Display Settings:

Format

Send to:

Choose Destination
    Fed Regist. 2003 Jun 13;68(114):35290-3.

    Skin protectant drug products for over-the-counter human use; astringent drug products; final monograph; direct final rule. Direct final rule.

    Abstract

    The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (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 (68 FR 33362, June 4, 2003) and adds labeling for certain small packages (styptic pencils). This action is part of FDA's ongoing review of OTC drug products. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedure for notice-and-comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule.

    PMID:
    12807133
    [PubMed - indexed for MEDLINE]
    Free full text

      Supplemental Content

      Icon for Federal Register

      Save items

      loading

      Recent activity

      Your browsing activity is empty.

      Activity recording is turned off.

      Turn recording back on

      See more...
      Write to the Help Desk