Prescription labels get paperwork refresh: FDA seeks comments
Published Date: 2/3/2025
Notice
Summary
The FDA is updating its paperwork rules for prescription drug labels to keep things clear and safe. Drug makers must follow specific label info and can ask for exceptions, like barcode waivers or special rules for emergency stockpile products. Comments on these changes are open until March 5, 2025, so get your thoughts in before then!
Analyzed Economic Effects
7 provisions identified: 0 benefits, 7 costs, 0 mixed.
Big Labeling Burden for Drug Sponsors
If you are a prescription drug sponsor, you must design, test, and submit required labeling ("Highlights," "Contents," and "Full Prescribing Information") to FDA. The FDA estimates 414 applicants will prepare an average of 549 labels annually, with an average burden of 3,349 hours per labeling submission (totaling 1,838,601 hours).
New Medical Gas Labeling Tasks
Labeling requirements for new medical gas containers under 21 CFR 201.161(b) and 201.328 were added to the information collection. FDA estimates 260 respondents with an average of 0.17 hours (10 minutes) per response for design, testing, production, and submission, and reports total burden hours of 73,505 for this activity.
Barcode Exemption Requests Allowed
Drug makers may submit a written request to FDA for an exemption from barcode requirements under 21 CFR 201.25(d). FDA reports very few such requests and estimates 2 total responses with about 24 hours of burden per request (48 hours total).
Exceptions for Strategic National Stockpile Products
There is a formal process for exceptions or alternatives to labeling requirements for human drug products held in the Strategic National Stockpile (SNS) under 21 CFR 201.26. FDA added this activity to the collection and estimates 1 response with about 32 hours of burden annually for this item.
Safety Labeling Actions and Rebuttals
FDA's safety-labeling activities under section 505(o)(4) require sponsors to prepare safety labeling and may include rebuttal statements. FDA estimates 36 respondents for this item with an average burden of 6 hours per response (216 total hours).
Post Approved Letter on Your Website
Application holders must post an FDA-approved letter on their website when required. FDA estimates 351 respondents will spend an average of 4 hours each for posting, totaling 1,404 hours for this activity.
Hypertension Labeling Guidance Burden
FDA maintains guidance on hypertension indication labeling for cardiovascular outcome claims. The agency estimates 5 respondents for related labeling considerations with an average burden of 18 hours per response (90 total hours).
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