FDA clarification on GMP's for practitioners

[Guest guest]

There is a law that was passed during the Carter administration called the

Regulatory Flexibility Act. It states that government agencies need to find

the least restrictive rules to accommodate small businesses. I suspect that

this law has always been waiting in the wings to help out private

practitioners with this GMP issue.

[source <http://www.thecre.com/pdf/Carter_RegFlexAct1980.PDF>]

 

On Tue, Mar 4, 2008 at 6:13 PM, bill_schoenbart <plantmed2 wrote:

 

> These comments expanded on the information provided in

> the Federal Register when the GMP rule was issued last June. The

> following are direct quotes:

>

> 'We did invoke enforcement discretion insofar as the final cGMP

> applies to practitioners in clinical settings.'

>

> 'To apply the GMP requirements [in these settings] would be quite

> onerous.'

>

> 'We are not going to be enforcing the GMP for practitioners in

> one-on-one consultations.'

>

> 'We are going to stay out of the individual practitioner relationship.' "

>

> This is very encouraging news regarding FDA's enforcement of the GMP's.

>

> - Bill Schoenbart

>

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

--

, DAOM

Pain is inevitable, suffering is optional.

 

 

 

[Guest guest]

The American Herbal Products Association attended a meeting today in

Washington DC titled 'Traditional s Workshop'. Below

are comments from the AHPA president about the meeting:

 

 

" I don't want to get into a full report of the day's activities except

to say that there was a lot of useful information provided by numerous

presenters from both China and the U.S. One overriding message that

came through from our Chinese colleagues – including those from the

Chinese State Food and Drug Administration – is how strongly they

believe that these medicines make important contributions to the

health of their citizens.

 

" But I am writing to focus on one presentation in particular, that of

Vasilios Frankos, Ph.D. Dr. Frankos is the Director of FDA's Division

of Dietary Supplements and so is the highest ranking official in this

FDA office.

 

" Dr. Frankos reported on the U.S. regulation of dietary supplements

and, not surprisingly, discussed the new GMP regulation. He made

several statements in relation to how this new rule will affect

practitioners. These comments expanded on the information provided in

the Federal Register when the GMP rule was issued last June. The

following are direct quotes:

 

'We did invoke enforcement discretion insofar as the final cGMP

applies to practitioners in clinical settings.'

 

'To apply the GMP requirements [in these settings] would be quite

onerous.'

 

'We are not going to be enforcing the GMP for practitioners in

one-on-one consultations.'

 

'We are going to stay out of the individual practitioner relationship.' "

 

 

This is very encouraging news regarding FDA's enforcement of the GMP's.

 

- Bill Schoenbart

[Guest guest]

FDA had previously indicated that it would consider enforcement

discretion. The indication here is that it will actually invoke

enforcement discretion with respect to individual practitioners who

compound herbal formulas for patients.

 

There are a couple of caveats to be aware of.

First, there is no guarantee of the duration of enforcement discretion.

 

Second, there is no exemption of such practitioners from the

standards. Conformance to those standards is required of small

entities by June 25, 2010 (and earlier for entities with >20

employees). From a liability perspective (which extends beyond the

risks of FDA enforcement actions), practitioners should therefore

prepare to be in compliance.

 

 

Best regards,

 

David Kailin, Ph.D., M.P.H., L.Ac.

Author, Quality in Complementary & Alternative Medicine

http://www.convergentmedical.com

[Guest guest]

If somebody is a bad player and starts getting a lot of patients sick,

of course FDA could use GMP's to bring them down. The main good news

is that they aren't targeting practitioners, so no witch hunts are on

the horizon.

 

 

 

, " convergentmedical "

<kailin wrote:

>

> FDA had previously indicated that it would consider enforcement

> discretion. The indication here is that it will actually invoke

> enforcement discretion with respect to individual practitioners who

> compound herbal formulas for patients.

>

> There are a couple of caveats to be aware of.

> First, there is no guarantee of the duration of enforcement

discretion.

>

> Second, there is no exemption of such practitioners from the

> standards. Conformance to those standards is required of small

> entities by June 25, 2010 (and earlier for entities with >20

> employees). From a liability perspective (which extends beyond the

> risks of FDA enforcement actions), practitioners should therefore

> prepare to be in compliance.

>

>

> Best regards,

>

> David Kailin, Ph.D., M.P.H., L.Ac.

> Author, Quality in Complementary & Alternative Medicine

> http://www.convergentmedical.com

>

[Guest guest]

FDA had previously indicated that it would consider enforcement

discretion. The indication here is that it will actually invoke

enforcement discretion with respect to individual practitioners who

compound herbal formulas for patients.

 

There are a couple of caveats to be aware of.

First, there is no guarantee of the duration of enforcement discretion.

