Q&A: Pharmacists Must Navigate GLP-1 Compounding Regulations Carefully, Compliantly

Amid ongoing pressures from the FDA and other regulatory entities, the dispensing of compounded glucagon-like peptide-1 (GLP-1) medications has garnered increased scrutiny in the past few weeks. As this booming drug class goes in and out of shortage, community pharmacies of all types must be well aware of the compliance and regulatory hurdles needed to be overcame in order to dispense these compounded alternatives.

“For community pharmacists that are performing GLP-1 compounding, they really need to be prepared to justify their rationale for their anticipatory batch quantities to avoid the impression of mass production,” Annie Lambert, PharmD, BCSCP, clinical program manager for compliance solutions at Wolters Kluwer and board-certified compounding expert, told Drug Topics. “I think that's where the FDA is really targeting in on some of their quantities.”

With outside regulation through laws like the Drug Supply Chain Security Act, pharmacies in the US are often held accountable for the prescriptions they distribute. As compounded GLP-1s pose additional challenges both at community pharmacy counters and the national level, it’s important for pharmacists to understand their capabilities.

“Then, for community pharmacists that are not actually involved in compounding, maybe patients are coming to you with questions,” she continued. “Just being able to help them navigate what those differences are, where products can come from; most of the patients, I think, are also having those conversations with their providers.”

Learn more from Lambert as she dives deeper in part 2 to discuss the nuances of dispensing these heavily debated-upon products.

READ MORE: Pharmacists Should Verify Supplier Quality for Compounded GLP-1s

Drug Topics: Given the FDA’s recent crackdown on the “mass-marketing” of compounded GLP-1s, how should community pharmacists distinguish between legitimate patient-specific compounding under 503A and the large-scale production of 503B outsourcing facilities?

Annie Lambert: This topic seems to be in the headlines almost every day. It’s something that I know that I'm paying attention to and probably many of your listeners are too.

I think community pharmacists practicing the compounding of GLP-1s really need to be very well-versed in these regulatory requirements and the changing landscape. During the times of commercial drug shortage, when we couldn't get the brand-name products, that's when the 503B facilities were allowed to compound the GLP-1s. Then in some states, the 503A pharmacies were also able to dispense those doses to their patients as patient-specific doses.

Since the shortage has been resolved, 503A pharmacies may continue to compound those patient-specific doses pursuant to a prescription or in reasonable quantities in anticipation of a prescription. Now, of course, we have to follow those US Pharmacopeia Code 797 (USP 797) requirements and batch limitations. For community pharmacists that are performing GLP-1 compounding, they really need to be prepared to justify their rationale for their anticipatory batch quantities to avoid the impression of mass production. I think that's where the FDA is really targeting in on some of their quantities.

Then, for community pharmacists that are not actually involved in compounding, maybe patients are coming to you with questions. Just being able to help them navigate what those differences are, where products can come from; most of the patients, I think, are also having those conversations with their providers. It's really a provider, patient, and pharmacist conversation to navigate.

Drug Topics: The FDA has recently issued dozens of warning letters to telehealth firms for implying sameness or genericity between compounded and FDA-approved drugs. How can pharmacists ensure their own marketing and promotional materials remain compliant with the Food, Drug, and Cosmetic Act, while still communicating the value of compounded alternatives to their patients?

Annie Lambert: First, I would say read those warning letters and learn from them what not to do. There are some very specific examples of language that the FDA saw on particular websites or things in their marketing to point out and say, ‘We don't want you to do this.’ So that's very helpful. Learn from those that have already made those mistakes. Then, what you can do, you can promote the experience of your personnel about what training they have. You can talk about the qualifications of your pharmacy, your room—like your 797 or 800 room. Maybe patients aren't going to understand what that means, but if they have people that are helping them, like pharmacists or providers in their family, they might have a little clue into that.

Then, if you have any accreditation such as Pharmacy Compounding Accreditation Board (PCAB) or if you're a part of the National Association of Boards of Pharmacy (NABP) Verified Pharmacy Program, one of the things I tell patients and friends and family is you have a right to know who your pharmacy is [and] where you're getting this medication from. Showing some of those accreditations or quality standards should be a boost of confidence. Be proud of them because you worked really hard to get them.

Some other things that you can do on your website or other marketing is also be very clear that you require a prescription for any doses or any services that you provide. This is 503A patient-specific compounding. [You] just need to be clear about that. People can't just come and see a list of services, a menu on your site, and say, ‘Well, I want that GLP-1 or I want that thyroid medication.’ It really is, again, going back to your provider.

I think, just in general, having some description about the purpose and benefits of compounded medications, about the compounding process, not revealing all about how the sausage is made necessarily but why we do what we do [is important]. Compounding meets a patient need when it can't be met in the market otherwise. Whether that’s because there's an allergy to a particular ingredient or a dosage form that is not available in the market or just doses that are not available, you can talk about those benefits in general.

READ MORE: Obesity Management Resource Center

Don’t get left behind: Sign up today for our free Drug Topics newsletter and get the latest drug information, industry trends, and patient care tips delivered straight to your inbox.