2.6 FDA product serialization, tracking, tracing, handling, and quarantining requirements

What does the Drug Supply Chain Security Act (DSCSA) do?

Prevents counterfeit, contaminated, or diverted drugs from entering the US Drug Supply Chain

What are the four parts that make up product identification?

NDC number, lot number, expiration date, serial number

At what level is serialization required?

At the unit level which means every single item

What is the first thing that must go with a drug when it changes hands?

Info - Details of the specific drug transaction like name, NDC and quantity

What is the second thing that must go with a drug when it changes hands?

History - Historical Record showing every place the product has been

What is the third thing that must go with a drug when it changes hands?

Statement - An attestation from the seller that the product is legitimate

What documentation must pharmacies keep to trace a drug’s path?

T3

What are signs of a suspect product?

Broken seal, incorrect packaging, labelling errors, price too low

What does quarantining mean?

Physically isolating the product

What is the first step if you have an illegitimate product?

Quarantine - physically isolate the product from all other product inventory

What is the second step if you have an illegitimate product?

Remove - Remove the product from your pharmacy’s inventory system

What is the third step if you have an illegitimate product?

Notify FDA - Notify the FDA within 24 hours

What is the fourth step if you have an illegitimate product?

Notify partners - Notify the trading partners (Wholesalers & Manufacturers)

What is the fifth step if you have an illegitimate product?

Document - Document all actions taken and maintain records for 6 years

What are the DSCSA requirements?

Serialization and T3

How long should you keep these records for?

6 years