by Eric Brand

GMP Laws and Herbal Pharmacies

Herbal safety and GMP regulations seem to be hot topics lately. Recent changes to FDA cGMP law regarding the dispensing of dietary supplements technically cover many of our individual private practices and school clinics, raising many questions from practitioners and clinic managers. In response, the Council of Colleges has formed a committee to help school clinics to understand the implications of these new laws. As a member of this committee, I am trying to learn all the intricacies of cGMP laws as they apply to businesses and practitioners, and I will be using the Blue Poppy blog to keep readers up to date.

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While FDA representatives have semi-officially stated that individual practitioners mixing customized herbs for their patients will be excluded from enforcement of these new cGMP laws, we nonetheless technically fall under the scope of these laws if we mix customized granule formulas for our patients. At present, it appears that licensed practitioners generally have very little to worry about with these changes, since the FDA’s primary focus is on suppliers rather than practitioners. Nonetheless, most cautious practitioners believe that improved standards of recordkeeping and better tracking of dispensed medicinals are desirable.

Companies that produce concentrated extracts sell them as “dietary supplements” in the US. Dietary supplements are already subject to cGMP laws, and responsible companies already maintain vigorous quality control practices that ensure the safety and authenticity of the products that are produced. Blue Poppy has long been a leader on issues of herbal safety and transparency, and we are proud to be the only company that uses 3rd party testing on every single batch of every concentrated extract product that we produce. The factory that supplies Blue Poppy now also has 3rd party certification that it is in complete compliance with the FDA’s cGMP guidelines.

Raw herbs fall under different regulations than dietary supplements. They are governed by different rules of labeling and testing, and are subject to comparatively less regulation. Raw (crude) medicinals exist in a wide variety of qualities, and it takes a bit of expertise in pharmacy to obtain the highest quality products. Premium products are generally sold on the raw herb market because they fetch a premium price, but all of the lots of low-grade herbs that get rejected by the QC divisions of granule companies end up in the minimally-regulated raw herb market as well. Thus, it is possible to find both very high-end and very low-end products on the crude market; most raw herbs come from a mixture of multiple farms or regions, and most have been minimally tested for constituents, pesticide residues, and heavy metals. By comparison, granule extracts are always tested for their proper species, adequate constituents, as well as pesticides, molds, bacteria, and heavy metals.

Given the minimal regulation of raw herbs both in the U.S. and in Asia, it is uncommon to see sophisticated tracking systems in place for raw herb pharmacies. At the core of cGMP laws is attention to lot tracking, so that problematic products can be identified, recalled, and traced back to their source. Raw herbs typically do not have the same standards in this regard, and they are usually graded and sold based on traditional parameters of quality discernment, with diverse lots being mixed together and then graded based on quality.

Recently, I saw an amazing herbal tracking system in place for raw herbs at the TCM clinic of Hong Kong Polytechnic University (HKPU). The current U.S. law regarding crude medicinals (vs. dietary supplements) is not demanding enough to require the use of such a system at this time, but it is fascinating to see HKPU’s techniques. Most practitioners agree that better tracking and record-keeping can only improve herbal safety, and HKPU’s system is the most sophisticated one I have seen for crude medicinals.

Hong Kong Polytechnic University’s System

Hong Kong Polytechnic University is not a medical school, but it has a TCM clinic that utilizes a very advanced system of herbal tracking (conveniently developed by their IT students). Patients have access to a touch-screen kiosk in the waiting room that gives them detailed information about 610 Chinese medicinals, and the pharmacy is based around the use of smart cards.

The smart cards are linked with PDAs, which in turn are linked to the computers used by practitioners. A practitioner sends a prescription to the pharmacy, and the prescription shows up on the PDA of a pharmacy worker. The worker then looks down the list, which tells them the correct drawer for each medicinal. Every drawer has four medicinals within it, and each one has a smart card that is scanned by the PDA. If the wrong medicinal is chosen, a warning sounds alerts the worker. After each correct herb is filled, the PDA is updated until the prescription is complete. This smart card system makes sure that the herb is rapidly located and properly identified. If any herbs that are incompatible (such as the 18 traditionally incompatible herbs) are combined, a warning alerts the practitioner and the pharmacy worker. Incompatible herbs raise a red flag, which must be resolved before the prescription can be filled.

Following the filling of the prescription with a smart card checklist, a digital photograph is taken of the final prescription. This photograph is kept in the patient file forever. If any problems are ever reported, the photograph can be culled to check to make sure that the prescription was properly filled. The smart card system ensures that the correct herbs are always used, and it links the practitioners with the pharmacy to form a paperless, integrated system. It also allows the university to trace each batch of herbs back to their original source and lot number, and allows for automatic inventory updating.

Hong Kong is different than the U.S. in that toxic medicinals require special regulations. In the U.S. toxic medicinals are sometimes available and sometimes not, as they tend to exist in a grey area of the law. Some products are banned outright, while others are not illegal for use but are periodically held up at customs. Others get through without any problem whatsoever. In Hong Kong, there are about 31 medicinals that require a special permit and safeguards for use, which allows access to these medicinals by professionals while minimizing danger to the public. At HKBU, these medicinals are stocked in locked drawers and require special approval for access. Examples include cinnabar, toad venom, arsenic, tabanus, etc.

I think that the HKPU system is quite remarkable. It brings quality control of raw medicinals to a whole new level. While such sophistication is not yet needed for compliance with U.S. law or for the general safe use of Chinese medicine, we should stay informed on the developments in our field with regard to pharmacy practices. Chinese medicine is generally quite safe, but we still have issues of species identification and other safety issues that we must stay abreast of, and practitioner education in herbal pharmacy is variable within our community. In light of all the current discussion on herbal safety and traceability, it seemed that the timing was right to share the experiences of HKPU in their efforts to make crude medicinal use as safe and accountable as possible.

Copyright Blue Poppy Ent., Inc., 2009. All rights reserved.