Guest guest Posted November 14, 2007 Report Share Posted November 14, 2007 I was told by a chinese herbalist friend of mine in N.C., USA, that, new herbal laws slated to be in effect soon, would restrict one from compiling herbal prescriptions, unless (s)he were registered as a manufacturer. Which means, any formula given or sold to someone, must be purchased pre-mixed by a manufacturer. I'm not sure I understand this correctly. Can someone please unlighten me? Thanks. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 14, 2007 Report Share Posted November 14, 2007 Your friend in NC is probably referring to the new Current Good Manufacturing Practice (cGMP) governing dietary supplements (including herbs) adopted in June 2007 by FDA. The new regulation does not require registration but does require any dietary supplement manufacturer to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. While it is true that individual compounding herbalists were not exempted from this regulation, FDA has indicated that they would use " enforcement discretion " in deciding whether to apply the cGMP to individual herbalists as long as the herbalist meets certain criteria. Namely... 1. Are appropriately trained to prescribe herbs; 2. Provide individualized, appropriate herbal formulations based upon a one-on-one personal consultation; and 3. Avoid the use of dietary supplements or dietary ingredients— including herbs—that pose a known or suspected safety concern. Rather than going into all the details here, you can read more on the CSOMA website... http://www.csomaonline.org/i4a/pages/index.cfm?pageid=3401 Regards, Bill Mosca -- Bill Mosca, LAc Executive Director California State Oriental Medical Association (CSOMA) 703 Market Street, Suite 250 San Francisco • CA • 94103-2100 [Toll Free Voice]: (800) 477-4564 • [Fax]: (415) 357-1940 : bill • [Website]: csomaonline.org On Nov 14, 2007, at 12:50 PM, ykcul_ritsym wrote: > I was told by a chinese herbalist friend of mine in N.C., USA, that, > new herbal laws slated to be in effect soon, would restrict one from > compiling herbal prescriptions, unless (s)he were registered as a > manufacturer. Which means, any formula given or sold to someone, must > be purchased pre-mixed by a manufacturer. > I'm not sure I understand this correctly. Can someone please > unlighten me? Thanks. > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 14, 2007 Report Share Posted November 14, 2007 Yes, that was exactly it. Thanks Bill. Bill Mosca <mosca wrote: Your friend in NC is probably referring to the new Current Good Manufacturing Practice (cGMP) governing dietary supplements (including herbs) adopted in June 2007 by FDA Get easy, one-click access to your favorites. Make your homepage. Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.