Boehringer Questions FDA Guidance on Child-Resistant Packaging Labels
Boehringer Ingelheim suggested the FDA draft guidance on child resistant packaging labeling, published in August, could confuse consumers who may not understand why only some drug products bear the CRP statement. Prescription drugs are often repackaged by dispensers or pharmacists, running the risk of the information never reaching the consumer, Boehringer said.
In addition, if CRP statements become too commonplace, it could dampen the effectiveness of other labeling statements that indicate packaging is not child-resistant, the company said, adding it is “not clear how manufacturer's labeling of a child-resistant package is expected to benefit healthcare professionals and consumers.”
The American Academy of Family Physicians also called for the draft guidance to apply to medicines dispensed at pharmacies. The AAFP also called for graphic warning labels to convey the dangers visually, and for specific warning to “keep out of sight and reach of children.”
The American Academy of Pediatrics, meanwhile, said it supported the draft, and it urged the agency to use any means at its disposal to ensure compliance even though the guidance is voluntary.