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 designation signifies a commitment to the highest standards of quality, safety, and consistency for compounded medications. Located at 2160 W State Road 434, Longwood, FL 32779, this 503B outsourcing facility provides essential pharmaceutical preparations to healthcare providers and their patients. The operations at this specific location are distinct from traditional compounding pharmacies, as they are subject to current Good Manufacturing Practices (cGMP), which are the same rigorous standards followed by conventional drug manufacturers.
The primary function of 503B Compounding Pharmacy is the large-scale compounding of sterile medications. This includes the production of injectables, infusions, and other sterile preparations that are vital for hospital and clinical use. By operating under the 503B framework, the pharmacy at 2160 W State Road 434 ensures that every batch of medication is produced in a controlled environment with extensive quality control testing. This process provides an additional layer of safety and reliability for the medications dispensed from this facility. The 503B model is designed to provide healthcare practitioners with access to medications that may be in short supply or not commercially available, thereby supporting patient care in the local community.
Patients and healthcare providers who utilize the services of 503B Compounding Pharmacy can be assured of the integrity of every preparation. The facility's adherence to cGMP standards involves rigorous validation of processes, testing of components and finished products, and meticulous documentation. This level of oversight is a fundamental aspect of the 503B outsourcing facility's operation at its Longwood location. The team at 2160 W State Road 434 is dedicated to upholding these principles, ensuring that all compounded medications meet precise specifications for strength, purity, and quality.
For more information about the services provided by this FDA-registered outsourcing facility, please visit the official website at https://503bcompoundingpharmacy.com/ or contact the pharmacy directly by phone at (407)993-1381. The professionals at 503B Compounding Pharmacy are available to assist with inquiries regarding their compounded preparations available from their location at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means that this facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with stringent current Good Manufacturing Practice (cGMP) regulations. This ensures that medications are compounded in a standardized, quality-controlled environment with batch-level testing for safety and potency.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, this location specializes in the compounding of sterile medications, such as injectables and intravenous (IV) preparations. These are often produced in larger batches for use by healthcare practitioners to support patient treatment plans.
Who can receive medications from 503B Compounding Pharmacy?
Medications compounded at the 2160 W State Road 434 facility are typically distributed to healthcare providers and facilities for administration to patients under professional supervision. Patients should consult their healthcare provider to determine if a compounded medication from this 503B pharmacy is appropriate for their needs.
How does the 503B model enhance patient safety?
Patient safety is enhanced through the mandatory cGMP standards required of all 503B outsourcing facilities. The processes at the Longwood location include environmental monitoring, sterility testing, and verification of ingredient quality, which provide a high level of assurance regarding the safety and quality of the compounded preparations.
How can I contact 503B Compounding Pharmacy?
You can contact 503B Compounding Pharmacy by visiting their website at https://503bcompoundingpharmacy.com/ or by calling (407)993-1381. The facility is located at 2160 W State Road 434, Longwood, FL 32779.