FDA Considerations Put Compounding Pharmacy Services at Risk

A recent report from the National Academies of Sciences, Engineering, and Medicine (NASEM) titled, “The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use,” has raised concerns for the staff of San Ysidro Pharmacy (SYP) and other compounding pharmacies around the nation. 

The report included a recommendation for across-the-board restrictions on compounded hormones with critics of the report claiming that it expressed bias and was not comprehensive enough, only considering 13 studies in its analysis.

The FDA has stated that it will base its next decisions on compounded hormone therapy around this report, with its conclusion indicating that the FDA may place bioidentical hormones on a ‘difficult to compound’ list, effectively making them unavailable for their customers. 

The concerns raised by the SYP staff was heard by U.S. Congressman Salud Carbajal, who paid the store a visit this past Monday. Meeting with their staff, the congressman stated, “Today I’m visiting the pharmacy to see this community treasure firsthand. All that they do for the community and area residents. They’ve been around for 68 years. They perform some services that other pharmacies don’t necessarily always perform.” 

When I spoke with San Ysidro Pharmacy owner Lara Edington-Hove beforehand, she expressed, “That’s our main focus here. That the FDA wants to stop bioidentical hormones from being manufactured by compounding pharmacies. So that’s what we’re asking today. If he could just have open ears and realize, there’s more to it than just the safety of others.”

Congressman Carbajal joined Hove and her staff at this Upper Village mainstay to learn about compounding pharmacies and their concerns noting, “[compounding medications] is a unique function that they provide. And at the end of the day, this pharmacy has been here for years, decades. And it’s just amazing the work that they do and the services that they provide to the community for decades on.”

Speaking to some of their staff and the press, Salud made clear, “First of all, they’re my constituents. And anytime my constituents have challenges or issues that they want to bring me up to speed on and make me aware of – I love that – because then I go back to Washington and explore what I can do to help. And in this case, I am going to do that. I’m going to explore what, if anything, is within my authority that I could address this very challenge that we are facing with the decision that might be made by the FDA.”

One of the main concerns by Hove and other compounding pharmacists is that this new consideration by the FDA may affect availability of bioidentical hormones, plant-derived compounds that are chemically identical to those your body produces. Hove further explained, “For instance, the estrogen is from yams. So, it is naturally occurring. Of course, they’ve changed it into a powder. But that’s very different from synthetic hormones that have nothing to do with nature. They just make the body respond a certain way, and those tend to be harsher.” 

Many of their visitors rely on the facility to prepare these plant-derived hormones for their specific biological needs. “There are a lot of women going through menopause right now. You know, with the baby boomers, it’s the largest amount. And andropause is real. Not every man gets andropause, but some do, and that’s where your testosterone starts lowering. So we also make that – I don’t think that’s bioidentical but we do compound it in low levels – and that’s the key. We can get to lower levels than what the prefab stuff does. And some men just don’t need a lot. They just need a little,” says Hove.

With concerns around the source of what we put in our body becoming ever more prevalent, some people also may simply not want to ingest the synthetic compounds found in pharmaceuticals.

“This has been researched enough – I’ve been here for over 20 years and a compounding pharmacist for close to 50 years – this is what my profession does,” says Andrea Dominic, a longtime SYP pharmacist who has been compounding hormones since 1989. “We’ve helped many, many women through menopause using natural hormones.” Adding that these compounds are naturally-derived and therefore not patentable by pharmaceutical companies. 

The implications of this new report and the outcome it may have has raised concerns for her and the staff. “There’s some [upcoming] legislation that’s designed to limit our ability to compound medications, take you through natural hormone therapy. And we don’t feel that the study that was done by the FDA really included much of the research that is out there on the safety and efficacy of hormone products. And it will severely impact our business,” says Dominic. 

In addition to these compounds, the patients that come in for medication might be sensitive allergic to different binders, fillers, and even coloring agents, that are found in their commercial counterparts. Compounding medications do not just serve their more seasoned clients, but their younger, smaller ones as well, with similar concerns surrounding the fillers, preservatives, and binders found in pediatric medications. 

“It’s personalized medicine. That’s the future of healthcare. Not every body is the same. One or two or three different strengths [of a medicine] may not be good for an elderly patient, even if it’s the lowest strength available; it may not be good for an elderly person whose systems are slowing down a little bit. They may need half of the lowest dose and we’re able to compound that,” says Dominic.

This is not just in the consideration of their human patients; specific pets can also have different sensitivities to these additives with some of their customers looking for naturally-derived or more chemically-pure treatments for their pets.

Dominic sees another concern for their regulars. “There are going to be more and more drug shortages. It’s happening. People come in and we have a different brand every time because there’s a shortage list. We’re able to use a pure compounding powder, not in tablet form, to be able to get people through the shortages. They don’t want us to do that anymore so therefore people have to change their medication when that might not always be the best thing for the patient.”

With the congressman visiting, Dominic and the staff hoped to teach him more about the ways they help the community, their services, and how the FDA considerations will affect their business. “We’re trying to do our part, and having Salud here is really great. We want to be heard and our community wants to be heard.” 

We later headed back into the lab area to meet with the congressman. The two spoke in the backroom filled with glass-lined shelves, scales, and the clean tables where they measure and mix the various medications to one’s specific needs. As Andrea and the congressman met, Salud noted, “The decision has been made administratively, not through the legislative process, through the FDA. But where I come in is that the question is always: ‘Are there legislative things that can direct the FDA to take a different course of action?’ I don’t know the answer but I’m going to go back, consult with my team, and learn more about this and explore what can be done.”