditional compounding, providing healthcare providers and patients at our location with medications that meet specific, bulk-level needs without the necessity of patient-specific prescriptions.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded drugs for office use. This means physicians, surgeons, veterinarians, and other healthcare practitioners practicing in and around our facility at 2160 W State Road 434 can maintain an inventory of essential medications for immediate administration to their patients. Our operations are designed to support the local medical community by providing a reliable, compliant source for high-quality medications that are often in short supply or unavailable from conventional manufacturers. By serving this critical need, we enable smoother clinical operations and enhanced patient care directly from our Longwood location.
Our state-of-the-art facility at 2160 W State Road 434 is equipped with advanced environmental controls and technology to ensure the integrity of our sterile compounding processes. We specialize in a range of preparations, including injectables, ophthalmics, and other dosage forms required for hospital, clinic, and office settings. Every batch is produced by our highly trained staff under exacting quality assurance protocols, which include stringent testing and documentation. For healthcare providers at our location, this translates to confidence and trust in the medications they use daily in their practice.
Engaging with 503B Compounding Pharmacy is a streamlined process for local medical professionals. Orders are managed through our dedicated channels, ensuring efficient fulfillment and delivery. We prioritize clear communication and reliability, understanding that the medications we provide are essential for patient treatments and procedures happening in our community. Our team is committed to supporting the specific needs of the healthcare providers we serve from our facility at 2160 W State Road 434, Longwood, FL 32779.
To learn more about our services or to initiate an order, please contact 503B Compounding Pharmacy directly. Our team is ready to provide detailed information and support. You can reach us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for further details.
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 strict federal standards for compounding medications in bulk. We operate under Section 503B of the FD&C Act, which requires adherence to Current Good Manufacturing Practices (cGMP) for higher-volume production, rigorous testing, and routine FDA inspections to ensure drug quality and safety.
2. As a healthcare provider at your location, how do I order medications from your pharmacy?
Healthcare providers can place orders for office-use compounded medications by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will guide you through the ordering process, which is designed for efficiency and compliance, ensuring you receive the medications needed for your practice at 2160 W State Road 434.
3. What types of compounded medications do you provide from your Longwood facility?
From our location at 2160 W State Road 434, we provide a range of sterile and non-sterile compounded medications in larger batches. This includes but is not limited to injectable medications, ophthalmic solutions, and other preparations that are typically used by physicians, hospitals, and surgical centers for office use and immediate patient administration.
4. Can patients directly receive prescriptions from 503B Compounding Pharmacy?
No. As a 503B outsourcing facility, we provide medications for office use by healthcare providers. We do not compound patient-specific prescriptions. Medications are supplied in bulk to physicians, clinics, and hospitals for them to administer to their patients within their practice at our location.
5. How does your service benefit my practice specifically at 2160 W State Road 434?
Our service provides your practice with a local, reliable, and FDA-regulated source for essential compounded medications that may be on shortage or unavailable from standard manufacturers. This ensures you have the necessary inventory on hand for procedures and treatments, minimizing delays and enhancing the care you provide to your patients from our location.