What is required for office use compounded medications for humans?

The requirement for office-use compounded medications for humans is that they must be distributed by an FDA-registered outsourcing facility. This regulation ensures that the compounding facility adheres to stringent guidelines regarding the quality and safety of the medications produced.

Outsourcing facilities are authorized under the Drug Quality and Security Act (DQSA) to produce compounded medications in larger quantities without needing a prescription for each individual patient. This allows healthcare providers to obtain medications that can be utilized in their office settings or for specific patient populations without the standard requirement of a patient-specific prescription, provided that the facility is compliant with the relevant regulations.

In contrast, obtaining a prescription from a veterinarian is not applicable since the question pertains to human medications. Documentation from a patient does not meet the regulatory standards for office-use compounded medications, which require robust compliance and oversight. Similarly, while local health department approval can be relevant in certain contexts, it does not specifically address the statutory requirements for compounded medications designed for office use. The focus on FDA-registered outsourcing facilities ensures patient safety and medication efficacy.