Guest guest Posted June 17, 2003 Report Share Posted June 17, 2003 Hi All According to 21 USC (United States Code) 353a(b)(1) compounding pharmacies are primarily limited to use of substances listed in the USP (United States Pharmacoepia). (sigh - not all of Bensky and Gamble adopted, yet) However, rules governing compounding pharmacy at the state level supercede the federal (in the same way that our acupuncture licenses vary from state to state). Check your state regulations - it is unlikely that what you currently do meets the compounding pharmacy requirements, still it is an interesting model for us to pursue. Like drug compounding, we are preparing specific formulas for individuals without advertising products or producing bulk beforehand. What we do is different from drug compounding in that we are working with natural, not synthesized substances that have more variables and therefore may require a different set or different process of evaluation. For example, chemical analyses may be used for heavy metals, pesticides, or herbs known to have potential for toxicity, but organoleptic analysis is better in determining the finer characteristics of quality, in the same way that coffee beans or wine are evaluated. But what the cGMP's are really about is not just herb identification and testing, but the clean process of assembly. I will enter the link again here in case anyone missed it the first time - look out! it is 200+ pages. See the great detail on what kind of spoon, surface, light bulb, water, and bowl can be used. :-P http://www.cfsan.fda.gov/~lrd/fr030313.html <http://www.cfsan.fda.gov/%7Elrd/fr030313.html> There definitely is value in writing down pharmacy procedures and standards - a lot of detail is already in our education (honey-frying, charring, cooking 5 minutes, cooking 40 minutes unless powdered, etc.) but some parts (some of the record-keeping, some of the assembly processes, better C of A) could be developed to the greater satisfaction of a proposal that we are compounding pharmacies. To my thinking, the most important thing to be accomplished right now is to get everybody we know writing letters to the FDA to demand an exemption for trained herb practitioners from the proposed cGMP's, because these regulations require testing and storage of every finished batch, and this is clearly not intended to govern what we do. Trained herb practitioners are not a safety risk. In fact, I strongly believe that safety is improved when the public has access to trained herb practitioners. Don't you? Thank you for your time and consideration. Mercy Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 17, 2003 Report Share Posted June 17, 2003 Maybe someday our colleges will develop a pharmacist program like they have in China. I think it will be a while until that is financially rewarding enough, though. David Molony In a message dated 6/17/03 4:28:16 AM, mercyyule writes: Hi All According to 21 USC (United States Code) 353a(b)(1) compounding pharmacies are primarily limited to use of substances listed in the USP (United States Pharmacoepia). (sigh - not all of Bensky and Gamble adopted, yet) However, rules governing compounding pharmacy at the state level supercede the federal (in the same way that our acupuncture licenses vary from state to state). Check your state regulations - it is unlikely that what you currently do meets the compounding pharmacy requirements, still it is an interesting model for us to pursue. Like drug compounding, we are preparing specific formulas for individuals without advertising products or producing bulk beforehand. What we do is different from drug compounding in that we are working with natural, not synthesized substances that have more variables and therefore may require a different set or different process of evaluation. For example, chemical analyses may be used for heavy metals, pesticides, or herbs known to have potential for toxicity, but organoleptic analysis is better in determining the finer characteristics of quality, in the same way that coffee beans or wine are evaluated. But what the cGMP's are really about is not just herb identification and testing, but the clean process of assembly. I will enter the link again here in case anyone missed it the first time - look out! it is 200+ pages. See the great detail on what kind of spoon, surface, light bulb, water, and bowl can be used. :-P http://www.cfsan.fda.gov/~lrd/fr030313.html <http://www.cfsan.fda.gov/%7Elrd/fr030313.html> There definitely is value in writing down pharmacy procedures and standards - a lot of detail is already in our education (honey-frying, charring, cooking 5 minutes, cooking 40 minutes unless powdered, etc.) but some parts (some of the record-keeping, some of the assembly processes, better C of A) could be developed to the greater satisfaction of a proposal that we are compounding pharmacies. To my thinking, the most important thing to be accomplished right now is to get everybody we know writing letters to the FDA to demand an exemption for trained herb practitioners from the proposed cGMP's, because these regulations require testing and storage of every finished batch, and this is clearly not intended to