Good Distribution Practices (GDP) in Pharmaceuticals

Wonder what are the regulations and/or guidance for GDP of pharmaceuticals in the US

2 Replies

In the US the GDPs are not as clearly demarcated as in the EU, with regulations scattered across FDA regulations and guidelines and the various state licensing organizations (often, but not always the pharmacy boards), and depending on what you are manufacturing, DEA requirements as well.

Unsurprisingly enough, some of the most important requirements are in the USP, such as <1079> and <1083>

And like most things in the US, you pretty much need to level set to the State of California.

Hello Jeremiah,

Thanks for this comprehensive answer; truly appreciate it.

I'm learning so much from this.

We sure have had audits from the National Pharmacy Board on distribution, but never thought USP was so invested in setting standards for distribution.

Thank you.