The voice for pharmacy compounding │ 6 October 2023

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From our Board Chair

Keeping prescribers in the know

The providers you work with may be smart cookies, but they don’t always know compounding.

They often are unfamiliar with the laws, regs, and standards we have to adhere to, much less the threats we face. Invariably, though, those threats have implications for prescribers, too. From possible restrictions on hormones compounding to batch-size restrictions in the new USP standards to the legal assault on shortage-drug compounding by some drug manufacturers — patient access to compounded meds is threatened.

Providers need to know about those issues, and it’s up to you to keep them informed.

A new APC briefing paper can help with that. It’s titled ‘PROVIDER UPDATE: Three threats that may impede patient access to compounded medications.’ Download it and share it with the prescribers you work with — either in the APC-branded PDF form here or cut and paste the text of it into your pharmacy’s e-newsletter or other provider communication.

And don’t forget that APC provides an entire suite of topical Prescriber Briefings to which you can add your logo and share with providers. Topics range from the regulatory framework of pharmacy compounding to a brief on GFI 256 to a primer on peptide compounding (speaking of which, read below about FDA’s recent reclassification of several peptides as Category 2 substances).

These briefing docs are just another way APC is helping position you as a trusted advisor to your providers and patients. Use ’em!

— Anthony

P.S. Our APC staff has been flooded with calls and emails this past week about the new PFM credit card processing deal we announced last week. In case you missed that news, you’ll see a link to it below. It’s worth a look.

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

This week’s news

FDA puts some peptides off-limits

Last Friday, the FDA announced that it has updated the list of bulk drug substances nominated for use under section 503A. Notably, GHK-Cu (with some limitations) and L-Theanine have been added to Category 1, making them eligible to use as active ingredients in 503A compounding. In addition, among other substances, several peptides have been added to Category 2 “because FDA has identified significant safety risks with [those] substances,” the agency said.

While the FDA definitions of categories 2 and 3 don’t state overtly that substances in those categories may not be compounded, they do state that FDA can take regulatory action against pharmacies using those substances.

“We’ve reviewed last week’s updates, particularly the addition of some peptides to Category 2,” said APC’s Scott Brunner. “There’s been no groundswell from our members about challenging these items, perhaps because they don’t meet the criteria under 503A.”

Under Section 503A of the Food, Drug & Cosmetic Act, an eligible bulk drug substance for compounding must be a component of an FDA-approved drug, must have a USP or NF monograph, or must appear on FDA’s 503A Bulks List or Interim Bulks List Category 1. The peptides now listed in Category 2 have never met those criteria.

Here’s where to view the full list of changes.

Senators to FDA: Preserve access to cBHT

Five U.S. Senators have written to the FDA urging that the agency assure continued patient access to compounded hormones for patients.

“FDA has long acknowledged that its scope does not extend to regulating the practice of medicine,” the senators wrote, “And we encourage the agency to not upend treatment for the millions of men and women who rely on compounded hormones because their doctors have determined they are a more appropriate medication. It is important to note that patients often choose cBHTs because they prefer them and because their physicians recommend cBHTs as the best course of treatment for them.”

The letter was led by Senators Roger Marshall (MO) and Tammy Baldwin (WI). They were joined by Senators Katie Britt (AL), Ted Budd (NC), and Kevin Cramer (ND).

“We’re deeply grateful to these senators for their leadership and support on this issue,” said APC Board Chair Anthony Grzib. “Millions of Americans depend on compounded hormone therapy to live normal lives. It’s important that FDA gather stakeholder input and not take any rash action that would impede access. That’s the point this letter makes.”

Licensed in California?

You’ll want to see this

APC staff has prepared a comparison document illuminating the differences between the new USP Chapter <797> on sterile compounding that takes effect November 1 and proposed regulation from the California Board of Pharmacy on that same topic.

“Clearly, the proposed California regs go well beyond the national standards set by USP, with no indication or documentation of how those more strenuous regs will keep patients safer,” said APC’s Savannah Cunningham.

Big thanks to CompPAC investors

CompPAC is the way APC supports members of Congress who think like you do about pharmacy compounding. And where does CompPAC get its funding? From compounders like you.

We’re grateful to our 2023 investors, and you should be, too. Here’s where to find a list of them … and also where to make an investment yourself.

We’ve raised about $80,000 thus far this year. Our goal is $125,000.

Please, A4PC — do your part and make an investment.

Time to vote in APC Board elections

Voting is now open for seats on the 2024 APC Board of Directors.

For review prior to voting, here is the slate of officers and board candidates. (Note that there is no vacant seat in District II, so members in that district will not receive a ballot.)

Current individual pharmacist, technician, or supporter members and those employed by a pharmacy/facility member are considered voting members of the association.

Voting members of APC will be receiving an email directly from Association Voting (look for announcement@associationvoting.com with instructions on how to cast your ballot.

Or you can just click here to vote.

Note: Voting ends October 25 at 11:59 pm ET.

Short takes

Compounding champions visit Keystone. Last week APC’s past president Dave Miller hosted a meet-and-greet with compounding champions U.S. Reps. John Moolennar (MI) & Diana Harshbarger (TN) at Keystone Pharmacy in Grand Rapids, Michigan. We love it when compounders host members of Congress!

New deal for PFMs coming soon: APC is working with Capital Drug on another exclusive benefit for our Pharmacy/Facility Members: A best-price guarantee on finished-form generic and brand-name drugs. Stay tuned. We’ll be announcing details soon.