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Child resistant

The two halves of the standard

On this page11
A closure an older adult cannot open has failed the standard. That is in the regulation, not an opinion.

The child half

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.

The adult half

"Special packaging shall have a senior adult use effectiveness (SAUE) of not less than 90%", measured on "a group of 100 senior adults" aged 50 to 70, in a specified age mix.

And it includes closing it again

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".

Resecured is the word to notice

A package an adult can open and cannot properly close is not special packaging. Which is exactly the failure that produces a child resistant cap sitting loose on a bottle.

Why the adult half exists

Because a package nobody can open gets defeated: decanted into a jar, left open on the counter, or the cap left off. The regulation treats usability as a safety requirement rather than a convenience.

Which is the argument to make to a clinic

Child resistant packaging is not a trade-off between safety and convenience. The standard has usability inside it, and a closure that fails the adult half is not compliant however hard it is for a child.

The age mix is specified

"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." Half the panel is 60 or over.

Which is the population that owns pets

And the population dispensing the medication at home. The test panel happens to describe the client base of a great many veterinary practices.

Show the client how it works

A closure that passes both halves still has to be understood. Thirty seconds of demonstration at the counter is the cheapest part of this entire system.

And offer the non-child-resistant option deliberately

For a household with no children and a client who struggles, that is a reasoned choice recorded in the notes rather than a default. The decision is what matters.

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.edu
16 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
Written from 16 CFR 1700.14, 1700.15 and 1700.20, and from the catalog as it stood on 18 October 2026. Whether a package system is compliant special packaging is a test result on that container, that closure and that product, held by whoever ran the test. State pharmacy rules for veterinary dispensing exist, vary, and are not summarized here.