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. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations and regular FDA inspections. This ensures that every preparation leaving our facility meets stringent quality assurance benchmarks for the medical professionals and patients we serve at our Longwood location.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) and non-sterile preparations. These medications are prepared for office use by healthcare practitioners, meaning they are administered to patients within a clinical setting rather than being dispensed directly to an individual for home use. Our services are essential for hospitals, clinics, surgical centers, and other healthcare providers in need of reliable, high-quality medications that may be commercially unavailable or in short supply. By operating from our facility at 2160 W State Road 434, Longwood, FL 32779, we provide a critical, local supply chain solution for the healthcare community, ensuring practitioners have access to the necessary medications for their patients without delay.
Our state-of-the-art facility at 2160 W State Road 434 is designed to uphold the impeccable standards required of a 503B outsourcing facility. This includes advanced environmental controls, such as ISO-classified cleanrooms, where our highly trained compounding personnel prepare medications under controlled conditions to ensure sterility and stability. Every step of our process, from ingredient sourcing to final packaging, is governed by robust quality control protocols. We utilize analytical testing to verify potency and sterility testing to confirm the absence of microbial contamination. This unwavering dedication to quality at our Longwood location provides healthcare providers with the confidence that the medications they use are safe, effective, and reliable.
503B Compounding Pharmacy is a vital partner for the local medical community. We understand the specific needs of healthcare providers and work to support their practices by offering a consistent supply of essential medications. Our team is dedicated to maintaining the highest level of service and quality from our location at 2160 W State Road 434, Longwood, FL 32779. For more information about our services or to speak with our team, please contact us via our website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381.
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 under Section 503B of the FD&C Act. This subjects us to federal oversight, mandatory compliance with current Good Manufacturing Practices (cGMP), and routine FDA inspections to ensure the highest quality and safety standards for our compounded medications.
2. Can I, as an individual patient, pick up my prescription directly from your location?
No. 503B Compounding Pharmacy prepares medications for office use by healthcare practitioners. Our preparations are intended for administration to patients within a clinical setting, such as a doctor's office, hospital, or surgery center. Individuals should obtain their personal prescriptions from a traditional 503A compounding pharmacy.
3. What types of medications do you compound at your Longwood facility?
Our FDA-registered outsourcing facility at 2160 W State Road 434 specializes in the large-scale compounding of both sterile and non-sterile preparations. This includes injectables, ophthalmics, and other medications that are often used by hospitals and clinics, particularly those that may be on drug shortage lists or are not commercially available.
4. How does your location ensure the sterility and quality of its compounded preparations?
Our facility at 2160 W State Road 434, Longwood, FL 32779 employs strict environmental controls, including ISO-classified cleanrooms, and our personnel follow rigorous aseptic techniques. We conduct extensive quality control testing, including sterility testing, endotoxin testing, and potency assays, on our preparations to verify their safety and efficacy before they are released.
5. How can a healthcare facility at your location order compounded medications?
Healthcare providers and facilities can initiate orders by contacting 503B Compounding Pharmacy directly. You can reach our team at our facility by calling (407)993-1381 to discuss your specific needs. Detailed information about our services and capabilities is also available on our website at https://503bcompoundingpharmacy.com/.