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 specific designation is a critical component of the pharmaceutical services provided directly from our facility at 2160 W State Road 434, Longwood, FL 32779. The 503B outsourcing facility status signifies a commitment to the highest standards of quality, safety, and compliance, distinguishing the services available at this location. The operations conducted at 2160 W State Road 434, Longwood, FL 32779 are dedicated to the large-scale compounding of medications that are patient-specific and not commercially available, serving an essential role for healthcare providers and patients who rely on these specialized formulations.
The core function of 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is the compounding of sterile medications in an environment that adheres to rigorous FDA standards. This process involves the creation of medications that are tailored to meet specific patient needs which cannot be met by commercially available, FDA-approved drugs. The facility at 2160 W State Road 434, Longwood, FL 32779 utilizes advanced pharmaceutical technology and employs stringent sterility testing protocols to ensure every preparation meets exacting specifications. The team of highly trained pharmacists and technicians at 2160 W State Road 434, Longwood, FL 32779 works meticulously to provide healthcare practitioners with reliable access to these critical compounded preparations.
As an FDA-registered 503B outsourcing facility, the pharmacy at 2160 W State Road 434, Longwood, FL 32779 is subject to federal oversight and must comply with Current Good Manufacturing Practices (cGMP). This regulatory framework ensures a level of quality control that goes beyond traditional compounding, providing an additional layer of assurance for the medications prepared on-site. The operations at 2160 W State Road 434, Longwood, FL 32779 are designed to support hospitals, clinics, and other healthcare entities by providing them with a dependable source for compounded sterile preparations, thereby enhancing patient care standards within the medical community served by this location.
Patients and healthcare providers seeking the services of 503B Compounding Pharmacy can be confident in the integrity of the medications produced at 2160 W State Road 434, Longwood, FL 32779. The facility's commitment to compliance, quality, and safety is paramount in every preparation that is dispensed. For more detailed information about the specific services and capabilities, please contact 503B Compounding Pharmacy directly at (407)993-1381 or visit the official website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions for 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means that 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under Section 503B of the FD&C Act. This registration signifies that the facility complies with federal standards, including Current Good Manufacturing Practices (cGMP), and is subject to periodic FDA inspections to ensure the quality and safety of its compounded medications.
What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 specializes in the large-scale compounding of sterile medications that are not commercially available. These are typically patient-specific preparations made for healthcare providers to address unique clinical needs that cannot be met by manufactured drug products.
Who can receive medications from 503B Compounding Pharmacy?
Medications compounded at 2160 W State Road 434, Longwood, FL 32779 are typically distributed to healthcare facilities and practitioners, such as hospitals, clinics, and physician offices, for administration to their patients. The facility does not generally dispense directly to individual patients without a prescription from a licensed practitioner.
How does the 503B outsourcing facility model benefit healthcare providers?
The 503B model provides healthcare providers utilizing the services at 2160 W State Road 434, Longwood, FL 32779 with access to medications that have been produced under the strict quality standards of an FDA-registered facility. This offers an added layer of confidence in the sterility, potency, and safety of the compounded preparations they use in patient care.
How can I contact 503B Compounding Pharmacy for more information?
For inquiries regarding the services provided at 2160 W State Road 434, Longwood, FL 32779, you may contact 503B Compounding Pharmacy directly by phone at (407)993-1381 or visit the official website at https://503bcompoundingpharmacy.com/ for more comprehensive information.