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, our 503B outsourcing facility adheres to rigorous current good manufacturing practices (cGMP), which are enforced by the FDA. This ensures that every batch of medication we produce meets consistent and stringent quality controls, providing healthcare providers and patients with a level of reliability that is critical for patient care.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for office use. This means we provide medications in larger quantities for physician offices, hospitals, clinics, and other healthcare providers located at or serving patients from our area. By preparing these essential medications in an FDA-registered facility, we empower local healthcare professionals to have the necessary supplies on hand for immediate administration to patients, supporting efficient and effective treatment protocols. Our operations are designed to be a reliable backbone for the local medical community, ensuring access to vital medications that may be in short supply or not commercially available.
Our state-of-the-art facility at 2160 W State Road 434 is equipped with advanced environmental controls, including ISO-classified cleanrooms, to guarantee the sterility and potency of every preparation. Every process, from ingredient sourcing to final product testing, is meticulously documented and controlled. This unwavering dedication to cGMP standards minimizes the risk of contamination and ensures product integrity. For healthcare providers at our location, this translates to confidence and peace of mind, knowing the medications they use are produced under the most scrupulous conditions.
503B Compounding Pharmacy provides a critical service by addressing drug shortages. When a commercially manufactured drug becomes unavailable, our facility can often compound a necessary formulation, helping to prevent interruptions in patient care for the local community. We work directly with healthcare providers to supply them with the specific medications their practice requires. For any inquiries or to discuss your facility's needs, please contact us directly. Our team is ready to assist you.
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
Address: 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 complies with strict federal standards for compounding, known as current good manufacturing practices (cGMP). This ensures a higher level of quality control and consistency for the compounded medications we produce compared to a traditional pharmacy.
2. Can I, as an individual patient, pick up my prescription directly from your location?
No. 503B Compounding Pharmacy primarily supplies compounded medications in bulk for office use by healthcare providers. Individual patient prescriptions are typically compounded and dispensed by traditional 503A compounding pharmacies. We serve the healthcare providers at our location.
3. What kinds of medications does 503B Compounding Pharmacy produce?
We specialize in producing large batches of compounded sterile preparations (CSPs). These are typically injectable medications, such as IV bags, hormone injections, ophthalmics, and other preparations that must be sterile. Our products are intended for use by medical professionals within their practices.
4. How do I, as a healthcare provider at this location, order from your facility?
Healthcare providers can initiate orders by contacting our facility directly at (407)993-1381. Our team will work with you to understand your specific needs and requirements for office-use compounded medications available at 2160 W State Road 434.
5. Why should a healthcare provider choose a 503B outsourcing facility like yours?
Choosing our 503B Compounding Pharmacy ensures that the medications you use in your practice are produced under the most rigorous quality and safety standards mandated by the FDA. This provides a significant layer of protection for your patients and reduces liability for your practice, as you can be confident in the quality and consistency of every batch we produce.