FDA issues fresh guidance as DSCSA deadline looms

The FDA has published guidance on the reporting requirements for wholesalers and shipping firms under the US's upcoming traceability scheme.

The latest document - issued on December 8 - lays out the information wholesale distributors and third-party logistics providers (3PLs) must provide to the FDA every year to meet the requirements of the Drug Supply Chain Security Act (DSCSA).

The DSCSA - also known as Title II of the Drug Quality and Security Act (DQSA) - was adopted last year and lays out a schedule for the introduction of a track-and-trace system for pharmaceutical products.

The main objective is to introduce full traceability for medicine packs through the supply chain within 10 years, with a requirement for all drug packages to carry a unique serial number within four years.

In the meantime, the FDA must produce a series of guidance documents - as detailed on its website - to help actors in the medicines supply chain meet the interim stages in the programme's roll-out.

Towards the end of last month it issued draft guidance explaining its thinking on how transactional information should be exchanged between organisations as goods move through the supply chain, indicating it should be retained for at least six years.

The latest document indicates that - beginning on January 1, 2015 - wholesalers and 3PLs must report "state licensure information for each facility, contact information for each facility, and any significant disciplinary actions taken by a state or the federal government."

The agency has previously indicated that it like facilities to be identified using the DUNS number, which can be obtained from Dun & Bradstreet at no cost.

Wholesale distributors should submit their initial report to the FDA between January 1 and March 31, 2015, while 3PLs should do so between November 27 of this year and March 31, 2015. There is also a 30-day deadline for notification of any newly-licensed facilities and any significant disciplinary actions.

Subsequent reports should be filed in the first three months of the year, according to the FDA, which will take comments on the proposals until February 9, 2015.