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 from its location at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act establishes a critical distinction, setting this facility apart from traditional compounding pharmacies. As a 503B outsourcing facility, this pharmacy adheres to the most rigorous current good manufacturing practices (cGMP) mandated by the FDA. This commitment to the highest regulatory standards ensures that every preparation leaving the facility is produced in a controlled, sterile environment with stringent quality assurance protocols, providing healthcare providers and patients with unparalleled confidence in the safety, potency, and purity of their medications.
The core service of 503B Compounding Pharmacy is the large-scale compounding of sterile injectable medications. This is not a retail pharmacy for individual patient prescriptions but rather a bulk manufacturer that supplies healthcare facilities. The medications produced are essential, often including intravenous bags, syringes, and other sterile preparations that are in short supply or unavailable from conventional pharmaceutical manufacturers. By focusing on this specific, high-need area, 503B Compounding Pharmacy plays a vital role in the local healthcare infrastructure, ensuring that clinics, hospitals, and surgical centers in the area have reliable access to these critical drugs. The operations are designed for volume, consistency, and sterility, making them a key partner for medical professionals who require these specific compounded preparations for their patients.
Quality control is the absolute foundation of everything done at 2160 W State Road 434. The cGMP standards require a level of environmental monitoring, personnel training, and product testing that far exceeds standard pharmacy practice. Every batch of medication is meticulously crafted and undergoes rigorous analytical testing to verify its identity, strength, quality, and purity before it is released. This process includes sterility testing, endotoxin testing, and potency assays. This unwavering dedication to quality ensures that every preparation is safe for patient administration and performs exactly as intended, providing healthcare providers with a trusted source for these vital medications.
Engaging with 503B Compounding Pharmacy is a process designed for healthcare entities. Orders are typically placed by physicians, hospitals, ambulatory surgery centers, and other healthcare providers based on patient need. The team at the Longwood facility works directly with these medical professionals, providing support and information about their available preparations. For entities seeking a reliable source for 503B compounded medications, initiating contact to discuss specific needs is the primary step. The facility's team is prepared to provide information on its processes and capabilities to qualified healthcare providers.
For more detailed information about its services and capabilities, or to initiate contact as a healthcare provider, 503B Compounding Pharmacy can be reached through its official website at https://503bcompoundingpharmacy.com/ or by telephone at (407)993-1381. The facility located at 2160 W State Road 434, Longwood, FL 32779 is dedicated to upholding the highest standards of pharmaceutical compounding as an essential partner to the medical community.
Frequently Asked Questions
What does it mean that this is a 503B outsourcing facility?
It means this facility is registered with the FDA under Section 503B of the FD&C Act. This registration requires compliance with strict current good manufacturing practices (cGMP) for the large-scale compounding of sterile medications, which are primarily supplied to healthcare facilities rather than directly to individual patients.
What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy specializes in the compounding of sterile injectable medications, such as IV bags, syringes, and other parenteral preparations. These are often drugs that are on shortage or are not commercially available from large pharmaceutical manufacturers.
Can I come to the location at 2160 W State Road 434 to pick up a prescription?
No. 503B Compounding Pharmacy is not a retail pharmacy. It is an outsourcing facility that compounds medications in bulk for healthcare providers like hospitals and clinics. Individual patients cannot fill personal prescriptions at this location.
How does a healthcare provider place an order with your facility?
Healthcare providers interested in sourcing 503B compounded medications can contact the facility directly to discuss their needs and establish a relationship. You can initiate this process by calling (407)993-1381 or visiting the website at https://503bcompoundingpharmacy.com/ for more information.
Why is choosing a 503B outsourcing facility important for patient safety?
503B outsourcing facilities are subject to federal oversight and must adhere to rigorous cGMP standards. This ensures sterility, potency, and purity through extensive testing and quality control measures that provide a higher level of safety assurance for administered medications.