US judge bars copies of Lilly weight-loss drug

Man, things gonna get interesting.

(Why do you get an extension if you are a bigger company? If anything it ought to be the reverse, a bigger business is more likely to weather a loss in revenue.)
 
Morbius said:
Man, things gonna get interesting.

(Why do you get an extension if you are a bigger company? If anything it ought to be the reverse, a bigger business is more likely to weather a loss in revenue.)
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Because the 503B pharmacies are envisioned as compounding beforehand to meet a need. The 503As are only supposed to compound for specific patients. Strictly speaking, it's not size that counts, but the provision that of law that authorizes the compounding that makes a difference.
 
StopCraving_12 said:
"Small compounding pharmacies must halt selling copies immediately, larger facilities by March 19"

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I know many compounding pharmacies plan to continue compounding. The FDA's announcement and the court ruling as to it affect only affect one exception to the ban on compounding of patented medications. There are many others. See Food Drug & Cosmetic Act §§ 503A (21 U.S.C. § 353a), 503B (21 U.S.C. § 353b). Despite me being a lawyer, this is far outside my area of expertise. But I have heard from lawyers from compounding pharmacies who say the plan on continuing to compound. I make no predictions about how this will all turn out. I'm not super interested in this topic right now simply because I believe the folks using compounding pharmacies ought to switch to grey.
 
keangkong said:
I know many compounding pharmacies plan to continue compounding. The FDA's announcement and the court ruling as to it affect only affect one exception to the ban on compounding of patented medications. There are many others. See Food Drug & Cosmetic Act §§ 503A (21 U.S.C. § 353a), 503B (21 U.S.C. § 353b). Despite me being a lawyer, this is far outside my area of expertise. But I have heard from lawyers from compounding pharmacies who say the plan on continuing to compound. I make no predictions about how this will all turn out. I'm not super interested in this topic right now simply because I believe the folks using compounding pharmacies ought to switch to grey.
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I appreciate a lawyer’s perspective.

I don’t know if they everyone should be switching. The GLP1 Facebook groups prove that some people need a lot of hand holding. The amount of people who accidentally inject their thumb is incredible. Idk even know how that would happen
 
Areyoukitten said:
I appreciate a lawyer’s perspective.

I don’t know if they everyone should be switching. The GLP1 Facebook groups prove that some people need a lot of hand holding. The amount of people who accidentally inject their thumb is incredible. Idk even know how that would happen
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Wait that's a thing? I thought @DwightTheDelight was joking.
 
keangkong said:
I know many compounding pharmacies plan to continue compounding. The FDA's announcement and the court ruling as to it affect only affect one exception to the ban on compounding of patented medications. There are many others. See Food Drug & Cosmetic Act §§ 503A (21 U.S.C. § 353a), 503B (21 U.S.C. § 353b). Despite me being a lawyer, this is far outside my area of expertise. But I have heard from lawyers from compounding pharmacies who say the plan on continuing to compound. I make no predictions about how this will all turn out. I'm not super interested in this topic right now simply because I believe the folks using compounding pharmacies ought to switch to grey.
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This forum is going to get very Interesting in the future I predict. Probably a lot more interesting than just us parrot owners in here with a weird post or two.
 
Super Trips said:
This forum is going to get very Interesting in the future I predict. Probably a lot more interesting than just us parrot owners in here with a weird post or two.
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Wait wait wait wait wait..... US parrot owners? 😍😍
 
hexagonal said:
I've pricked my thumb when re-capping the pen needles. They get bent and shoot out the side of the top. Oops.

Not sure how someone would managed to inject their thumb, though...
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Oh come ON. Even you?!

I suspect you earned unreliable narrator, there's no way.
 
chmuse said:
Oh come ON. Even you?!

I suspect you earned unreliable narrator, there's no way.
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To be fair, I'm paying much less attention after I've finished the injection! Just recapping stuff, twisting it off the top of the pen, tossing it in the sharps container.
 
hexagonal said:
To be fair, I'm paying much less attention after I've finished the injection! Just recapping stuff, twisting it off the top of the pen, tossing it in the sharps container.
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I'm still gonna give you side eye. At least until I do it myself, then I promise to DM you and apologize.
 
hexagonal said:
I've pricked my thumb when re-capping the pen needles. They get bent and shoot out the side of the top. Oops.

Not sure how someone would managed to inject their thumb, though...
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i.... have done this more times than i'd like to admit. i just stop paying attention once the important part of injecting myself is done.
 
chmuse said:
I'm still gonna give you side eye. At least until I do it myself, then I promise to DM you and apologize.
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I think side eye is the problem, or depth perception. I've got wonky vision and have stuck myself replacing syringe caps as well (the needle will stick right through the orange cap). Hitting the plunger at the same time is beyond me. I have a good time sewing my hand to all my mending and hemming projects. 🪡
 
nonyabizznez said:
I think side eye is the problem, or depth perception. I've got wonky vision and have stuck myself replacing syringe caps as well (the needle will stick right through the orange cap). Hitting the plunger at the same time is beyond me. I have a good time sewing my hand to all my mending and hemming projects. 🪡
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It's probably an anxiety thing. I'm so afraid of sticking myself that I'm extra careful.
 
chmuse said:
It's probably an anxiety thing. I'm so afraid of sticking myself that I'm extra careful.
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Thumb injector here ! Racing out the door late for work, removed the cap, wasn't looking and thought the pen was the correct direction pressing on my thigh and boop --- holy hell the pain 😭😳😭 !! Straight to the thumb.

Then a friend told me tell Lilly you wasted a pen and they will replace it ... and sure enough; here came an entire new box... a whole box !! 😳

Thumb injector's may not be so stupid after all 😆🤣
 
keangkong said:
Because the 503B pharmacies are envisioned as compounding beforehand to meet a need. The 503As are only supposed to compound for specific patients. Strictly speaking, it's not size that counts, but the provision that of law that authorizes the compounding that makes a difference.
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Does this include the tirz with added this and that I wonder ?
 
Valerie said:
Does this include the tirz with added this and that I wonder ?
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The 503B pharmacies clearly cannot get around compounding restrictions simply by adding something for a specific patient. The 503A pharmacies may do so. Section 503A bars them generally from compounding what is "essentially a copy of a commercially available drug product" except when done irregularly and only manufactured in small amounts.

However, the term “ 'essentially a copy of a commercially available drug product' does not include a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product." Food, Drug & Cosmetic Act, sec. 503A(b)(2). The attorneys for compounding pharmacies will try to make this exception as big as possible and argue that the language of the Food Drug & Cosmetic Act makes the prescribing physician the only person that can decide. That interpretation seems to create such a big loophole that it swallows the rule: A doctor can always ask the compounding pharmacy to tweak the drug in some way. I won't venture an opinion as to what the outcome will be because (1) as far as I can tell, no one really knows right now and (2) this is far outside my area of expertise. However, if a compounding pharmacy is selling tirzepatide with some special additive that supposedly makes it work better, there is a good chance that whatever was added is an attempt to get around compounding restrictions.
 
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