Additions to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness

Resumo

The Food and Drug Administration (FDA) is proposing to amend its regulations to add two drug products to the list of drug products that may not be used for pharmacy compounding under the exemptions provided by the Federal Food, Drug, and Cosmetic Act (the act) because they have had their approval withdrawn or were removed from the market because the drug product or its components have been found to be unsafe or not effective.