Boehringer Questions FDA's Draft Guidance on Optional Child-Resistant Packaging Statements

Regulatory NewsRegulatory News | 10 October 2017 |  By 

Boehringer Ingelheim has questions on how new US Food and Drug Administration (FDA) draft guidance on optional child-resistant packaging (CRP) statements will benefit health care professionals and consumers.

The draft guidance, released 2 August, offers help for drugmakers looking to use the statements and ensure they are clear, useful, informative and, to the extent possible, consistent in content and format.

Boehringer, however, questions "whether this new draft guidance on optional statements for CRP, however well intentioned, could inadvertently introduce confusion to consumers if some drug products have such CRP statements and others do not."

The drugmaker also notes that many prescription drugs, particularly solid oral drug products, are repackaged by pharmacists for dispensing, so CRP labeling statements in the manufacturer's labeling may not reach the consumer.

"Thus, it is not clear how manufacturer's labeling of a child-resistant package is expected to benefit healthcare professionals and consumers," Boehrineger said, also noting that if statements about CRP packaging are more commonly applied in labeling, this could dilute the impact of another important safety message to consumers that is required and that says a package is not child resistant.

Other Comments

The American Academy of Family Physicians also offered FDA six recommendations to:

  • Apply the draft guidance to product labeling for child resistant drug products;
  • Expand the language to note that the products are not child resistant;
  • Include the warning language: "Keep out of sight and reach of children";
  • Consider graphic warning labels to convey the potential dangers;
  • To apply the draft to medicines dispensed at a pharmacy;
  • To apply the guidance to all nicotine delivery devices, especially liquid nicotine bottles.

The American Academy of Pediatrics, meanwhile, noted that while the guidance "is voluntary, we urge FDA to use all available options to ensure compliance with these recommendations."



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