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• Let’s talk about that Lilly announcement

  There’s been plenty of coverage of Eli Lilly’s announcement this week that it will sell vials of Zepbound directly to consumers at a discount. But the company seems to have left out a few important caveats. read more →

• Our response to the op-ed in The Hill

  The Hill published an editorial by Dr. Kenneth McCall titled “Fake, unsafe weight-loss drugs are a worsening public health dilemma” in which he makes unfounded claims about pharmacy compounding. Here’s the response from our CEO. read more →

• The shortage ends … then what? (Find out at CCH) 

  We’ve added a new session to the Compounders on Capitol Hill lineup. Don’t miss the discussion of what’s on many a compounder’s (and regulators’ … and reporters’...) mind. read more →

• A new bronze corporate patron

  A big welcome to Ro, APC’s newest tier-level corporate patron! read more →

• Education (and CE) from USP

  For the fourth year in a row, USP will be holding a hybrid live/virtual workshop dedicated to improving the quality of compounding. read more →

• Compounding post-Chevron

  At least three issues affecting pharmacy compounding might be affected by the overturning of the decades-old “Chevron doctrine.” read more →

• 503B sourcing: our state-by-state analysis

  Do you work for one of APC’s PFMs? If you’re with a Pharmacy/Facility Member, you’ve got access to a new resource. read more →

• What we’ll be talking about at CCH

  When we get together on Capitol Hill to meet with legislators and their staffs, as much as we’d like to talk about a half-dozen issues (easily!), we’re going to be focusing on the three most important.  read more →

More News

At least three issues affecting pharmacy compounding might be affected by the overturning of the decades-old “Chevron doctrine.” With federal agencies having their authority complicated (or potentially stripped altogether in certain circumstances) by the SCOTUS “Loper” ruling, APC commissioned a briefing from the Hanszen Laporte law firm.

To be clear, the memo is not an expression of APC’s position on the issues, and we do not endorse it. It’s strictly informational and speculative. We believe, however, that it’s important for members to understand how that ruling might affect these three pharmacy compounding policy issues.

Remember, the analysis isn’t about FDA’s actions themselves, but if and how the Loper ruling might open those actions to a legal challenge. The issues:

1. FDA’s memorandum of understanding with states regarding shipping compounded medications out of state — “Loper’s holding may prove significant in determining the outcome of this issue.”
2. The FDA’s Demonstrably Difficult to Compound lists for both 503A pharmacies and 503B facilities — “For now, the issue is not yet ripe for a legal challenge [due to Loper].”
3. Non-binding guidance documents, including GFI 256 — “[I]t would be an uphill battle to convince a court that FDA does not possess the designated authority to regulate veterinary products.”