FDA Medication Guides

Started by DHG
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DHG

Senior Member
15+ Year Member
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I am trying to get a list of the drugs FDA requires to have a medication guide dispensed with the drug (NOT a medication information sheet, but a med guide).

The FDA website only has this list, which has a disclaimer at the top saying it may not be complete:

This web page may not contain a complete listing of all available medication guides. To see if a drug has a Medication Guide, please view the labeling found in Drugs@FDA.

But when you go to that second link, it just takes you to the entire drug database for all drugs...

IS there actually a list someplace where they list ALL the drugs that are required to have a med guide? How can they require us by law to distribute these things, but then not tell us which ones are included 🙄

I've been all over the FDA site and this is all I could find. Maybe I'm ******ed... anyone else know any more? Did I just over look it? I just find it hard to believe that there's no COMPLETE list someplace.

Of course fluoroqinolones have just been added, and they aren't on the list, so I understand that because it's been recent. But surely they could update the page with a placeholder at least, with the statement "medguide available soon," or something!

Any thoughts?