By Eric Brand

A few years ago, the U.S. FDA announced that manufacturers of dietary supplements must comply with cGMP (current Good Manufacturing Practices) regulations. This law takes effect at different times for companies of different sizes, and the compliance date for small companies is at the end of June this year. As the compliance date draws closer, people have started to panic a bit and there is a lot of confusion out there as to what implications, if any, FDA cGMP laws have on private clinics.

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The FDA has stated that they will exercise “enforcement discretion” for trained healthcare professionals that dispense dietary supplements to patients on a one-to-one basis. Enforcement discretion does not apply if the practitioner makes a large batch that is intended for sale without a personal evaluation, but it can be generally assumed that practitioners that see patients individually and give customized treatments typically fall under this enforcement discretion. Technically, anyone who is opening sealed bottles and compounding formulas is still classified as a “manufacturer” under FDA law (and thus subject to cGMP requirements), but it is widely believed that there will not be enforcement unless the practitioner did something truly egregious.

There are a number of gray areas that cause practitioner confusion. First, there is the question of whether or not GMP laws apply to us as private practitioners. Simply stated, the laws do technically apply but they are unlikely to be enforced because of the FDA policy of “enforcement discretion.” It is basically impossible for most practitioners to achieve true GMP compliance, and unfortunately the FDA has no established framework that regulates “good dispensary practices” or any category that is less arduous than true GMPs. Thus, enforcement for trained practitioners will probably be minimal but the lack of a specific exemption or separate regulatory category leaves the door open for legal problems if major mistakes are made and serious adverse events ensue.

Given that most practitioners will never be able to achieve GMP compliance, there is a push to develop voluntary good dispensing practices within the field. In fact, the NCCAOM has even added questions on the exam to deal with good dispensing practices (hurray!). A number of classes have popped up to help practitioners understand these issues, and sometimes the advice from vocal people in the community sends conflicting messages. Some people take the position that the new laws don’t affect practitioners at all while others think the sky is falling. To help bring clarity to the profession, the AAAOM has formed a committee on Good Compounding and Dispensary Practices that aims to produce some guidance for the field. The new acronym GCDP (Good Compounding and Dispensary Practices) was created to focus on a practical model of self-regulation for clinics based on GMPs rather than the full GMP regulations that are suited to genuine manufacturers.

I was just at the recent AAAOM meeting, where a class taught by Al Stone focused on GCDP guidelines. These guidelines are going to be posted as a wiki online resource for general feedback by the profession. Other classes are offered on GCDP and GMP issues, such as COMRE’s course on understanding the implications of GMP laws and courses by vendors such as Mayway. Ultimately, no course can certify that a clinic is in compliance with GMP or GCDP recommendations, but these various courses do introduce the details about aspects of GMPs that a vigilant clinic should be paying attention to.

Generally speaking, GMP compliance is way beyond what a private clinic can hope to achieve, so really what we are shooting for would be more accurately called good dispensing and compounding practices. However, the only legal framework that exists is GMP law, so when we say that someone has good compounding practices we are really just saying that they do as much as they can to replicate the aspects of GMP law that are realistic and practical given the limitations of their setting. Private practitioners are not going to get randomly busted because their facility isn’t GMP compliant, but there is a small but real risk that aspects of GMP law could be a legal sticking point if say, you poison someone with Guang Fang Ji that you mixed up in your garage.

Everything we do carries some degree of risk- driving to the clinic, needling GB-20, dispensing Bai Zhu, etc. The risk of serious adverse events from acupuncture needling is low, but we still clean points and pay attention to our angle and insertion depth to minimize the risk. The risk of driving to the clinic is low, but we still wear a seatbelt and pay attention to the safety of our driving habits. The risk of dispensing Bai Zhu is lower than the risk of dispensing Guang Fang Ji, but ultimately every activity carries some risk.