 

Second, there is no exemption of such practitioners from the

standards. Conformance to those standards is required of small

entities by June 25, 2010 (and earlier for entities with >20

employees). From a liability perspective (which extends beyond the

risks of FDA enforcement actions), practitioners should therefore

prepare to be in compliance.

 

 

Best regards,

 

David Kailin, Ph.D., M.P.H., L.Ac.

Author, Quality in Complementary & Alternative Medicine

http://www.convergentmedical.com

[Guest guest]

What this comes down to is merely to pick the lowest hanging fruit first,

namely businesses who compound, then group practitioners, then single

practitioners, as they get enforcement monies and regulatory acceptance from

the next

president's appointees. They don't care if it takes 20 years. That is why it is

important to have a say in HHS and FDA bureaucracy, so we get included and

not excluded.

David Molony

 

In a message dated 3/5/08 5:01:03 PM, kailin writes:

 

 

> FDA had previously indicated that it would consider enforcement

> discretion. The indication here is that it will actually invoke

> enforcement discretion with respect to individual practitioners who

> compound herbal formulas for patients.

>

> There are a couple of caveats to be aware of.

> First, there is no guarantee of the duration of enforcement discretion.

>

 

 

 

 

 

" If in a competitive society you are sincere and honest, in some

circumstances people may take advantage of you. If you let someone do so, he or

she will

be engaging in an unsuitable action and accumulating bad karma that will harm

the person in the future. Thus it is permissable, with an altruistic

motivation, to take counteraction in order to prevent the other person from

having to

undergo the effects of this wrong action. "

Dalai Lama

 

" Liberals claim to want to give hearing to other views, but then are shocked

and offended to learn that there are other views. "

William Buckley

 

David Molony

101 Bridge Street

Catasauqua, PA 18032

Phone (610)264-2755

Fax (610) 264-7292

 

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[Guest guest]

Yes, FDA is in a position to (over)control herbalism big time. I also

expect that the screws will be tightened in the long run.

 

Having a voice in FDA policy is probably not granted equally to all

interested parties. Really big players have a dominant voice in US

politics in general. Individual herbal practitioners are just not in

the same league as Big Pharm and the AMA. Even within herbalism, the

larger manufacturers arguably have (and will continue to have) better

representation at the FDA than do individual herbal practitioners.

 

We still have 2-plus years until the cGMP for Dietary Supplements is

in full force for small entities. Conceivably enough time to draft a

Bill to exclude individual herbalists from the Final Rule, and move it

through Congress. But this would require the services of a national

association with enough interest and vision to spearhead the effort,

and enough capacity to see it through.

 

David Kailin, Ph.D., M.P.H., L.Ac.

Author, Quality in Complementary & Alternative Medicine

http://www.convergentmedical.com

[Guest guest]

Anyone here on the AAOM or whatever it's called these days? Seems like

someone better spearhead lest the herbal part of our practice become

theory without the substance.

 

Frances Gander

Athens, Ohio

[Guest guest]

Frances:

 

You can contact the AAAOM Directly at www.aaaomonline.org. The AAAOM

is a membership organization that works best when members themselves

participate and take up issues. If you don't have the time to

spearhead this yourself, one way you can help to protect the herbal

part of our practice is to make the AAAOM aware of your concerns, and

to join the organization so that your membership dollars can go

toward AAAOM Lobbyists who will make our voice heard in Washington.

 

Warmly,

 

Ray Rubio

On Mar 13, 2008, at 10:26 AM, Frances L. Gander wrote:

 

> Anyone here on the AAOM or whatever it's called these days? Seems like

> someone better spearhead lest the herbal part of our practice become

> theory without the substance.

>

> Frances Gander

> Athens, Ohio

>

>

 

Ray Rubio, D.A.O.M.

President/CEO ABORM

 

Westlake Complementary Medicine

900 Hampshire Road, Suite B/C

Westlake Village, CA 91361

Phone: (805) 497-1335

Fax: (805) 497-1336

email: rtoo

 

 

 

 

 

 

[Guest guest]

Does anyone know of a straight forward synthesis of the cGMPs Final

Rule as it would apply to an herbal practitioner? I'm trying to

understand how my small herbal dispensary would need to change in

order to become complaint. I'm getting lost in the 300+ pages of the

FDA rule and am wondering if there is an easier way to learn what

specifics are needed for compliance.

 

Thanks in advance,

 

 

Michelle N. Soucy, Lic. Ac., MAOM

Concord Center Acupuncture

91 Main St., Ste. 201

Concord, MA 01742

978-369-9400

info

www.concordcenteracupuncture.com

 

 

 

 

 

 

 

, " convergentmedical "

<kailin wrote:

 

FDA had previously indicated that it would consider enforcement

discretion. The indication here is that it will actually invoke

enforcement discretion with respect to individual practitioners who

compound herbal formulas for patients.

