• Home
• Learn
• Lifestyle Practices
• Chinese Herbal Medicine
• References
• Herbal Compounding in Clinic

Herbal Compounding in Clinic

Summary of a Survey Exploring Best Practices for Herbal Compounding by Licensed Acupuncturists in the U.S.  

Abstract

Objective

This empirical qualitative study assessed the current beliefs of acupuncture/herbalist advocates and governing bodies regarding possible “best practices” by licensed acupuncturists (L.Ac.’s) who maintain herb clinics in the US in light of the FDA’s Final Rule.

Methodology

A survey utilizing SurveyMonkey.com software was emailed to possible participants from four major groups: 1) Government bodies who influence the practice of acupuncture. 2) Associations who work to support acupuncture profession 3) Experts working in the herbal industry. 4) Academic professionals involved in training professional acupuncturists. The survey used mainly closed questions as the realm of possible actions that can be taken by L.Ac’s regarding FDA GMP compliance is finite.

Results

Opinions expressed through the survey showed highly diverse stances about best practices in the acupuncture herbal clinic. However, the survey lead to a leading-edge document published just ahead of the submission of this capstone by the American Herbal Products Association (AHPA) that has been shared with the acupuncture governing boards regarding this matter.

Conclusion

A decade after the Final Rule was adopted by the FDA stating that licensed acupuncturists were NOT exempt from GMP regulations governing supplements manufacturing, no documentation of clear guidance from acupuncture governing boards, associations, or schools was found. Further consideration of best practices that may alleviate confusion and to protect the interests of acupuncturists on this matter are suggested.

Keywords: cGMP, acupuncture, best practices, herb compounding, compliance

Introduction

         In 2007, the US Food and Drug Administration’s (FDA’s) Good Manufacturing Practices (GMP’s) Final Rule regarding herbal supplements was presented. This legislation possibly requires licensed acupuncturists and herbalists to comply with arduous regulations; these are the same regulations required for large herb manufacturers.^[1]

The FDA did not specifically “clarify that the proposed regulations do not apply to licensed acupuncturists” as noted in an Acupuncture Today article published after the final rule was presented.^[2] In the years since the Final Rule a national professional certifying association called the American Herbalist Guild (AHG) has advocated the use of “best practices” based on GMP’s by professional herbalist for practitioners to remain compliant with FDA oversight.^[3] More recently the American Herbal Products Association published a white paper: Good Herbal Compounding and Dispensing Practices.^[4]

The intent of this study was to determine if there has been a consensus among the acupuncture community and governing boards as to actions that should be taken, if any, by US L.Ac.’s who maintain herb pharmacies in their clinics to remain compliant with FDA regulations since 2007.

Definition of Key Terms

Best Practices-Used to maintain quality as an alternative to mandatory legislated standards and can be based on self-assessment or benchmarking^[5] (whereas) preliminary evidence of effectiveness in small-scale interventions or for which there is potential for generating data that will be useful for making decisions about taking the intervention to scale and generalizing the results to diverse populations and settings.^[6]

Adulteration-Mixing something impure with something genuine, or an inferior article with a superior one of the same kind, or harmful substance with food, herbs or drink intended to be sold making it impure and unfit for human consumption.^[7]

Efficacy-The extent to which a specific intervention, procedure, regimen, or service produces a beneficial result under ideal conditions.^[8]

Food and Drug Administration (FDA)-One of the oldest U.S. Consumer Protection agencies, the FDA protects the public from unsafe foods, drugs, medical devices, cosmetics, and other potential hazards.^[9]

Good Manufacturing Practices (GMP’s)-A production and testing practice that helps to ensure a quality product. Basic concepts of these guidelines are to safeguard the health of the patient as well as producing good quality medicine….^[10]

Standard Operating Procedures (SOP’s)-set of detailed, written instructions designed to achieve uniformity of performing a specific activity (e.g., a laboratory test).^[11]

Certificates if Analysis (C of A’s)-An official document that shows the results of scientific tests on a product such as a food or drug, listing the chemicals, etc.^[12]

History

“Statement of FDA Mission: FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.”^[13]

