Guest guest Posted June 12, 2003 Report Share Posted June 12, 2003 From the FDA at http://www.cfsan.fda.gov/~lrd/fr030313.html: " Section 402(a)(4) of the act states that a food is deemed adulterated if ``it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.'' One comment to the ANPRM, relating to the scope of the CGMPs, requested an exemption from the CGMP for ``herbalist'' practitioners who individually manufacture dietary supplements for their clients. We decline to exempt herbalist practitioners from the proposed rule. If an herbalist practitioner introduces or delivers for introduction into interstate commerce, a dietary ingredient or dietary supplement, that practitioner must use the same good manufacturing practices as other manufacturers to ensure that their clients receive dietary supplements that are not adulterated. The risks of adulteration are not eliminated just because the practitioner is an herbalist. Therefore, we decline to exempt ``herbalist'' practitioners who manufacture dietary ingredients and dietary supplements. Herbalist practitioners who introduce or deliver for introduction into interstate commerce, a dietary ingredient or dietary supplement, are manufacturers who must meet CGMPs. " Mercy Yule wrote: FDA rules can come in to play if one is engaged in " interstate commerce " which can include buying as well as selling across state (or national) lines. Does anyone else know if this is true about buying across state lines. Look at the last line of the quote from the FDA above. It refers to one who INTRODUCES or DELIVERS an herb into interstate commerce. It says nothing about any compliance issues for one who RECEIVES an herb through interstate commerce. And there would be no need for this. Because if the seller is in compliance then the buyer has received an unadulterated product when it crossed state lines. If the buyer then re-packages the product AFTER it has crossed state lines, then this is now a state regulatory issue. The FDA would have no jurisdiction. However we should be concerned that states will model their laws after this FDA rule, thus imposing the restrictions on the local level. On the other hand, we should be very suspicious that this is just another attempt to generate hysteria about regulations that are NOT focused on all practitioners, but only herbalists who SELL across state lines. Much of this rule I would support. In fact, I would support the whole thing if this interpretation about interstate commerce is wrong and I think it may be. the supplement market is a disaster right now. and the " food handling " in most private clinics and schools is atrocious. there is need for real reform. but we should have to abide by the regulations of those who make food products in restaurants, not the manufacturers who package and process raw ingredients. I know the FDA has explicitly said that herbs are not foods and cannot be regulated in the exact same fashion, but rather just modeled on food regs. But I would argue that our licensing laws and scope of practice give another potential layer of security to our practices. The rules for laypersons and companies should not apply to us. As licensed practitioners, we should be exempt if we follow certain food handling and record keeping rules (just like pharmacists are). We need to distance ourselves from the greedy supplement manufacturers who are dumping worthless and dangerous products on the market due to no real GMP regs in place and also distance ourselves from the unlicensed lay herbalists. We have no interest in protecting the former group. As I have argued many times, they are not our allies, they are our enemies. As for the latter group, I believe we can longer shield them and sacrifice ourselves. Many of them don't deserve to shielded anyway, being uneducated and often dangerous, IMO. It is unfortunate that those lay herbalists who are great herbalists cannot be protected by our scope of practice anymore. But the current political climate is not going to exempt non professional lay herbalists from manufacturing laws. However we have a chance, but only if we choose the right allies. tough choices. But I will not lose my access to herbs in order to protect either of these other interests. Chinese Herbs " Great spirits have always found violent opposition from mediocre minds " -- Albert Einstein Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 12, 2003 Report Share Posted June 12, 2003 There is an article, " Herbal Lottery, " in the June 7, 2003 issue of Science News (Vol. 163, pp. 359-361) which reports on many of the issues and concerns about herbal regulation discussed in this forum. It discusses herb quality and efficacy (in terms of ingredients), proposed FDA regulations, GMPs, small vs. large nutraceutical companies, and the difficulty of creating rules and standardization for the complexity of herb biology. A good overall summary, except they do not mention Chinese medicine or other herbalists at all. They estimate that first-year costs for small firms adopting the new FDA rules, if