Federal Register Direct final rule: FDA is confirming the effective date of 10/27, for the final rule that appeared in the 6/13 Federal Register proposing to amend the regulation that established conditions under which OTC skin protectant astringent drug products are generally recognized as safe and effective and not misbranded. This action revises some labeling for astringent drug products to be consistent with the final rule for OTC skin protectant drug products and adds labeling for certain small packages (styptic pencils). To view this final rule, click here.