In the late 1980s and early 1990s, the U.S. Congress was reviewing several legislative bills proposing to increase the powers of the FDA’s oversight of nutritional supplements. One of these acts, the Nutrition Advertising Coordination Act of 1991, would have created stringent regulations regarding supplement labeling. In response to the proposed bill, public grass roots movements such as the Alliance for Natural Health^[14] and health food companies joined together to lobby the government to vote against laws regulating supplements; a publicity campaign was created that implied the FDA was planning on banning dietary supplements.^[15]

The efforts of many resulted in legislation safeguarding the public’s access to dietary supplements that was introduced by Senator Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) and was called The Dietary Supplement Health and Education Act of 1994 (DSHEA); it was enacted by Congress. Signing DSHEA into law on October 25, 1994, President Clinton said:

“After several years of intense efforts, manufacturers, experts in nutrition, and legislators, acting in a conscientious alliance with consumers at the grassroots level, have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law.”^[16]

DSHEA provisions include labeling guidelines and GMP practices related to dietary supplements including herbal and botanical supplements; the law resulted in the FDA’s Final Rule. In a Statement before the House Committee on Government Reform March 25, 1999 Jane E. Henney, M.D., the Commissioner Food and Drug Administration Department of Health and Human Services stated, “DSHEA grants FDA explicit authority to establish good manufacturing practice (GMP) regulations for dietary supplements. Such regulations would be intended to establish a mechanism to help assure purity and consistency in dietary supplement products.^[17]

The FDA’s Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide specifically states that professional herbalists are not exempt from the Final Rule regulations as specified below:

Methods

A survey utilizing SurveyMonkey.com software was emailed to 115 possible participants from three major groups fitting the following criteria: 1) Government bodies who influence the practice of acupuncture. 2) Associations who work to support acupuncture profession 3) Experts working in the herbal industry. 4) Academic professionals involved in training professional acupuncturists.

The goal of the survey was to collect opinions regarding possible actions that L.Ac.’s should take regarding FDA’s oversight of practitioner herbal pharmacies in light of the Final Rule.^[19] The survey is part of an empirical qualitative study to explore any possible official guidelines provided to L.Ac’s by governing boards and associations that support the acupuncture profession in additions to opinions on the subject.

After an exhaustive internet search, emails and contacts were collected from the following locations:

• National Certification Commission of Acupuncture and Oriental Medicine (NCCAOM) website state acupuncture boards listing-33 contacts used^[20]
• Council of Colleges of Acupuncture and Oriental Medicine (CCAOM) website acupuncture schools listing-52 contacts used^[21]
• American Herbalist Guild (AHG) website member directory-30 used^[22]
• Internet search of acupuncture associations-12 used

 

Several follow-up emails were also sent to collect data and clarification as referenced and discussed in the Conclusion of this capstone.

Most survey questions were answered with a sliding bar rating the answer from 0-100 in importance or likelihood.

Of the 126 emails sent, 26 participants responded. The survey used mainly closed questions as the realm of possible actions that can be taken by acupuncturists regarding best practices by L.Ac.’s was finite. The survey was emailed to participants April 31^st and was closed March 15. Graphs and excerpts of the survey to follow show the results. 

Survey Results 

 

Survey Heading: Please tell us a bit about yourself

 

Question 1 graph clarifications:

• I am a licensed acupuncturist
• I run an herbal dispensary
• I am an educator teaching on the subject of Oriental medicine and/or herbalism
• I am associated with a government board overseeing acupuncture profession
• I am employed by an association that supports the acupuncture profession
• I am an authority in the area of cGMP as related to herbs

The following two survey questions were derived from the Good Manufacturing Practice guidelines as described by the FDA:^[23]

Heading: Overview

Q3 scale measured from left to right: unimportant/good idea/highly recommended

Q4 scale measured from left to right: will never happen/ it may happen/ it will happen

Q5 scale measured from left to right: unimportant/good idea/highly recommended

Q6 Approximately how many acupuncture clinics do you know of that have had their herbal pharmacy inspected by a government entity? Please notate what government agency if known-Example: State Health Board-None answered as confirmed

Heading: Bulk Herb Management

As part of cGMP documentation, please rate the importance of following actions that licensed acupuncturists might perform in a clinic pharmacy when managing bulk herbs in your opinion.

