This week, the US Food and Drug Administration (FDA) issued its first guidance under Title II of the Drug Quality and Security Act, the “Drug Supply Chain Security Act”.
The FDA advises drug supply chain stakeholders, which includes wholesalers, regulatory officials, care-givers and patients, to make note of potential signs of suspicious medicines, including:
- Product labeling that contains misspelled words or looks different from the standard labeling;
- The finished product is a different shape or color from the standard product or has an unusual odor;
- The packaging is missing identifying information such as the lot number or expiration date;
- The original packaging seals have been opened, damaged, repaired or altered.
As advised by the FDA, if buying drugs from a source that could have a much higher chance of selling fake medicines, we must all be especially vigilant. This would include:
- Purchasing drugs from a new source;
- Responding to an unsolicited offer, usually with a significantly lower price, that comes through an advertisement, email, fax or telephone call;
- Purchasing a product on the Internet from an unknown source; and
- Purchasing a product that is in high demand or one that is on the drug shortage list.
Read the full guidance on the FDA’s website.