Bill > S1134

This bill aims to strengthen the authority of the Food and Drug Administration (FDA) with respect to inspections of foreign drug facilities. The key provisions are: 1. The FDA is generally prohibited from notifying foreign drug facility owners or operators in advance of an inspection, except when such advance notification is required by the laws of the country where the facility is located or when the FDA determines that advance notification is needed to protect public health. 2. When advance notification is provided, the FDA must minimize the time between notification and the actual inspection. 3. If a country enacts a law that prevents the FDA from conducting inspections as described in the bill, the manufacturer must agree to waive any right to enforce any advance notice requirement under that law. If the manufacturer does not agree to the waiver, it will be deemed to have refused entry or inspection, which is a violation of the Federal Food, Drug, and Cosmetic Act. 4. The bill's requirements do not apply to pre-approval, pre-licensure, or for-cause inspections.

Health and Social Services

https://www.congress.gov/bill/118th-congress/senate-bill/1134/all-info