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 designation is central to the operations at our specific location: 2160 W State Road 434, Longwood, FL 32779. The 503B outsourcing facility status signifies a commitment to the highest standards of pharmaceutical compounding, adhering to rigorous federal regulations for sterile and non-sterile preparations. This facility is dedicated to serving the specific needs of healthcare providers and their patients from our Longwood location.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are not commercially available. This process is conducted within a controlled environment at 2160 W State Road 434, Longwood, FL 32779, ensuring a level of quality and consistency that meets exacting federal guidelines. The medications produced are intended for office use by healthcare practitioners, providing them with essential tools for patient care that would otherwise be inaccessible. The operations are distinct from traditional pharmacy models, focusing on bulk preparation for distribution to healthcare facilities and practices.
Quality assurance is a fundamental principle at this 503B Compounding Pharmacy. The facility at 2160 W State Road 434, Longwood, FL 32779 implements comprehensive testing and validation processes for all compounded preparations. This includes stringent environmental monitoring, sterility testing, and endotoxin testing to ensure every product meets its specified strength, quality, and purity. This dedication to quality control is a direct requirement of the facility's 503B registration and is integral to every batch compounded at this location.
The services provided by 503B Compounding Pharmacy are designed to support the local medical community. Healthcare providers can access a reliable source for compounded medications necessary for their practice. The facility at 2160 W State Road 434, Longwood, FL 32779 operates with a focus on compliance, safety, and meeting the specific demands of healthcare professionals. For more information or to inquire about services, please contact 503B Compounding Pharmacy directly at (407)993-1381 or visit the official website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that this is a 503B outsourcing facility? 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility. This means it compounds medications in large volumes for office use by healthcare practitioners and must comply with federal current good manufacturing practices (cGMP) and other specific FDA regulations.
Who can receive medications from this 503B Compounding Pharmacy? Medications compounded at this facility are primarily distributed for office use to healthcare providers and their practices. The 503B Compounding Pharmacy location at 2160 W State Road 434, Longwood, FL 32779 provides these medications to practitioners for administration to patients within their care.
How does the quality control at this location work? The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 adheres to strict FDA cGMP standards. This includes rigorous environmental monitoring, sterility testing, and validation of all processes to ensure the safety, potency, and purity of every compounded preparation that leaves the facility.
Can I pick up a prescription directly from this location? As an outsourcing facility, the primary function of 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is to supply compounded medications in bulk to healthcare providers for office use. It does not typically serve individual patients for direct prescription dispensing.
How can a healthcare provider place an order with this facility? Healthcare providers interested in the services provided by 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 should contact the facility directly to discuss their needs. You can reach them by phone at (407)993-1381 or find more information on their website at https://503bcompoundingpharmacy.com/.