Industry news

US FDASIA Implementation

On 15 July 2025 the FDA announced a proposed regulation to implement administrative detention authority with respect to drugs as authorized by amendments made to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the Food and Drug Administration Safety and Innovation Act (FDASIA). When finalized, the regulation will allow the agency to better protect the integrity of the drug supply chain by allowing FDA officers to prohibit distribution of believed misbranded or adulterated drugs until the agency’s course of action is decided. The proposed rule specifies:

• The duration of administrative detention cannot exceed 30 days unless otherwise officially extended
• The content of the detention order including the reason for detention, identification of the detained drugs, time/date of the detention order and details on appeals to this detention
• How product subject to the detention order must be labeled/marked
• How to appeal the detention order
• How drugs under the order may be moved
• Other actions that may be implemented and
• How the order may be terminated

Also on 15 July 2013, FDA announced the availability of a draft guidance document entitled, “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.” This draft guidance defines, by way of example, the circumstances that FDA would consider to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated. The guidance provides examples of what constitutes the following actions:

• Delay of Inspection for preannounced inspections, delay during an inspection and delay in producing records
• Denial of Inspection
• Limiting the inspection including limiting access to the facility and manufacturing process, limiting photography, limiting access to or copying of records, and limiting or preventing sample collection
• Refusal to permit entry or inspection