FDA Guidance Explains DSCSA Verification Systems for Certain Drugs

The FDA issued draft guidance outlining what the agency considers an ideal and robust verification system that’s also in line with legislative requirements.

The guidance provides recommendations on how to design a verification system — used to assess suspect products and quarantine illegitimate ones — that adheres to requirements under the Drug Supply Chain Security Act (DSCSA).

The DSCSA put in place verification requirements for certain drug manufacturers, wholesale distributors, dispensers and repackagers. Under the legislation, these “trading partners” must have a system in place that can identify and determine suspect products, quarantine products found to be illegitimate, and clear products for distribution after investigation.