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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is a critical distinction that sets this facility apart from traditional compounding pharmacies. Located at 2160 W State Road 434, Longwood, FL 32779, this 503B Compounding Pharmacy adheres to the highest standards of pharmaceutical compounding, providing healthcare providers with access to large-scale, high-quality compounded medications that are essential for patient care.
The core function of this 503B Compounding Pharmacy is the production of compounded sterile preparations (CSPs) in a controlled environment that meets rigorous federal standards. This includes the compounding of injectables, infusions, and other sterile medications that are often in short supply or unavailable from conventional pharmaceutical manufacturers. By operating as a 503B outsourcing facility, this pharmacy is subject to current Good Manufacturing Practice (cGMP) regulations, ensuring every batch of medication is produced with consistent quality, purity, and sterility. Healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 can confidently source medications, knowing they are produced under the strict oversight of the FDA.
Patients and medical practices that rely on the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 benefit from a reliable supply of critical medications. The services provided by this 503B Compounding Pharmacy are integral to hospitals, clinics, and surgical centers, helping to mitigate drug shortages and ensure that essential treatments are available when needed. The team of highly trained pharmacists and technicians at this location utilizes advanced technology and rigorous testing protocols, including sterility testing and endotoxin testing, to guarantee the safety and efficacy of all preparations before they are dispensed.
Engaging with the 503B Compounding Pharmacy is a streamlined process for healthcare providers. Orders are managed professionally, with a focus on reliability and timely delivery to support uninterrupted patient treatment plans. The dedicated staff is committed to upholding the integrity of the 503B designation through every step of the compounding process. For more information or to discuss specific compounding needs, contact the 503B Compounding Pharmacy directly at (407)993-1381 or visit their website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that this is a 503B Compounding Pharmacy?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility that compounds large volumes of sterile medications in accordance with strict federal current Good Manufacturing Practice (cGMP) regulations, unlike traditional pharmacies.
Who can order from the 503B Compounding Pharmacy?
This 503B Compounding Pharmacy provides medications exclusively to healthcare providers and facilities, such as physicians, hospitals, and clinics. Medications are not dispensed directly to individual patients at 2160 W State Road 434, Longwood, FL 32779 without a prescription from a licensed practitioner.
What types of medications does this 503B Compounding Pharmacy provide?
This 503B Compounding Pharmacy specializes in producing sterile compounded preparations, including injectables, intravenous (IV) bags, and other medications that are often on drug shortage lists, all prepared at the facility on 2160 W State Road 434, Longwood, FL 32779.
How does the 503B Compounding Pharmacy ensure medication safety?
As an FDA-registered 503B outsourcing facility, this pharmacy follows cGMP standards, which mandate rigorous environmental monitoring, extensive testing for sterility and potency, and validated processes for every batch of medication produced at 2160 W State Road 434, Longwood, FL 32779.
How can a healthcare provider place an order with this 503B Compounding Pharmacy?
Healthcare providers can initiate orders by contacting the 503B Compounding Pharmacy directly at (407)993-1381. The team will guide you through the process to meet your specific patient care needs from our location at 2160 W State Road 434, Longwood, FL 32779.