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Just in Time for Summer – How to Label OTC Skin Protectant Drug Products!

As you know, I’m constantly on the look-out for undiscovered corners from the business of governing.¬†And this morning I came across a timely item for you.

As luck would have it – just in time for those summer vacations – the Food and Drug Administration put a note in the Federal Register this morning announcing the availability of a draft guidance entitled “Labeling OTC Skin Protectant Drug Products.”

A “guidance” is a document that agencies put out to clear up the ambiguities in their regulations. Now, regulations are supposed to clear up the ambiguities in the statutes that Congress has passed, but, hey, sometimes that’s hard. So you’ve got to have a guidance to clear up what’s in the regulation that cleared up what’s in the statute. There’s one last step to know about: if the guidances don’t actually clear things up – or if the guidances conflict with one another – another important part of the regulatory process kicks in: you’re screwed.

Anyway, the FDA this guidance is on “Labeling OTC Skin Protectant Drug Products.” That’s your sunscreens and burn creams and whatnot. “OTC” means “over-the-counter,” so we’re talking about the junk you go buy at the drug store when you’re heading out to get some sun, or when you’ve already gotten too much sun, or when your outdoor adventures brought some poison ivy in contact with your thighs, or whatever.

So, each of the active ingredients in these topical ointments has specific labeling requirements. But what do you do when there is more than one active ingredient? You’re looking at some serious label clutter! And is it even allowed? That’s where this FDA publication comes in: “This guidance is designed to clarify the permitted combinations of active ingredients along with the corresponding required labeling.” The summer’s looking bright indeed . . .

Now the FDA only told us in the Federal Register about the availability of the guidance. It didn’t actually put it in there. But luckily I was able to go dig it up on Regulations.gov using a search of the docket number. (Who wants to go out in the sun anyway when you can be searching Regulations.gov?)

So without further ado, we present the FDA’s “Guidance for Industry: Labeling OTC Skin Protectant Drug Products.” Download it and take it to the beach or the lake with you this summer. Give it a read over and see if you understand it. ‘Cause it looks like a whole bunch of gobbledegook to me. But that gobbledegook is there to make your summer ointment a smooth and creamy one. Thank you, FDA!

Visitor Comments for Just in Time for Summer – How to Label OTC Skin Protectant Drug Products! RSS 2.0


You look at the guidance document and regulations for CFR 21 Part 11. A huge validation industry exists to clarify the FDA’s guidance, regulation and statute for computer systems.

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