FDA Issues Guidance on Identifying Suspect Drugs

FDA has issued a draft guidance document on how to identify suspect drug products in the supply chain. The draft guidance, developed under the Drug Supply Chain Security Act, describes potential signs that drug supply-chain stakeholders can look for to identify suspect drugs, including product labeling that may contain misspelled words or looks different than the standard labeling; packaging that has missing lot numbers or expiration dates or has been opened, damaged, or altered; or a change in shape or color from the standard product.

Supply-chain stakeholders are encouraged by FDA to be cautious when purchasing drugs from a new or unknown source, from the Internet, or purchasing drugs on the drug shortage list. Unsolicited offers for lower-priced drugs should also be avoided. The draft guidance provides supply-chain stakeholders with information on how to notify FDA of illegitimate products and details a process for stakeholders to follow when terminating previously made notifications.

FDA is requesting that comments on the draft be submitted by Aug. 11, 2014 for consideration as the agency works on the final version of the guidance.