Exempt Products

The following are examples of products that are exempt from the law.

  • Blood and blood components intended for transfusion.
  • Radioactive drugs and radioactive biologics.
  • Intravenous products intended for replenishment of fluids and electrolytes or calories.
  • Intravenous products used to maintain the equilibrium of water and minerals in the body.
  • Medical gases.
  • Compounded drugs.
  • Dispensing drugs pursuant to a prescription.
  • Medical convenience kits and combination products.
  • Sterile water and products intended for irrigation.

For more information on DSCSA, visit https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa.