At long last, FDA publishes its DSCSA waiver guidance

Yesterday, the FDA published draft guidance intended to help trading partners in the medicines supply chain request exemption from the requirements of the Drug Supply Chain Security Act (DSCSA).

The DSCSA, which was signed into law in 2013, aims to establish an identify and trace system for drugs as they pass through the US supply chain, including placing unique identifiers on medicine packs that can be scanned and verified. The overall aim is to monitor the distribution of drugs in the US to prevent counterfeit, contaminated and diverted drugs.

The Act stipulates that the FDA has to provide guidance detailing the circumstances in which a trading partner in the supply chain – i.e. a manufacturer, repackager, wholesale distributor or dispenser – can request an exception, exemption or waiver from those requirements. The intention is to give some leeway in special cases, for example if adhering to the DSCSA might cause undue economic hardship or a medical emergency such as a drug shortage. The guidance had been on the FDA’s work programme for 2017.

According to the draft document, the Health and Human Services secretary can choose whether to grant the request after an FDA review of the application, which can be made on paper or electronically, and the agency will consider a number of factors in its assessment and, if granted, contact trading partners to explain its reasoning. The FDA can also initiate the waiver process if it thinks such a course of action is warranted.

Aside from the economic hardship and emergency medical reasons for a waiver, the FDA guidance also notes that an exemption might be granted for example if the product package is too small or otherwise unable to accommodate a label bearing the information required under the DSCSA – but says it will weigh all requests against the security of the drug supply chain. Any waivers that are given will be reviewed every two years.

Under the DSCSA, the FDA has committed to preparing a long list of guidance documents intended to allow the smooth implementation of the Act when it comes fully into force in 2023. Recent publications have covered standardization of data and documentation practices, its ‘grandfathering’ policy for medicines in the supply chain with a unique identifier when the requirement is enforced, and the definition of trading partners under the DSCSA.