We need to decide for ourselves which risks are acceptable and which safety measures are appropriate. I could easily drive to the clinic everyday without a seatbelt and it is likely that there would never be any negative consequences. On the other hand, wearing a seatbelt is easy and helps to reduce the risk of larger problems. We are no more likely to have a solution to the legally gray area of GMP laws that we are to have a crash-proof car, so being aware of the spirit of GMP regulations is probably a reasonable idea in terms of risk management. A practitioner can’t solve every GMP compliance problem any more than they can avoid every possible traffic accident, but the risk can be reduced significantly with attention to details.

The details involved in GMP/GCDP issues are far beyond the scope of this blog, but there are a few gray areas that I’d like to mention in the blog. These topics currently lack consensus even amongst the people that are closely involved in discussions on GMP/GCDP issues.

Gray Areas

For example, there is a gray area on where one draws the line between raw materials and dietary supplements. Powders, pills, liquids, and other products that are intended for direct ingestion are regarded as dietary supplements, and thus technically fall under the GMP category. However, raw materials are not subject to the Dietary Supplement GMP Laws. We have a big gray area around whether or not whole, bulk medicinal agents can be sold as raw materials or whether they constitute dietary supplements once the prescription is assembled and the patient is advised to extract it and consume it.

This gray area is particularly complex when it comes to products such as Ma Huang. A product sold as a dietary supplement cannot contain ephedrine, but the sale of bulk Ma Huang as a raw material is not prohibited. If one could get away with calling the thing they are selling a raw material, Ma Huang is legal. However, if the product is a dietary supplement, it would be illegal. Complicating the issue, some importers have taken to grinding Ma Huang so that it doesn’t get detained at customs, which makes it a powder (and, by extension, potentially a dietary supplement).

This and many other issues come down to a question of interpretation. The issue of interpretation is also clouded by the abundance of questionable advice out there- for example, some compounding pharmacies have heard that dispensing herbs in bags that aren’t mixed can get around the manufacturing provision of GMP laws, and such clinics mix granules but don’t shake them or sell Ma Huang separately from the rest of the prescription. Such procedures are very unlikely to offer significant protection.

Another gray area that is subject to interpretation lies around the issue of compounding for others. If a professional saw a patient one-to-one and sent the prescription to a pharmacy where it was filled for that one patient, does the pharmacy enjoy enforcement discretion? The pharmacist didn’t see the patient but they did dispense on a one-to-one basis- very sticky. The law is silent on this one; it is a question of interpretation. In the AAAOM’s GCDP presentation, one committee member was of the impression that enforcement discretion would still apply while another member believed that it didn’t apply at all in this context. And what about the Chinatown shops? I used to work in a Chinese pharmacy in California and we had an “A” from the health inspectors like a restaurant- apparently this was sufficient for dispensing bulk herbs, at least it was back then. But would they need to be GMP if they compounded granules? For that matter, would they need to be GMP for the raw herbs in this day and age? Once again, subject to interpretation, and we can only hope that the interpretation would come with a healthy dose of “enforcement discretion.”

Here’s another gray area- if a clinic sees patients one-on-one and they are properly trained, they have enforcement discretion from the perspective of dietary supplement GMPs. But let’s say they also make liniments for injuries, which they sell over the counter. If they were selling liquid products for internal consumption over the counter without a consultation, this would definitely be manufacturing. However, the liquid isn’t intended for ingestion, so it isn’t a dietary supplement and thus doesn’t fall under this latest GMP discussion. Nonetheless, what regulatory category does it go under? Cosmetics are worse than food in terms of regulations. If there are medical claims, it would be a drug product, equally arduous. No medical claims, no cosmetic value, just a liquid extract of raw aconite… where does it fit? Yet another very gray area with minimal precedent. One assumes that there is minimal enforcement but it is fundamentally a gray area.

At the end of the day, chances are that most of our clinics will be business as usual and the sky will not fall. However, I am very happy to see that there is an increasing amount of professional dialogue on these issues, and I am very happy to see that our entire industry is rising to the challenge. The best thing that we can do for now is to pay attention and keep in close communication so that our entire community knows what is going on in this new regulatory landscape. Hopefully we will also see positive trends such as better collection practices for adverse event data, better education on pharmacy issues in our schools, and increased awareness of critical aspects such as the correct identification of medicinals. Stay tuned to our blog to keep up with the information and trends, and thanks for visiting!