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Read the full text of the source article, so you can be sure about what is included and excluded from the one year delay in enforcement action.
According to the article:
"The US Food and Drug Administration has given pharmaceutical distribution trading partners an extra year to comply with package-level Drug Supply Chain Security Act product tracing requirements that take effect 27 November [2023] before it starts enforcing them."
Source Article: As Supply Chain Partners Ramp Up For November DSCSA Deadline, US FDA Gives Them Another Year - Pink Sheet
Go to the FDA Guidance: Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies - FDA.gov
If your company needs another a California Designated Representative - Wholesaler, or a California Designated Representative - 3PL, they'll need Board-approved training to apply for their Designated Representative license application.
ReplyDeleteBoard-approved California Designated Representative courses:
- Wholesaler Training Course
- 3PL Training Course
- Reverse Distributor Training Course