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            The voice for pharmacy compounding │ 3 May 2024             

From our CEO

Compounded sublingual semaglutide: It's not a copy

A couple of weeks ago, we shared with you concerns raised by a state board of pharmacy about sublingual semaglutide (they asserted it’s essentially a copy of an FDA-approved drug). APC submitted a letter to the board last week, but the confusion in general suggests a primer is needed. So, here goes:


Federal law generally prohibits the compounding of a medication that is “essentially a copy” of an FDA-approved drug but provides for a few important exceptions, including drug shortages.

Under FDA guidance, the agency does not consider a compounded version of an FDA-approved drug “essentially a copy” of a commercially available drug when the FDA-approved drug is listed as “currently in shortage” on the FDA drug shortage webpage. This exception is essential for continuation of patient care when a drug is in shortage – as, amid continuing post-COVID supply chain issues, many are from time to time.

 

But what about compounded sublingual semaglutide – a dosage form that does not exist in FDA-approved form? Let’s remember the rules. 

 

FDA’s Guidance for Industry titled “Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act” provides three criteria for determining whether a human compounded medication is a copy of a commercially available drug product: 

 

  1. The compounded preparation has the same API as the commercially available drug product;
  2. The API has the same, similar, or an easily substitutable dosage strength; and   
  3. The commercially available drug product can be used by the same route of administration as prescribed for the compounded drug.

 

When compounding doses not within 10 percent of the dosages offered by the commercially available product, a drug product does not meet the second criteria of the FDA guidance and is therefore not considered essentially a copy. 

 

Compounding pharmacists must keep this criteria in mind when choosing to compound and market certain drug products. 

 

Recently, pursuant to a prescription, some compounding pharmacies have begun offering a compounded sublingual version of semaglutide using Rybelsus tablets (the FDA-approved oral semaglutide medication) as the source of the API. The commercially available drug product is not indicated for and cannot be used via the sublingual route of administration (and therefore does not meet the third criteria in the FDA guidance). As a result, this should not be considered a copy of the FDA-approved drug. 

 

Take care to consult the criteria listed in the FDA guidance and use precise language – in this case, sublingual, not oral – when marketing compounded drug products to clearly differentiate the compound from the commercially available product.


— Scott


Scott Brunner, CAE, is APC’s chief executive officer. You can reach him at scott@a4pc.org.

ICYMI


This week's news

Major new study: Hormone therapy benefits outweigh risks in menopause

A recent study published in JAMA suggests that the benefits of hormone therapy outweigh the risks for treating menopause symptoms, particularly among women under 60. Based on two decades of follow-up data from the Women's Health Initiative study, which initially raised concerns about hormone therapy, researchers now indicate that newer hormone formulations at lower doses are safer and more effective. With various hormone therapy options available, including lower-dose compounded transdermal dosage forms, experts suggest reconsidering hormone therapy for managing menopause symptoms and potential long-term health benefits, such as protection against bone loss and heart disease.

NABP gets it right in their latest report


Drugmakers, newsmedia, and even regulators have been wrongly conflating legitimate compounding of GLP-1s with illegal online drug sales. In their latest RogueRx Activity Report, NABP doesn’t make that mistake. The report explores how diabetes drugs like Ozempic and Mounjaro have "gone viral" for their off-label use in weight loss and how bad actors are taking advantage of the drugs’ popularity, putting patients at risk. Read the full report here — it’s worth your time. 

Let's get together


APC may soon be coming to a city near you — and we’d love to meet up. 

We’ll be in the Tampa/St. Pete area on June 12 for our next CompoundED UpDATE — part of a series of regional meetings made possible by a grant from PCCA. At these meetings, you’ll get two hours of live CE, a compounding issues briefing, dinner, and networking time with other compounders in your area — all for only $25. We kicked off the first one last night at PCCA headquarters in Houston with a great crowd. 


We’re planning additional regional meetings in Los Angeles, Seattle, and Columbus later this year. If you’re in those areas, keep an eye on your mailbox for an invitation from us.

Journalistic malpractice


This piece is appalling – both the bias and error in the article itself AND that Pharmacy Times would take a swipe at a legitimate pharmacy practice like pharmacy compounding. The author seems to have swallowed what the drugmakers fed her without chewing it. But then, note all those drug ads surrounding the online piece. And no, APC was not asked to provide perspective.

Short takes

Prior to the Houston regional meeting yesterday, APC’s Jen Petska, Jason Dunn, and Scott Brunner were able to tour Empower Pharmacy with CEO (and APC board member) Shaun Noorian. Thank you to Noorian and Empower for showing them your beautiful facility.


Kentucky is the first state to decriminalize medical errors. The bill provides immunity from criminal liability for “any harm or damages alleged to arise from an act or omission relating to the provision of health services” but does not apply to "gross negligence or wanton, willful, malicious, or intentional misconduct."

CompPAC trustee and APC board member Cheri Garvin attended an event honoring Virginia Senator Tim Kaine, a member of the Senate HELP committee. Kaine is interested in APC’s proposal to broaden the definition of drug shortage, allowing FDA to respond more quickly to interruptions in the supply chain.


Viatris gets USPTO to review one of Novo’s semaglutide patents. An expert panel will review the patent related to the “dosage regimes” used for Ozempic and Wegovy to determine if it is valid. This decision comes on the heels of news that FTC sent warning letters to 10 pharmaceutical companies challenging "junk patents."


FDA is hosting a listening session on June 13 as part of the agency’s effort to reconsider how it uses advisory committees.

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APC is committed to addressing any concerns or complaints within one business day. Please send them — and, of course, any compliments — to info@a4pc.org.

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