Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 5333) 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, as amended. The Clerk read the title of the bill. The text of the bill is as follows: H.R. 5333 Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018''. TITLE I--OTC DRUG REVIEW SEC. 101. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT ARE MARKETED WITHOUT AN APPROVED NEW DRUG APPLICATION. (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 505F of such Act (21 U.S.C. 355g) the following: ``SEC. 505G. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT ARE MARKETED WITHOUT AN APPROVED NEW DRUG APPLICATION. ``(a) Nonprescription Drugs Marketed Without an Approved Application.--Nonprescription drugs marketed without an approved new drug application under section 505, as of the date of the enactment of the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018, shall be treated in accordance with this subsection.…
Share & report
More from Bob Latta
Madam Speaker, as I mentioned already, the NTIA has not been reauthorized since 1992. Again, as stated before, many of the responsibilities that it has didn't even exist or were irrelevant at that time, such as Federal spectrum management…
Mr. Speaker, the CEO of TikTok appeared before the Energy and Commerce Committee and admitted to me during questioning that ByteDance has access to U.S. user data. This should be an alarm to every TikTok user. There is no reason why the…
Mr. Speaker, I move to suspend the rules and pass the bill (S. 2787) to authorize the Federal Communications Commission to process applications for spectrum licenses from applicants who were successful bidders in an auction before the…
Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and include extraneous material on the bill. The SPEAKER pro tempore. Is there objection to the request of the…