 

There are a couple of caveats to be aware of.

First, there is no guarantee of the duration of enforcement discretion.

 

Second, there is no exemption of such practitioners from the

standards. Conformance to those standards is required of small

entities by June 25, 2010 (and earlier for entities with >20

employees). From a liability perspective (which extends beyond the

risks of FDA enforcement actions), practitioners should therefore

prepare to be in compliance.

 

 

Best regards,

 

David Kailin, Ph.D., M.P.H., L.Ac.

Author, Quality in Complementary & Alternative Medicine

http://www.convergentmedical.com

 

--- End forwarded message ---

[Guest guest]

Hi Michelle,

you are right. this is a complicated topic.

i was participating in a committee to create a set of guidelines for

practitioners. at the moment, the focus is on creating guidelines for

schools. a meeting on this topic will take place in april for OM

schools.

 

that said; at the very least you should create a tracking system for

your herbs: when you receive them and when you dispense them: so if

there is a reaction you have a path you can follow to find the source.

If you compound your own formulas then be sure to give your patients a

copy of the invoice/ written formula, so that there is full disclosure.

 

anyway- that's a start!

hope this helps

Cara O. Frank, R. OM

Six Fishes

China Herb Company Chinese Herb Department

Tai Sophia Institute

www.carafrank.com

215-772-0770

 

On Feb 16, 2009, at 2:58 PM, Michelle Soucy wrote:

 

> Does anyone know of a straight forward synthesis of the cGMPs Final

> Rule as it would apply to an herbal practitioner? I'm trying to

> understand how my small herbal dispensary would need to change in

> order to become complaint. I'm getting lost in the 300+ pages of the

> FDA rule and am wondering if there is an easier way to learn what

> specifics are needed for compliance.

>

> Thanks in advance,

>

> Michelle N. Soucy, Lic. Ac., MAOM

> Concord Center Acupuncture

> 91 Main St., Ste. 201

> Concord, MA 01742

> 978-369-9400

> info

> www.concordcenteracupuncture.com

>

> , " convergentmedical "

> <kailin wrote:

>

> FDA had previously indicated that it would consider enforcement

> discretion. The indication here is that it will actually invoke

> enforcement discretion with respect to individual practitioners who

> compound herbal formulas for patients.

>

> There are a couple of caveats to be aware of.

> First, there is no guarantee of the duration of enforcement

> discretion.

>

> Second, there is no exemption of such practitioners from the

> standards. Conformance to those standards is required of small

> entities by June 25, 2010 (and earlier for entities with >20

> employees). From a liability perspective (which extends beyond the

> risks of FDA enforcement actions), practitioners should therefore

> prepare to be in compliance.

>

> Best regards,

>

> David Kailin, Ph.D., M.P.H., L.Ac.

> Author, Quality in Complementary & Alternative Medicine

> http://www.convergentmedical.com

>

> --- End forwarded message ---

>

>

>

[Guest guest]

Hi Michelle--

Cynthia Beehner has worked as a consultant for multiple AOM

organizations and colleges. She wrote a book that addresses the

material that you are requesting entitled " Handbook of Dispensary

Practices for Traditional Medicines: A Practical Guide for Dispensary

Practitioners. " She covers the dispensary (pharmacy) compounding

standards of the US Pharmacopeia and the cGMP standards of the FDA and

provides suggestions for compliance strategies. To borrow a quote from

the intro to the book, " the intent of this work is to state generally

applicable principles and practices in a clear & concise format with

supplementary guidance to facilitate compliance requirements. "

 

You would still need to weed through the text, develop your own

internal procedures & systems, and possibly identify areas of the

regulations that you may be unable, or unwilling, to comply with.

 

While the book is not a particularly light, enjoyable read, it comes in

at 244 pages & is MUCH easier to work through than the FDA regulations

themselves. It does not provide all of the answers, but it is a good

place to start. Cindy has already combed through the most boring part

for us.

 

As Beehner has relocated recently, she is tough to find online. You

can contact me off list for her email & phone (I do not have them

readily available right now).

 

hope this helps.

Jason Wright

Assistant Professor - Finger Lakes School of AOM at NYCC

co-chair of CCAOM Herb Committee

>

[Guest guest]

Thank you all for your help! I will reference the handbook and see

where that leads me.

 

There are many that are saying that herbal practitioners dispensing

formulas to their patients are exempt from the cGMP rules. However

there are a few also still stating that this may be a temporary

exemption. In either case, many, like myself, probably have little to

no idea what it means for a practitioner's dispensary to be cGMP

compliant. When you start to read the FDA rules it's hard to

understand how much of the manufacturing details would apply to the

small practitioner's dispensary. For example, would we need to hire

outside Quality Control staff or purchase expensive electronic

scanning devices that track inventory or reduce the potential for

human error in the mixing process? Or is it a matter of general

cleanliness, ingredient disclosure and a modest paper trail of checks

and balances?

