A child resistant cap on the wrong neck is just a cap.
The neck did not match
A 24-410 closure on a 28-410 bottle crossthreads and seals badly, and the child resistance mechanism depends on the threads engaging properly. This is the first failure and the easiest to avoid.
The package was never tested as a system
A closure sold as child resistant on a bottle nobody tested it with. The standard is a result for a system and the result does not transfer.
The client could not open it
Which is a failure in the regulation's own terms: senior adult use effectiveness of not less than 90 percent, including resecuring it. A closure that defeats an older client is not compliant packaging.
So they decanted it
Into a jam jar, unlabelled, on a kitchen shelf. Every control the clinic applied is now gone, and the cause was a closure chosen without the second half of the standard in mind.
Or they left the cap off
Because resecuring it was the hard part. The protocol tests resecuring for exactly this reason and it is the step people forget to check.
Nobody showed them
A push-and-turn closure is not obvious to somebody meeting it for the first time. Thirty seconds at the counter is the cheapest intervention in this whole property.
The iron threshold was crossed by the bottle size
The 250 mg limit is per single package. Dispensing a longer course into one container can take a product into the requirement that two containers would not.
The label did not fit
Patient, owner, drug, dose, frequency, cautions, clinic details. On a 30 mL tapered bottle there is not room, and the result is a label wrapped over itself or information left off.
The assumption that no rule means no risk
The prescription drug paragraph is human use only, and the child in the house does not know that. The gap in the rule is not a gap in the hazard.
The fix is a written policy
Which closures on which bottles, tested as what, with which exceptions and how they are recorded. One page, and it survives staff changes.
References
16 CFR 1700.15(b), the standards for special packaging. Child resistant effectiveness of "not less than 85 percent without a demonstration and not less than 80 percent after a demonstration", or "not less than 80 percent" for unit packaging. And "special packaging shall have a senior adult use effectiveness (SAUE) of not less than 90%", with a younger adult test substituted for aerosol and metal container products that cannot use alternative packaging.
law.cornell.edu16 CFR 1700.14(a)(10), prescription drugs, opens "Any drug for human use that is in a dosage form intended for oral administration". Across the whole of 1700.14(a), the only entry naming animals is (a)(12), iron-containing drugs: "noninjectable animal and human drugs providing iron for therapeutic or prophylactic purposes, and containing a total amount of elemental iron, from any source, in a single package, equivalent to 250 mg or more elemental iron", excluding animal feeds used as a vehicle for drug administration and preparations in which iron is present solely as a colorant, and applying at or above 0.025 percent on a weight to volume basis for liquids and 0.05 percent weight to weight for nonliquids.
law.cornell.edu16 CFR 1700.20(a), the test protocol for special packaging. Child panels: "Use from 1 to 4 groups of 50 children", with "Thirty percent of the children in each group shall be of age 42-44 months, 40% of the children in each group shall be of age 45-48 months, and 30% of the children in each group shall be of age 49-51 months". A failure is "any child who opens the special packaging or gains access to its contents". Each child has "up to 5 minutes to open his/her package" and then "an additional 5 minutes" after the tester demonstrates opening on a separate demo package. Senior adult panel: "a group of 100 senior adults", with "Twenty five percent of the participants shall be 50-54 years of age, 25% of participants shall be 55-59 years of age, and 50% of the participants shall be 60-70 years old", and senior adult use effectiveness is "the percentage of adults who both opened the package in the first (5-minute) test period and opened and (if appropriate) properly resecured the package in the 1-minute test period".
law.cornell.edu 