Q7 scale measured from left to right: unimportant/good idea/highly recommended

Q8 scale measured from left to right: unimportant/good idea/highly recommended

Heading: Bulk Herb Management Continued

Q9 scale measured from left to right: unimportant/good idea/highly recommended

Q9 scale measured from left to right: unimportant/good idea/highly recommended

Heading: Bulk Herb Management Continued

Q11 scale measured from left to right: unimportant/good idea/highly recommended

Q12 scale measured from left to right: unimportant/good idea/highly recommended

Q13 Other Recommendations:

Respondent 22 said: GMPs are primarily related to MANUFACTURING. This means that if you make a product, such as a tincture the practitioner must follow GMPs. If you are mixing food products (tinctures, granules, bulk) the product falls under food regulations. This qualifies under sanitation, health, and safe food handling regulations as governed by local township governments. I am in NJ and teach herbal medicine for an AHG accredited school. (I am a licensed acupuncturist I run an herbal dispensary I am an educator teaching on the subject of Oriental medicine and/or herbalism)

Respondent 24 said: I feel the burden of proof should be on the Vendors for herb quality and identification, rather than the acupuncture clinic. I am a licensed acupuncturist I run an herbal dispensary I am an educator teaching on the subject of Oriental medicine and/or herbalism (I am employed by an association that supports the acupuncture profession)

Respondent 18 said: Our organization (AHPA - American Herbal Products Association) has almost completed a document called "Guidance: Good herbal compounding and dispensing practices." This will be reviewed by the AHPA Board of Trustees next week and will then be provided to organizations that represent practitioners - including AAAOM and NCCAOM - for review as a template for best practices (and hopefully for endorsement, adoption, or revision by herbalists, acupuncturists, naturopaths, etc.). So my recommendation is that AHG consider reviewing this guidance once it's available - it addresses all or nearly all the points identified in this survey.

Respondent 12 said: Documentation in patient notes as to what was given, proper labeling, written instructions and potential side effects. (I am an educator teaching on the subject of Oriental medicine and/or herbalism)

Respondent 8 said: CEUs related to herbs and regulations should be a required part of every state relicensing (I am a licensed acupuncturist I run an herbal dispensary I am an educator teaching on the subject of Oriental medicine and/or herbalism I am employed by an association that supports the acupuncture profession I am an authority in the area of cGMP as related to herbs)

Heading: Custom Formula Labeling

What elements should be included on a custom formula made for a patient in an acupuncture clinic in your opinion?

Q14 scale measured from left to right: unimportant/good idea/highly recommended

Q15 scale measured from left to right: unimportant/good idea/highly recommended

Heading: Custom Formula Labeling Continued

Q16 scale measured from left to right: unimportant/good idea/highly recommended

Q16 scale measured from left to right: unimportant/good idea/highly recommended

Heading: Custom Formula Labeling Continued

Q18 scale measured from left to right: unimportant/good idea/highly recommended

Q19 scale measured from left to right: unimportant/good idea/highly recommended

Heading: Custom Formula Labeling Continued

Q20 scale measured from left to right: unimportant/good idea/highly recommended

Q21 scale measured from left to right: unimportant/good idea/highly recommended

Heading: Custom Formula Labeling Continued

Q22 scale measured from left to right: unimportant/good idea/highly recommended

Q23 scale measured from left to right: unimportant/good idea/highly recommended

Q25 Other Recommendations

Respondent 24 said: Ingredients with proportions and lot numbers/expiration dates should be kept in the patient file. Patient identifiers, dosing instructions, and expiry date should be on the medicine's packaging. (I am a licensed acupuncturist I run an herbal dispensary I am an educator teaching on the subject of Oriental medicine and/or herbalism)

Respondent 23 said: While putting the herb names on formulas may be of some benefit, it can also be problematic when patients look up the individual herbs on the internet. As such, I would not recommend listing them on the formula given to patients, but would recommend that the clinician keep a log of the ingredients and lot/batch #s of every formula dispensed in the respective patient's chart. (I am a licensed acupuncturist I run an herbal dispensary I am an educator teaching on the subject of Oriental medicine and/or herbalism)

