Warning Letter: Palace Pharmacy

On March 23, the US Food and Drug Administration's (www.fda.gov) Denver, CO district office sent a warning letter to Palace Pharmacy (Lander, WY) concerning the company's drug-compounding activities.

The agency expressed special concern about Palace Pharmacy'sproduction of domperidone in 10-, 15-, and 20-mg capsules for humanuse. The letter noted that domperidone (sometimes used to increaseprolactin levels and improve breast milk production) is not approvedfor any human use in the United States, is not approved for enhancing lactation inany country, and has cardiovascular side effects that have forced itswitdrawal from the market in several countries where it had beenapproved to treat gastric stasis and gastropaiesis.

FDA warned Palace that the current domperidone label "fails to bearadequate direction for their use" and that the products themselves areunapproved drugs under 21 CFR § 201.115.