implemented, would be about $100,000, with annual costs of $60,000 (and they say these figures are probably substantially underestimated). Pat ============================================================================== NOTE: The information in this email is confidential and may be legally privileged. If you are not the intended recipient, you must not read, use or disseminate the information. Although this email and any attachments are believed to be free of any virus or other defect that might affect any computer system into which it is received and opened, it is the responsibility of the recipient to ensure that it is virus free and no responsibility is accepted by Cadwalader, Wickersham & Taft LLP for any loss or damage arising in any way from its use. ============================================================================== Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 12, 2003 Report Share Posted June 12, 2003 Mercy Yule wrote: FDA rules can come in to play if one is engaged in "interstatecommerce" which can include buying as well as selling across state (ornational) lines. Does anyone else know if this is true about buying across state lines. Yes, Mercy Yule has correctly and succinctly represented the case. A meeting of Chinese herbal manufacturers occurred just recently to address this point and be advised by AHPA regarding FDA rules. The cost of even the cheapest herbal products that you are used to seeing will increase do to the extra costs of FDA due diligence. Some will skyrocket. But that's just the manufacturer and distributor side of the equation. Implementation of this is still in it's evolution, but the reality of it looks fairly inevitable. The equation goes on to address individual practitioners in their offices. If you then compound and/or encapsulate for sale to patients, you are also subject to FDA rules which actually preempt state law. I don't pretend to know what that legally means. Again how this will be implemented, much less enforced, is all a matter of conjecture. It is, however, inevitable. Welcome to professional development in the U.S. This is part of the initiation of professional practice which wants to evolve into recognition of it's professional efficacy. As you come into your professional authority, you, of course, also come into your professional due diligence in all areas and the associated levels of regulation. What you might not have yet thought about is your rising costs of malpractice insurance. To protect your future happiness, start soon to consider what Mercy Yule's national organization can offer you regarding this. Issues and costs of malpractice may become bigger than you might be able to anticipate from this moment. All the Best, Emmanuel Segmen Merritt College, Asia Natural Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 13, 2003 Report Share Posted June 13, 2003 On Thu, 12 Jun 2003 11:13:49 -0400 " Pat Ethridge " <Pat.Ethridge wrote: > There is an article, " Herbal Lottery, " in the June 7, 2003 issue of Science > News (Vol. 163, pp. 359-361) which reports on many of the issues and > concerns about herbal regulation discussed in this forum. [....]A good overall summary, except they do not mention Chinese > medicine or other herbalists at all. > We have got to overcome this invisibility. > They estimate that first-year costs > for small firms adopting the new FDA rules, if implemented, would be about > $100,000, with annual costs of $60,000 (and they say these figures are > probably substantially underestimated). > Thank you for mentioning this article, Pat. -Laurie Burton Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 13, 2003 Report Share Posted June 13, 2003 > Thu, 12 Jun 2003 11:13:49 -0400 > " Pat Ethridge " <Pat.Ethridge > Re: FDA proposed rule > > There is an article, " Herbal Lottery, " in the June 7, 2003 issue of Science > News (Vol. 163, pp. 359-361) which reports on many of the issues and > concerns about herbal regulation discussed in this forum. It discusses > herb quality and efficacy (in terms of ingredients), proposed FDA > regulations, GMPs, small vs. large nutraceutical companies, and the > difficulty of creating rules and standardization for the complexity of herb > biology. A good overall summary, except they do not mention Chinese > medicine or other herbalists at all. They estimate that first-year costs > for small firms adopting the new FDA rules, if implemented, would be about > $100,000, with annual costs of $60,000 (and they say these figures are > probably substantially underestimated). > > Pat If this is referring to the same thing I read the other night (and forgive me, this may have been discussed on CHA already- I don't always read every post): [Federal Register: March 13, 2003 (Volume 68, Number 49)] " SUMMARY: The Food and Drug Administration (FDA) is proposing current good manufacturing practice (CGMP) regulations for dietary ingredients and dietary supplements. The proposed rule would establish the minimum CGMPs necessary to ensure that, if you engage in activities related to