Pill Pushers' Paperwork: FDA Seeks Input on Drug Distributor Checks
Published Date: 2/20/2026
Notice
Summary
The FDA wants your thoughts on how it collects info about groups that check and license drug wholesalers and delivery companies. This helps keep medicine safe and the supply chain strong. If you’re involved or interested, send your comments by April 21, 2026—no cost to join, just your voice!
Analyzed Economic Effects
4 provisions identified: 0 benefits, 4 costs, 0 mixed.
Third Parties Can Drive Licenses
FDA will allow approved third-party organizations (AOs) to perform licensure reviews and inspections for wholesale drug distributors and third-party logistics providers (3PLs). FDA says it can rely on AO reports when deciding whether to issue a license under sections 583(c) and 584(d)(2)(A) of the FD&C Act.
Paperwork Burden Hours Estimated
FDA estimates the annual reporting burden as 15 respondents, 279 total responses, and 1,386 total hours. FDA also estimates recordkeeping as 18 recordkeepers, 102 total records, and 204 total hours per year for these collections under 21 CFR part 205.
7-Day AO Inspection Report Deadline
When an AO inspects a 3PL facility, the AO must provide FDA with an inspection report within 7 days after completion of the inspection. FDA will use the AO's report to make the final licensing decision for the facility.
AOs Must Keep Records Five Years
FDA proposes that an approved organization (AO) must maintain certain records for at least 5 years and make those records readily available to FDA upon request. This recordkeeping requirement applies as a condition of keeping AO approval.
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