Makena Compounding Case Dismissed - FDA's Enforcement Discretion Not Subject to Judicial Review

Updated March 14, 2026

The original link broke.

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---  the original post follows below  ---

Makena Compounding Case Dismissed - FDA's Enforcement Discretion Not Subject to Judicial Review - FDA Lawyers Blog:

"Regarding K-V's assertion that FDA would exercise broad enforcement discretion for compounded versions of Makena™, FDA stated:

In order to support access to this important drug, at this time and under this unique situation, FDA does not intent to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products. As always, FDA may at any time revisit a decision to exercise enforcement discretion."

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