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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

Earlier this week, FDA issued a new guidance to compounders, Know Your Bulks and Excipients Suppliers.

In the document, FDA reminds compounders that sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act contain provisions regarding bulk drug substances (APIs) use in compounding, including:

• API compliance with applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph standards
• Sourcing API from FDA-registered facilities, and valid certificates of analysis. 

The announcement also points out provisions regarding excipient compliance with applicable USP or NF monograph standards.