govern what we do. Trained herb practitioners are not a safety risk. In fact, I strongly believe that safety is improved when the public has access to trained herb practitioners. Don't you? Thank you for your time and consideration. Mercy Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 17, 2003 Report Share Posted June 17, 2003 Dear Mercy, Thank you for your due diligence with regard to cGMPs. Can you give us a ball park outline of a typical, classical practitioner in her or his clinical setting. Assume that the practitioner took the time to have several sets of lovely wooden cases built, each with 50 drawers. Our classical practitioner has perhaps 200 raw herbs stored in her drawers. She has plastic bags or paper wrapping with scales and so on. To keep it simple for the moment don't even consider that she has a whole shelf of 100 gram bottles of single herb extracts (maybe tell us that one tomorrow). What is this practitioner looking at, in general, in order to assemble formulas from her array of raw herbs and to meet cGMPs? Do you have in your mind's eye a visual scenario of how you will proceed? Do you have a clear mental sense of what part of the work up is clear and known and what part is as yet unknown? Are you already re-arranging and transforming your own clinic? Are these questions too numerous and too complex? After reading your given links below, I got the impression that these rules governed manufacturers and hospital clinics, but did not address individual practitioner office set-ups. Thank you for even your most general comments to clarify the big picture. In gratitude, Emmanuel Segmen - Mercy Yule Monday, June 16, 2003 11:18 PM FDA cGMP comments Hi All According to 21 USC (United States Code) 353a(b)(1) compounding pharmacies are primarily limited to use of substances listed in the USP (United States Pharmacoepia). (sigh - not all of Bensky and Gamble adopted, yet) However, rules governing compounding pharmacy at the state level supercede the federal (in the same way that our acupuncture licenses vary from state to state). Check your state regulations - it is unlikely that what you currently do meets the compounding pharmacy requirements, still it is an interesting model for us to pursue. Like drug compounding, we are preparing specific formulas for individuals without advertising products or producing bulk beforehand. What we do is different from drug compounding in that we are working with natural, not synthesized substances that have more variables and therefore may require a different set or different process of evaluation. For example, chemical analyses may be used for heavy metals, pesticides, or herbs known to have potential for toxicity, but organoleptic analysis is better in determining the finer characteristics of quality, in the same way that coffee beans or wine are evaluated. But what the cGMP's are really about is not just herb identification and testing, but the clean process of assembly. I will enter the link again here in case anyone missed it the first time - look out! it is 200+ pages. See the great detail on what kind of spoon, surface, light bulb, water, and bowl can be used. :-Phttp://www.cfsan.fda.gov/~lrd/fr030313.html <http://www.cfsan.fda.gov/%7Elrd/fr030313.html> There definitely is value in writing down pharmacy procedures and standards - a lot of detail is already in our education (honey-frying, charring, cooking 5 minutes, cooking 40 minutes unless powdered, etc.) but some parts (some of the record-keeping, some of the assembly processes, better C of A) could be developed to the greater satisfaction of a proposal that we are compounding pharmacies. To my thinking, the most important thing to be accomplished right now is to get everybody we know writing letters to the FDA to demand an exemption for trained herb practitioners from the proposed cGMP's, because these regulations require testing and storage of every finished batch, and this is clearly not intended to govern what we do. Trained herb practitioners are not a safety risk. In fact, I strongly believe that safety is improved when the public has access to trained herb practitioners. Don't you? Thank you for your time and consideration. Mercy Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 20, 2003 Report Share Posted June 20, 2003 , Mercy Yule <mercyyule@w...> wrote: > According to 21 USC (United States Code) 353a(b)(1) compounding > pharmacies are primarily limited to use of substances listed in the USP > (United States Pharmacoepia). (sigh - not all of Bensky and Gamble > adopted, yet) However, rules governing compounding pharmacy at the > state level supercede the federal (in the same way that our acupuncture > licenses vary from state to state). Check your state regulations - it is > unlikely that what you currently do meets the compounding pharmacy > requirements, still it is an interesting model for us to pursue. Like > drug compounding, we are preparing specific formulas for individuals > without advertising products or producing bulk beforehand. What we do is > different from drug compounding in that we are working with natural, not > synthesized substances Mercy a couple of points. 