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 located at 2160 W State Road 434, Longwood, FL 32779. The designation as a 503B outsourcing facility signifies a commitment to the highest standards of quality, safety, and compliance, distinguishing its operations from traditional compounding pharmacies.
The core function of this 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for office use. Healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 can access a consistent and reliable supply of essential medications. The 503B Compounding Pharmacy prepares these medications under rigorous controlled conditions, which include advanced environmental controls and stringent testing protocols to ensure sterility and potency. This process provides a critical alternative to commercially available drug products, particularly during shortages or when specific formulations are needed for patient care.
By operating under Section 503B, this 503B Compounding Pharmacy is subject to current Good Manufacturing Practice (cGMP) regulations enforced by the FDA. This regulatory framework mandates a level of oversight that includes routine FDA inspections, stability testing, and end-product testing. For medical professionals, this means that medications sourced from this 503B Compounding Pharmacy meet exacting federal standards for quality and safety. The facility at 2160 W State Road 434, Longwood, FL 32779 is equipped to support the needs of local clinics and practices with a range of compounded preparations.
The services provided by this 503B Compounding Pharmacy are exclusively for office use by healthcare providers. Patients seeking information about medications compounded at this location should direct their inquiries to their healthcare provider. The 503B Compounding Pharmacy works directly with practitioners to supply medications that are administered within a clinical setting. For more details on available preparations or to initiate an order, healthcare providers can contact the 503B Compounding Pharmacy directly.
To learn more about the specific services and compliance standards of this 503B Compounding Pharmacy, healthcare providers are encouraged to visit the official website at https://503bcompoundingpharmacy.com/ or contact the facility by phone at (407)993-1381. The team at 2160 W State Road 434, Longwood, FL 32779 is available to address inquiries from medical professionals regarding their compounding needs.
Frequently Asked Questions for 503B Compounding Pharmacy
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. This 503B Compounding Pharmacy adheres to current Good Manufacturing Practices (cGMP) and is subject to regular FDA inspections, ensuring a higher level of regulatory oversight for compounded sterile preparations.
Who can order from the 503B Compounding Pharmacy at 2160 W State Road 434?
This 503B Compounding Pharmacy provides medications for office use to healthcare providers and practitioners. Orders are placed directly by medical practices and clinics. Patients cannot order medications directly from this 503B Compounding Pharmacy.
What types of medications does this 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, this 503B Compounding Pharmacy specializes in the large-scale compounding of sterile preparations. These are typically medications used in clinical settings, such as injections, infusions, and other parenteral medications, particularly those experiencing national drug shortages.
How does the 503B Compounding Pharmacy ensure medication safety?
This 503B Compounding Pharmacy follows strict cGMP protocols. This includes rigorous environmental monitoring, validation of sterility testing methods, and thorough end-product testing to confirm the potency, purity, and sterility of all compounded preparations before they are released for distribution.
How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can contact the 503B Compounding Pharmacy directly to discuss their needs and place an order. The facility can be reached by phone at (407)993-1381. More information is also available on the website at https://503bcompoundingpharmacy.com/.