Thursday, January 21, 2016

DSCSA Regulations & Guidances From The FDA Are Overdue

This should interest wholesale drug distributors and third-party logistics providers (3PLs).

A total of four DSCSA regulations and guidances were expected from the FDA by November 27, 2015 (Source: Drug Supply Chain Security Act (DSCSA) Implementation Plan):

Section of DSCSA

Deliverable Type

Deliverable Description

Estimated Target Date

202
Guidance
Publish guidance on processes for waivers, exceptions, exemptions
11/27/2015
202
Guidance
Publish final guidance on grandfathering product
11/27/2015
204
Regulation
Develop regulations establishing standards for licensing of wholesale drug distributors
11/27/2015
205
Regulation
Develop regulations establishing standards for licensing of third-party logistic providers
11/27/2015





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