1. There are already herbs in the USP that have been there for a century and still remain. So I believe pharmacists are allowed to compound things like valerian if legally prescribed. My father studied pharmacy in the 50's when pharmacists still did this regularly. He even had to take herb ID tests. 2. Would it be possible to establish our own version of the pharmacy profession (registered herbalist perhaps)? My guess would be that this would have to be a separate profession from L.Ac. because the pharmacy exemption appears to depend on their role as a regulated intermediary between patient and doctor. According to the pharm d. at PCOM, MD's can only sell 10% of the rx they actually prescribe in CA. In some states, I believe the % is 0. So we may be looking at a best case scenario where we lose 90% of our raw and powdered herb revenues. I suppose this could be a boon for those who would want to pursue herbal pharmacy as a career. 3. what is the chance of getting the contents of benksy in USP? the contents are part of the the offficial state chinese pharmacopeia and china is a member of WTO. 4. We should all study the SHL and master the style of using unmodified classical formulas (oh well, I think Dan would call that traditionalism). Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 20, 2003 Report Share Posted June 20, 2003 3. what is the chance of getting the contents of benksy in USP? the contents are part of the the offficial state chinese pharmacopeia and china is a member of WTO.Todd When I worked at Min Tong in 1991-94, Sun Ten contacted us and asked us to participate with them in doing the above. They had contacted the FDA to see about legalizing "claims" from the perspective of CM regarding herbs. As you can see, they were not successful as currently no medical claims can be made for CM herbal products. FDA indicated to Sun Ten that they (the FDA) were are part of the executive branch of U.S. govt. Therefore, they had a mandate only to carry out legislative mandates. They said they were guided by law in this regard as well as USP. So FDA advised Sun Ten hire lobbyists to influence federal congressmen and senators. USP is a private non-profit organization. It was Sun Ten's intention to also attempt to influence them. At the time of this interaction between Sun Ten and Min Tong, it was the mood of Dr. Chiang, Min Tong's president, to maintain a low profile. He had a newly acquired green card and was going through the naturalization process. He was also addressing FDA chemists at annual meetings regarding HPLC markers for CM herbs. He was not interested, therefore, in political activism. Now in 2003 there is more of a precedent for interacting with politicians. I concur with you, that the national organization should lead the way. The AMA was the force in the early 1900s that created the FDA and the current credentialling of American medical colleges. Thus, it seems that AAOM would be the natural organization to lead the way for Chinese medicine. Emmanuel Segmen Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 21, 2003 Report Share Posted June 21, 2003 Hi David and all A TCM school in Sydney has developed an herbal pharmacy program in conjunction with the University of Sydney. Biochemistry included. I think maybe their curriculum is geared more toward industry than the small professional dispensary. Does anybody know more about it? Mercy , acuman1@a... wrote: > Maybe someday our colleges will develop a pharmacist program like they have > in China. I think it will be a while until that is financially rewarding > enough, though. > David Molony > > In a message dated 6/17/03 4:28:16 AM, mercyyule@w... writes: > > > > Hi All > > According to 21 USC (United States Code) 353a(b)(1) compounding > > pharmacies are primarily limited to use of substances listed in the USP > > (United States Pharmacoepia). (sigh - not all of Bensky and Gamble > > adopted, yet) However, rules governing compounding pharmacy at the > > state level supercede the federal (in the same way that our acupuncture > > licenses vary from state to state). Check your state regulations - it is > > unlikely that what you currently do meets the compounding pharmacy > > requirements, still it is an interesting model for us to pursue. Like > > drug compounding, we are preparing specific formulas for individuals > > without advertising products or producing bulk beforehand. What we do is > > different from drug compounding in that we are working with natural, not > > synthesized substances that have more variables and therefore may > > require a different set or different process of evaluation. For example, > > chemical analyses may be used for heavy metals, pesticides, or herbs > > known to have potential for toxicity, but organoleptic analysis is > > better in determining the finer characteristics of quality, in the same > > way that coffee beans or wine are evaluated. But what the cGMP's are > > really about is not just herb identification and testing, but the clean > > process of assembly. I will enter the link again here in case anyone > > missed it the first time - look out! it is 200+ pages. See the great > > detail on what kind of spoon, surface, light bulb, water, and bowl can > > be used. :-P > > http://www.cfsan.fda.gov/~lrd/fr030313.html > > <http://www.cfsan.fda.gov/%7Elrd/fr030313.html> > > There definitely is value in writing down pharmacy procedures and > > standards - a lot of detail is already in our education (honey-frying, > > charring, cooking 5 minutes, cooking 40 minutes unless powdered, etc.) > > but some parts (some of the record-keeping, some of the assembly > > processes, better C of A) could be developed to the greater satisfaction > > of a proposal that we are compounding pharmacies. > > To my thinking, the most important thing to be accomplished right > > now is to get everybody we know writing letters to the FDA to demand > > an exemption for trained herb practitioners from the proposed cGMP's, > > because these regulations require testing and storage of every finished > > batch, and this is clearly not intended to govern what we do. Trained > > herb practitioners are not a safety risk. In fact, I strongly believe > > that safety is improved when the public has access to trained herb > > practitioners. Don't you? > > Thank you for your time and consideration. > > Mercy > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 22, 2003 Report Share Posted June 22, 2003 Mercy Sydney University has a postgraduate masters program on the biochemistry and pharmacology of herbal medicine, including Chinese herbs. It is run through the faculty of pharmacy and is not associated with any TCM school. It is geared towards pharmacists and researchers in the drug industry. Very heavy on the science with little in the way of practical clinical application. The university website has more info (usyd.edu.au) Will Maclean Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 22, 2003 Report Share Posted June 22, 2003 Hi Emmanuel and all Hmmmmm. About the wooden case for holding herbs: Can we demonstrate that the herbs are held in the appropriate " temperature, humidity, and light " to prevent their " deterioration or contamination " ? Maybe so. I don't know if I can adequately answer all of your points. But to paint a picture, the proposed cGMP regulations want floors, walls, and ceilings to be " smooth, hard surfaces " because they are easier to " clean and sanitize, " possibly with a drain in the center of the floor. The herbalist might wear an apron ( " outer garments in a manner that protects against contamination of components " ), jewelry either covered or removed ( " might fall into components " ), hairnets, beard covers, etc. No personal belongings on contact surfaces, no gum chewing or beverages. Spoons must " have seams that are smoothly bonded " to prevent microorganisms from lurking in the crevices. Pipes and vents situated so condensation doesn't drip into ingredients. Safety lightbulbs. Self-closing bathroom doors. Recordkeeping on calibration and maintenance of measuring equipment. Recordkeeping on the disposition of returns. And so on. But, Emmanuel, although thinking of these possibilities may make us feel itchy with confinement, some of these adjustments are perhaps affordable in three years compliance time. The concern is this: the requirement to test each finished batch, and to store a sample of each finished batch for three years sounds like bulk production, not preparing formulas for individual patients and it is simply not feasible for us. We are not manufacturers, yet we have been erroneously roped into regulations that are intended for manufacturers. Misidentified ingredients put into pills, or pills mixed in the wrong bottle causing bad reactions for the consumer--these are given as the argument in favor of the new regulations. There are no examples of trained herbalists causing these problems. We are doing no harm. We are providing valuable health care that may be constrained if our small dispensaries are asked to comply with regulations that are written for manufacturers. You have asked if I am rearranging my dispensary. I'd rather, with your help, rearrange these regulations. It does give me the opportunity to work harder on envisioning the future of herbal dispensary practice. If we don't have our own clear vision, it will be handed to us. One other note: it is clear that these regulations can apply to us as currently written, if they choose. " Trained herbalists " are specifically not exempted. (maybe if we were untrained?) The question of FDA enforcement depends on the scope of your state law (it may protect you), the number of agents available in a particular area, and whether herb safety is a current focus. Thank you for your important questions. Mercy , " Emmanuel Segmen " <susegmen@i...