On March 16, 2023, the Food and Drug Administration (FDA) released final guidance regarding definitions of "suspect product" and "illegitimate product" as part of a continued effort to prepare trading partners for the...more
3/22/2023
/ Counterfeit Drugs ,
Drug Distribution ,
DSCSA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Stolen Goods
Last week the Supreme Court ("the Court") released a decision holding that the Federal Controlled Substance Act (the "Act") provision that criminalizes the dispensing of a controlled substance “except as authorized” includes...more
7/5/2022
/ 21 U.S.C. § 841 ,
Controlled Substances ,
Controlled Substances Act ,
Criminal Liability ,
DEA ,
Food & Drug Regulations ,
Health Care Providers ,
Healthcare ,
Intent ,
Jury Instructions ,
Mens Rea ,
Opioid ,
Pharmaceutical Industry ,
Prescribing Authority ,
Prescription Drugs ,
Reasonable Doubt ,
Ruan v United States ,
SCOTUS ,
Statutory Violations ,
Subjective Standard