Fairness and the FDA

Check out the latest entry in FDA Law Blog: “Lemonade from Lemons: Fairness in FDA Enforcement Actions.” It’s about executive order 13924, which says federal agencies “shall consider” fairness in enforcement actions. How might that apply to FDA?

What’s at stake in the Supreme Court?

Specifically in the Rutledge v PCMA case? The practices of thousands of community pharmacies and their patients, that’s what. Our allies explain: “States vs. PBMs at the Supreme Court: What’s at Stake for Patients.”

GFI #256: Congress sends a joint letter to FDA

A big thank you to all the members of Congress who signed onto the joint letter to FDA — led by Reps. Norcross, Pocan, and Yoho — asking that the agency withdraw GFI #256 on animal compounding. Here’s the list; read the letter here.

James R. Baird
Jaime Herrera Beutler
Andy Biggs
Dan Bishop
Sanford Bishop
Earl L. Buddy Carter
John R. Carter
Bonnie Watson Coleman
Henry Cuellar
Madeleine Dean
Jefferson Van Drew
Neal P. Dunn, M.D.
Paul A. Gosar, D.D.S.
Mark Green
Jim Hagedorn
Fred Keller
Andy Kim
Debbie Lesko
Zoe Lofgren
Donald Norcross
Ralph Norman
Eleanor Holmes Norton
Mark Pocan
Bill Posey
Denver Riggleman
David P. Roe, M.D.
Michael F.Q. San Nicolas
Kurt Schrader
David Schweikert
Christopher H. Smith
W. Gregory Steube
Van Taylor
Bruce Westerman
Ted S. Yoho, D.V.M.

Rep. Morgan Griffith pens a great op-ed

APC is loving this powerful op-ed from Congressman Griffith about the FDA’s MOU. It makes important patient access and economic arguments against the MOU as presently proposed. Please share and spread the word (and a thank-you to the congressman wouldn’t hurt, either).

Nominations are still open: Run for the foundation board

The Pharmacy Compounding Foundation needs compounding pros who want to do more for the practice of pharmacy compounding.

The foundation is APC’s charitable extension. It helps fund educational and scientific programming and research — chances are you’ve seen or even joined a foundation-sponsored activity.

Join the foundation board! Help direct its mission, advance pharmacy compounding, and do more for patients. NOMINATIONS CLOSE THURSDAY, OCTOBER 15. Just click here to self-nominate!

Tricare clawback update

APC’s been working on the Tricare clawback issue, and we’ve got some pretty good news. It’s too much for a quick post here, so we’ve scheduled a (final?) briefing call THIS WEDNESDAY, October 14, at 4:00pm EDT. Free to all, but registration required — click here to do that.

Raw material substitution?

The new blog post from Gus Bassani, PCCA’s chief scientific officer, explains “Why Brand and Generic Substitution Is Not the Same as Raw Material Substitution” — definitely worth a read.

You already know to get your ingredients from reputable repackagers and manufacturers, but Bassani explains that substitutability is a bit of a different creature. “USP specifications,” he explains, “may not cover every important aspect of a raw material.”

Check out the whole story.

Pharmacists to be allowed to give Covid-19 vaccine

Great news: HHS is preemptively authorizing pharmacists and pharmacy interns across the country to administer any approved Covid-19 vaccine to patients 3 and older. (This follows the agency’s August 19 announcement that it was authorizing pharmacists to provide all CDC-approved vaccines.)

As with the August announcement, this rule applies across the country, and supersedes state laws that may limit pharmacist delivery of vaccines either by vaccine or by age.

The Pharmacy Times news story is here.

Reminder: USP’s holding an open forum on <795> and <797>

USP has announced its next step as it reconsiders the BUD provisions in General Chapters <795> and <797>, following APC’s successful appeal last year.

Next up: An all-day virtual public forum on Tuesday, September 15 where USP will share its current findings, then take questions, comments, recommendations from participants that will inform the 2020 – 2025 Compounding Expert Committee, chaired by APC member Brenda Jensen.

Click here to register for the forum.

Got questions? Contact the USP Healthcare Quality and Safety staff at CompoundingSL@usp.org.

Make sure your pharmacy can be found

Unlike some other organizations, the folks at Boston Children’s Hospital want to make it easier for kids to get vaccinated. So make sure your pharmacy is on VaccineFinder — a national registry that helps parents find the closest and most convenient place to get their kids the shots they need: Click here to register.

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