FDA Seeks Comments on Medication Guide Reporting Rules
Published Date: 7/1/2026
Notice
Summary
The FDA is updating how it collects info about Medication Guides—those important leaflets that come with some prescription drugs to keep patients safe. This affects drug makers who must follow new rules about what info to include and how to share it. Comments on these changes are open until July 31, 2026, and the update aims to keep patients informed without adding extra costs.
Analyzed Economic Effects
5 provisions identified: 0 benefits, 4 costs, 1 mixed.
Drug Sponsors Must Submit Medication Guides
If you are a holder of a new drug application, FDA expects 70 application holders to prepare and submit one Medication Guide annually. FDA estimates each submission takes 320 hours on average, totaling 22,400 hours across all sponsors.
Manufacturers Must Ensure Adequate Guide Supply
Manufacturers who hold relevant applications must ensure distributors and authorized dispensers have an adequate supply or means to produce Medication Guides. FDA estimates 70 manufacturers will make an average of 9,000 disclosures each annually, with an average 1.25 hours per disclosure, totaling 787,500 hours.
Distributors Must Provide Guides to Pharmacies
Distributors that ship drugs requiring Medication Guides must provide the Guide or the means to produce it to authorized dispensers. FDA estimates 191 such distributors will each make 9,000 disclosures annually, with 1.25 hours per disclosure, totaling 2,148,750 hours.
Pharmacies' Dispensing Time Estimated at 10 Seconds
Authorized dispensers (pharmacies) are expected to dispense Medication Guides to patients; FDA estimates 88,736 authorized dispensers will each distribute to 5,705 patients annually, for a total of 506,238,880 dispensings. FDA attributes 10 seconds (0.0027 hours) of burden per dispensing, totaling 1,366,845 hours.
Net Change: Hours Decrease, Responses Increase
FDA states that after adjusting estimates, the information collection reflects a decrease of 22,938,375 hours and an increase of 4,829,782 responses annually related to Medication Guide requirements.
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