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.
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act. This 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy designation signifies a commitment to the highest standards of quality, safety, and compliance, producing large batches of compounded medications for office use by healthcare practitioners. The 503B Compounding Pharmacy provides these medications without patient-specific prescriptions, serving the specific needs of medical practices and clinics.
The core function of this 503B Compounding Pharmacy is the sterile and non-sterile compounding of medications in an environment that adheres to rigorous Current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving the facility at 2160 W State Road 434, Longwood, FL 32779 meets stringent quality control benchmarks for potency, purity, and sterility. The 503B Compounding Pharmacy provides healthcare professionals with access to essential medications that may be in shortage, discontinued, or not commercially available in the required form or strength. By supplying these critical medications, the 503B Compounding Pharmacy supports the local medical community in delivering personalized and effective patient care.
Healthcare providers in need of compounded medications for their practice can rely on the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy team is dedicated to upholding the principles of a 503B outsourcing facility, ensuring reliability and consistency in every batch. For more information or to discuss your practice's needs, please contact the 503B Compounding Pharmacy directly. The 503B Compounding Pharmacy can be reached via phone at (407)993-1381. Additional details about the 503B Compounding Pharmacy and its services can be found online at .
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this is a 503B Compounding Pharmacy?
This 503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation means the 503B Compounding Pharmacy adheres to strict Current Good Manufacturing Practices (cGMP) for the production of compounded medications, ensuring a higher level of regulatory oversight, quality control, and sterility assurance for office-use products.
2. Who can order medications from this 503B Compounding Pharmacy?
This 503B Compounding Pharmacy supplies medications to licensed healthcare practitioners for office use. Orders are placed by medical practices, clinics, and other healthcare entities for administering to patients within their practice at 2160 W State Road 434, Longwood, FL 32779. This 503B Compounding Pharmacy does not fulfill prescriptions for individual patients.
3. What types of medications does this 503B Compounding Pharmacy prepare?
This 503B Compounding Pharmacy specializes in compounding sterile and non-sterile medications that are often on drug shortage lists, have been discontinued by manufacturers, or are not commercially available in a specific strength or formulation required by healthcare providers at 2160 W State Road 434, Longwood, FL 32779.
4. How does the 503B Compounding Pharmacy ensure medication quality?
As a 503B Compounding Pharmacy, the facility follows rigorous cGMP standards. This includes stringent testing of ingredients, validated processes, environmental monitoring, and final product testing to ensure every preparation meets exacting standards for potency, purity, and sterility before it is supplied.
5. How can a healthcare provider place an order with this 503B Compounding Pharmacy?
Healthcare providers can contact this 503B Compounding Pharmacy directly to discuss their practice's needs and place an order. The 503B Compounding Pharmacy can be reached by phone at (407)993-1381. More information for providers is also available on the 503B Compounding Pharmacy's website at .