> wrote: > Dear Mercy, > > Thank you for your due diligence with regard to cGMPs. Can you give us a ball park outline of a typical, classical practitioner in her or his clinical setting. Assume that the practitioner took the time to have several sets of lovely wooden cases built, each with 50 drawers. Our classical practitioner has perhaps 200 raw herbs stored in her drawers. She has plastic bags or paper wrapping with scales and so on. To keep it simple for the moment don't even consider that she has a whole shelf of 100 gram bottles of single herb extracts (maybe tell us that one tomorrow). What is this practitioner looking at, in general, in order to assemble formulas from her array of raw herbs and to meet cGMPs? Do you have in your mind's eye a visual scenario of how you will proceed? Do you have a clear mental sense of what part of the work up is clear and known and what part is as yet unknown? Are you already re-arranging and transforming your own clinic? Are these questions too numerous and too complex? > > After reading your given links below, I got the impression that these rules governed manufacturers and hospital clinics, but did not address individual practitioner office set-ups. Thank you for even your most general comments to clarify the big picture. > > In gratitude, > Emmanuel Segmen > - > Mercy Yule > > Monday, June 16, 2003 11:18 PM > FDA cGMP comments > > > Hi All > According to 21 USC (United States Code) 353a(b)(1) compounding > pharmacies are primarily limited to use of substances listed in the USP > (United States Pharmacoepia). (sigh - not all of Bensky and Gamble > adopted, yet) However, rules governing compounding pharmacy at the > state level supercede the federal (in the same way that our acupuncture > licenses vary from state to state). Check your state regulations - it is > unlikely that what you currently do meets the compounding pharmacy > requirements, still it is an interesting model for us to pursue. Like > drug compounding, we are preparing specific formulas for individuals > without advertising products or producing bulk beforehand. What we do is > different from drug compounding in that we are working with natural, not > synthesized substances that have more variables and therefore may > require a different set or different process of evaluation. For example, > chemical analyses may be used for heavy metals, pesticides, or herbs > known to have potential for toxicity, but organoleptic analysis is > better in determining the finer characteristics of quality, in the same > way that coffee beans or wine are evaluated. But what the cGMP's are > really about is not just herb identification and testing, but the clean > process of assembly. I will enter the link again here in case anyone > missed it the first time - look out! it is 200+ pages. See the great > detail on what kind of spoon, surface, light bulb, water, and bowl can > be used. :-P > http://www.cfsan.fda.gov/~lrd/fr030313.html > <http://www.cfsan.fda.gov/%7Elrd/fr030313.html> > There definitely is value in writing down pharmacy procedures and > standards - a lot of detail is already in our education (honey-frying, > charring, cooking 5 minutes, cooking 40 minutes unless powdered, etc.) > but some parts (some of the record-keeping, some of the assembly > processes, better C of A) could be developed to the greater satisfaction > of a proposal that we are compounding pharmacies. > To my thinking, the most important thing to be accomplished right > now is to get everybody we know writing letters to the FDA to demand > an exemption for trained herb practitioners from the proposed cGMP's, > because these regulations require testing and storage of every finished > batch, and this is clearly not intended to govern what we do. Trained > herb practitioners are not a safety risk. In fact, I strongly believe > that safety is improved when the public has access to trained herb > practitioners. Don't you? > Thank you for your time and consideration. > Mercy Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 22, 2003 Report Share Posted June 22, 2003 Dear Mercy, Thank you for your thoughts. I'd like to meditate on your fabulous response and hear the response of others. I feel that the FDA's cGMPs are being "generalized" toward many who are inappropriately burdened. Along with practitioners, I believe companies like my own who import and store for distribution are inappropriately impacted. Some rules apply while most simply replicate work already done. Also application of GMP standards to every entity is grossly inappropriate. We have until August to reply publicly to the FDA individually or in groups. The FDA's attunement is mainly to corporate structures wherein ISO-9000 GMP rules prevail. The vast majority of business in America is not ISO-9000 GMP business structured. It's like the Army Corps of Engineers deciding to pave the entire surface of North America. It's not necessarily helpful to the majority of enterprises. We do need to address these issues quite soon and with directness and ardor. Emmanuel Segmen - mercyyule Sunday, June 22, 2003 9:33 AM Re: FDA cGMP comments Hi Emmanuel and allHmmmmm. About the wooden case for holding herbs: Can we demonstratethat the herbs are held in the appropriate "temperature, humidity, andlight" to prevent their "deterioration or contamination"? Maybe so. I don't know if I can adequately answer all of your points. But topaint a picture, the proposed cGMP regulations want floors, walls, andceilings to be "smooth, hard surfaces" because they are easier to"clean and sanitize," possibly with a drain in the center of thefloor. The herbalist might wear an apron ("outer garments in a mannerthat protects against contamination of components"), jewelry eithercovered or removed ("might fall into