It has been quite a while since FDA totally updated the class labeling guidance for combined hormonal contraceptives (CHC). FDA notes “this newer CHC labeling may be different from the labeling for some older CHC products. The updates to this guidance set forth labeling recommendations that represent newer class labeling that should be included in all CHC prescribing information consistent with the labeling requirements set forth in the PLR and PLLR (21 CFR 201.56 and 201.57)…” There have been some minor modifications such as the “Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling” (commonly referred to as the pregnancy and lactation labeling rule (PLLR)) that was issued in 2014, which amended the 2006 PLR regulations.” However, this new draft class labeling guidance provides a comprehensive update and gives specific instructions for where product-specific information should be included.
While the guidance does not provide any timelines for implementation (likely because it is draft), it is believed that firms should consider evaluating their currently approve CHC labeling and firms with pending applications will likely be asked to comply with the tenants of this document. A complete copy of the guidance can be found here.