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Fed Regist. 2001 Aug 2;66(149):40111-6.

Child-resistant packaging for certain over-the-counter drug products. Final rule.


Pursuant to its 3-0 vote to do so, the Consumer Product Safety Commission (CPSC or Commission) is issuing a rule to require child-resistant (CR) packaging on drugs (OTC switched drugs) approved by the Food and Drug Administration (FDA) for over-the-counter (OTC) sale that contain active ingredients previously available only in prescription drugs. Current Commission regulations require CR packaging for most oral drug products containing prescription-only active ingredients.However, prior to issuance of this rule there was no general requirement to maintain CR packaging of such drug products in forms subsequently approved by the FDA for OTC sale. The Commission is also revoking the current prohibition on granting a petition for an exemption from a CR packaging requirement prior to FDA approval of the drug product in question. The Commission takes these actions under authority of the Poison Prevention Packaging Act of 1970, as amended.

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