Client Alert - FDA Peptide Interim Access Policy

FDA may stop enforcing its restrictions on some compounded peptides, but that won't make them legal.

Many of the compounded peptides being sold today are not legally compoundable. FDA has sent the White House an interim access policy that isn't public yet. According to people familiar with it, FDA would stop enforcing the restrictions on certain peptides it pulled from the compounding list over safety concerns in 2023.

That is enforcement discretion. It isn't approval, it doesn't change the law, and FDA can withdraw it at any time. It also doesn't limit your state pharmacy board or medical board.

If your clinic makes or sells compounded peptides, you may get a reprieve. Don't mistake it for permission. For more health law updates, visit texashealthlaw.com.