The US Drug Quality and Security Act comprises two elements. The first part deals with compounded drugs while the second part deals with drug supply chain security and is referred to as DSCSA. It was signed into law on November 27th 2013. The primary purpose of the bill was to grant the FDA more authority to regulate and monitor compounded drugs and to make it easier to trace drugs through the US supply chain.
The regulation affects manufacturers, repackagers, wholesale distributors and dispensers and introduces requirements for product serialization, product tracing, product verification, product investigation, removal and notification of illegitimate products, verification and enhanced drug distribution security (unit-level traceability).
What are the implications?
- Must apply a product identifier to each drug package and homogenous case: product identifier data will be included in a 2D data matrix bar code on each package and linear or 2D matrix bar code on each homogenous case.
- Must verify suspect products at the package level
- Investigation records to be retained for 6 years
- When receiving a saleable returned product, must verify the product identifier for legitimacy
- Must respond to a verification request within 24 hours
- if the product cannot be verified, treat it as suspect and conduct an investigation
- must advise if the product is believed to be illegitimate
The FDA issued a draft guidance on 30th June 2017 indicating that it will not enforce this deadline until 27/8/2018, due to concerns about the readiness of manufacturers and trading partners. A final guidance will be issued in due course.
- Must exchange transaction information and statements in an interoperable, digital form and transaction information must include the product identified at package level
- Must have systems and processes in place that enable the provision of transaction information for a product, as well as transaction information going back to the manufacturer in the event of a product recall or product investigation of a suspect product
- Upon request by federal or state officials
- Upon request by a trading partner conducting or assisting an investigation
- Will accept saleable returns only if they can associate the relevant transaction data and statements to the product