To amend the Federal Food, Drug, and Cosmetic Act to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved new drug application, and for other purposes.
Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018
This bill amends the Federal Food, Drug, and Cosmetic Act to substantially revise how over-the-counter (OTC) drugs are approved.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 413.
Received in the Senate.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Committee Consideration and Mark-up Session Held.
Ordered to be Reported (Amended) by Voice Vote.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 115-827.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 115-827.
Placed on the Union Calendar, Calendar No. 640.
Mr. Latta moved to suspend the rules and pass the bill, as amended.
Considered under suspension of the rules. (consideration: CR H6227-6237)
DEBATE - The House proceeded with forty minutes of debate on H.R. 5333.
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Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H6227-6235)
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H6227-6235)
Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 518.