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 precisely 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 outsourcing facility undergoes rigorous FDA oversight, ensuring that every preparation meets exacting specifications for the medical professionals we serve.
The core function of 503B Compounding Pharmacy at 2160 W State Road 434 is the large-scale production of compounded sterile preparations (CSPs). These preparations are produced in advance of a prescription and are based on the historical needs of healthcare providers. Our operations are designed to support hospitals, clinics, and other healthcare entities by providing them with critical medications that are often on shortage or are not commercially available. By operating from our specific location, we provide a reliable, local source for these essential medications, ensuring timely access for the medical community.
Our state-of-the-art facility at 2160 W State Road 434 is equipped with advanced environmental control systems, including ISO-classified cleanrooms. Our highly trained staff of pharmacists and technicians adhere to strict aseptic techniques and robust quality control protocols. Every batch of medication is subjected to rigorous testing, including sterility and endotoxin testing, to guarantee patient safety. The operational model of 503B Compounding Pharmacy is built on a foundation of reliability, quality, and compliance, making us a trusted partner for healthcare providers.
503B Compounding Pharmacy provides its services exclusively to healthcare practitioners and facilities. We do not dispense medications directly to individual patients. Instead, we work directly with prescribers and institutions, ensuring that compounded medications are integrated seamlessly into patient care protocols. Our location at 2160 W State Road 434, Longwood, FL 32779, serves as a centralized hub for the production and distribution of these vital pharmaceutical products.
For more information about our services or to discuss your facility's needs, 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 compliance and offerings: https://503bcompoundingpharmacy.com/.
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. We operate under Section 503B of the FD&C Act, which mandates adherence to Current Good Manufacturing Practices (cGMP) for higher-risk compounded sterile preparations.
2. Can I, as an individual patient, pick up a prescription at 2160 W State Road 434?
No. 503B Compounding Pharmacy does not dispense medications directly to individual patients. We are an outsourcing facility that provides compounded medications in large batches exclusively to healthcare facilities and practitioners based on their prescriptions and orders.
3. What types of medications does 503B Compounding Pharmacy at this location produce?
Our facility at 2160 W State Road 434 specializes in producing compounded sterile preparations (CSPs). This includes a wide range of injectable medications, such as IV bags, epidurals, and ophthalmics, that are often on drug shortage lists or are not available from commercial manufacturers.
4. How does a healthcare facility based at this location order from you?
Healthcare facilities and practitioners can initiate orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will work with you to understand your needs and requirements for compounded sterile preparations.
5. Why should a local healthcare provider choose your specific facility?
Choosing our facility at 2160 W State Road 434 provides a local source for high-quality, FDA-oversighted compounded medications. Our adherence to cGMP standards and rigorous testing protocols ensures reliability and patient safety, while our local presence supports timely delivery and responsive service.