Big Buttons

• Lilly intervenes in OFA lawsuit against FDA

  Lilly says the FDA isn’t allowed to decide when compounders can compound FDA-approved drugs. read more →

• Reason #1 to come to the APC Owner Summit

  "Turning Science into Stories" with Andrew Buck will teach you how to turn facts into stories that will connect with both rational and emotional audiences. read more →

• FDA releases final interim guidance on bulk drug substances for both 503As and 503Bs 

  This new guidance supersedes the 2017 versions of the same titles. read more →

• Why you need to sign up for an APC Package Deal — and why now is the right time

  The beginning of the calendar year is the best time to be grab a package deal. read more →

• FDA doubles down: Tirzepatide is off shortage

  ...but that doesn't mean the issue is completely settled. read more →

• A couple of state updates

  Good news from Alabama, but a problem in Massachusetts read more →

• Defending GLP-1 compounding

  The latest letters APC's been sending to oppose efforts to restrict compounding read more →

• Thumbs-up for FDA crackdown

  APC was thrilled when the FDA announced it was taking action against illegal online businesses claiming to sell “research-grade” compounds. read more →

More News

As the Outsourcing Facilities Association goes ahead with its lawsuit against the FDA over the agency’s determination that tirzepatide was out of shortage, Eli Lilly is weighing in on the suit. The company claims that just because a drug is on the FDA shortage list doesn’t mean compounders should be allowed to prepare it.

Politico’s “Prescription Pulse” covered this story, and it quoted APC’s statement refuting Lilly. The law is clear, we point out: The FDA has the power to decide when a drug can be compounded, not a court.