Beyond-use-dates for magic mouthwash

[justjoe]

For a magic mouthwash that contains

lidocaine 2% viscous
generic Maalox
diphenhydramine elixer

what would you put for the BUD? I'm guessing it would be the USP 795 of 6 months or the earliest expiration date of the ingredients, whichever is earlier.

Thanks.

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[PharmhopefulNC]

This is what we use in NC:

Q: What is the appropriate Beyond Use Date (BUD) for Magic Mouthwash?

A: The appropriate USP <795> BUD for Magic Mouthwash depends on whether it is compounded and dispensed as an oral formulation or as a mucosal formulation.

Oral Formulation. USP <795> requires that water-containing oral formulations be assigned a BUD that is no longer than 14 days under refrigerated storage conditions. The directions for an oral formulation of Magic Mouthwash would be “swish and swallow” or similar.

Mucosal Liquid Formulation. USP <795> requires that water-containing topical, dermal, and mucosal liquid and semisolid formulations be assigned a BUD that is no longer than 30 days under room temperature storage. The directions for a mucosal liquid formulation of Magic Mouthwash would be “swish and spit” or similar.
If a pharmacy compounds one batch of Magic Mouthwash to fulfil all Magic Mouthwash prescriptions – whether the directions are “swish and spit” mucosal formulation or “swish and swallow” oral formulations – the assigned BUD must be the stricter one: no longer than 14 days under refrigerated storage.

USP <795> does allow for longer BUD for Magic Mouthwash if the pharmacy has independent stability testing information.

For Commercially Available compounding kits please follow the manufacturers BUD and storage recommendations. Their stability testing information should be included with the kit.




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[justjoe]

Is the preparation considered aqueous if the ingredients contain water, or only if you add water?

 

[zelman]

Is the preparation considered aqueous if the ingredients contain water, or only if you add water?

Contain.

 

[Wickett]

For a magic mouthwash that contains

lidocaine 2% viscous
generic Maalox
diphenhydramine elixer

what would you put for the BUD? I'm guessing it would be the USP 795 of 6 months or the earliest expiration date of the ingredients, whichever is earlier.

Thanks.

Oral rinses are always 14 days for us.

 

[Charcoales]

Anything with water that goes in the mouth = 14 days unless recipe says it's longer expiration based on studies.

 

[Baalzeebub]

Contain.

How are creams/ointment/gels 180 days BUD? Don't they all contain at least a tiny amount of water? I guess my gripe is that every inspector has gone bananas crazy over BUD's. It is basically the only thing they focus on. Yet so many other things could ruin a compound or be forged, fudged, done poorly, etc. I guess because it is a small number that can be looked at quickly.

 

[zelman]

How are creams/ointment/gels 180 days BUD? Don't they all contain at least a tiny amount of water? I guess my gripe is that every inspector has gone bananas crazy over BUD's. It is basically the only thing they focus on. Yet so many other things could ruin a compound or be forged, fudged, done poorly, etc. I guess because it is a small number that can be looked at quickly.

To be more specific, it's anything where water is acting as a solvent.

 

[BidingMyTime]

How are creams/ointment/gels 180 days BUD?

Aren't most creams/ointments/gels 30 days when compounded? Other than maybe a butt paste, I don't know of any that over 30 days (which granted, it's a pretty small number of compounded topicals that I'm familiar with.) I'm just surprised that there are a lot of apparently common ones getting 6 months BUD.