In March 2003, the U.S. Food and Drug Administration (FDA) approved new guidelines for acupuncturists dispensing herbs. According to the FDA, Chinese herbs are classified as dietary supplements.The current Good Manufacturing Practice (cGMP) guidelines can be difficult to understand since they are complicated by legal terminology. You can access the guidelines online by clicking here.
What do these regulations mean to the profession? How will they affect practitioners? Will it affect the distribution of herbs and herbal formulas? Of course, these are many diversified opinions concerning the cGMP regulations. One issue that seems to unite most acupuncturists is that practitioners cannot be in cGMP compliance. David Kailon, LAc, studied the regulations and came to the conclusion that complete compliance for a practitioner would be achieved at the financial cost of $60,000 to $65,000. So the generally accepted opinion is that we can follow compliance but can't be totally compliant. From this has come the idea that practitioners will be able to follow compliance through compounding and dispensing guidelines and policies. This is a necessary first step on our road to compliance with the new regulations.
In many ways, this discussion of practitioner compliance reminds me of the various opinions that were discussed when the Health Insurance Portability and Accountability Act (HIPAA) was first enacted. When all those discussions were said and done, acupuncturists across the country were classified as "covered entities."
One thing that most acupuncturists agree upon is that the profession must present a unified front in regard to the compliance issue. Several of the leading minds in acupuncture and Oriental medicine have been taking the time to study compliance matters and elicit responses from the profession. Kevin Engil and Jason Wright from the New York School of Acupuncture, along with Al Stone, LAc, in California, are examining various aspects of the compounding and dispensing issue.
Greg Zimmerman, LAc, and Eric Brand have studied and researched the pertinent issues relating to acupuncturists in private practice. Greg and Eric have now completed teaching two seminars. The material covered is sourced back to the cGMP compliance document itself, various books, and a range of consultants with knowledge of the cGMP.
One of the attendees at the seminar provided the following as feedback: "I attended the Herbal Dispensary Guidelines and Procedures seminar today. Whenever the government creates new rulings, there is always a problem translating. So much of the ruling is gray instead of black and white. Today, we were given a clear roadmap of how to prepare for the June 2010 deadline for the cGMP. For us to be fully protected, we need to know not only how to prepare, but also who is there to protect us if the issues are gray. I walked out inspired that I am no longer going to be alone in my practice. In the seminar, you will learn how unseen forces within our industry are coordinating with each other and us to be proactive with the government agencies. I also left knowing that I was on the cutting edge of current knowledge in our industry, so much was discussed in a very dynamic atmosphere with the top experts in our field."
Thanks for attending the seminar and for such a nice evaluation.
I've included a picture of attendees at the first dispensary guidelines seminar. Thanks to all of the participants. I look forward to many more stops on the profession's road to compliance with the cGMP.
Click here for more information about Marilyn Allen, Editor-at-Large.