Tuesday, August 22, 2017

FDA Offers Draft Guidance to Further Secure Drug Supply Chain | RAPS

Read the full article: FDA Offers Draft Guidance to Further Secure Drug Supply Chain | RAPS:

"Last Friday, FDA released new draft guidance to help industry, state and local governments categorize the entities in the drug supply chain in accordance with the DSCSA and help clarify which companies are engaged in activities that require licensure and annual reporting.

The 18-page draft, titled "Identifying Trading Partners Under the Drug Supply Chain Security Act," notes the confusion related to defining wholesale distributor and wholesale distribution, as well as confusion over what an affiliate of a manufacturer means."

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