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PharFromNormal

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What’s the deal here? It’s not FDA approved but they claim to be Rx only, has an NDC, website clearly advertises itself as prescription only...

Why does the FDA permit them to market if it’s unapproved?

Since it is unapproved, who/what enforces their self proclaimed status of Rx Only? What’s stopping me from selling this OTC?

Is the pharmacist/pharmacy potentially at risk for dispensing mislabeled product?

It’s not like there isn’t a plethora of other prenatals out there that play nice by the FDA... not sure why these get a pass...

Classic govt inaction.
 
WVUPharm2007 said:
Vitamins aren't in the purview of the FDA.

Anything can be sold "as a prescription."

So...yeah.
Click to expand...

They market the product with a labeled indication with health claims. Pretty sure that’s a no no for an unapproved FDA product? Vitamins don’t/can’t make the claims on indication these do... or atleast that’s my understanding.

I get vitamins can be dispensed as rx but my question is the other way around. This manufacturer self-proclaims to be “Rx-only” but there’s really no regulatory body that sits behind that claim to my knowledge. So this info that’s printed on the package is wrong IMO and I don’t see why couldn’t be sold in the front of the store without a prescription.
 
PharFromNormal said:
They market the product with a labeled indication with health claims. Pretty sure that’s a no no for an unapproved FDA product? Vitamins don’t/can’t make the claims on indication these do... or atleast that’s my understanding.

I get vitamins can be dispensed as rx but my question is the other way around. This manufacturer self-proclaims to be “Rx-only” but there’s really no regulatory body that sits behind that claim to my knowledge. So this info that’s printed on the package is wrong IMO and I don’t see why couldn’t be sold in the front of the store without a prescription.
Click to expand...

I don't think the FDA cares, but maybe you're right.
 
Unapproved Rx-only products hit the market all the time

Example (FDA Notification Regarding Isometheptene-Containing Drug Products): "generic" Midrin presentations were being sold in 2013 but guess it took FDA 4 years to notify manufacturers & labelers to stop distributing them

www.fda.gov

Unapproved Drugs

Unapproved prescription drugs pose significant risks to patients because they have not been reviewed by FDA for safety, effectiveness or quality.
www.fda.gov www.fda.gov
 
Sine Cura said:
Unapproved Rx-only products hit the market all the time

Example (FDA Notification Regarding Isometheptene-Containing Drug Products): "generic" Midrin presentations were being sold in 2013 but guess it took FDA 4 years to notify manufacturers & labelers to stop distributing them

www.fda.gov

Unapproved Drugs

Unapproved prescription drugs pose significant risks to patients because they have not been reviewed by FDA for safety, effectiveness or quality.
www.fda.gov www.fda.gov
Click to expand...

Ah so I agree that unapproved products hit the market all the time. But I’m not sure I understand how you add the “rx-only” in there as I understand that to be a designation provided by the FDA. Maybe “Alleged Rx-Only” unapproved products? I’m still not sure why I can’t just reject this claim as false...cover that part up about prescription only and just sell otc if I was going to dispense as rx.
 
Isometheptene is a DESI drug and didn't have any (A)NDA done. Those companies would get even more heat trying to sell OTC

FDA just cares less about unapproved "rx-only" prenatals
 
Sine Cura said:
Isometheptene is a DESI drug and didn't have any (A)NDA done. Those companies would get even more heat trying to sell OTC

FDA just cares less about unapproved "rx-only" prenatals
Click to expand...

When you say “these companies” who are you referring to? I’m suggesting the pharmacy sell the falsely claimed “Rx-Only” products OTC... not have the manufacturer make any changes. Not sure how the FDA could justify going after a small pharmacy selling the unapproved product and not go after the manufacturer as well.
 
WVUPharm2007 said:
I don't think the FDA cares, but maybe you're right.
Click to expand...

The FDA at this point is so broken an agency that they wait for CNN to tell them what to do. The methanol hand sanitizer should have triggered an immediate Class I recall with consequences to the distributor. This is not just a Republican failure in this case, the agency has been broken since the GW Bush era (Clinton had the last functional FDA).


@PharFromNormal

The folate 1mg is what makes this prescription strength (remember that exception), but is otherwise considered a dietary supplement for regulation. Folic acid does have medical claims, which is why there is an ANDA for it, but the ANDA is hilariously not captured on the FDA Access (which is normal because the Commissioned Corps officers assigned are some of the stupidest, most useless deadwood in the business). That's a good MPJE question. I'll make sure to get that into testing next round.
 
lord999 said:
The FDA at this point is so broken an agency that they wait for CNN to tell them what to do. The methanol hand sanitizer should have triggered an immediate Class I recall with consequences to the distributor. This is not just a Republican failure in this case, the agency has been broken since the GW Bush era (Clinton had the last functional FDA).


