FROM APC: FDA clarifies on semaglutide sodium, states misstate the rules, and more… │ 28 April 2023

The voice for pharmacy compounding │ 28 April 2023

From APC's CEO

When states misstate the rules

In the past three weeks, three state pharmacy associations have issued licensee communications on semaglutide compounding that misread (and misstate) FDA guidance on when 503a pharmacies can compound “essentially a copy” of an FDA-approved drug that is on the FDA drug shortage list.

The guidance states that if a drug is listed as “currently in shortage”—that’s the exact language—it may be compounded. The state boards I mentioned apparently went to the FDA website, saw that some dosage strengths of Wegovy or Ozempic were listed as “available,” and took that to mean they were not in shortage and thus could not be compounded.

But availability is not mentioned in the FDA guidance. “Currently in shortage” is the determinative language, and as of this writing, semaglutide remains in that category.

APC’s concern is not so much semaglutide compounding—that’s a whole ‘nother can of worms. Our concern is that states are misreading FDA guidance and could well apply that misreading to the compounding of other FDA-approved drugs in shortage.

We reached out to FDA and NABP this week to urge them to help correct this misunderstanding, and APC and NCPA have written letters to the three state boards in question, urging them to correct their licensee communication. Late Thursday, FDA sent a letter to NABP, to be shared with state boards of pharmacy, clarifying this issue. That FDA letter clarified some other things, too. Read more below…

– Anthony

Anthony Grzib is VP of quality and compliance, state-regulated pharmacies at Wedgewood Pharmacy in Swedesboro, New Jersey. You can reach him at agrzib@wedgewoodpharmacy.com.

ICYMI

Catch up on these recent stories that you might've missed:

This week

FDA clarifies position on compounding semaglutide sodium

In a letter sent this week to NABP, FDA clarified its position on the compounding of semaglutide sodium.

FDA stated that it is aware that some compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate. However, the FDA emphasized that it is not aware of any basis for compounding a drug using these semaglutide salts that would meet federal law requirements that limit the types of active ingredients that can be used in compounding.

Compounded drugs can be made and distributed with fewer restrictions when the drug appears on the FDA’s drug shortages list. However, the FDA has clarified that the listing of Wegovy and Ozempic on the Drug Shortage website does not authorize the compounding of semaglutide sodium or any other salt form of semaglutide.

Share this with your prescribers

The threat to compounded hormone therapy affects them, too

APC-Prescriber-Briefing_Compounding-Hormones_THUMBNAIL_April-2023_Page_1 image

Though APC has engaged thousands of patients and compounders in our campaign to preserve compounded hormone therapy, prescribers continue to be largely absent. It’s up to you to educate them about the threat, and we’ve developed a new resource to help you do that.

Download and ask your sales reps to share it— either a hard copy or the digital version—with all the prescribers of compounded hormones you work with. What they don’t know about FDA’s implicit threat to restrict cBHT can hurt them and their patients. Help us engage them.

Another NASEM conflict of interest

A recent article revealed that the National Academies of Science, Engineering and Medicine reportedly received funds—to the tune of $19 million—from members of the Sackler family, a few of whom are associated with the family business, Purdue Pharma.

Hmmm. Sounds familiar, a lot like FDA’s inappropriate influencing of NASEM’s 2020 report on compounded hormones.

According to the article, some efforts have been made over the years to discredit the NASEM reports that were funded by members of the OxyContin manufacturer, but these attempts are too little, too late.

One of the scientists interviewed for the article remarked that “the group’s longtime failure to disclose financial ties between committee members and industry placed the Academies in the ‘dark ages’ of research integrity.”

Exactly.

Save these dates

Now available on-demand: The FDA Compounding Quality Center of Excellence is announcing the availability of two self-guided, online courses:

May 16-17: PCCA ACT Legislative Conference, Washington DC

May 25: An APC webinar, IV Nutrition in Compounding.

June 1: APC Fellows Program application deadline

June 6: An APC webinar, Popular Compounds and Unique Ingredients for Cosmetic Compounding

June 29: An APC webinar, Trends in Veterinary Pharmacy: What Compounders Need to Know. More details coming soon.

September 19-20: APC's Compounders on Capitol Hill 2023; Hilton National Mall; Washington, DC

2024

April 4-6: Owner Summit, La Jolla, CA

Short takes

PBMs in the hot seat. Earlier this week, the Senate HELP Committee announced it is considering four bipartisan bills next week, including a 91-page one that scrutinizes PBM business practices. Multiple committees in the House and Senate also have PBMs in their sights, including the Senate Finance Committee, which aims to have a bipartisan PBM bill by the summer.

Makena petition started. Yesterday, advocacy organization Public Citizen issued FDA a petition asking the agency to add Makena to its list of banned drugs to prevent compounding pharmacies from replicating the banned medication.

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