Imprimis Rx LLC – FDA Warning Letter, Jun 30, 2022

The FDA issued a Warning Letter to Imprimis Rx LLC on June 30, 2022, regarding promotional materials for their compounded drug product, Pred-Moxi-Brom (PMB). The FDA reviewed content in "Glaucoma Physician" (March 2021) and "The Ophthalmic ASC" by "Ophthalmology Management" (February 2021).

The FDA determined that the promotional materials make false or misleading claims, misbranding PMB under sections 201(g)(1), 352(bb), 321(n), and 331(a) of the FD&C Act. This is concerning due to known risks of PMB's active ingredients.

Specific violations include: 1. **False or Misleading Claims Regarding FDA Approval:** Promotional materials suggest PMB components are FDA-approved, implying use of FDA-approved drug products. However, ImprimisRx uses bulk drug substances, which are not FDA-approved, to compound PMB. 2. **Unsubstantiated Superiority Claims:** Materials misleadingly suggest PMB is superior to individual FDA-approved products, improves patient compliance and outcomes, and is of higher quality than "drugs produced by the major pharmaceutical companies," without supporting data. A cited 1975 study did not support preference claims and is outdated. 3. **False or Misleading Risk