The ninth year of RxTrace ended on the Fourth of July, 2018. This year has been marked by a resurgence of activity by the FDA aimed at their obligations under the Drug Supply Chain Security Act (DSCSA). In the last 12 months we have seen the FDA:
- Delay the date drug manufacturers have to apply serial numbers to drug packages and homogeneous cases (see “FDA Delays Enforcement of DSCSA November Deadline: What It Means”)
- Published four (that’s right, FOUR!) new important draft guidance documents (see “FDA’s New DSCSA Grandfathering Guidance,” “DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations,” “DSCSA Guidance: Standardization of Data & Documentation Practices for Product Tracing” and “FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption”)
- Held three public meetings about the DSCSA (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals,” “FDA DSCSA Public Meeting #2, Still A Gulf” and “FDA DSCSA Public Meeting #3: A Difference?”)
- Considered holding one or more DSCSA-related pilots (see “What Should FDA Pilot?”), and
- Candidly discussed progress toward the Enhanced Drug Distribution Security (EDDS) phase in 2023 during the 2017 Healthcare Distribution Alliance (HDA) Traceability Seminar (see “FDA Speaks About DSCSA At HDA”).
There is no doubt that over the last 12 months, the FDA has been more active with regard to the DSCSA than any other period of time. Will it continue? In January, I thought FDA would want to keep the momentum in the industry moving by announcing another series of DSCSA meetings for 2018 (see “2018: The Year of FDA DSCSA Public Meetings”), but, no. That’s not happening.
The FDA isn’t the only organization that has been busy in the last 12 months. The HDA has also been very active, responding to FDA guidance documents and public meetings with smart comments that should help the FDA improve them (see “HDA Schools FDA On DSCSA,” “HDA Questions FDA’s Authority To Mandate A Centralized System For the EDDS,” “HDA Urges FDA…Please Re-Read The DSCSA” and “HDA Urges FDA To Withdraw Draft Guidance ‘In Its Entirety’”). Don’t miss these comment submissions by the HDA. They are very educational. They will make you think.