manufacturing, packaging, or holding dietary ingredients or dietary supplements, you do so in a manner that will not adulterate and misbrand such dietary ingredients or dietary supplements. The provisions would require manufacturers to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements. The proposed rule is one of many actions related to dietary supplements that we (FDA) are taking to promote and protect the public health. " http://www.cfsan.fda.gov/~lrd/fr030313.html What I picked up on (since my wife and I run a small powder/liquid pharmacy prescription service for PCOM and a few other practitioners around the country) is the language PACKAGING and HOLDING. That would apply to anyone who holds herbs and then mixes and/or packages them. All practitioners with pharmacies of their own, all manufacturers, all herb shops. You not only have to not ADULTERATE them, which should be easy (then again, does that require clean-room environments, space suits, what? We have a " clean needle " technique book, organization, and licensing requirement. Perhaps we need an equally specific and regulated " clean herbal formula preparation " technique.), or MISBRAND them (don't know what that means - any ideas? Is that just mislabeling?). Manufacturers would have to do processes that are expensive, but we are not manufacturers- we're more like pharmacies that do compounding... but even simpler. B Brian Benjamin Carter, M.Sci., L.Ac. http://www.pulsemed.org/briancarterbio.htm Acupuncturist & Herbalist Editor, The Pulse of Oriental Medicine Columnist, Acupuncture Today (619) 208-1432 San Diego (866) 206-9069 x 5284 Tollfree Voicemail The PULSE of Oriental Medicine http://www.pulsemed.org/ The General Public's Guide to Chinese Medicine since 1999... 9 Experts, 240+ Articles, 195,000+ readers.... Our free e-zine BEING WELL keeps you up to date Sign up NOW. Send a blank email to: beingwellnewsletter- Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 13, 2003 Report Share Posted June 13, 2003 In a message dated 6/13/03 1:59:11 AM, Pat.Ethridge writes: There is an article, "Herbal Lottery," in the June 7, 2003 issue of Science News (Vol. 163, pp. 359-361) which reports on many of the issues and concerns about herbal regulation discussed in this forum. It discusses herb quality and efficacy (in terms of ingredients), proposed FDA regulations, GMPs, small vs. large nutraceutical companies, and the difficulty of creating rules and standardization for the complexity of herb biology. A good overall summary, except they do not mention Chinese medicine or other herbalists at all. They estimate that first-year costs for small firms adopting the new FDA rules, if implemented, would be about $100,000, with annual costs of $60,000 (and they say these figures are probably substantially underestimated). Pat So one might consider this an anti small business regulatory action? Has anyone approached the NAtional Federation for Independent Business? David Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 16, 2003 Report Share Posted June 16, 2003 , " Brian Carter " <bbcarter@p...> wrote: > > What I picked up on (since my wife and I run a small powder/liquid pharmacy > prescription service for PCOM and a few other practitioners around the > country) is the language PACKAGING and HOLDING. That would apply to anyone > who holds herbs and then mixes and/or packages them. All practitioners with > pharmacies of their own, all manufacturers, all herb shops. > > Manufacturers would have to do processes that are expensive, but we are not > manufacturers- we're more like pharmacies that do compounding... but even > simpler. > Brian You picked up right. that is definitely what the rule says. the schools need to move on this now. the schools are the largest purchasers of chinese herbs outside manufacturers of prepared products. the manufacturers all know what's up and will either fight, comply or fold. But I would guess that half the schools in the country, if not more, would have to give up prescribing raw herbs or mixed powders due to unacceptable costs. The schools would have to batch test every single formula filled. this is a potential serious threat depending on how the interstate commerce clauses are interpreted. This could completely destroy our profession overnight if the schools could not supply raw herbs to patients and thus not train students in this art. As long as our herbs did not cross state lines, the FDA can't do anything, so there are ways around this. But few states besides California could generate enough income for local herb phamracies to justify the costs involved. wouldn't be ironic if we had to send our patients to Rite-aid to have their rx filled either because rite-aid could afford the costs or because the existing pharmacist exemption would extend to mixed herbs. In fact, I am sure it does, as pharmacists used to mix herbs on their premises under controlled regulated conditions. they are still legally allowed to do this in most states as far as I know. the passage of this law could perhaps creat opportunities for