Re: I wonder if anyone else is having this problem [veterinarians being told by pharmacies that there is adequate stock of pergolide]
Posted by Dr. Kellon on EC List May 7, 2007 Msg #91278
The big compounders were saying "no problem" initially too - until
they tried to place an order for bulk drug.
- pills are gone
- legitimate drug wholesalers (who supply compounding pharmacies)
have no drug
- Customs is *allegedly* (haven't confirmed this) stopping drug at
the border
There are US manufacturers who make bulk pergolide that *might* (this
isn't confirmed either) be able to supply compounders under a
veterinary use only order, but the rock bottom lowest price I've
found from the US companies is over $1 per mg, so the compounded
product would be at least $2/mg, probably more.
A compounder still selling the drug without a price mark up and
saying "no problem" is either selling VERY old stock, or is getting
it black market. Tell any vets claiming this isn't an issue to ask
the compounder where their drug is coming from and when did they last
check with their supplier about availability.
Make no mistake about this. There definitely is a crisis.
Eleanor
Showing posts with label Questions. Show all posts
Showing posts with label Questions. Show all posts
Monday, May 7, 2007
Thursday, May 3, 2007
Medically Necessary Veterinary Imports Request II
Posted to EC List by Dr. Kellon May 3, 2007 Msg #91069
Answers for the "13 Questions" in the request letter.
Answers in [brackets]. You can cut/paste this into a word file so most of the information does not need to be retyped for printing on letterhead.
To:
Michael Zimmerman
Food and Drug Administration
Center for Veterinary Division of Compliance, HFV-235
7519 Standish Place
Rockville, MD 20855
Fax: (240)276-9241
Re: Medically Necessary Personal Veterinary Imports
Please determine the following in the initial contact:
How did the veterinarian learn of this product?
[Pergolide has been the drug of choice for Cushing's in equines at least 10 years.]
Please submit the following information:
1. Veterinarian's name
2. Clinic's name, address, & phone number
3. Client's name and address
4. Patient name and non-food species
[1-5 are obvious]
5. Name of drug
[Pergolide]
6. Drug family or class
[Dopamine agonist]
7. Name and address of drug supplier
[You will have to have picked out a pharmacy in another country
before this question can be answered and the application submitted.
Fairly easy to do on line. You don't have to actually place an order
or open an account, etc. They just need to know where it will be
coming from. Be prepared to be shocked at these prices.
See list below for suppliers.]
8. Legal status of the drug in the foreign country
[Legal]
9. Amount of drug to be imported, must be small, non-commercial
quantities. Please be sure to specify # of mg as well as # of
bottles (each bottle contains 100 capsules)
[Need to specify the strength of the pills you are importing and
how many pills each time - e.g. a 100 count bottle of 0.5 mg generic
pergolide pills.]
10. Disease condition to be treated
[PPID/Cushings]
11. Reason why an approved human or animal drug will not treat the
disease condition
[There are no approved human or animal drugs other than pergolide
which are known to adequately treat the condition.]
12. A statement that:
- you will notify the animal owner that the drug is not approved
- that the drug will not be used in any food animal
- and that you agree to notify the FDA if there are any adverse reactions?
[Veterinarian needs to answer "yes" to all three questions.]
13. Please include your email address.
[Veterinarian's email address]
Example Suppliers for Question 7:
http://www.rxcarecanada.com/Permax.asp?prodid=1348
http://www.smartmed.ca/canada_drugs/buy_pergolide_canada.asp
http://www.1drugstore-online.com/showprice.asp?name=pergolide&bysearch=ok
http://goldpharma.com/?show=search&search_srt=Parkotil&affiliate=1629522380&ref=search
Answers for the "13 Questions" in the request letter.
Answers in [brackets]. You can cut/paste this into a word file so most of the information does not need to be retyped for printing on letterhead.
To:
Michael Zimmerman
Food and Drug Administration
Center for Veterinary Division of Compliance, HFV-235
7519 Standish Place
Rockville, MD 20855
Fax: (240)276-9241
Re: Medically Necessary Personal Veterinary Imports
Please determine the following in the initial contact:
How did the veterinarian learn of this product?
[Pergolide has been the drug of choice for Cushing's in equines at least 10 years.]