Respondent 22 said: All of the ingredients and ratios (in pinyin latin or whatever) should be on hand if requested by the patient or as a result of potential herb/drug interactions, allergies, etc. but should not be required to be labeled for custom formulas I am a licensed acupuncturist I run an herbal dispensary I am an educator teaching on the subject of Oriental medicine and/or herbalism I am employed by an association that supports the acupuncture profession

Respondent 14 said: Item 24 copy of the label in the patient file is not appropriate. It is a solution, batter would be a copy of the formula as provided I am a licensed acupuncturist I am an educator teaching on the subject of Oriental medicine and/or herbalism I am associated with a government board overseeing acupuncture profession I am an authority in the area of cGMP as related to herbs

Respondent 12 said: Be aware of out of date herbs being used. (I am an educator teaching on the subject of Oriental medicine and/or herbalism)

Respondent 7 said: Ingredient source necessary for the dispenser not for the client; client name establishes a one-on-one consultation required to meet FDA regulatory discretion (I am an educator teaching on the subject of Oriental medicine and/or herbalism)

Respondent 4 said: Component ratios could be replaced with component weights. I am a licensed acupuncturist I am an educator teaching on the subject of Oriental medicine and/or herbalism

Heading: Standard Operating Procedures (SOP’s)

Please rank the importance of the following actions involved with maintaining Standard Operating Procedures (SOP’s) in an acupuncture clinic pharmacy in your opinion.

Q26 scale measured from left to right: unimportant/good idea/highly recommended

Q27 scale measured from left to right: unimportant/good idea/highly recommended

Q28 scale measured from left to right: unimportant/good idea/highly recommended

Q29 scale measured from left to right: unimportant/good idea/highly recommended

Survey Review

Participants

Licensed acupuncturists and those educating acupuncturists made up most respondents to the survey. Many participants were multi-disciplined as educators were typically also licensed acupuncturists, those running herbal dispensaries were also licensed acupuncturists, and so on.

• I am a licensed acupuncturist 65.38% 17
• I run an herbal dispensary 42.31% 11
• I am an educator teaching on the subject of Oriental medicine and/or herbalism 65.38% 17
• I am associated with a government board overseeing acupuncture profession 23.08% 6
• I am employed by an association that supports the acupuncture profession 19.23% 5
• I am an authority in the area of cGMP as related to herbs 11.54% 3 Total Respondents: 26

Over 30% of the participants were unaware that professional herbalists were not exempt from the Final Rule. More than 60% of respondents felt that licensed acupuncturists should maintain basic GMP paperwork in their herbal pharmacies. 42% believed that it was possible that the FDA will begin to inspect acupuncturist’s clinic herb pharmacies in the future but no one reported any incident of an inspection that they knew of specifically. Over 70% believed that acupuncture colleges should train students in GMP compliance.

Bulk Herb Management

The FDA requires record keeping as part of GMP; examples include receiving records (including records such as certificates of analysis, suppliers' invoices) and suppliers' guarantees (such as a Quality Assurance Questionnaire) showing herbalists dispensing botanicals purchase only from GMP compliant facilities.^[24] Never-the-less, pre-qualifying bulk herb suppliers/granules suppliers with a Quality Assurance Questionnaire establishing that they are in compliance with all FDA regulations overseeing handling and storage of bulk medicinal herbs only ranked in importance at 70.

Proper identification of herbs to avoid adulteration is a main concern motivating the FDA to implement GMP regulatory oversight. Regardless, respondents only ranked that Documentation of the organoleptic identification of bulk herbs used in custom formulas received from suppliers at 64 and microscopic identification at 52.

Note: Organoleptic identification of botanical materials may include

• Shape: conical (carrot), cylindrical (astragalus), tear-shaped (tuber), entire, serrate, etc.

• Color: address differences in intensities, growth stage, variegation

• Taste: sweet, salty, pungent, bitter, bland, astringent, etc.

• Smell: Aromatic, hay-like, pleasant, unpleasant; intensity

• Texture: smooth, rough, wrinkled, corky, oily, hairy, etc.^[25]

Note: Microscopic elements are defined as those too small to be seen by the unaided eye but large enough to be studied under a microscope.^[26] A microscope would be used to identify traits of herbs that cannot be identified through organoleptic methods such as herbs that are often adulterated and powdered substances.