privately owned compounding pharmacies. schools could perhaps circumvent this matter by establishing compounding pharmacies on their premises. they would thus not be required to pay the exorbitant costs as the state allows them to manufacture small batches due to the legally regulated role they play as intermediaries between patients and licensed px. It should be a simple matter to establish that same linkage for us. While this would help small pharmacies unless the big boxes swooped it all up, it would force private px to either use only unmixed patents, do business only with local suppliers (not easy for some) or sacrifice an essential part of their income. As all courses on making 100 grand a year tell you, in house herb sales are the key. But we may soon have to contend with a loss of that privilege. MD's long ago lost the right to compound and sell medicnal substances in their offices. That right is forever given to another profession. Pharmacy. I not supporting this, but there is a precedent for this type of move in TCM. And if we want to be like them in every professional way, this might be one of the sacrifices. an ironic possible solution to this government theft of our right to practice freely is kind of a hippy one. cooperative herbal compounding pharmacies established by local px. Hopefully they would be regulated as exempt pharmacies. the local pharmacies would be funded my members dues. The economies of scale would allow bulk herb purchasing at volume discounts. costs to patients would decrease and it could easily be set up to allow px to still generate profit. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 16, 2003 Report Share Posted June 16, 2003 < wrote: "As all courses on making 100 grand a year tell you, in house herb sales are the key." I don't think herb sales are always such a big portion of a practitioner's practice. For example, let's say a person sees 40 patients per week at $50 per visit for 50 weeks per year (40 x $50 x 50 = $100,000). Let's say you gave each patient one bottle of herbs each week. For simplicity sake, let's take a Blue Poppy formula at a cost of $9.50 and a retail price of $17.95. That's a profit of $8.45 per patient...carry out the formula and you get 40 x $8.45 x 50 = $16,900; so almost 17%. But, that's assuming you have 100% of your patients taking herbs. IMHO, 50% might be a more realistic number. Therefore, a practitioner's income from herbal medicine would be more like $8,450; a mere 8.5% of total income. Nothing to sneeze at, but certainly not a make or break situation. Something for consideration. Regards, Eric Popp SBC DSL - Now only $29.95 per month! Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 16, 2003 Report Share Posted June 16, 2003 Brian and All, I hate to even broach this subject after the wonderful glow of acknowledgements for the good conference. But let me dip my toe in here for a moment. The cost of due diligence for manufacturers may be anywhere from $30,000 to start to $100,000 or more depending on the level of work the company is doing. After a few years of economic decline in America and the many blows of Prop 65, I can't imagine even the strongest of the companies dealing with this in stride. Presumably companies have three years to comply, yet it may be quite challenging for many. My bet is that some product lines or companies may get bought out by larger entities which I won't go into on this post. My concern for you and other kindred souls on this list is that the best of CM in my own humble mind is when you put together bags of raw noble herbs as formulas for your patients. In addition some of you compound dry dosage extract. Merely stocking any and all of these items becomes an issue under the new FDA guidelines. My hope is that even under the new guidelines that current practice will continue to be accepted for individual practitioners and small clinics. I personally know of many MDs that stock medicine either as samples or from wholesale purchasing. They then dole out various amounts to patients for free or at a small profit. Is this a legal practice? I'd always assumed it was either acceptable or simply overlooked. Generally individuals or companies have to hit about $500,000 per year of any given item for you to even hit the FDA radar. That includes even a manufacturer. So a small clinic or herbal pharmacy could put things in bottles and label those bottles and sell them to your patients. Technically even under current law, your label has to meet a myriad of specifications including font size and nutritional information. Generally practitioners and small clinics in my opinion will not get bothered by FDA inspectors. You don't meet the $500,000 per year radar levels. Unless ..... (and this is ugly!) .... unless someone "complains" specifically to the FDA. Not a nice thing. I won't name names, but a company here in CA got many sister companies busted on Prop 65. You might have noticed that some of those CEOs endured hundreds of thousands of dollars in penalties and changed the names of their companies