FDA Announces Enforcement Delay for Manufacturers But Law Still in Effect
On June 30, 2017, the FDA published draft guidance regarding DSCSA that included information about a one-year enforcement delay for manufacturers that will be in effect from November 27, 2017 through November 26, 2018. The enforcement delay does not change the timing of the law itself, so it is important that you and your trade partners understand exactly what the new guidance means.
DSCSA requires manufacturers to affix or imprint a unique product identifier at both the package level and at the secondary homogenous-case level before the product enters the supply chain. In addition, manufacturers must verify serialized drug product at the package level within 24 hours when receiving a verification request by the FDA, when requested by trading partners as part of a suspect product investigation, or as part of verifying the identity of saleable returns.
Has the DSCSA law been delayed?
No. The FDA guidance states that it will exercise “enforcement discretion” regarding the federal requirements for product identifiers until next year. This does not delay the law—it will still go into effect on November 27, 2017.
Does enforcement discretion mean that there’s no chance of penalties until November 2018?
No. Because DSCSA will be the law in November, non-compliance can still be penalized. The FDA reserves the right to inspect and penalize companies if it so chooses, although it will not go out of its way to enforce DSCSA during the period of delay.
Under what circumstances could my company be penalized during the period of enforcement discretion?
How does enforcement discretion apply specifically for manufacturers?
If you’re a manufacturer, the FDA has indicated that between November 27, 2017, and November 26, 2018, it does not plan to inspect your operation at random and take action if you are not currently:
- Correctly affixing or imprinting a product identifier on each package of homogenous case of drug product prior to introducing it into commerce.
- Performing verification of suspect product or if a verification request is received.
- Performing verification at the request of a trade partner.
- Performing verification of a saleable returned product.
What does the period of enforcement discretion mean for downstream trade partners?
This compliance policy does not affect the separate requirement that repackagers have to affix or imprint a product identifier on products beginning November 27, 2018.
Why is the FDA instituting enforcement discretion for a year?
Does the delay impact lot-level DSCSA?
No. This enforcement delay does not apply to lot-level requirements under DSCSA. Manufacturers are still required to validate T3 of suspect product or for a verification request when it is received from the FDA, or if a trade partner has possession of suspect product.