Drug Quality and Security Act

[AI summary unavailable — showing source text] Drug Quality and Security Act - Compounding Quality Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounding drugs. Exempts compounded drugs from new drug requirements, labeling requirements, and track and trace requirements if the drug is compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility and meets applicable requirements. Establishes annual registration requirement for any outsourcing facility. Requires a facility to report biannually to the Secretary of Health and Human Services on what drugs are compounded in the facility and to submit adverse event reports. Subjects such facilities to a risk-based inspection schedule. Requires the Secretary to: (1) publish a list of drugs presenting demonstrable difficulties for compounding that are reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug, taking into account the risk and benefits to patients; and (2) convene an advisory committee on compounding before creating the list. Requires the Secretary to assess an annual establishment fee on each outsourcing facility and a reinspection fee, as ne…