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, adhering to the stringent regulations outlined in Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is a critical distinction that sets this facility apart, ensuring the highest standards of quality, safety, and consistency in the preparation of compounded medications. Located at 2160 W State Road 434, Longwood, FL 32779, this pharmacy provides essential pharmaceutical services with a focus on producing large-scale compounded sterile preparations for office use by healthcare practitioners.
The core mission of 503B Compounding Pharmacy is to support the local medical community by providing a reliable, high-quality source of medications that are not readily available from commercial manufacturers. This includes producing formulations that are on the FDA drug shortage list, or creating specific dosage forms, such as sterile injectables, ophthalmics, and other complex preparations that meet the unique needs of patients. By operating under Section 503B, the facility is subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations, which govern the methods, facilities, and controls used in manufacturing, processing, and packaging of drugs. This ensures that every preparation leaving the facility at 2160 W State Road 434, Longwood, FL 32779 meets exacting standards for purity, sterility, and potency.
Healthcare providers in need of compounded medications for their office practice can rely on 503B Compounding Pharmacy as a trusted outsourcing partner. The facility’s operations are designed for volume, allowing it to efficiently supply physicians, hospitals, and clinics with the specific medications required for their procedures and patient treatments. This local resource at 2160 W State Road 434, Longwood, FL 32779 eliminates the need for individual practitioner offices to engage in small-scale compounding, thereby enhancing patient safety and allowing medical professionals to focus on patient care. The pharmacy’s commitment to compliance, quality assurance, and service makes it an integral part of the healthcare infrastructure.
For more information about the services provided or to discuss your specific needs, please contact 503B Compounding Pharmacy directly. The team is prepared to assist healthcare professionals with their compounding requirements. You can reach them via their website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381. The facility welcomes inquiries from practitioners seeking a dependable outsourcing partner for their compounded pharmaceutical needs.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with strict federal standards, including current Good Manufacturing Practices (cGMP). This ensures the medications we compound for office use meet the highest levels of quality, sterility, and safety.
Who can receive medications from 503B Compounding Pharmacy?
As an outsourcing facility, we provide compounded medications for office use to healthcare practitioners, such as physicians, clinics, and hospitals. These medications are administered to patients within the practitioner’s care at their practice location.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile preparations, including injectables, infusions, and ophthalmics. We often produce medications that are on national shortage lists or are needed in specific strengths and formulations not available from traditional manufacturers.
How does a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can place orders by contacting our facility directly at (407)993-1381. Our team will work with you to understand your specific requirements and provide information on availability and ordering procedures for your practice.
Why should a practitioner choose 503B Compounding Pharmacy for their office-use medications?
Choosing our facility ensures you are receiving medications produced under the most rigorous quality controls mandated by the FDA. This provides an added layer of safety for your patients and reduces the liability and logistical burden of in-office compounding for your practice at 2160 W State Road 434, Longwood, FL 32779.