GMP applies to individual compounding of formulas

[Guest guest]

I wanted to alert people to comment on this to the FDA: Note that even if

all your herbs are locally grown, your containers or dropper bottles may put

you under federal regulation.

 

> Regarding GMPs. The FDA estimated that approximately 50% of the

> existing companies will not be able to comply. Thus, they will be put

> out of business. However, the economic impact of this has, as well

> as FDA's economic impact estimates have been heavily challenged by

> AHPA on behalf of small companies. What should be of greater concern

> to practitioners is that GMPs also apply to practitioners compounding

> for individual patients. As far as I know, AHG and AHP were the only

> organization submitting comments regarding this. I alerted AANP and

> the TCM community but heard nothing from them. It is a very bad

> precedent if this requirement is not removed from the GMP proposals.

> --

As a point of clarification regarding the proposed GMPs; FDA has

established in case law that any materials used in the manufacturing

or packaging of products that have been subject to interstate

distribution; droppers, bottles, AAPER alcohol, plastic bottles, etc.

constitutes interstate commerce and thus are subject to federal

regulations.

 

> Roy Upton, Herbalist

> Executive Director

> American Herbal Pharmacopoeia

>

 

 

Karen Vaughan

Creation's Garden

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Brooklyn, NY 11215

 

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