or left the state. That sort of thing is worrisome for companies but not generally for a small clinic or a small herbal pharmacy. School pharmacies might not fly under the radar since they are a part of accredited institutions. They might need to do what Elephant Pharmacy in Berkeley has done. At that store there is a regular licensed pharmacist hired right out of U.C.S.F. Medical Center to operate the regular prescription pharmacy. In addition there are L.Ac.s hired to advise customers regarding sales of raw herbs and bottled herbal products. From this model I can envision a school clinical pharmacy hiring a licensed pharmacist to meet FDA standards under upcoming laws. I wonder how you would feel about that at PCOM? Emmanuel Segmen - Monday, June 16, 2003 10:00 AM Re: FDA proposed rule , "Brian Carter" <bbcarter@p...> wrote:> > What I picked up on (since my wife and I run a small powder/liquid pharmacy> prescription service for PCOM and a few other practitioners around the> country) is the language PACKAGING and HOLDING. That would apply to anyone> who holds herbs and then mixes and/or packages them. All practitioners with> pharmacies of their own, all manufacturers, all herb shops.> > Manufacturers would have to do processes that are expensive, but we are not> manufacturers- we're more like pharmacies that do compounding... but even> simpler.> BrianYou picked up right. that is definitely what the rule says. the schools need to move on this now. the schools are the largest purchasers of chinese herbs outside manufacturers of prepared products. the manufacturers all know what's up and will either fight, comply or fold. But I would guess that half the schools in the country, if not more, would have to give up prescribing raw herbs or mixed powders due to unacceptable costs. The schools would have to batch test every single formula filled. this is a potential serious threat depending on how the interstate commerce clauses are interpreted. This could completely destroy our profession overnight if the schools could not supply raw herbs to patients and thus not train students in this art. As long as our herbs did not cross state lines, the FDA can't do anything, so there are ways around this. But few states besides California could generate enough income for local herb phamracies to justify the costs involved. wouldn't be ironic if we had to send our patients to Rite-aid to have their rx filled either because rite-aid could afford the costs or because the existing pharmacist exemption would extend to mixed herbs. In fact, I am sure it does, as pharmacists used to mix herbs on their premises under controlled regulated conditions. they are still legally allowed to do this in most states as far as I know. the passage of this law could perhaps creat opportunities for privately owned compounding pharmacies. schools could perhaps circumvent this matter by establishing compounding pharmacies on their premises. they would thus not be required to pay the exorbitant costs as the state allows them to manufacture small batches due to the legally regulated role they play as intermediaries between patients and licensed px. It should be a simple matter to establish that same linkage for us. While this would help small pharmacies unless the big boxes swooped it all up, it would force private px to either use only unmixed patents, do business only with local suppliers (not easy for some) or sacrifice an essential part of their income. As all courses on making 100 grand a year tell you, in house herb sales are the key. But we may soon have to contend with a loss of that privilege. MD's long ago lost the right to compound and sell medicnal substances in their offices. That right is forever given to another profession. Pharmacy. I not supporting this, but there is a precedent for this type of move in TCM. And if we want to be like them in every professional way, this might be one of the sacrifices. an ironic possible solution to this government theft of our right to practice freely is kind of a hippy one. cooperative herbal compounding pharmacies established by local px. Hopefully they would be regulated as exempt pharmacies. the local pharmacies would be funded my members dues. The economies of scale would allow bulk herb purchasing at volume discounts. costs to patients would decrease and it could easily be set up to allow px to still generate profit.Todd Chinese Herbal Medicine, a voluntary organization of licensed healthcare practitioners, matriculated students and postgraduate academics specializing in Chinese Herbal Medicine, provides a variety of professional services, including board approved online continuing education. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 16, 2003 Report Share Posted June 16, 2003 , Eric Popp <epopp3267> wrote: > > I don't think herb sales are always such a big portion of a practitioner's practice. For example, let's say a person sees 40 patients per week at $50 per visit for 50 weeks per year (40 x $50 x 50 = $100,000). one flaw I see here, I think. Half that revenue is not income, but your overhead in a well set up practice. If you cut the 100,000 to 50,000 and do give herbs to all your patients, its about 1/3 herb profit. In order to make 100 grand, I think one has to see more like 60 patients per week. