The FDA guidance letter is a delay in enforcement with the expectation pharmacies continue to progress toward DSCSA implementation. The FDA would like all trading partners to...Read More »
TOLEDO, Ohio (January 2022) – On January 19th, 2022, in The Wall Street Journal, Gilead Sciences Inc reported 85,247 bottles of HIV drugs were counterfeited and distributed to 17 different locations. The bottles were genuine Gilead bottled but the contents included fake pills and OTC pain killers. The counterfeit products were accompanied by false documentation, purchased from unauthorized distributors, and had their packaging altered. Biktarvy & Descovy are just two of the drugs that were counterfeited.
The financial impact to Gilead was $250 million dollars but the impact to consumers’ peace of mind was far more devastating. One patient reported not being able to walk or talk after consuming the fake drugs. Counterfeit drugs are a growing concern which the FDA is trying to combat with the Drug Supply Chain Security Act.
Far too many dispensers are not recognizing suspect and/or illegitimate product. The dispensers are the last line of defense for the public. It is now more important than ever to have the regulatory knowledge to fully comply with all aspects of DSCSA and what it takes to efficiently maintain compliance through interoperability. Very few companies offer the complete package and even fewer do so in an efficient manner for dispensers.