components"), hairnets, beardcovers, etc. No personal belongings on contact surfaces, no gumchewing or beverages. Spoons must "have seams that are smoothlybonded" to prevent microorganisms from lurking in the crevices. Pipesand vents situated so condensation doesn't drip into ingredients.Safety lightbulbs. Self-closing bathroom doors. Recordkeeping oncalibration and maintenance of measuring equipment. Recordkeeping onthe disposition of returns. And so on. But, Emmanuel, althoughthinking of these possibilities may make us feel itchy withconfinement, some of these adjustments are perhaps affordable in threeyears compliance time. The concern is this: the requirement to test each finished batch, andto store a sample of each finished batch for three years sounds likebulk production, not preparing formulas for individual patients and itis simply not feasible for us. We are not manufacturers, yet we havebeen erroneously roped into regulations that are intended formanufacturers. Misidentified ingredients put into pills, or pillsmixed in the wrong bottle causing bad reactions for theconsumer--these are given as the argument in favor of the newregulations. There are no examples of trained herbalists causing theseproblems. We are doing no harm. We are providing valuable health carethat may be constrained if our small dispensaries are asked to complywith regulations that are written for manufacturers. You have asked if I am rearranging my dispensary. I'd rather, withyour help, rearrange these regulations. It does give me theopportunity to work harder on envisioning the future of herbaldispensary practice. If we don't have our own clear vision, it will behanded to us. One other note: it is clear that these regulations canapply to us as currently written, if they choose. "Trained herbalists"are specifically not exempted. (maybe if we were untrained?) Thequestion of FDA enforcement depends on the scope of your state law (itmay protect you), the number of agents available in a particular area,and whether herb safety is a current focus.Thank you for your important questions.Mercy , "Emmanuel Segmen"<susegmen@i...> wrote:> Dear Mercy,> > Thank you for your due diligence with regard to cGMPs. Can you giveus a ball park outline of a typical, classical practitioner in her orhis clinical setting. Assume that the practitioner took the time tohave several sets of lovely wooden cases built, each with 50 drawers.Our classical practitioner has perhaps 200 raw herbs stored in herdrawers. She has plastic bags or paper wrapping with scales and soon. To keep it simple for the moment don't even consider that she hasa whole shelf of 100 gram bottles of single herb extracts (maybe tellus that one tomorrow). What is this practitioner looking at, ingeneral, in order to assemble formulas from her array of raw herbs andto meet cGMPs? Do you have in your mind's eye a visual scenario ofhow you will proceed? Do you have a clear mental sense of what partof the work up is clear and known and what part is as yet unknown? Are you already re-arranging and transforming your own clinic? Arethese questions too numerous and too complex? > > After reading your given links below, I got the impression thatthese rules governed manufacturers and hospital clinics, but did notaddress individual practitioner office set-ups. Thank you for evenyour most general comments to clarify the big picture. > > In gratitude,> Emmanuel Segmen> - > Mercy Yule > > Monday, June 16, 2003 11:18 PM> FDA cGMP comments> > > Hi All> According to 21 USC (United States Code) 353a(b)(1) compounding > pharmacies are primarily limited to use of substances listed inthe USP > (United States Pharmacoepia). (sigh - not all of Bensky and Gamble > adopted, yet) However, rules governing compounding pharmacy at the > state level supercede the federal (in the same way that ouracupuncture > licenses vary from state to state). Check your state regulations -it is > unlikely that what you currently do meets the compounding pharmacy > requirements, still it is an interesting model for us to pursue. Like > drug compounding, we are preparing specific formulas for individuals > without advertising products or producing bulk beforehand. What wedo is > different from drug compounding in that we are working withnatural, not > synthesized substances that have more variables and therefore may > require a different set or different process of evaluation. Forexample, > chemical analyses may be used for heavy metals, pesticides, or herbs > known to have potential for toxicity, but organoleptic analysis is > better in determining the finer characteristics of quality, in thesame > way that coffee beans or wine are evaluated. But what the cGMP's are > really about is not just herb identification and testing, but theclean > process of assembly. I will enter the link again here in case anyone > missed it the first time - look out! it is 200+ pages. See the great > detail on what kind of spoon, surface, light bulb, water, and bowlcan > be used. :-P> http://www.cfsan.fda.gov/~lrd/fr030313.html > <http://www.cfsan.fda.gov/%7Elrd/fr030313.html>> There definitely is value in writing down pharmacy proceduresand > standards - a lot of detail is already in our education(honey-frying, > charring, cooking 5 minutes, cooking 40 minutes unless powdered,etc.) > but some parts (some of the record-keeping, some of the assembly > processes, better C of A) could be developed to the greatersatisfaction > of a proposal that we are compounding pharmacies.