Once more with monotone: FDA again clarifies discretion on tirzepatide copies

FDA this week again clarified its enforcement discretion policy for compounded copies of tirzepatide injection, writing:

FDA has not changed its intentions regarding enforcement discretion as described below. To clarify, the timeframes during which the agency does not intend to take action against compounders for violations of the FD&C Act arising from conditions that depend on tirzepatide injection products’ inclusion on FDA’s drug shortage list are:

• • For a state-licensed pharmacy or physician compounding under section 503A of the FD&C Act until February 18, 2025, or until the date of the district court’s decision on the plaintiffs’ preliminary injunction motion in Outsourcing Facilities Association (OFA) v. FDA (N.D. Tex.), whichever is longer.
  • For outsourcing facilities under section 503B until March 19, 2025, or until the date of the district court’s decision on the plaintiffs’ preliminary injunction motion in OFA v. FDA, whichever is longer.

FDA may still take action regarding violations of any other statutory or regulatory requirements, such as to address findings that a product may be of substandard quality or otherwise unsafe.