Q. As both board chair of the Alliance for Pharmacy Compounding and a compounding pharmacy owner, what are you seeing lately in the world of pharmacy compounding?
There are big changes and great opportunities right now in pharmacy compounding, both for 503As and 503Bs. With updated USP chapters, some pharmacies that do a small volume of compounding in addition to traditional dispensing are deciding that the cost of compliance isn’t worth it — particularly hazardous drug compounding. They’re passing that portion of the business along to pharmacies who specialize in compounding.
Pharmacy compounding is also getting more media attention lately, especially with compounded GLP-1s, but a lot of the stories miss the nuance or report inaccurate information. APC is focused on cultivating more balanced and factual news coverage of compounding this year. We have a program where we’re bringing healthcare reporters into compounding pharmacies (particularly sterile compounding pharmacies) to allow them to see what compounders actually do. It shows them that compounding isn’t mixing random ingredients together in barrels out back but is a highly regulated industry held to rigorous standards, all in the interest of keeping patients safe and well. We’ll be doing more of those tours for reporters as the year progresses.
Q. Are you seeing anything that could interrupt patient access to compounded medications?
There is always a concern that legislation and regulation — or sometimes, a lack of it — could affect patient access. Right now, there are two main issues on the federal level that APC is addressing to maintain patient access to medications. First is legislation modifying how “drug shortage” is defined in federal law. We want to authorize the Food & Drug Administration (FDA) to collect information on drug shortages not only from manufacturers, but from health care practitioners and others. Combined, these changes will make the FDA shortage list more accurate and current and will enable drug manufacturers, pharmacies, and health care practitioners to more quickly identify and address drug shortages as they arise.
The other major issue is one the compounding industry has been dealing with for over 25 years — the MOU requirement in the Food, Drug & Cosmetic (FD&C) Act which would restrict shipments. The 5% cap on shipments by pharmacies in states that don’t sign the MOU — and about 10 states are saying they can’t or won’t — would significantly interrupt patient access to care. Since DQSA makes the need for an MOU obsolete, APC is proposing eliminating the MOU and replacing it with a framework for mandatory reporting by pharmacies that ship more than 50% of their production out of state. The proposal also includes reporting of serious adverse events by all 503A pharmacies, which is already required for 503Bs, and which we think will enhance our profession’s credibility.
The possibility that the FDA may move to restrict access to compounded hormones, based on a flawed and discredited 2020 report it commissioned from the National Academies of Sciences, Engineering, and Medicine (NASEM), is also an ongoing concern. The FDA has stated publicly and in correspondence with Members of Congress that it intends to use the flawed NASEM study’s recommendations to inform the agency’s policies on compounded hormones going forward. APC has an ongoing media campaign to preserve patient access to compounded hormones, and more information can be found at compounding.com.
Q. What can pharmacy compounders do to help ensure patient access isn’t interrupted?
There are three big things compounders can do. One, join an industry trade association. Being a member of organizations like APC can help assure you are informed about laws, standards, and trends in compounding — so that you can practice at the top of your expertise. Two, involve yourselves in advocacy on the part of your profession. Our collective strength as compounders depends on how engaged you are in helping shape legislation and regs in Congress and in the states where your licensed. And three, which should be a given, comply with all local and federal laws, adhere to USP standards, and follow best practices. In 2020, APC adopted a new Compounder Code of Ethics, and it requires members to commit themselves to the Code of Ethics when they join or renew their APC membership. I urge compounders to use that code and the training materials that go along with it to continually remind their compounding teams about their ethical obligations.
Q. What has been the impact of compounded GLP-1s on the compounding industry?
It has been an opportunity to show that compounding pharmacies can meet a need — short or long term — during drug shortages. We can help ensure patients don’t lose access to important medications. The role compounders have played during the GLP-1 shortage also shows why it is so important to address how shortages are defined and what compounders are allowed to do.
Compounded GLP-1s have garnered a lot of media attention, too. Like I mentioned before, a lot of the reporting right now misses nuance or repeats inaccuracies. But I think it also provides a huge opportunity for us to educate the media on the integral role compounding plays in the health of patients. Many reporters don’t seem to know compounding is authorized in the FD&C Act or that compounding “essentially” copies of FDA-approved drugs in shortages is allowed under FDA guidance.
