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 designation as a 503B outsourcing facility differentiates this pharmacy from traditional compounding pharmacies, as it signifies adherence to the highest level of federal regulation, which includes current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving the facility at 2160 W State Road 434, Longwood, FL 32779 meets rigorous standards for sterility, potency, and purity.
The core function of this 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for office use. Healthcare practitioners at medical facilities can utilize the services of this 503B Compounding Pharmacy to obtain essential medications, particularly those experiencing drug shortages or requiring specific formulations not readily available from conventional manufacturers. The 503B Compounding Pharmacy provides a reliable, regulated source for these critical medications, supporting the local healthcare infrastructure from its location on W State Road 434.
By operating under Section 503B, this 503B Compounding Pharmacy is permitted to compound medications without patient-specific prescriptions for distribution to healthcare facilities. This model allows for greater efficiency and readiness, ensuring that physicians and surgeons at local practices have immediate access to the compounded sterile preparations they need. The 503B Compounding Pharmacy’s commitment to cGMP standards at its Longwood facility guarantees a level of quality control and consistency that is paramount for patient safety.
The team at the 503B Compounding Pharmacy comprises highly trained professionals, including pharmacists and technicians who specialize in sterile compounding within a controlled environment. The processes at 503B Compounding Pharmacy are meticulously designed to prevent contamination, with environmental monitoring and stringent testing protocols integral to its daily operations. For healthcare providers seeking a trusted partner for compounded medications, the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents a source of unparalleled quality and reliability.
To learn more about the specific preparations available or to inquire about services, contact the 503B Compounding Pharmacy directly. The 503B Compounding Pharmacy can be reached by phone at (407)993-1381. Additional information about the 503B Compounding Pharmacy and its compliance standards is available on the official website at https://503bcompoundingpharmacy.com/.
FAQ
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 adheres to current Good Manufacturing Practices (cGMP), which are the strictest federal standards for drug production, ensuring the highest quality and safety for compounded sterile preparations.
2. Who can order from the 503B Compounding Pharmacy?
The 503B Compounding Pharmacy provides medications for office use by healthcare practitioners. Orders are placed by medical facilities and practices for their patient care needs. The 503B Compounding Pharmacy does not typically fulfill individual patient prescriptions directly from the public.
3. What types of medications does the 503B Compounding Pharmacy prepare?
The 503B Compounding Pharmacy specializes in producing large volumes of compounded sterile preparations (CSPs). This often includes medications that are on shortage from major manufacturers or specific formulations required by healthcare providers serving the community from 2160 W State Road 434, Longwood, FL 32779.
4. How does the 503B Compounding Pharmacy ensure medication safety?
Safety is paramount at the 503B Compounding Pharmacy. The facility operates under cGMP, which mandates rigorous testing, environmental controls, and validation processes. Every batch of medication produced at the 503B Compounding Pharmacy is subject to these stringent protocols to ensure sterility, potency, and purity.
5. How can a healthcare facility get started with the 503B Compounding Pharmacy?
Healthcare facilities interested in the services of the 503B Compounding Pharmacy should contact the facility directly to discuss their needs and establish an account. The 503B Compounding Pharmacy can be reached at (407)993-1381, and more information is available on their website at https://503bcompoundingpharmacy.com/.