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 consistency in pharmaceutical compounding. Unlike traditional compounding pharmacies, our 503B status means we are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations. This ensures that every preparation leaving our facility meets stringent federal quality testing and purity standards before it is delivered to healthcare providers for their patients.
The core mission of 503B Compounding Pharmacy is to provide bulk quantities of compounded sterile preparations (CSPs) to healthcare practitioners and facilities. Our operations at 2160 W State Road 434, Longwood, FL 32779 are dedicated to supporting the local medical community by producing large-scale batches of essential medications that are often in short supply or unavailable from conventional manufacturers. We serve as a critical partner to hospitals, clinics, and surgical centers, ensuring they have reliable access to high-quality, patient-ready medications. Our state-of-the-art cleanroom environment and advanced technology enable us to compound a wide array of injectable medications, including IV bags, epidurals, and ophthalmic drops, with uncompromising precision.
By focusing on large-volume production under cGMP, 503B Compounding Pharmacy helps to alleviate drug shortages and provides a trusted source for vital medications. Our processes are designed for efficiency and scale, allowing us to support the needs of the healthcare providers we serve from our location at 2160 W State Road 434, Longwood, FL 32779. Every batch is meticulously crafted and undergoes extensive quality control testing, including sterility and endotoxin testing, to guarantee safety and efficacy. We are a pivotal resource for the local healthcare infrastructure, ensuring that practitioners have the necessary tools to provide optimal patient care.
For more information about our services or to discuss how we can support your practice, please contact 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or visit our website to learn more about our capabilities and compliance standards at https://503bcompoundingpharmacy.com/.
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 and inspected by the U.S. Food and Drug Administration (FDA) under Section 503B of the FD&C Act. We operate under current Good Manufacturing Practice (cGMP) regulations, which are the same stringent standards required of major pharmaceutical manufacturers, ensuring the highest level of quality, purity, and sterility in our compounded preparations.
2. Who does 503B Compounding Pharmacy serve from its location?
503B Compounding Pharmacy provides compounded sterile preparations exclusively to healthcare practitioners and facilities. This includes hospitals, surgery centers, clinics, and other healthcare providers. We do not provide medications directly to individual patients; instead, we supply medications in bulk to the medical professionals who treat them.
3. What types of medications does 503B Compounding Pharmacy produce?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in producing large-scale batches of compounded sterile preparations (CSPs). This includes a wide range of injectable medications such as IV solutions, epidural injections, ophthalmic drops, and other preparations that must be sterile for patient use, particularly those that are on shortage or are not commercially available.
4. How does the quality control process work at your facility?
Quality control is paramount. Every batch of medication compounded at our facility undergoes a rigorous testing process as required by cGMP. This includes testing for sterility, potency, endotoxins, and other quality attributes. Only after a batch has passed all quality control checks is it released for distribution to healthcare providers.
5. How can a healthcare facility at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare facilities and practitioners can initiate an order or inquire about our services by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will work with you to understand your specific needs and provide information on our available preparations and ordering process. You can also find more information on our website at https://503bcompoundingpharmacy.com/.