Sema removed from Compounding?

[touringsedan]

No, that's not the impact of the overturning of Chevron deference here.

Statutes and regulations are two different things. Statutes are passed by Congress; regulations are created by agencies.

Chevron deference was where the courts deferred to agency interpretation of statutes. The overruling of Chevron deference means that the courts will no longer defer to the agencies in their interpretation of statutes, and that the interpretation of statutes will return to the courts (where it appropriately belongs, IMO).

But Auer deference remains. Auer deference is the deference the courts must give to agencies, including FDA, in the interpretation of their own agency regulations.

Courts get to interpret statutes (the overruling of Chevron deference), but agencies still get deference in how they interpret their own regulations.

OK, that clears that up. Thank you for the better details on this matter.

 

[HoneyBeez]

I doubt there's anything realistically they can do to stop China

I suspect they will go hard at domestic vendors and *try* at least to some extent to go after international vendors. Looks like EL has been filing complaints against peptide vendors (including CN) with the ITC.

Regulations.gov

www.regulations.gov

 

[YoYoFat]

Aren’t all regulations derived at some point from statute?

No. They are derived by the power of the Executive Branch, found in the Constitution.

That said, Congress controls the purse strings so they have a lot of influence and can pass their own statutes to trump agency regs.

 

[Glp1judd]

No. They are derived by the power of the Executive Branch, found in the Constitution.

That said, Congress controls the purse strings so they have a lot of influence and can pass their own statutes to trump agency regs.

I think post chevron, all that remains to be litigated.

 

[YoYoFat]

I think post chevron, all that remains to be litigated.

Anything can be litigated. But that doesn’t change the status of the law.