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.

 

[Bacchus]

I have heard that there are only a handful of raw peptide producers in China.

Could the Chinese government crack down on the peptide producers? Could Lilly or Novo work out some kind of deal with the Chinese government to make this happen? It would likely put a lot of pressure on the gray market companies that are just lyophilizing the peps.

I never underestimate greed as a motivator.

If by a handful you mean 3-5, or even under 10 - That's probably incorrect, though I can't guarantee that, since I don't know about more than 10 raw manufacturers.

There are more working on and already testing feasibility of producing raws, so there will be more, not less.

If that's a good or a bad thing for the consumer is another question, it might result in more low quality raws in the market.

Even if they tried to completely stop it, it'd just be a game of whack a mole. The overall quality of the end product might get a bit worse for a while, but I believe that would be the worst they could do (by could, I mean would - if they had no concerns about resources and truly wanted to, I guess they COULD, but that just isn't happening.

Governments don't really have a lot to gain by throwing a bunch of resources at solving these kinds of "problems". Just enough to play nice on the surface and smile while claiming to "cooperate" with international relations is probably the extent they will go to.