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Posted On: 06/27/2022 8:21:46 PM
Post# of 1418
Re: 49erforgold #1108
I think you are talking about the link swordman shared
https://content.govdelivery.com/accounts/USFD...ns/31de37d
I think this paragraph is key. You only apply IF labeling alone is not sufficient is how I read it.
"Under the proposed rule, when the FDA finds that labeling alone is not sufficient to ensure that the consumer can appropriately self-select and use a drug product in a nonprescription setting, an applicant may submit an application proposing an additional condition for nonprescription use that a consumer must successfully fulfill to obtain the nonprescription drug product. "
https://content.govdelivery.com/accounts/USFD...ns/31de37d
I think this paragraph is key. You only apply IF labeling alone is not sufficient is how I read it.
"Under the proposed rule, when the FDA finds that labeling alone is not sufficient to ensure that the consumer can appropriately self-select and use a drug product in a nonprescription setting, an applicant may submit an application proposing an additional condition for nonprescription use that a consumer must successfully fulfill to obtain the nonprescription drug product. "
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