In a prepublication Notice from the Federal Register (here), the field of products permitted for compounding by 503A and 503B compounders decreased by two. The Agency will publish a final rule on Tuesday titled List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness. The Agency is “amending its regulations to revise the list of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective.”
The two additional and limitations related to these drugs for use in compounding are:
- Bromocriptine mesylate: All drug products containing bromocriptine mesylate for prevention of physiological lactation.
- Ondansetron hydrochloride: All intravenous drug products containing greater than a 16 milligram (mg) single dose of ondansetron hydrochloride.
In the cost and benefits section of the final rule, the FDA notes that they “are not aware of routine compounding of the drug products that are the subject of this final rule.” Further on in the rule, the Agency discusses their past withdrawal of Parlodel (bromocriptine mesylate) due to a very unfavorable risk benefit. In addition, the FDA explained that doses higher than 16 mg of ondansetron were associated with a higher risk of heart rhythm irregularities caused by a QT segment prolongation.
The FR Notice goes on to discuss the comments and FDA’s responses that were submitted to the proposed rule to place each of these drugs on the “not to be compounded” list, as well as other future actions that the Agency has yet to take on others initially discussed in the proposed rule.