503B Compounding Pharmacy

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.

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Contact Information

Address:

2160 W State Road 434, Longwood, FL 32779

Phone:

(407)993-1381

Website

https://503bcompoundingpharmacy.com/

Location

503B Compounding Pharmacy operates as an FDA-registered outsourcing facility in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. This 503B Compounding Pharmacy is situated at 2160 W State Road 434, Longwood, FL 32779. The designation as a 503B outsourcing facility differentiates this pharmacy from traditional compounding pharmacies, as it is subject to rigorous federal oversight and current good manufacturing practices (cGMP). The core mission of this 503B Compounding Pharmacy is to provide healthcare practitioners with access to high-quality, sterile compounded medications that are not commercially available, thereby supporting patient care in the local community.

The operations at 2160 W State Road 434, Longwood, FL 32779 are dedicated to the large-scale compounding of medications without receiving patient-specific prescriptions. This 503B Compounding Pharmacy prepares medications in advance of receiving orders based on a history of receiving valid prescriptions. The sterile preparations produced by this 503B Compounding Pharmacy are essential for various medical settings, including hospitals, clinics, and surgical centers, ensuring a reliable supply of critical drugs. The team at this location comprises skilled pharmacists and technicians who are experts in aseptic processing and quality control, guaranteeing that every preparation meets exacting standards for potency, purity, and sterility.

Quality assurance is the foundation of every activity at this 503B Compounding Pharmacy. The facility at 2160 W State Road 434, Longwood, FL 32779 adheres to a robust quality management system that includes stringent environmental monitoring, validation of sterilization processes, and thorough testing of components and finished preparations. This unwavering commitment to quality ensures that healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can confidently utilize the medications provided by this 503B Compounding Pharmacy. Patients ultimately benefit from the safety and efficacy of these preparations, which are vital for treatments ranging from hormone replacement therapy to intravenous nutrition and pain management.

Engagement with the local medical community is a priority for this 503B Compounding Pharmacy. The professionals at 2160 W State Road 434, Longwood, FL 32779 work closely with physicians and healthcare facilities to understand their needs and provide compounded medications that fulfill specific clinical requirements. This 503B Compounding Pharmacy serves as a vital partner in the local healthcare ecosystem, helping to mitigate drug shortages and provide essential medications that are otherwise inaccessible. For more information about the services provided, you can visit the website at https://503bcompoundingpharmacy.com/ or contact the facility directly at (407)993-1381.

Frequently Asked Questions for 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779

What does it mean that this is a 503B Compounding Pharmacy? This 503B Compounding Pharmacy is an FDA-registered outsourcing facility that compounds sterile medications in large batches for healthcare facilities. It operates under stricter federal regulations, including current good manufacturing practices (cGMP), which differ from the standards applied to traditional 503A pharmacies.

Can I, as an individual patient, order medications directly from this 503B Compounding Pharmacy? No. This 503B Compounding Pharmacy does not accept prescriptions directly from individual patients. It provides medications to healthcare practitioners and facilities, such as hospitals, clinics, and physician offices located at 2160 W State Road 434, Longwood, FL 32779, for administration to their patients.

What types of medications does this 503B Compounding Pharmacy at 2160 W State Road 434 prepare? This 503B Compounding Pharmacy specializes in compounding sterile injectable medications, including IV bags, hormone injections, ophthalmics, and other preparations that must be prepared in an ISO-classified cleanroom to ensure sterility and patient safety.

How does this 503B Compounding Pharmacy ensure the quality of its preparations? The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 implements a comprehensive quality program. This includes rigorous testing of ingredients, environmental monitoring of its cleanrooms, validation of sterilizing equipment, and end-product testing to ensure every batch meets specified standards for potency, purity, and sterility.