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Panayotis77

WRONG Psychiatrist states 30% dosage disparity allowed by FDA

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Panayotis77

Hello community - My psychiatrist has informed me that “The FDA allows for a 30% upward or downward margin of error on Zoloft pills.” He explained that a 50mg  Sertraline (Zoloft) may have up to 65mg or as low as 38.5mg. Another example, a 25mg Sertraline may have have as much as 32.5mg and as low as 17.5mg. Can anyone validate this? If this is true, it is unimaginable for those of us who have a sensitivity to the medication.
 

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Altostrata

Your psychiatrist is wrong.

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MaggieJK

In the US it’s a 20% variance in strength that is allowed generic vs name brand medication.  Each generic can be up to 20% stronger or weaker than the name brand.  

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Altostrata

I don't believe the allowed variation is so great. Please post informational links for that kind of assertion. @brassmonkey has some information about this.

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brassmonkey

According to the FDA website:

 

"A generic medicine is the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, and quality, as well as in the way it is taken and should be used."

 

Generic medications are manufactured and inspected using the same criterion as brand name drugs and can only vary in Shape, Color, Packaging, Flavorings and Inactive ingredients.  Except for those five areas they must be exactly the same.

 

There is also a major misconception that the active ingredient is not mixed evenly through out the tablet or capsule.  Many years ago there was a case come up of a unlicensed generic manufacturer that had poor mixing quality and even some batches that didn't have any active ingredient at all.  This was a one off problem that has plagued the industry ever since.  If you buy from a reputable manufacturer you should be getting a quality product.  There are manufacturing standards that the makers have to adhere to or they face heavy fines and loss of their license.  In regards to even distribution of the active ingredient in the filler there is no problem with dry cutting tablets or taking the powder out of capsules. The same goes for commercially made liquid products.

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lxjuice

The 20% variance allowed is in blood concentrations. Blood concentrations are affected by a huge range of factors including the composition of the pill (binders etc) and how much/when you ate food. The dosage in generics is the same as the brand in countries with good regulation.

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Altostrata

Thanks, @lxjuice, for bringing sense to this question.

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