I usually don’t blog about Federal Register (FR) notices on collections of information as they are usually not that exciting and typically just announce the Agency’s collection of certain information as is an OMB requirement under the Paperwork Reductions Act of 1995 (as an aside, there sure does seem to be a lot of paperwork invested in the goal of reducing paperwork).  However, this morning, while browsing through the pre‑publication of the FR, I came across a collection of information comment request for General Drug Labeling Provisions and Over-the-Counter Monograph Drug User Fee Submissions (here) that was a bit more substantive and thought that it would be of interest to our readership.

This comment request addresses many of the new draft guidances on OTC drug product labeling and provides a handy reference to regulatory citations as well as direction to many of the new guidance documents based on the changes in the old OTC Monograph System in favor of the newly instituted Administrative Order Process, eliminating the previous cumbersome comment and rulemaking process.

The notice and request for comment addresses the following topics:

  • General OTC Product Labeling
  • OTC Labeling Requirements for Principal Display Panels
  • OTC Drug and Prescription Drug Facts Labeling
  • Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products
  • Labeling Related to Adverse Event Reporting
  • Submissions to Request Exemptions or Deferrals from OTC Drug Labeling Requirements
  • OTC Monograph Drug User Fee Program Submissions

It’s always useful to review such a summary as procedures and policies change over time and to have so much OTC information in one document makes the brush up that much easier!  Enjoy the read.