FDA unveils new guidance on secure medicines supply

The FDA has finalised two guidance documents and drafted another to improve the security of medicines in the US supply chain.

The new draft guidance is a questions and answers (Q&A) document on the use of product identifiers in the supply chain, which underpins Drug Supply Chain Security Act (DSCSA) provisions to ensure that prescription drug products are identified and traced properly as they move through the supply chain.

Meanwhile, the FDA has also finalised two earlier drafts, namely one on compliance with the new product ID requirements and another on ‘grandfathering’, in other words how to handle medicine packs traceable product ID introduced into the supply chain before the DSCSA deadline of 27 November 2018.

The agency has also pledged to publish another long-awaited guidance in the coming weeks – on verification systems that manufacturers, repackagers, wholesale distributors and dispensers must have in place under the DSCSA to quarantine and investigate suspect and illegitimate products.

The new Q&A guide is “intended to help manufacturers and repackagers understand the requirements to affix or imprint a product identifier on each package and homogenous case of product that they introduce in a transaction into commerce,” says the agency.

It covers agency contacts, the formats for product identifiers, the procedure for submitting label changes, and explains the respective uses of linear and 2D barcode formats.

“Patients should expect safe and high-quality drugs. And the manufacturers who develop and ship these products should expect a secure supply chain that guarantees the custody of these medicines. That means accountability throughout the supply chain,” commented FDA Commissioner Scott Gottlieb (pictured).

However,” given the breadth and complexity of our US drug supply chain and its continued expansion and diversification, we recognise the need to ensure greater accountability for manufacturers, repackagers and other intermediaries in the supply chain,” he added.

By increasing the traceability of drugs at every point in the supply chain, these measures protect patients from exposure to drugs that may be counterfeit, stolen, contaminated or otherwise harmful, said Gottlieb.

“By creating a tighter, closed system, we’ll be able to better prevent the introduction of illegitimate products, better detect the introduction of illegitimate products, and enable stakeholders and the FDA to respond rapidly when such products are found.”

“The three guidances we’re issuing today will help bring us towards a more secure supply chain to help avoid these types of issues going forward.”