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 large-scale compounding of sterile and non-sterile medications. This designation means we adhere to the highest federal standards for quality control, testing, and production, providing healthcare providers and patients with medications they can trust.
The core function of 503B Compounding Pharmacy is the production of compounded medications in bulk for office use by healthcare practitioners. Physicians, surgeons, dermatologists, and other medical professionals located at and serving patients from our local area can order these preparations for their office inventory. This allows for immediate administration to patients during procedures or appointments, ensuring timely and effective treatment without the delays associated with traditional pharmacy dispensing. Our location at 2160 W State Road 434 is a centralized hub for these essential pharmaceutical services.
As a 503B outsourcing facility, our operations are distinct from traditional retail compounding pharmacies. We manufacture medications based on anticipated patient needs, not individual patient-specific prescriptions. This model provides a critical supply of medications that are often in short supply or no longer available from large commercial manufacturers. Healthcare providers in Longwood can rely on our facility for a consistent, high-quality supply of essential drugs, all produced within a robust quality management system that includes rigorous sterility testing, stability studies, and endotoxin testing.
The team at 503B Compounding Pharmacy is comprised of skilled pharmacists, pharmacy technicians, and quality assurance professionals. Every individual at our Longwood facility is committed to the precise science of compounding. We utilize state-of-the-art technology and equipment within our controlled environments to ensure every vial, syringe, and preparation meets exacting specifications. Our commitment is to safety, potency, and purity in every product that leaves our facility at 2160 W State Road 434.
For healthcare practices and providers operating in and around our specific location, 503B Compounding Pharmacy serves as a vital partner in patient care. We encourage local medical professionals to learn more about our current offerings and how our services can integrate seamlessly into their practice. To discuss your office use needs, please contact us directly. You can reach our facility by phone at (407)993-1381 or visit our website for more information at https://503bcompoundingpharmacy.com/.
FAQ
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific facility at 2160 W State Road 434, Longwood, FL 32779 is registered with and inspected by the U.S. Food and Drug Administration. We compound medications in accordance with strict federal current Good Manufacturing Practices (cGMP), which include rigorous testing for sterility, potency, and purity. This provides an additional layer of safety and quality assurance for healthcare providers.
Who can order medications from 503B Compounding Pharmacy?
Our medications are intended for office use by licensed healthcare practitioners. Physicians, clinics, hospitals, and other healthcare entities that serve patients from our local area can order compounded preparations to have on hand for procedures and treatments at their practice location.
Can I as an individual patient pick up a prescription at 2160 W State Road 434?
No. 503B Compounding Pharmacy operates as a bulk manufacturer for healthcare facilities and does not dispense medications directly to individual patients based on a prescription. Your healthcare provider will administer any medication we compound directly to you during your appointment.
How do I place an order for my practice?
Healthcare providers interested in utilizing our services should contact 503B Compounding Pharmacy directly to establish an account. You can initiate this process by calling our facility at (407)993-1381 to speak with a representative.
Why would a healthcare provider use a 503B outsourcing facility?
Providers use our services to ensure a reliable supply of high-quality, compounded medications for office use. This is especially critical for drugs that are on shortage or have been discontinued by large-scale manufacturers. It allows for efficient patient care with medications that meet elevated federal quality standards.