FDA Delays Enforcing Certain DSCSA Product Identifier Provisions (US) | Practical Law

FDA Delays Enforcing Certain DSCSA Product Identifier Provisions (US) | Practical Law

The FDA released draft guidance on its compliance policy under the Drug Supply Chain Security Act (DSCSA) for transactions with products lacking product identifiers.

FDA Delays Enforcing Certain DSCSA Product Identifier Provisions (US)

Practical Law Legal Update w-009-0954 (Approx. 3 pages)

FDA Delays Enforcing Certain DSCSA Product Identifier Provisions (US)

by Practical Law Life Sciences
Published on 12 Jul 2017USA (National/Federal)
The FDA released draft guidance on its compliance policy under the Drug Supply Chain Security Act (DSCSA) for transactions with products lacking product identifiers.
On July 3, 2017, the FDA announced draft guidance entitled Product Identifier Requirements Under the Drug Supply Chain Security Act–Compliance Policy, delaying enforcement of certain product identifier provisions. Under the Drug Supply Chain Security Act (DSCSA), prescription drug manufacturers must mark packaging with product identifiers by November 27, 2017 (21 U.S.C. § 360eee-1(b)(2)). Products without identifiers after this date would be misbranded under Section 502(cc) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 352(cc)).
Under the DSCSA, manufacturers must also verify product identifiers:
  • When investigating a suspect product or upon receiving a verification request from the FDA.
  • When requested by an authorized repackager, distributor, or dispenser.
  • On all saleable returns that the manufacturer intends to further distribute.
Repackagers, wholesale distributors, and dispensers—starting November 27, 2018, November 27, 2019, and November 27, 2020, respectively—are required to only enter into transactions with products that bear a product identifier and verify those products if requested.
In response to comments from the industry, the FDA does not intend to take action for misbranding or noncompliance under certain parts of these regulations. The FDA does not intend to take action against manufacturers that:
  • Do not mark their packaging with product identifiers prior to November 27, 2018.
  • Do not verify products or saleable returns introduced into commerce prior to November 27, 2018 because they lack product identifiers. Manufacturers must still verify any transaction history or information they possess if they, or a trading partner, control a suspect product or they are requested to by the FDA.
The FDA does not intend to take action against repackagers, distributors, and dispensers that, on their respective date of compliance:
  • Transact in products without product identifiers introduced into commerce prior to November 27, 2018.
  • Do not verify products or saleable returns introduced into commerce prior to November 27, 2018 because they lack product identifiers. These entities must still verify any transaction history or information they possess for suspect products.
This guidance only applies to products introduced into commerce between November 27, 2017, and November 26, 2018. Repackagers, distributors, and dispensers should retain documentation that products they receive without product identifiers were introduced during this time period. Other compliance dates, including the product identifier compliance date for repackagers, were not changed by this guidance. The FDA said it will release further guidance on products covered under the grandfathering provision of the DSCSA in the future (21 U.S.C. § 360eee-1).
Comments on this guidance should be submitted by September 1, 2017.