@PharFromNormal

The folate 1mg is what makes this prescription strength (remember that exception), but is otherwise considered a dietary supplement for regulation. Folic acid does have medical claims, which is why there is an ANDA for it, but the ANDA is hilariously not captured on the FDA Access (which is normal because the Commissioned Corps officers assigned are some of the stupidest, most useless deadwood in the business). That's a good MPJE question. I'll make sure to get that into testing next round.
Click to expand...

Dietary supplement or fortified food? There also most certainly is 1000mcg folic acid OTC.

I think you may hit on my conundrum through... just because it has a prescription strength ingredient does that make the entire product prescription required. Furthermore if attempting to wade through the FDA’s resources to find such information on their platforms and it wasn’t there, if I could demonstrate good faith effort to check presence of ANDA and could not find one... I’d feel pretty good on any attempted retribution they attempted to make although back to my original point it doesn’t seem like they care about these in the first place. I’m trying to think through the potential course of legal action they would pursue if a pharmacy sold these OTC’s while they remained in an unapproved status. Additionally could they in theory pursue this same action against the pharmacy if they were selling via rx? I know they permit some exceptions on dispensing unapproved drugs in certain situations but nothing I’m finding makes me believe these products would qualify as those.

I saw we all just start doing it (OTC) and force the FDA to not care and not act or trigger a manufacturer level review.
 
And I’m really hoping you say medical food because it seems it would run in guidance of being able to make health claims... BUT medical foods do NOT require a prescription. They require supervision of a physician but explicitly not a prescription per FDA guidance AND per FDA guidance they should not bear the phase “Rx Only” on the bottle (as these products do) because they do not require a prescription.


Maybe I’m just getting too excited
 
No, the citation is this for labeling, folic acid has very specific ones which are exceptional in 21 CFR:
Folic acid is one of the few chemicals that has a specific exception to the claims issue as they are enumerated in the public law. That is a law question asked from time-to-time.


The history is this, and I helped some Harvard person update it more than a decade ago for some inane reason while I was a postdoc. Suzanne definitely knows where the bodies are buried in FDA too, she participated in some of them.

I'm sure folic acid 1 mg is prescription strength, that's why there are sold at 800 mcg. Unless they've changed it during the 2016 reform where they started adding folate to a bunch of food, that was the standing though I'm curious enough now to look it up. The old justification for making it that way was to deal with alcoholic treatment issues from cyanocobalmin deficiency taking folic acid without it
 
lord999 said:

Yep, folic acid 1mg is still a legend (prescription) drug, 1 mg is still not OTC. This is the original NDA entry.
Click to expand...

uh oh Walmart

www.walmart.com

Nature's Blend Folic Acid 1000 mcg 1,000 mcg 1000 Tabs - Walmart.com

Buy Nature's Blend Folic Acid 1000 mcg 1,000 mcg 1000 Tabs at Walmart.com
www.walmart.com

and gnc

Folic Acid 1000 MCG

Supports healthy fetal development<br><br>Required for proper red blood cell formation<br><br>Adequate folate in a healthy diet may reduce a woman’s risk of having a child with a brain or spinal cord defect. Folate intake should not exceed 250% of the DV (1,000 mcg).
www.gnc.com www.gnc.com
 
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lord999 said:
No, the citation is this for labeling, folic acid has very specific ones which are exceptional in 21 CFR:
Folic acid is one of the few chemicals that has a specific exception to the claims issue as they are enumerated in the public law. That is a law question asked from time-to-time.


The history is this, and I helped some Harvard person update it more than a decade ago for some inane reason while I was a postdoc. Suzanne definitely knows where the bodies are buried in FDA too, she participated in some of them.

I'm sure folic acid 1 mg is prescription strength, that's why there are sold at 800 mcg. Unless they've changed it during the 2016 reform where they started adding folate to a bunch of food, that was the standing though I'm curious enough now to look it up. The old justification for making it that way was to deal with alcoholic treatment issues from cyanocobalmin deficiency taking folic acid without it
Click to expand...

As an FYI this references what’s going on. A Fine Line Between Prescription and Under a Doctor’s Supervision: The Case of Medical Foods and First Databank’s Classification | News & Insights | Arnall Golden Gregory LLP

FDB’s changes just took effect. Since they were determining these products as medical foods they ultimatkey decided not to classify them as OTC (O) and not to classify them as prescription only (F) so they straight up deleted them from the database. They had considered moving to O and considered adding a new class different than O and F but ultimately landed on neither, just dropped. Legendary. Can only imagine the panic at the manufacturers when FDB actually finally pulled the trigger on this a few weeks ago.
 
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