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 16, 2003 Report Share Posted June 16, 2003 Along that tangent- aquestion that comes to me is what type of life you want to have, what kind of quality we as practitioners are choosing. this was topuched on by Ze'v in his lecture. there is a fine balance between doing well economically towards meeting your needs and working yourself towards an imbalance, far from nature and well being/ we have to maintain our own qi and connection to nature as well as be good business people. It is such an art! And it sometimes will mean that we push ourselves to the limit, but be aware enough of where we are at within our being, like in qi gong or tai chi. A philosophical rambling - Eti < wrote: , Eric Popp <epopp3267> wrote:> > I don't think herb sales are always such a big portion of a practitioner's practice. For example, let's say a person sees 40 patients per week at $50 per visit for 50 weeks per year (40 x $50 x 50 = $100,000). one flaw I see here, I think. Half that revenue is not income, but your overhead in a well set up practice. If you cut the 100,000 to 50,000 and do give herbs to all your patients, its about 1/3 herb profit. In order to make 100 grand, I think one has to see more like 60 patients per week.ToddChinese Herbal Medicine, a voluntary organization of licensed healthcare practitioners, matriculated students and postgraduate academics specializing in Chinese Herbal Medicine, provides a variety of professional services, including board approved online continuing education. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 17, 2003 Report Share Posted June 17, 2003 There are many factors with $100k design. (Perhaps this is not the forum for such a discussion.) Is that $100k gross or net after expenses? If it's net, you could have, say, $15k in office expenses. What about health insurance? If you have to pay that yourself, you could easily add another $12k. What about having an employee, as Bob Flaws recommended in one of the previous success e-mails? What does that cost annually, $18k? So, one really needs to gross $145k to net $100k after expenses. Using your suggested number & having every pt. get acupuncture and herbs: Acupuncture sales: 60 patients/wk x $50 x 50 weeks = $150k. Herb sales: 60 patients/wk x $18 x 50 weeks = $54k Gross Sales = $204k Acupuncture Sales = 73.5% Herb Sales = 26.5% Office Expenses = $15k Health Insurance = $12k Employee = $18k Herb Costs = $29k TOTAL EXPENSES = $74 Gross Income - Expenses = $204k - $74k = $130 Net (before taxes). My point with all of this is that I don't think most practitioners are giving herbs to all of their patients and therefore income from herbs in a typical practice are only a percentage of total income. Using the above calculations, if 100% of patients get herbs, herb sales make up 26.5%, and if only 50% of patients get herbs, herbs sales make up 15%. Regards. < wrote: , Eric Popp <epopp3267> wrote:> > I don't think herb sales are always such a big portion of a practitioner's practice. For example, let's say a person sees 40 patients per week at $50 per visit for 50 weeks per year (40 x $50 x 50 = $100,000). one flaw I see here, I think. Half that revenue is not income, but your overhead in a well set up practice. If you cut the 100,000 to 50,000 and do give herbs to all your patients, its about 1/3 herb profit. In order to make 100 grand, I think one has to see more like 60 patients per week.ToddChinese Herbal Medicine, a voluntary organization of licensed healthcare practitioners, matriculated students and postgraduate academics specializing in Chinese Herbal Medicine, provides a variety of professional services, including board approved online continuing education. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 17, 2003 Report Share Posted June 17, 2003 Eti, I agree wholeheartedly! There are many factors. The practitioner who has three children and a spouse that is a homemaker, and another practitioner with no kids and a spouse that makes $60k....very different situations, challenges, etc. Eti Domb <etidomb wrote: Along that tangent- aquestion that comes to me is what type of life you want to have, what kind of quality we as practitioners are choosing. this was topuched on by Ze'v in his lecture. there is a fine balance between doing well economically towards meeting your needs and working yourself towards an imbalance, far from nature and well being/ we have to maintain our own qi and connection to nature as well as be good business people. It is such an art! And it sometimes will mean that we push ourselves to the limit, but be aware enough of where we are at within our being, like in qi gong or tai chi. A philosophical rambling - Eti < wrote: , Eric Popp <epopp3267> wrote:> > I don't think herb sales are always such a big portion of a practitioner's practice. For example, let's say a person sees 40 patients per week at $50 per visit for 50 weeks per year (40 x $50 x 50 = $100,000). one flaw I see here, I think. Half that revenue is not income, but your overhead in a well set up practice. If you cut the 100,000 to 50,000 and do give herbs to all your patients, its about 1/3 herb profit. In order to make 100 grand, I think one has to see more like 60 patients per week.ToddChinese Herbal Medicine, a voluntary organization of licensed healthcare practitioners, matriculated students and postgraduate academics specializing in Chinese Herbal Medicine, provides a variety of professional services, including board approved online continuing education. