PTCB 26-27: Federal Laws

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Last updated 1:20 AM on 7/7/26
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6 Terms

1
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Durham-Humphrey Amnedment

distinguishes prescription drugs from OTC drugs

2
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Kefauver-Harris Amendment

required drugs must be proven safe and effective before approval

3
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thalidomide issue

caused severe birth defects due to teratogenic effects

4
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Poison Prevention Packaging Act

requires child-resistant packaging for many medicines and household susbstances

5
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child-resistance standard for children

difficult for at least 80% of children under age 5 to open

6
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child-resistant standard for adults

at least 90% of adults should be able to open