More on New FDA (Herbal Supplement) Dispensary Guidelines and Procedures

Monday, September 21, 2009
Posted in: Practice Management

By Jason Luban, L.Ac.

A few days ago I posted a question about whether or not anyone knew of new FDA Good Manufacturing Process (GMP) guidelines that may apply to practitioners selling herbal supplements.  I’ve since gotten some more information from Bill Egloff at Crane Herbs (Craneherb.com).  Apparently, new FDA guidelines are going into effect that create and maintain standards, primarily for those who combine herbs or herbal medicines ("compounding" formulas).  These regulations will primarily affect schools, herbal formula manufacturers, and larger clinics that do compounding, but a new course by Marilyn Allen (see below) is aimed at practitioners.  The thinking is that, if you have been through a course where you have learned the basics of GMP guidelines, and you keep records and attempt to adhere to the GMP standards, as well as using GMP-certified herbal sources, you should have a better defense in case a patient or customer complains that the formula you gave them caused them undue harm.

I don’t know much more than this, and would welcome any comments from those who may know more.  In the mean time, I’m posting Marilyn Allen’s course flyer below, which includes contact information:

FDA Good Manufacturing Procedures:

Dispensary Guidelines and Procedures

Information You Need to Know to be in Regulatory Compliance

Saturday, August 29, 2009

Whittier, CA

Southern California University of Health Sciences

Presented by American Acupuncture Council, the Consortium for Oriental Medicine Research and Education in coordination with Marilyn Allen

There are new FDA regulations regarding good manufacturing procedures.  Schools and practitioners must be able to comply through dispensary guidelines and procedures.  It is important for you to understand these regulations to be in compliance and to keep your practice growing and thriving through your increased knowledge.  The upcoming seminars will present the necessary information and provide you with the following additional benefits:

• Continuing Education Credit
• Certificate
• A disc containing all forms you need to be compliant
• A handout to put in your Policies and Procedures notebook
• Information on the Adverse Reaction Database
• Lunch
• Vendor interactions and coupons
• A raffle
  

Topics to be discussed include: introduction to the FDA ruling, processing and product information, sanitation, equipment and utensils, record keeping, and more!

Come learn the ins and outs for your office’s dispensary in this one day seminar.  This is information you absolutely must know and incorporate.  You must be in the loop.

Just $199 for 8 CEUs (California Board) and 7 PDAs (NCCAOM)!

AND…all proceeds from this seminar will go back into building the acupuncture profession through research and legislation.

(800) 562-3335

Don’t be left behind!  Reserve your spot today!

_______________________________________________________________
Additional Dates and Locations

August 29, 2009                  Southern California University of Health Sciences (Whittier, CA)

October 3, 2009                   Texas College of Traditional Chinese Medicine (Austin, TX)

October 10, 2009                 Five Branches Institute (San Jose, CA)

November 1, 2009               American Academy of Acupuncture & Oriental Medicine

(Minneapolis/St. Paul, MN)

November 7, 2009               Acupuncture and Massage College (Miami, FL)

November 21, 2009            Phoenix Institute of Herbal Medicine & Acupuncture
                                                            (Phoenix, AZ)

December 5, 2009               Pacific College of Oriental Medicine (San Diego, CA)

December 13, 2009            Pacific College of Oriental Medicine (New York, NY)

January 30, 2010                Northwestern Health Sciences University
                                                            (Minneapolis/St. Paul, MN)

February 6, 2010                 Arizona School of Acupuncture and Oriental Medicine
                                                            (Tucson, AZ)

February 20, 2010               University of East-West Medicine (Sunnyvale, CA)

                                                          *This seminar will be conducted in Chinese

March 21, 2010                    Institute of Clinical Acupuncture and Oriental Medicine                                                            (Honolulu, HI)

March 27, 2010                    Traditional Chinese Medical College of Hawaii (Kamuela, HI)

April 3, 2010                         Five Branches Institute (Santa Cruz, CA)

April 4, 2010                         American College of Acupuncture (Houston, TX)

                                                          *Seminars in both Chinese and English this day at                                                                  this location

May 1, 2010                         Emperor’s College of Traditional Chinese Medicine
                                                            (Santa Monica, CA)

May 15, 2010                       Southwest Acupuncture College (Santa Fe, NM)

June 26, 2010                     Dragon Rises College of Oriental Medicine (Gainesville, FL)

Dates pending at several additional locations including

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