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 18, 2003 Report Share Posted June 18, 2003 , Eric Popp <epopp3267> wrote: Is that $100k gross or net after expenses? If it's net, you could have, say, $15k in office expenses. What about health insurance? If you have to pay that yourself, you could easily add another $12k. What about having an employee, as Bob Flaws recommended in one of the previous success e-mails? What does that cost annually, $18k? So, one really needs to gross $145k to net $100k after expenses. In san diego, rent and other overhead for a 3 room clinic is more like 30,000 a year (2000/month rent plus 6000 miscellaneous). the employee would be 20,000. Without insurance, that's 50,000 in costs, so let's leave it at that for simplicity's sake. I think seeing 60 patients per week is unrealistic for most people. I know very few acupuncturists who see more than 40 per week even after ten years or more in practice. Also, to be clear. I always assume we are talking about net income in these discussions. In San Diego, we could charge 60 per pt., so the pt. revenues could be 120,000. that's 70,000 net. so the only way to make up the difference would be to sell patients enough supplements to make up the difference to 100,000, which would be about 30% of net revenues. that would require an average profit of $15 per patient per week all year long. Which would mean patients have to spend $120 per month on herbs. And I do expect all my ongoing patients to be on herbs or supplements of some sort. I think these numbers really depend where one lives and exactly what one has in mind as one's style of practice? I always tell people there are better places to practice than San Diego. However I do not run a practice of this sort any longer as the quality of my life suffers as a result. But we should be careful not to project what makes us suffer onto others. I know many people who thrive on this type of life, do a lot of good for huge numbers of patients and that is quality for them. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 24, 2003 Report Share Posted June 24, 2003 Dear Geoff and All, Yes, I have until August 11th (?) to comment. I will coordinate my efforts with those in the circuitry of my business as well as with other interested parties. The idea is to speak with a larger voice. Also when one objects to a rule for a particular reason, one must then propose a remedy. That's where the initial negotiation comes in. We need to propose remedies for those things that would force us out of business. So the remedy must address concerns of the FDA yet allow for the community of practitioners, distributors and manufacturers to move forward. This is not entirely a local matter. The Bioterrorism Act forces all companies in the China and elsewhere who want to do business with America to register with the FDA. So all products manufactured in Taiwan and mainland China will be stopped at the border under authomatic detention until the manufacturers register. This is not a small matter as they must also then meet FDA cGMPs. How that works with raw herbs is yet to be determined. Emmanuel Segmen - " Geoffrey Hudson " <geoffhudson <susegmen Tuesday, June 17, 2003 12:31 AM Re: FDA proposed rule > Dear Emmanuel, > I was wondering if you have made a public comment on the FDA proposed > rule website? You are a knowledgeable and articulate writer and I'm > sure you would serve our community well by doing so! > > Cheers, > Geoff > > > Message: 18 > Mon, 16 Jun 2003 16:00:19 -0700 > " Emmanuel Segmen " <susegmen > Re: Re: FDA proposed rule > > Brian and All, > > I hate to even broach this subject after the wonderful glow of > acknowledgements for the good conference. But let me dip my toe in here > for a moment. The cost of due diligence for manufacturers may be > anywhere from $30,000 to start to $100,000 or more depending on the > level of work the company is doing. After a few years of economic > decline in America and the many blows of Prop 65, I can't imagine even > the strongest of the companies dealing with this in stride. Presumably > companies have three years to comply, yet it may be quite challenging > for many. My bet is that some product lines or companies may get bought > out by larger entities which I won't go into on this post. > > My concern for you and other kindred