Big Buttons

• FDA reconsiders on tirzepatide, big questions remain

  After a court order, the FDA agreed to reconsider taking tirzepatide off the shortage list. read more →

• Reporter briefing: Patient impacts of tirzepatide shortage resolution

  APC's media briefing shared compounders' first-hand stories with more than 30 reporters from across the country. read more →

• Be sure your marketing follows these best practices

  APC's new guide will help you stay on the right side of laws and regs. read more →

• A fake survey from a pharma-funded organization

  What the Partnership for Safe Medicines released "Ain't a legitimate survey." read more →

• Lots of letters

  On the compounding front, the FDA’s inbox is getting quite a workout lately. read more →

• Slick new dosing pen for compounders

  Love Lifesciences’ UniPen injector pen is not only a Very Big Deal, it's available at a discount for APC PFM members. read more →

• FDA says tirzepatide shortage “resolved”

  As of this afternoon, the FDA Drug Shortage List is showing that the shortage of tirzepatide injection is “resolved.” Pharmacies must immediately cease preparing and dispensing compounded copies of Mounjaro and Zepbound. read more →

• Get yer law and patient safety CE here

  We've made the most popular segment of our 15-hour legal course into a standalone 3-hour, on-demand CE program. read more →

More News

The FDA’s inbox is getting quite a workout lately. Here’s a rundown of what the agency has received lately just on compounding-related issues:

• Our letter to Gail Bormel, director of the Office of Compounding Quality and Compliance, urging “that FDA immediately implement an ‘off-ramp’ period of at least 60 days after a GLP-1 drug [comes] off shortage.”
• A joint APC-NCPA letter to Commissioner Califf and others explaining our concern for patient continuity of care with tirzepatide coming off shortage. We reiterated our request for a 60-day off-ramp, and we also asked for clearer guidance on 503A pharmacies sourcing tirzepatide from 503B facilities.
• A bipartisan letter to FDA Commissioner Robert Califf from members of the House Energy and Commerce Committee expressing concern “about counterfeit Ozempic entering through illegal channels.” Of note is that the letter is clear about the distinction between legitimate compounding pharmacies and illegal, counterfeit-drug operations.
• A letter from four Republican members of Congress to Commissioner Califf asking for FDA to make its oversight of 503B facilities clearer and less burdensome so those facilities can better fill the gaps during drug shortages, as well as “take steps to improve the drug shortage list, including better utilization of drug shortage information provided to the agency by health care providers, including both 503B outsourcing facilities and 503A state licensed compounding pharmacies.”