By Eric Brand

In previous blogs, we have often mentioned the topic of cGMP (current Good Manufacturing Practices) regulations and Chinese herbal dispensaries. Despite the fact that cGMP regulations technically classify all compounding pharmacies as “manufacturers,” the majority of practitioners in our field enjoy what the FDA calls “discretionary enforcement” because they prescribe herbs to patients on a one-to-one basis. This means that most practitioners probably have little need to worry about any legal problems regarding their herbal dispensary as long as nothing goes terribly wrong.

As individual practitioners, we generally don’t have the ability to achieve true GMP compliance so we just keep our fingers crossed, try to maintain a clean space and good records, and hope that we don’t make any major mistakes. For most of us, the cost of maintaining a GMP-compliant space outweighs the risk of operating in the gray area of enforcement discretion. But what does a cGMP-compliant dispensing pharmacy really look like in real life?

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The only example I’ve seen of a fully cGMP-compliant Chinese herbal pharmacy is the setup that Bill Egloff runs at Crane Herb. I’ve only been to his Crane Herb West location in Sebastopol, CA; though small, it is a very impressive little operation. Most of us will never have the desire or resources to transform our clinic into a Crane-style dispensary, but seeing what a real GMP pharmacy looks like in action is a fascinating educational experience. If you are ever up in the Northern California wine country, I’d strongly encourage you to stop by Crane to check it out.

The first thing that strikes you when you walk into the Crane dispensary is the sophistication of the processes and equipment, and of course the cleanliness. I spent many of my formative years filling formulas in a classic Chinatown-style shop packed high with dusty boxes, hand-scribbled Chinese formulas, and a constant feeling of loveable chaos, so I am by no means a hygiene snob when it comes to old-school Chinese herb dispensing. That said, it is really quite impressive to see the clean, modern setup of Crane, and I can see why this model would be the pie in the sky that safety regulators dream of.

All GMP facilities basically insulate the clean area from the outside world. In many ways, a GMP compounding space is a like a clean field for acupuncture, it is a special area that has its own rules and techniques. In a GMP factory, access to the clean area often involves sex-segregated changing rooms, forced air, physical barriers, and special gowns. Crane is much smaller than a real factory but they still use hairnets, gloves, shoe covers and gowns to prevent contamination of the space, and they even have a sticky mat to remove extra debris from the underside of the booties that cover one’s shoes. Inside the clean space it is meticulously clean, and all the surfaces and containers are designed to minimize cross-contamination.

As one moves further into the Crane dispensary, the initial feeling of “wow, I could eat off the floor” gradually gives way to the awestruck feeling of technology envy. The granule powders are equipped with a full internal bar code system, and the computerized prescription is linked to each bottle by a bar code system that only allows one to proceed if the right herbs are selected. The digital scale is integrated into the computer, and it records the weight of each item as it goes into the prescription. Each item must be properly selected, scanned, and weighed to within 1/10th of a gram before one can proceed to the next item, and the computer records each step in a digital tracking system.

After weighing, the herbs are then mixed. Most of us individual practitioners mix our granules by putting them in a big, sealed container, which we shake vigorously. Some people use single-use mixing vessels, some clean a common container, and others just re-use the same container repeatedly (hopefully most brush it out a bit after dispensing centipedes and aconite). By contrast, at Crane they only use one single, clean container throughout the weighing and mixing process. While most of us have to dump the herbs from the small jar into a big container, Crane has a special pharmaceutical mixing device from Europe that automatically shakes the powder in a complex sequence of movements for about 20 minutes. Such a device eliminates the need for shaking by hand in a separate container and achieves a uniform mixture of powder that passes even pharmaceutical standards for uniformity. Crane’s mixing machines fill a room and cost tens of thousands of dollars, but they offer a unique ability to avoid cross-contamination and their ability to mix the powder in a uniform fashion is undisputable. From there, the prescription can go into an encapsulation machine or it can be labeled and sent off as is.

Despite all the fancy trappings of a high-tech facility, ultimately much of the work of cGMP compliance happens in a simple file drawer. GMP regulations are obsessive about tracking lot numbers and keeping a paper trail that allows for recalls, complaints, and records of what medicine went to which person. Crane’s system allows the practitioner to submit an order online for drop-shipping to the patient, and it allows the practitioner to quietly add whatever level of markup (if any) they desire. Many practitioners (and even schools) want to limit the hassle of maintaining a pharmacy due to concerns about space, liability, and cost, so Crane’s prescription service is quite popular. Some patients live far away where herbs are hard to find, and other practitioners are simply too busy to deal with filling their own formulas. Outsourcing all that hassle to someone like Crane makes sense in many situations, and they give the practitioners a monthly check based on whatever markups the practitioners specify. While such perks are the things that give Crane their business base, the thing that brings their GMPs to another level is the fact that all those submitted prescriptions are traced to the exact bottle that was used to fill each herb in the formula. This means that there is a digital paper trail that links every prescription to the specific batches of herbs that were used to fill it, which is no easy feat to engineer. The bottle even comes with a nice, FDA-complaint label that actually tells the patient what they have.

The degree of accuracy and traceability that a pharmacy like Crane uses is above and beyond what most of us ever hope to attain, but it is worth a field trip up there for anyone in the Bay Area that is interested in GMP issues. I am personally just as comfortable getting my herbs in a dusty little Chinatown shop as I am in a high-tech epicenter of hygiene, but admittedly I’m a guy who loves eating street food in Thailand and I’m about a million miles away from some of the paranoid hypochondriacs that come in to see me for acupuncture.

Crane fills an important niche in our community so they deserve a little plug of recognition for the effort that they have made to be a model of real GMP compliance. Larger manufacturers (such as Blue Poppy and many of the other big companies) run a tight, GMP-compliant operation out of necessity, but applying GMPs at the cottage industry scale remains uncommon and out of reach for most. My hat goes off to Bill at Crane for making the GMP compounding option available. Even if you usually just mix syrupy goop in your garage, you never know when you might run into one of those crazy paranoid patients… better to send those types to Crane and save the moonshine ginseng paste for your friends.