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. This 503B Compounding Pharmacy is situated at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy model represents a significant advancement in the compounding field, adhering to the highest standards of pharmaceutical quality and safety for healthcare providers and their patients at this location.
The core function of this 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) and, in certain instances, non-sterile preparations. Unlike a traditional pharmacy, this 503B outsourcing facility prepares medications proactively, before receiving a patient-specific prescription. This allows the 503B Compounding Pharmacy to supply significant quantities of essential medications to healthcare facilities, ensuring they have critical drugs on hand when needed. The operations at 2160 W State Road 434 are conducted under a framework of rigorous testing, cGMP (current Good Manufacturing Practices), and stringent quality control protocols mandated for all 503B outsourcing facilities.
Healthcare practitioners in Longwood can rely on the 503B Compounding Pharmacy for a consistent supply of high-quality medications. The 503B Compounding Pharmacy provides a vital service by compounding drugs that may be on shortage or are not commercially available from large pharmaceutical manufacturers. By sourcing from this local 503B Compounding Pharmacy, medical professionals at 2160 W State Road 434 can be assured of the integrity, potency, and sterility of the medications they administer, all produced under the exacting oversight required of a 503B facility.
The team at this 503B Compounding Pharmacy comprises highly trained pharmacists and technicians who specialize in the complex processes of large-scale compounding. Every procedure within the 503B Compounding Pharmacy is designed to mitigate risk and prevent contamination, ensuring every preparation meets its predefined specifications. The commitment of the 503B Compounding Pharmacy is to uphold the trust placed in it by the medical community through unwavering dedication to quality and safety in every batch produced.
For more detailed information about the specific preparations available from this 503B Compounding Pharmacy, healthcare providers are encouraged to contact the facility directly. The 503B Compounding Pharmacy can be reached at (407)993-1381 or through their official website at https://503bcompoundingpharmacy.com/. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is dedicated to supporting the local healthcare infrastructure with reliable, quality-compounded medications.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this is a 503B Compounding Pharmacy?
This designation means our facility at 2160 W State Road 434 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. As a 503B Compounding Pharmacy, we adhere to more rigorous manufacturing and quality control standards, including current Good Manufacturing Practices (cGMP), which are required for large-scale compounding.
2. Who can order medications from the 503B Compounding Pharmacy?
The 503B Compounding Pharmacy primarily supplies medications to healthcare facilities and practitioners, such as hospitals, clinics, and physician offices. We do not typically fulfill individual patient prescriptions directly from the public. Healthcare providers at 2160 W State Road 434 can establish an account to order compounded preparations.
3. What types of medications does the 503B Compounding Pharmacy produce?
The 503B Compounding Pharmacy specializes in producing compounded sterile preparations (CSPs), often in larger volumes. This includes medications that are in short supply or not commercially available. The specific drug formulations produced by this 503B Compounding Pharmacy can be discussed by contacting our facility directly.
4. How does the quality assurance at a 503B Compounding Pharmacy differ?
As a 503B Compounding Pharmacy, our processes are governed by strict cGMP standards. This includes robust environmental monitoring, rigorous testing of components and finished preparations, and comprehensive documentation for every batch produced at our location on W State Road 434. This ensures a consistently high level of quality and safety for all medications we compound.
5. How can a healthcare provider at this location place an order?
Healthcare providers interested in the services of the 503B Compounding Pharmacy can initiate the process by calling our facility at (407)993-1381. Our team will provide information on our available preparations, ordering procedures, and account setup. You can also visit https://503bcompoundingpharmacy.com/ for more contact information.