latest cGMP

[Guest guest]

Well folks, here it is...

 

I got this from Crane Herb.

 

Comment 32) Many comments question the ruleUs applicability to various

practitioners

such as herbalists, acupuncturists, naturopaths, and other health care providers

who

prepare individualized herbal formulas for specific individuals on a

case-by-case basis.

Most comments say such practitioners should not be covered by the rule. These

comments

give various reasons to justify their position, including:

%These practitioners do not broadly sell products;

These practitioners make very small quantities of individualized formulas, and

can

therefore be very selective as to the quality of ingredients used;

The testing and storage requirements of each finished batch cannot apply to a

small

dispensary where several different modified herbal formulas are prepared each

day;

Based on the projected costs to implement CGMPs, it would be virtually

impossible for an

individual practitioner or university clinic to develop the necessary quality

control unit,

maintain reserve samples, maintain the required paperwork, or retrofit clinics

to comply

with the rule;

%Many States regulate or license these practitioners, so further Federal

regulation is

unnecessary;

%Some practitioners do not consider themselves to be manufacturers;

In an analogous situation, compounding pharmacists are not required to comply

with

drug CGMPs; and

Despite the growing number of such practitioners, there is no proof that

greater harm has

occurred to the general public from the herbs these practitioners sell.

 

(Response) We stated in the 2003 CGMP Proposal (68 FR 12157 at 12175) that we

declined

to exempt herbalist practitioners from the proposed rule. We continue to believe

that the

risks of adulteration are not eliminated just because the practitioner is an

herbalist, and

therefore, such an exemption should not be included in this final rule. However,

after

further consideration, 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.

We find it noteworthy that the comments identified two potential safeguards that

could

support the exercise of our enforcement discretion on whether to apply the

requirements

of the final rule to certain practitioners:

(1) Adequate training in the professional practice and (2) an individual client

and

practitioner relationship. For example, comments claimed that the practitioners

receive

adequate training to formulate dietary supplements and that they provide the

dietary

supplements to individuals in the course of a one-on-one consultation on the

premises of

the practitioner. One comment from a practitioner states that she received her

training

from an accredited 4year university and it included didactic and clinical

training in

acupuncture and Chinese herbs. Another comment from an organization provides

detailed

training guidelines for practitioners, including 1,600 hours of training, 400

hours of which

should include clinical work. Moreover, many comments also assert that the

practitioners

are different from dietary supplement manufacturers because they formulate the

dietary

supplements in the course of a one-on-one consultation at their premises. That

enables

them to ensure the formulations are made to meet the specific needs of the

individuals.

We believe that a one-on-one consultation by a practitioner who is adequately

trained in

their profession may not necessitate the same types of controls as we are

establishing in

this final rule for manufacturing activities that are on a larger scale. Such a

practitioner

may make some formulations in advance of the consultation and still make the

formulations in very limited quantities for the individual client. We believe

that it would be

appropriate to consider the exercise of our enforcement discretion, on a

case-by-case

basis, to determine whether to apply the requirements of this final rule to such

persons.

We do not expect the number of those subject to the consideration of our

enforcement

discretion to be very large. Many products that are manufactured by

practitioners would

not necessarily be considered to be dietary supplements (e.g., certain products

used by

traditional Asian medicine practitioners). Further, we are not considering

exercising our

enforcement discretion with respect to practitioners who prepare batches of

herbs and sell

them to individual consumers without determining whether the dietary supplement

is

appropriate for each consumerUs needs in a one-on-one personal consultation, or

those

that prepare batches of a dietary supplement for which there is a known or

suspected

safety concern.

....

 

Any comments??

 

Looks to me like the FDA is holding the ace card for future actions.

It reminds me of what they said about Ma Huang.

Anyway, there you have it.

 

regards,

dr.w