FDA Issues Draft Guidance on Voluntary Child-Resistant Packaging Statements in Drug Product Labeling

On August 3, 2017, FDA announced the availability of a draft guidance regarding child resistant packaging statements on drug products labels and labeling. To be clear, this draft guidance addresses the inclusion of a voluntary statement in the labeling for drug products, prescription as well as over-the-counter, that the packaging is child-resistant. FDA’s guidance does not address or affect the requirement for child resistant packaging under the Poison Prevention Packaging Act and the Consumer Product Safety Commission’s (CPSC’s) implementing regulations.

FDA asserts that the draft guidance “is intended to help ensure that such labeling is clear, useful, informative, and, to the extent possible, consistent in content and format.” Among other things, FDA recommends against the use of abbreviations, and recommends the use of the term “supplied” as opposed to “available.” The guidance further discusses the placement and appropriate terminology companies should use when including the statement in prescribing information, patient information, on the carton and immediate container labeling, and in the drug facts box (used on OTC products).

FDA does not explain what inspired FDA to issue a draft guidance for this type of label claims. It also provides no information about the interest of industry to use this type of voluntary claims on their drug products.

Comments must be submitted by October 2, 2017.