FDA Enforcement Action for Human Drugs Compounded by traditional compounders (not outsourcing facilities) Who Violate Section 503A Will Include

Warning Letters
Seizure of products
Injunction
Criminal Prosecution

The federal criminal prosecution includes but it is not limited to:

1. Producing Adulterated Drugs
2. Producing Unapproved Drugs; and
3. Misbranded Drugs

Source Draft Guidance Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug and Cosmetic Act