Big Buttons

• CALL TO ACTION: Tell FDA to deny drugmakers’ request

  Drugmakers are urging FDA to prohibit compounded GLP-1s. FDA needs to hear from you and your patients NOW! read more →

• APC to FDA: Just say no to Lilly

  This week APC's lawyers sent a formal comment to the FDA about Eli Lilly’s request that tirzepatide be added to the Demonstrably Difficult to Compound list. read more →

• California BOP sends proposed compounding regs to comment period

  The California State Board of Pharmacy decided to move the modified proposed sterile compounding regulations forward to a 30-day comment period. read more →

• Checking in on the post-Chevron fallout

  What’s happened in the world of federal regulation since the end of Chevron? read more →

• Hi, Noom!

  Welcome to our newest Bronze-level Corporate Patron, Noom! read more →

• PFMs can get 2.5% credit card processing

  A new benefit for APC’s Pharmacy/Facility Members: They may be able to cut their credit card processing fees to just 2.5% – 2.8%. read more →

• Phoenix compounders, rise!

  The latest of APC’s new regional meetings — CompoundED UpDATE — is coming to the Phoenix area December 5. read more →

• APC election results: directors and bylaws

  See the results of APC's elections, including four new directors and several changes to our bylaws. read more →

More News

APC this week asked FDA’s Center for Veterinary Medicine to provide additional guidance on compliance with its GFI 256 on animal drug compounding. In a letter to the CVM’s Dr. Bill Flynn, APC raised several issues that have come up in our training sessions for members. 

The letter asks CVM to clarify whether compounded drugs should be allowed when a drug is not available due to supply chain issues or backorders. The FDA had previously said that compounders should contact the agency in case of a drug shortage but that the agency does not provide blanket enforcement discretion for compounding copies of drugs in shortage.

The letter also takes issue with CVM’s assertion that compounders are expected to know what ingredients may be harmful or cause side effects to the species for which the drug is being compounded. 

“Because they are not listed in the approved package insert, it simply is not possible for pharmacists to know the excipients in manufactured animal drug products,” the letter states.