FDA Proposes 1 Year Enforcement Delay

FDA Proposes 1 Year Enforcement Delay

Product Identifier Requirements would take effect no later than November 26, 2018

June 30, 2017

FDA issues a draft DSCSA compliance guidance delaying enforcement action against drug manufacturers who do not apply the product identifier by the November 27, 2017 deadline. Drug manufacturers had just 100 working days to go before DSCSA Phase 2 was set to take effect.

FDA is proposing this enforcement delay in response to industry wide readiness concerns of drug product manufacturers to meet the product identifier requirements.

In the absence of such guidance, current FDA Drug Supply Chain Security Act regulations required drug manufacturers to apply a product identifier in both human readable and machine-readable form to each package and homogeneous case. The product identifier encodes the production lot number, expiration date, national drug code (or NDC), and a unique serial number.

This new guidance informs manufacturers and other supply chain stakeholders that although manufacturers are to begin including a product identifier on prescription drug packages and cases on November 27, 2017, the FDA is delaying enforcement of those requirements until November 2018 to provide manufacturers additional time and avoid supply disruptions. While manufacturers work to meet product identifier requirements, they must comply with other DSCSA requirements.

This represents a one year delay in enforcement of the requirement for manufacturers to affix or imprint product identifiers. Furthermore, this draft guidance addresses responsibilities of downstream trading partners impacted by the lack of a product identifier. FDA intends to take no enforcement action against a repackager, wholesale distributor, or dispenser that engages in a transaction involving product without a product identifier unless there is an independent requirement to apply a product identifier. Verification of the product identifier is not intended to be enforced by the FDA against wholesale distributors, repackagers or dispensers who do not verify the product identifier for the product, even in situations where that product is intended for further distribution as a salable return.

In Summary:

This proposed guidance does not alter the regulation; the law remains unchanged. Rather, this guidance proposes that the FDA take no enforcement action for a period of one year beyond the published regulatory dates concerning the product identifier. This proposed compliance policy applies only to product without product identifiers introduced by a manufacturer between November 27, 2017 and November 26, 2018 and the requirements for manufacturers to verify product identifiers on such products. Furthermore, manufacturers must still validate any applicable transaction records in its possession if the manufacturer has determined the product in their possession or control is suspect or if the manufacturer receives notification of suspect product from the FDA or authorized trading partner.

The impact of product identifier compliance on the drug supply chain can be summarized as follows:

Initial Deadline Proposed Enforcement Deadline
Manufacturers to apply product identifier

November 27, 2017

November 26, 2018

Repackagers to apply product identifier

November 27, 2018

November 27, 2018

Repackagers require product identifier in order to transact drug product

November 27, 2018

Excludes unmarked product which enters supply chain prior to November 26, 2018
Wholesaler distributors require product identifier in order to transact drug product

November 27, 2019

Excludes unmarked product which enters supply chain prior to November 26, 2018
Dispensers require product identifier in order to transact drug product

November 27, 2020

Excludes unmarked product which enters supply chain prior to November 26, 2018
Manufacturers must verify product identifier if investigating suspect product

November 27, 2017

Excludes unmarked product which enters supply chain prior to November 26, 2018
Repackagers shall verify product identifier

November 27, 2018

Excludes unmarked product which enters supply chain prior to November 26, 2018
Wholesaler distributors shall verify product identifier

November 27, 2019

Excludes unmarked product which enters supply chain prior to November 26, 2018
Dispensers shall verify product identifier

November 27, 2020

Excludes unmarked product which enters supply chain prior to November 26, 2018

 

Download > FDA Product Identifier Requirements Compliance Policy

Please note the Draft Guidance is being distributed for comment purposes only.

Submit electronic comments to https://www.regulations.gov.

Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

All comments should be identified with the docket number of 2017-13979 as listed in the notice of availability in the Federal Register.