This guidance is intended to assist applicants, manufacturers, packagers, and distributors
(collectively referred to as firms) who choose to include child-resistant packaging (CRP)
statements in their drug product labeling. The guidance discusses what information should be included to support CRP statements in labeling for new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and supplements to these applications. In addition to recommendations for labeling of prescription drug products, this guidance also includes recommendations for labeling both for nonprescription drug products approved under an NDA or ANDA and those that are marketed under the Over-theCounter (OTC) Drug Review. This guidance is intended to help ensure that such labeling is clear, useful, informative, and, to the extent possible, consistent in content and format.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required…