FDA issues draft guidance, seeks comment on identifying illegitimate drugs in supply chain

WASHINGTON — The Food and Drug Administration has published a draft guidance document for prescription drug supply chain stakeholders as part of the agency’s implementation of the Drug Supply Chain Security Act, the National Association of Boards of Pharmacy has reported.

The draft “Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification” provides information about identifying and reporting suspect and illegitimate prescription drug products in the supply chain.

According to the NABP, the FDA is seeking public comment on the proposal by Aug. 11. Comments received by this deadline will be considered before the agency begins work on the final guidance, notes FDA. Signs of potentially illegitimate drug products discussed in the draft include:

  • Labels containing misspelled words or other deviations from standard labeling;
  • Products with unusual shapes, colors, or odors compared to standard products;
  • Packages missing identifying information such as the lot number or expiration date; and
  • Opened, damaged, repaired, or altered packaging seals.
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