Respondents believed that maintaining a log tracking source herb materials such as supplier receipts was important with a ranking of 69. Maintaining a log of Certificates of Analysis (CofA's) also ranked high at 64. Taking and storing samples of herbs received from suppliers had little merit in respondent’s opinions with a ranking of 44.

Custom Formula Labeling

The Final Rule specifically mandates the elements of a label for herb supplements products.^[27] However, the GMP guidelines implemented by the Cleveland Clinic for custom herb formulas seemed more appropriate for this survey; the questions used in the were derived from and Acupuncture Today article reviewing their practices.^[28]

There was a great deal of agreement on many of the elements that should be included on the label of a custom formula dispensed by a licensed acupuncturist; these items ranked at 90 or higher:

• Patient name
• Clinic contact information-address & phone number
• Licensed acupuncturist's name
• Treatment instructions

This was followed closely in ranking by the date of formulation (85), notes placed in patient's file (75), and actual ingredients pin yin names (73). Inclusion of botanical or Latin name (63), ingredients ratios (62) Source/lot #’s seemed less important to participants (54).

Standard Operating Procedures (SOP’s)

Participants felt strongly that a log of complaints should be maintained by L.Ac.s regarding custom herb formulas as it ranked at 84. The FDA Final Rule explains, “Examples of product complaints are: foul odor, off taste, illness or injury, disintegration time, color variation, tablet size or size variation, under-filled container, foreign material in a dietary supplement container, improper packaging, mislabeling, or dietary supplements that are super potent, sub potent, or contain the wrong ingredient, or contain a drug or other contaminant.^[29] However, this paperwork is suggested but not required by the Final Rule.^[30]

The FDA requires written procedures as part of GMP’s including written Standard Operating Procedures.^[31] Here is how survey respondents ranked the importance of SOP’s:

• 76-Developing a master SOP manual
• 74-Developing a housekeeping/cleaning SOP’s detailing cleaning and maintenance chores to be performed in the acupuncture clinic pharmacy
• 67-Develop SOP for qualifying outside vendors of pre-packaged vitamins and herbal supplements sold in clinic using a tool such as a Quality Assurance Questionnaire

Other Comments

When beginning this survey, I was unaware of Internal Review Board (IRB)-type guidelines; had the survey been run through an IRB, open ended comments would have likely been discourages.^{[32] [33]} Little useful information was gathered through most of the comments but the wide range of varied views on the topic of GMP for L.Ac.’s was demonstrated.

One important development did occur due to the inclusion of the comment field: Respondent 18 (see page 16) said, “Our organization (AHPA - American Herbal Products Association) has almost completed a document called Guidance: Good herbal compounding and dispensing practices."

Conclusion

When the FDA’s Final Rule pertaining to GMP was released in 2007 it quickly became apparent that the subject of compliance on the part of L.Ac.s was going to be a contentious topic among those who influence acupuncture education and regulatory compliance. This played out in an article featured in Acupuncture Today at the time^[34]and in a follow-up article issued a month later.^[35] The American Association of Acupuncture and Oriental Medicine (AAAOM) published a Position Paper on the FDA's proposed regulations on Dietary Supplements Good Manufacturing Practices which stated that acupuncturists were exempt from the new regulations. The Council of Colleges of Acupuncture and Oriental Medicine (CCAOM) disagreed.

The second article stated, “The Council of Colleges of Acupuncture and Oriental Medicine correctly interpreted that this Final Rule would not exempt individual herbal practitioners or schools...” The AAAOM stated in the same article, “We appreciate the complexity of this issue and the need for our members to be fully informed. Our intent is to analyze this systematically and thoroughly with the highest levels of expertise possible so that the community has information that it can rely upon.” However, I could find no evidence or follow-up documentation demonstrating that the CCAOM has worked to fully inform members regarding GMP compliance.

The general opinion expressed in this survey is that inspections of acupuncture herb clinics by the FDA are unlikely. However, it was expressed to me in private conversations with GMP experts that inevitably an incident of adverse effects of herbs would occur sometime in the future due to misidentification or adulterated material. Such an incident could motivate the FDA to begin inspecting acupuncture clinics who dispense granules and/or bulk herbs.