 

Hopefully this handbook will answer these questions as I really have

no idea what cGMP would mean for my practice if or when the demand came.

 

thanks again,

 

Michelle N. Soucy, Lic. Ac., MAOM

Concord Center Acupuncture

91 Main St., Ste. 201

Concord, MA 01742

978-369-9400

info

www.concordcenteracupuncture.com

 

On Feb 17, 2009, at 10:14 PM, wrightatnycc wrote:

 

Hi Michelle--

Cynthia Beehner has worked as a consultant for multiple AOM

organizations and colleges. She wrote a book that addresses the

material that you are requesting entitled " Handbook of Dispensary

Practices for Traditional Medicines: A Practical Guide for Dispensary

Practitioners. " She covers the dispensary (pharmacy) compounding

standards of the US Pharmacopeia and the cGMP standards of the FDA and

provides suggestions for compliance strategies. To borrow a quote from

the intro to the book, " the intent of this work is to state generally

applicable principles and practices in a clear & concise format with

supplementary guidance to facilitate compliance requirements. "

 

You would still need to weed through the text, develop your own

internal procedures & systems, and possibly identify areas of the

regulations that you may be unable, or unwilling, to comply with.

 

While the book is not a particularly light, enjoyable read, it comes in

at 244 pages & is MUCH easier to work through than the FDA regulations

themselves. It does not provide all of the answers, but it is a good

place to start. Cindy has already combed through the most boring part

for us.

 

As Beehner has relocated recently, she is tough to find online. You

can contact me off list for her email & phone (I do not have them

readily available right now).

 

hope this helps.

Jason Wright

Assistant Professor - Finger Lakes School of AOM at NYCC

co-chair of CCAOM Herb Committee

>

 

 

 

 

 

 

 

[Guest guest]

I would like to chime in one more time regarding the GMP issue and

the message recently posted addressing the " exemption " of

practitioners & small dispensaries. Now, bear in mind that one can

always take the doomsayers approach to governmental oversight & it

may never end up coming to fruition, but it is worthy of

consideration none the less.

 

While the FDA has indicated that recently published current Good

Manufacturing Practices for supplements and botanicals (cGMPs) will

not be applied to private practices and college dispensaries, the

language of the cGMPs explicitly includes such dispensaries. On this

basis practitioners that combine granular extracts, blend natural

medicinals, grind, poultice, or otherwise manipulate medicinals could

be considered to be engaged in " manufacturing " .

 

I am going to beg the pardon of Mr. David Kailin & include an

extended quotation from a paper posted on his website, as his

explanation states the case well. From David Kailin's

article " Herbalists' Options Under the FDA Final Rule for Current

Good Manufacturing Practice for Dietary Supplements " found at

convergentmedical.com in the News Desk, he explains:

 

" Under the terms of the final rule, herbal practitioners who

compound formulas for individual patients are considered to be

manufacturers of dietary supplements engaged in interstate commerce,

and therefore subject to the rule. However, the FDA states " ...we

have determined that it would be appropriate for us to consider the

exercise of our enforcement discretion in deciding whether to apply

the requirements of this final rule to certain health care

practitioners, such as herbalists, acupuncturists, naturopaths, and

other related health care providers " (p.156, pre-publication copy of

final rule).

Note that considering the exercise of enforcement discretion is no

guarantee of such discretion. Nor does it constitute exemption from

the rule. Even if FDA initially chooses a policy of non-enforcement,

it may quickly change that policy at any time by processes entirely

internal to the FDA.

FDA regulations are drawn on by the courts to establish standards of

practice. The new CGMP standards will become part of the evolving

legal definition of the standard of herbal practice. The CGMP

standards will be cited by judges and lawyers when things go awry and

suits start flying. Thus it is unwise to ignore the rule in the

belief that regulatory compliance is not necessary as long as it is

not enforced by the FDA. Herbalists should begin to prepare now for

the altered legal liabilities they will face in three years. "

 

So, to automatically take for granted that private herbalists are

promised exemption may not be the best approach. What the FDA has

offered is " discretionary enforcement " which gives them the ability

to apply the rules to small practices if/when they see fit.

 

Hope this is helpful in clarifying the issue.

Jason Wright

[Guest guest]

Well said, this is opened and on the books, there isn't solid ground.

 

--- On Thu, 2/19/09, wrightatnycc <wrightpoint wrote:

wrightatnycc <wrightpoint

Re: FDA clarification on GMP's for practitioners

 

Thursday, February 19, 2009, 2:54 PM