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?
Specifically the Rutledge v PCMA case? The practices of 1000s 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."
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. (Click here to see the list and read the letter.)
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).
Join the board of the Pharmacy Compounding Foundation! Help direct its mission, advance pharmacy compounding, and do more for patients. NOMINATIONS CLOSE THURSDAY, OCTOBER 15. Just click here to self-nominate!
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.
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".
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.
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.
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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