FDA Seeks Comments on Prescription Drug Import Data Collection
Published Date: 4/16/2026
Notice
Summary
The FDA wants your thoughts on how they collect info about importing prescription drugs. This affects drug companies and anyone involved in bringing meds into the U.S. You’ve got until June 15, 2026, to share your comments—no cost to join, just your voice! The goal? Make sure the rules are clear and easy to follow.
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Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Recordkeeping Burden for Importation Sponsors
If you are a Section 804 Importation Program (SIP) Sponsor, an importer (pharmacist or wholesale distributor), or a drug manufacturer, FDA estimates the paperwork burden at 100 total annual records and 6,040 hours per year. Specifically, Subpart B is estimated at 60 records at 72 hours each (4,320 hours) and Subpart C at 40 records at 43 hours each (1,720 hours).
Section 804 Aims to Lower Drug Costs
The purpose of section 804 of the Federal Food, Drug, and Cosmetic Act is to reduce the cost of covered prescription products to American consumers without imposing additional risks to public health and safety. The regulations in 21 CFR part 251 set procedures for SIP Sponsors to submit plans for time-limited programs to begin importation of drugs from Canada and establish criteria for FDA review and authorization.
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