> To my thinking, the most important thing to be accomplished right > now is to get everybody we know writing letters to the FDA to demand > an exemption for trained herb practitioners from the proposedcGMP's, > because these regulations require testing and storage of everyfinished > batch, and this is clearly not intended to govern what we do. Trained > herb practitioners are not a safety risk. In fact, I strongly believe > that safety is improved when the public has access to trained herb > practitioners. Don't you?> Thank you for your time and consideration.> Mercy Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 29, 2003 Report Share Posted June 29, 2003 Hi Todd and all Citing the WTO agreement - what an interesting angle! Certainly international trade will be affected if our practice is limited. The herbal pharmacy degree would be helpful to us. Seems like the CCAOM should get involved. The USP has about 30 botanical monographs including ren shen and wu jia shen. Inclusion of CH seems a worthy long term pursuit. Right now we need to demonstrate that because of our training and procedures, we are able to prevent adulteration of the herbs we prepare on a case-by-case basis for the individuals we serve. Canadian regulations give us the kind of language we would like to see: " 'manufacturer' means a person who fabricates or processes a natural health product for the purpose of sale, but does not include a pharmacist or other health care practitioner who, at the request of a patient, compounds a natural health product for the purpose of sale to that patient. (fabricant) " For entire text, see: http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/regs_cg1_doc3_e.html Proposed Regulations - Natural Health Products Directorate Thanks, Mercy , " " <@i...> wrote: > , Mercy Yule <mercyyule@w...> > wrote: > > > According to 21 USC (United States Code) 353a(b)(1) compounding > > pharmacies are primarily limited to use of substances listed in the USP > > (United States Pharmacoepia). (sigh - not all of Bensky and Gamble > > adopted, yet) However, rules governing compounding pharmacy at the > > state level supercede the federal (in the same way that our acupuncture > > licenses vary from state to state). Check your state regulations - it is > > unlikely that what you currently do meets the compounding pharmacy > > requirements, still it is an interesting model for us to pursue. Like > > drug compounding, we are preparing specific formulas for individuals > > without advertising products or producing bulk beforehand. What we do is > > different from drug compounding in that we are working with natural, not > > synthesized substances > > Mercy > > a couple of points. > > 1. There are already herbs in the USP that have been there for a century and > still remain. So I believe pharmacists are allowed to compound things like > valerian if legally prescribed. My father studied pharmacy in the 50's when > pharmacists still did this regularly. He even had to take herb ID tests. > > 2. Would it be possible to establish our own version of the pharmacy > profession (registered herbalist perhaps)? My guess would be that this would > have to be a separate profession from L.Ac. because the pharmacy exemption > appears to depend on their role as a regulated intermediary between patient > and doctor. According to the pharm d. at PCOM, MD's can only sell 10% of the > rx they actually prescribe in CA. In some states, I believe the % is 0. So we > may be looking at a best case scenario where we lose 90% of our raw and > powdered herb revenues. I suppose this could be a boon for those who would > want to pursue herbal pharmacy as a career. > > 3. what is the chance of getting the contents of benksy in USP? the contents > are part of the the offficial state chinese pharmacopeia and china is a member > of WTO. > > 4. We should all study the SHL and master the style of using unmodified > classical formulas (oh well, I think Dan would call that traditionalism). > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 29, 2003 Report Share Posted June 29, 2003 , " mercyyule " <mercyyule@w...> wrote: > Canadian regulations give us the kind of language we would like to > see: " 'manufacturer' means a person who fabricates or processes a > natural health product for the purpose of sale, but does not include a > pharmacist or other health care practitioner who, at the request of a > patient, compounds a natural health product for the purpose of sale to > that patient. (fabricant) " the canadian regs are perfect. it basically allows the patient to release the px from harm in this matter. Canada is not only in WTO, but also NAFTA. Perhaps we should involve the Canadian government in this dispute as it may affect trade across the US-canada border. Quote Link to comment Share on other sites More sharing options...
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