Guest guest Posted July 6, 2009 Report Share Posted July 6, 2009 Hi, Can someone point me in the right direction w/ regard to the regulatory hoops one must jump through when creating an internally taken formula? Thank you. Martha Martha Lucas, Ph.D., L.Ac. 303-947-6224 Have Patience, be Inspired, practice Gratitude. Miracles happen. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 6, 2009 Report Share Posted July 6, 2009 Hi Martha, If you are making your formula for a single patient with a face-to-face contact, you're covered under your malpractice insurance assuming that the use of herbs is in your scope of practice. If you're making something for sale to the masses, sight unseen, that's a " dietary supplement " that is regulated by the FDA and the DSHEA law. (DSHEA=Dietary Supplement and Health Education Act) Here's a quicky tutorial to get you up to speed on DSHEA: http://gancao.net/DSHEA/ al. On Mon, Jul 6, 2009 at 12:36 PM, Martha Lucas, Ph.D., L.Ac. < drmlucas wrote: > > > Hi, > > Can someone point me in the right direction w/ regard to the > regulatory hoops one must jump through when creating an internally > taken formula? > > Thank you. > Martha > Martha Lucas, Ph.D., L.Ac. > 303-947-6224 > Have Patience, be Inspired, practice Gratitude. Miracles happen. > > -- , DAOM Pain is inevitable, suffering is optional. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 6, 2009 Report Share Posted July 6, 2009 I can plug Al Stone's short CEU on line class at gancao.net. Very comprehensive and practical, not the least in terms of language and claims. Doug , " Martha Lucas, Ph.D., L.Ac. " <drmlucas wrote: > > Hi, > > Can someone point me in the right direction w/ regard to the > regulatory hoops one must jump through when creating an internally > taken formula? > > Thank you. > Martha > Martha Lucas, Ph.D., L.Ac. > 303-947-6224 > Have Patience, be Inspired, practice Gratitude. Miracles happen. > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 6, 2009 Report Share Posted July 6, 2009 Al, That is a great service you've provided on your website. Without having read all the sections, it doesn't look like you have up to date info on GMP's and how they affect practitioners. Does anyone know a where there is a quick read on this issue, or Al, is it imbedded in your website somewhere? Thanks again, Ben al Mon, 6 Jul 2009 13:58:58 -0700 Re: regulations Hi Martha, If you are making your formula for a single patient with a face-to-face contact, you're covered under your malpractice insurance assuming that the use of herbs is in your scope of practice. If you're making something for sale to the masses, sight unseen, that's a " dietary supplement " that is regulated by the FDA and the DSHEA law. (DSHEA=Dietary Supplement and Health Education Act) Here's a quicky tutorial to get you up to speed on DSHEA: http://gancao.net/DSHEA/ al. On Mon, Jul 6, 2009 at 12:36 PM, Martha Lucas, Ph.D., L.Ac. < drmlucas wrote: > > > Hi, > > Can someone point me in the right direction w/ regard to the > regulatory hoops one must jump through when creating an internally > taken formula? > > Thank you. > Martha > Martha Lucas, Ph.D., L.Ac. > 303-947-6224 > Have Patience, be Inspired, practice Gratitude. Miracles happen. > > -- , DAOM Pain is inevitable, suffering is optional. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 6, 2009 Report Share Posted July 6, 2009 cGMP is a different animal, but I'm (literally right now) working on a document to do address the cGMP issues. Hope to have it complete inside of a month. -al. On Mon, Jul 6, 2009 at 3:25 PM, ben zappin <btz23 wrote: > > Al, > > That is a great service you've provided on your website. Without having > read all the sections, it doesn't look like you have up to date info on > GMP's and how they affect practitioners. Does anyone know a where there is a > quick read on this issue, or Al, is it imbedded in your website somewhere? > > Thanks again, > > Ben -- , DAOM Pain is inevitable, suffering is optional. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 7, 2009 Report Share Posted July 7, 2009 Thank you! On Jul 6, 2009, at 2:58 PM, Al Stone wrote: > > > Hi Martha, > > If you are making your formula for a single patient with a face-to- > face > contact, you're covered under your malpractice insurance assuming > that the > use of herbs is in your scope of practice. > > If you're making something for sale to the masses, sight unseen, > that's a > " dietary supplement " that is regulated by the FDA and the DSHEA law. > (DSHEA=Dietary Supplement and Health Education Act) > > Here's a quicky tutorial to get you up to speed on DSHEA: > http://gancao.net/DSHEA/ > > al. > > On Mon, Jul 6, 2009 at 12:36 PM, Martha Lucas, Ph.D., L.Ac. < > drmlucas wrote: > > > > > Quote Link to comment Share on other sites More sharing options...
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