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

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.