The FDA: Securing prescription drug safety

By Dr Nicola Davies

On June 21, 2021, the former owner of a supplement company, CCB Nutrition, pleaded guilty to the illegal distribution of supplements containing potentially harmful substances - anabolic steroids and an unapproved new drug.1 Such cases of illegitimate drug distribution pose a huge threat to consumer safety and the healthcare system.

To combat the distribution of illegitimate drugs in the USA, the Congress enacted the Drug Supply Chain Security Act (DSCSA) in November 2013.2 This Act outlines steps for developing an electronic, interoperable system by November 2023 to improve the identification and tracking of illegitimate prescription drugs. Since then, the FDA has been gradually enforcing various legal requirements, as per this Act, for ensuring the safety of prescription drugs. Additionally, the Administration has issued guidance documents to assist stakeholders in understanding these requirements and complying with the law.