Federal Register #FDA2026N3240

FDA Requests Public Comment on Prescription Drug Importation Information Collection

This notice from the Food and Drug Administration (FDA) seeks public input on information collection related to prescription drug importation regulation. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Purpose: - Request for public comment on proposed information collection for the regulation of prescription drug importation - Supports implementation of section 804 of the Federal Food, Drug, and Cosmetic Act - Scope: - Outlines procedures for sponsors (states, Indian Tribes, pharmacists, wholesale distributors) to submit importation program plans - Details FDA review and authorization criteria - Specifies requirements for eligible drugs and entities - Procurement Details: - No OEMs or vendors are mentioned - No products or services are being procured - No quantities or part numbers are requested - Unique Requirements: - Focus is on information collection and regulatory compliance, not acquisition of goods or services - Aims to reduce prescription drug costs while maintaining public health and safety

Description

The Food and Drug Administration (FDA) is seeking public comments on the proposed collection of information related to its regulation on the importation of prescription drugs. This collection supports implementation of section 804 of the Federal Food, Drug, and Cosmetic Act, which aims to reduce drug costs to American consumers without compromising public health and safety. The regulations set forth procedures for sponsors to submit plans for importation programs, criteria for FDA review, and requirements for eligible drugs and entities involved in importation. Comments on this information collection must be submitted by June 15, 2026.

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