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. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. The 503B designation signifies a commitment to the highest standards of quality, safety, and consistency, providing healthcare providers with a reliable source for patient-specific medications that are not commercially available. The operations at this specific location are focused on supplying these critical preparations directly to healthcare practitioners for office use.
The core service of 503B Compounding Pharmacy is the compounding of medications in an outsourcing facility environment. This process involves creating medications that are tailored to the specific needs of patients, particularly when a commercially manufactured drug is not suitable. This includes making dosage forms that are not available on the market, altering a medication to remove a non-essential allergen, or creating a more palatable flavor for a liquid preparation. By operating under Section 503B, the pharmacy adheres to Current Good Manufacturing Practices (cGMP), which are more rigorous than traditional compounding standards, ensuring every batch is produced with validated processes, stringent quality control, and extensive testing.
For medical professionals serving patients in the community, 503B Compounding Pharmacy at 2160 W State Road 434 provides an essential resource. The facility compounds a significant volume of medications that are vital for office-based procedures, hospital settings, and clinical use. This ensures that practitioners have immediate access to the necessary preparations without the need for in-house compounding, allowing them to focus on patient care. The pharmacy's work supports a wide range of therapeutic areas, providing high-quality, consistent medications that meet specific clinical requirements.
The team at 503B Compounding Pharmacy comprises highly trained pharmacists, pharmacy technicians, and quality assurance professionals who are experts in the science of compounding within a regulated outsourcing facility. Their expertise ensures that every product leaving the facility meets exacting specifications for potency, purity, and sterility. The commitment of the staff at the Longwood location is to uphold the integrity of the 503B standard, providing healthcare providers with confidence in the medications they administer to their patients.
Engaging with 503B Compounding Pharmacy is a streamlined process for healthcare providers. Orders and inquiries are managed through dedicated channels to ensure efficiency and accuracy. The facility welcomes communication to discuss specific compounding needs and requirements. You can learn more about the services and initiate contact by visiting the official website at https://503bcompoundingpharmacy.com/ or by calling the facility directly at (407)993-1381.
FAQ
What does it mean that 503B Compounding Pharmacy is an outsourcing facility?
As an FDA-registered outsourcing facility operating under Section 503B, 503B Compounding Pharmacy complies with Current Good Manufacturing Practices (cGMP) for large-scale compounding. This means medications are produced with rigorous quality control, testing, and oversight that exceeds traditional pharmacy standards, ensuring a higher level of safety and consistency for office-use medications.
Who can receive medications from 503B Compounding Pharmacy at 2160 W State Road 434?
503B Compounding Pharmacy provides medications exclusively to healthcare practitioners for office use. Medications are not dispensed directly to individual patients at this location. Healthcare providers can utilize these compounded preparations for procedures and treatments within their practice for their patients.
What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy specializes in compounding both sterile and non-sterile medications that are not available commercially or that need to be tailored for specific clinical applications. This includes a focus on preparations required by healthcare providers for use in their practice at 2160 W State Road 434.
How does the quality assurance process work at this facility?
The quality assurance process at 503B Compounding Pharmacy is comprehensive and mandated by its 503B status. It includes validated compounding processes, environmental monitoring, stringent ingredient testing, and final product testing to ensure every batch meets precise specifications for potency, purity, and sterility before it is released.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can place orders by contacting 503B Compounding Pharmacy directly. For more information or to discuss specific compounding needs, providers are encouraged to call (407)993-1381 or visit the website at https://503bcompoundingpharmacy.com/ to initiate the process.