Just such an occurrence happened in March of 2007 when a woman died due to aconite poisoning in San Francisco; the news went national.^[36] A Chinese herbalist was reported to have dispensed formulas with unprepared aconite that killed the woman and landed a man in the hospital. While the Chinese herbalist was not reported as having an acupuncture license,^[37] the general public and the FDA are unlikely to discern the qualifications of an untrained herbalist and a qualified one in my opinion. It should be noted that qualified herbalists and L.Ac. are not immune from egregious mistakes such as those documented by the NCCAOM Disciplinary Committee.^[38]

It was my hope that during this research I would unearth current guidelines outlining herb clinic best practices that L.Ac.’s could perform to remain compliant as dictated by one or more of the governing boards and/or associations advocating for the practice of acupuncture. Such guidance and documentation may exist, but I was unable to find it. I performed exhaustive internet searches and followed-up the survey with calls and emails to acupuncture boards and associations to no avail. Because the language in the Final Rule and subsequent documents relating to the subject have been vague, there appear to be perceived legal risks associated with formally commenting on herbal compounding best practice. This, complicated by the fact that acupuncture professional governing boards and schools cannot come to an agreement among themselves on appropriate best practices, appears to have resulted in an impasse on the matter by the acupuncture community.

Alternatively, the herbal industry has clearly taken lead in this matter providing sensible best practices guidelines for professional herbalists as provided by the American Herbalist Guild (AHG)^[39], American Herbal Pharmacopoeia (AHP),^[40] and now the Natural Herbal Products Association (AHPA). At the final hour before this study was due for submission, the president of the AHPA, Michael McGuffin, emailed an attachment of a white paper the association had developed called Good Herbal Compounding and Dispensing Practices.^[41] Mr. McGuffin had participated in the survey and kindly offered to provide this new document for inclusion in this capstone after it had been shared with governing bodies such as the NCCAOM as a matter of procedure.

Upon reviewing the AHPA’s 20-page white paper it is my opinion that this effort is an excellent example of sensible guidelines of best practices that licensed acupuncturists can implement in their herbal clinics. Mr. McGuffin commented (see page 16) that the document “will be provided to organizations that represent practitioners - including AAAOM and NCCAOM - for review as a template for best practices (and hopefully for endorsement, adoption, or revision by herbalists, acupuncturists, naturopaths, etc.).” The document generously “grants permission to other organizations for the creation of derivative works based on this document…”.

It is clear from the survey results that most participants felt that licensed acupuncturists should be maintaining some type of written standard operating procedures in their herb pharmacies insuring proper identification of botanicals to avoid adulteration. The survey also demonstrated that many L.Ac.’s are unaware that they are technically overseen by the FDA. It was also apparent that using the term “Best Practices” is preferred over “cGMP” when discussing this topic in regard to L.Ac.’s. I am hopeful that the AHPA white paper will be distributed to every practicing acupuncturist in the U.S. and be implemented in their herbal clinics. It is also my hope that acupuncture governing boards, associations, and schools can come together and endorse this guidance for use by L.Ac.’s or make a similar effort pertaining to herbal pharmacy best practices. I

My limitations due to inexperience in the field of research renders this survey and the results inconclusive; while the results are not definitive, they do demonstrate a need for clarification and further investigation about herb compounding best practices as it pertains to licensed acupuncturists. I attempted to break down the survey results by opinions expressed by the different groups of participants thinking that L.Ac’s opinions might be different from educators or GMP experts; this was incorrect. Rather, the survey responses clearly demonstrated varied opinions among all groups on what actions licensed acupuncturist should take to remain compliant with FDA regulations, if any.

Further study by qualified research professionals to help determine basic best practices in herbal dispensaries for L.Ac.’s is recommended.

Acknowledgment

I would like to express my sincere gratitude to my advisor Dr. Robyn Grieve continuous support of my DAOM study and research. Thank you for your patience, motivation, enthusiasm, and immense knowledge. A special thanks to Michael McGuffin and the American Herbal Products Association for their efforts on the white paper: Good Herbal Compounding and Dispensing Practices, and for providing the document ahead of publication for inclusion in this study.

References

Attachment: American Herbal Products Association. White paper: Good herbal compounding and dispensing practices. March 2017. AHPA: Silver Spring, MD