Q. What other trends do you see in the near future for pharmacy compounding, especially 503A compounders?
With the updated USP compounding standards, I see a lot of opportunity for compounding pharmacies to start specializing in certain practice areas — veterinary, HRT, ophthalmics/sterile meds, and others — to reduce costs and increase access. I see pharmacies moving to concentrate in a certain area so they can focus on producing high-quality, specialized service. I also see there continuing to be consolidation in the industry, which is an opportunity for owners who are looking for an exit strategy or who want to expand the scope of their practice and business.
Another issue on the horizon is expected final guidance from FDA on 503B wholesaling. The agency issued draft guidance last year that would allow 503B outsourcing facilities to distribute compounded drugs to 503A pharmacies for patient-specific dispensing. While some states may already allow this, final guidance would make it legal across the country. We think the guidance has huge implications on the competitive landscape of compounding. At a minimum, it will help strengthen the business model for 503As. It could also serve to level the playing field between sterile and non-sterile 503A compounding pharmacies — something that some people love and others are concerned about. It bears watching, for sure.
A couple of other trends that I believe will really take off in the near future are small, local clinical trials and the collection of patient-reported outcomes for compounded medications. In order to continue to demonstrate the value and importance of pharmacy compounding, we have to move past relying on anecdotes and start collecting data showing outcomes and how compounds affect patients in the short and long term. APC has a partnership with OutcomeMD, a patient-reported outcome platform, to help compounders with tracking and trending data to demonstrate the positive outcomes from compounded medications.
Q. What else do you want compounding pharmacy owners and managers to know?
I highly encourage compounding pharmacists to access available APC resources. We have resources for advocacy — briefing papers and other support on federal and state issue priorities — plus several education webinars and opportunities designed to support your whole compounding team. One important education tool is APC’s 15-hour online continuing education program called “The Ethical, Legal, & Regulatory Foundations of Pharmacy Compounding,” developed in partnership with the Pharmacy Compounding Foundation and the Virginia Commonwealth University School of Pharmacy. It’s a solid foundational course for entry-level learning for compounding pharmacists and technicians and a great refresher for seasoned compounders.
In addition to resources for compounders, we also have resources for prescribers. Most prescribers are unfamiliar with the laws and standards compounders have to adhere to, much less the threats pharmacy compounding faces. Our ‘Prescriber Briefs’ series helps pharmacy compounders educate and inform the prescribers they work with on a variety of topics, ranging from the regulatory framework of pharmacy compounding to a brief on GFI 256 to a primer on peptide compounding.
Q. Would you recommend a career in pharmacy compounding to student pharmacists?
Absolutely, positively. I’m a preceptor for a number of schools of pharmacy across the country, and we constantly have students at Town Total Compounding Center interning and learning. In fact, all of our current pharmacists are previous interns. I highly encourage students to look into compounding if they think they may be interested. It’s a completely different experience from traditional community or hospital pharmacy practice.
The Alliance for Pharmacy Compounding is the voice for pharmacy compounding, representing more than 500 compounding small businesses — including compounding pharmacists and technicians in both 503A and 503B settings — as well as prescribers, educators, researchers, and suppliers.
Joseph P. Navarra, R.Ph., FACA, FAPC, Owner of Town Total Compounding Center
Joseph P. Navarra, R.Ph., FACA, FAPC is the owner of Town Total Compounding Center, a PCAB/ACHC Accredited compounding pharmacy providing sterile and non-sterile patient specific prescriptions, following USP <795> , <797>, and <800> guidelines. He was previously the executive vice-president of Town Total Health, independent pharmacies that had a focus on specialty pharmacy. He graduated from St. John’s University College of Pharmacy in Queens, New York in 1992. Joseph has been very involved in professional organizations promoting and enhancing the practice of pharmacy at a high level. He is a past president and past chairman of the Pharmacists Society of the State of New York, and a past president and past chairman of the Italian-American Pharmacists Society. He is a current board member of the New York City Pharmacists Society and the current chairman of the Alliance for Pharmacy Compounding. His awards while practicing pharmacy include the Distinguished Young Pharmacists Award, Preceptor of the Year Awards, and Innovative Pharmacy Practice Award. Some of his other interests include classic car restoration, and he has been an active, long time martial artist ranked in multiple styles.
