Topics

Legality of Compounding #legalityofpergolide

Eleanor Kellon, VMD
 

Summary

The compounding issue is clear as mud.

It is perfectly legal to order a compounded version of any medication that is in a different form (e.g. liquid, powder, capsule, flavored treat)  or dosage, or as part of a specific drug combination, that is different from the FDA approved commercial drug.

Veterinarians also have wide leeway with nonfood animals in ordering drugs that do not have specific FDA approval for the species, including in ordering compounded drugs as long as this is in a nonfood animal and within the confines of an owner-veterinarian relationship to treat a specific condition for that individual.

The question arises in regard to using bulk drug (which considerably reduces costs) vs the FDA approved pharmaceutical as the source of the active ingredient. FDA considers bulk drug use illegal but two federal district court decisions held that the FDA was infringing on state rights to regulate pharmacy activity or being capricious in its enforcements or essentially trying to apply regulations intended for human drugs to animals. They are only enforceable in the relevant districts but do set  a precedent.

http://drugtopics.modernmedicine.com/drug-topics/news/modernmedicine/modern-medicine-feature-articles/fda-loses-vet-compounding-case

In any event, the prescribing veterinarian is not necessarily even involved in the controversy. It's one thing to compound a drug yourself from bulk ingredients, or directly sell one, but quite another to simply write a prescription that does not directly specify the source of drug.

Note: Most recently the FDA has published guidelines (these do not have the power of law) for compounding for animals that includes bulk drugs, including a specific list of drugs. What, if any, impact this has on future actions remains to be seen.


--
Eleanor in PA

 

www.drkellon.com 

EC Owner 2001

hinecedark
 

Thank you Dr. Kellon for trying to clear up a confusing topic for us. 
So, for those of us with fearful or misinformed vets . . . if the horse needs any other dose than 1mg. of pergolide, the prescription can be written for "Xmg. pergolide capsules". The owner directs the scrip to a compounding pharmacy, and the pharmacist fills it with what he/she thinks appropriate. Right? I don't think it is necessary for the vet to specify compounded. Might this mollify the fearful? Or am I confused about this?
Melinda
IN  2010

Nancy C
 

Just wanted to add a few things reported by members over the years.

At a veterinarian conference a leading researcher described horses as having mild laminitis during seasonal rise as okay. The  ECIR Group goal is zero laminitis.  Mild laminitis is not okay.

Researchers now suggest that pergolide may need to be at a higher dose in fall.  ECIR Group knew about seasonal rise in 2002 from a member who diligently tested her horse because her was not responding.

Also at conferences, and on the Prascend insert, doses higher than 2 mg are dismissed in the US b/c side effects may occur.  This level is 5 mg in the UK.  Members of tehe ECIR Group know the most typical side effect is inappetence, which is transitory and can be controlled in the vast majority of cases with titration of the drug and the simultaneous use of adaptogens.  APF is the product used most often here.

Personally, I have had just-out-of-vet-school practitioners tell  me they have learned the latest protocols such as the use of cyproheptadine when the 2 mg of Prascend didn't work.  We've know since about 2003 that it does not work.  I can vouch for that from personal experience.

Sending vets the proceedings from the 2013 and 2015 NO Laminitis! Conference can be helpful.  If they read it. They are free to download on IVIS and on ecirhorse.org.

If I could not get a vet to work with me on this, I'd be looking for another vet, and have done five times.  Takes work but I now have one who will listen to me and work with us.

Lastly -- anyone can still register for the 2017 NO Laminitis! Conference. The most comprehensive way of getting your ducks in a row.  You will not be the same.

www.nolaminitis.org


Nancy C in NH
ECIR Moderator 2003

 

The ECIR Group Inc. NO Laminitis! Conference, October 27-29, Tucson, AZ
www.nolaminitis.org

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Eleanor Kellon, VMD
 

Melinda,

That's correct.
--
Eleanor in PA

 

www.drkellon.com 

EC Owner 2001

regina bruno
 

On Sun, Sep 24, 2017 at 06:53 am, Nancy C wrote:
"At a veterinarian conference a leading researcher described horses as having mild laminitis during seasonal rise as okay. The  ECIR Group goal is zero laminitis.  Mild laminitis is not okay.

Researchers now suggest that pergolide may need to be at a higher dose in fall.  ECIR Group knew about seasonal rise in 2002 from a member who diligently tested her horse because her was not responding.

Also at conferences, and on the Prascend insert, doses higher than 2 mg are dismissed in the US b/c side effects may occur.  This level is 5 mg in the UK.  Members of tehe ECIR Group know the most typical side effect is inappetence, which is transitory and can be controlled in the vast majority of cases with titration of the drug and the simultaneous use of adaptogens.  APF is the product used most often here.

Personally, I have had just-out-of-vet-school practitioners tell  me they have learned the latest protocols such as the use of cyproheptadine when the 2 mg of Prascend didn't work.  We've know since about 2003 that it does not work.  I can vouch for that from personal experience.

Sending vets the proceedings from the 2013 and 2015 NO Laminitis! Conference can be helpful.  If they read it. They are free to download on IVIS and on ecirhorse.org.

If I could not get a vet to work with me on this, I'd be looking for another vet, and have done five times.  Takes work but I now have one who will listen to me and work with us."

Great points, Nancy. thanks for summarizing so clearly.

During the Prascend trial the side effects and deaths from keeping the dosages low are pitiful, unacceptable, and unnecessary from all I've learned here.  

 
--
Regina and Smokey
June 26, 2017
Laurelville,  Ohio

 https://ecir.groups.io/g/CaseHistory/files/Regina%20and%20Smokey  .
https://ecir.groups.io/g/CaseHistory/album?id=8316  .

regina bruno
 

"Researchers now suggest that pergolide may need to be at a higher dose in fall."

i want that research.  i'm looking...
--
Regina and Smokey
June 26, 2017
Laurelville,  Ohio

 https://ecir.groups.io/g/CaseHistory/files/Regina%20and%20Smokey  .
https://ecir.groups.io/g/CaseHistory/album?id=8316  .