souls on this list is that the best > of CM in my own humble mind is when you put together bags of raw noble > herbs as formulas for your patients. In addition some of you compound > dry dosage extract. Merely stocking any and all of these items becomes > an issue under the new FDA guidelines. My hope is that even under the > new guidelines that current practice will continue to be accepted for > individual practitioners and small clinics. I personally know of many > MDs that stock medicine either as samples or from wholesale purchasing. > They then dole out various amounts to patients for free or at a small > profit. Is this a legal practice? I'd always assumed it was either > acceptable or simply overlooked. Generally individuals or companies > have to hit about $500,000 per year of any given item for you to even > hit the FDA radar. That includes even a manufacturer. So a small > clinic or herbal pharmacy could put things in bottles and label those > bottles and sell them to your patients. Technically even under current > law, your label has to meet a myriad of specifications including font > size and nutritional information. Generally practitioners and small > clinics in my opinion will not get bothered by FDA inspectors. You > don't meet the $500,000 per year radar levels. Unless ..... (and this > is ugly!) .... unless someone " complains " specifically to the FDA. Not > a nice thing. I won't name names, but a company here in CA got many > sister companies busted on Prop 65. You might have noticed that some of > those CEOs endured hundreds of thousands of dollars in penalties and > changed the names of their companies or left the state. That sort of > thing is worrisome for companies but not generally for a small clinic or > a small herbal pharmacy. > > School pharmacies might not fly under the radar since they are a part of > accredited institutions. They might need to do what Elephant Pharmacy > in Berkeley has done. At that store there is a regular licensed > pharmacist hired right out of U.C.S.F. Medical Center to operate the > regular prescription pharmacy. In addition there are L.Ac.s hired to > advise customers regarding sales of raw herbs and bottled herbal > products. From this model I can envision a school clinical pharmacy > hiring a licensed pharmacist to meet FDA standards under upcoming laws. > I wonder how you would feel about that at PCOM? > > Emmanuel Segmen > _________ > Geoffrey E. Hudson, MTCM, L.Ac. 1833 Harvard Avenue > http://www.AcupunctureAndHerbs.com Seattle, WA 98122 > 206.223.2777 Ancient tradition, Modern healthcare > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 24, 2003 Report Share Posted June 24, 2003 That sounds great. If you wouldn't mind cc'ing us on the list, maybe we could include the theme of your letter in our own comments to sound like a cohesive group with a professional attitude. I agree that the comments should address the FDA concerns, rather than sounding like a rant letter that gets in the circular file. I would be interested to know if the FDA proposal is due to a certain incident (eg the ma huang issue) or something else. I highly doubt it has anything to do with herbal prescriptions by qualified practitioners. If so, then including the safety record of qualified practitioners would be a good counter point to the stringent proposed GMP rules. Thank you, Geoff > __________ > > Message: 25 > Tue, 24 Jun 2003 13:12:15 -0700 > " Emmanuel Segmen " <susegmen > Fw: FDA proposed rule > > Dear Geoff and All, > > Yes, I have until August 11th (?) to comment. I will > coordinate my efforts > with those in the circuitry of my business as well as with > other interested > parties. The idea is to speak with a larger voice. Also > when one objects > to a rule for a particular reason, one must then propose a > remedy. That's > where the initial negotiation comes in. We need to propose > remedies for > those things that would force us out of business. So the remedy must > address concerns of the FDA yet allow for the community of > practitioners, > distributors and manufacturers to move forward. > > This is not entirely a local matter. The Bioterrorism Act forces all > companies in the China and elsewhere who want to do business > with America to > register with the FDA. So all products manufactured in > Taiwan and mainland > China will be stopped at the border under authomatic > detention until the > manufacturers register. This is not a small matter as they > must also then > meet FDA cGMPs. How that works with raw herbs is yet to be > determined. > > Emmanuel Segmen > > - > " Geoffrey Hudson " <geoffhudson > <susegmen > Tuesday, June 17, 2003 12:31 AM > Re: FDA proposed rule > > > > Dear Emmanuel, > > I was wondering if you have made a public comment on the > FDA proposed > > rule website? You are a knowledgeable and articulate writer and I'm > > sure you would serve our community well by doing so! > > > > Cheers, > > Geoff Quote Link to comment Share on other sites More sharing options...
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