Please submit the following information:
1. Veterinarian's name
2. Clinic's name, address, & phone number
3. Client's name and address
4. Patient name and non-food species
[1-5 are obvious]
5. Name of drug
[Pergolide]
6. Drug family or class
[Dopamine agonist]
7. Name and address of drug supplier
[You will have to have picked out a pharmacy in another country
before this question can be answered and the application submitted.
Fairly easy to do on line. You don't have to actually place an order
or open an account, etc. They just need to know where it will be
coming from. Be prepared to be shocked at these prices.
See list below for suppliers.]
8. Legal status of the drug in the foreign country
[Legal]
9. Amount of drug to be imported, must be small, non-commercial
quantities. Please be sure to specify # of mg as well as # of
bottles (each bottle contains 100 capsules)
[Need to specify the strength of the pills you are importing and
how many pills each time - e.g. a 100 count bottle of 0.5 mg generic
pergolide pills.]
10. Disease condition to be treated
[PPID/Cushings]
11. Reason why an approved human or animal drug will not treat the
disease condition
[There are no approved human or animal drugs other than pergolide
which are known to adequately treat the condition.]
12. A statement that:
- you will notify the animal owner that the drug is not approved
- that the drug will not be used in any food animal
- and that you agree to notify the FDA if there are any adverse reactions?
[Veterinarian needs to answer "yes" to all three questions.]
13. Please include your email address.
[Veterinarian's email address]
Example Suppliers for Question 7:
http://www.rxcarecanada.com/Permax.asp?prodid=1348
http://www.smartmed.ca/canada_drugs/buy_pergolide_canada.asp
http://www.1drugstore-online.com/showprice.asp?name=pergolide&bysearch=ok
http://goldpharma.com/?show=search&search_srt=Parkotil&affiliate=1629522380&ref=search
Medically Necessary Veterinary Imports Request
Summary of Fax Cover Sheet:
From: Michael Zimmerman; (michael.zimmerman@fda.hhs.gov)
Re: Request Import Drug
Notes: Attached is a copy of the 13 questions that must be answered to consider your request to import medication for your patient(s). Please answer each question as thoroughly as possible and fax your completed request back to our office. Please call if you have any questions. Thank you.
Address and Question Sheet:
Please submit letter to:
Michael Zimmerman
Food and Drug Administration
Center for Veterinary
Division of Compliance, HFV-235
7519 Standish Place
Rockville, Maryland 20855
Or fax to 240-276-9241
Questions: (240)276-9202
Please determine the following in the initial contact:
How did the veterinarian learn of this product? If there is
any indication the product has been actively promoted in
U.S. markets it will be refused entry and an import alert will
be issued.
Please submit the following information:
1. Veterinarian's name
2. Clinic's name, address, & phone number
3. Client's name and address
4. Patient name and non-food species
5. Name of drug
6. Drug family or class
7. Name and address of drug supplier
8. Legal status of the drug in the foreign country
9. Amount of drug to be imported, must be small, non-commercial
quantities. Please be sure to specify # of mg as well as # of
bottles (each bottle contains 100 capsules)
10. Disease condition to be treated
11. Reason why an approved human or animal drug will not treat the
disease condition
12. A statement that:
- you will notify the animal owner that the drug is not approved
- that the drug will not be used in any food animal
- and that you agree to notify the FDA if there are any adverse reactions?
13. Please inlude your email address.
ALL REQUESTS MUST BE SIGNED BY THE VETERINARIAN AND BE ON LETTERHEAD
Please allow 3-4 weeks for processing.
Revised February 1, 2007
[Go to version formatted as letter]
From: Michael Zimmerman; (michael.zimmerman@fda.hhs.gov)
Re: Request Import Drug
Notes: Attached is a copy of the 13 questions that must be answered to consider your request to import medication for your patient(s). Please answer each question as thoroughly as possible and fax your completed request back to our office. Please call if you have any questions. Thank you.
Address and Question Sheet:
Please submit letter to:
Michael Zimmerman
Food and Drug Administration
Center for Veterinary
Division of Compliance, HFV-235
7519 Standish Place
Rockville, Maryland 20855
Or fax to 240-276-9241
Questions: (240)276-9202
Please determine the following in the initial contact:
How did the veterinarian learn of this product? If there is
any indication the product has been actively promoted in
U.S. markets it will be refused entry and an import alert will
be issued.
Please submit the following information:
1. Veterinarian's name
2. Clinic's name, address, & phone number
3. Client's name and address
4. Patient name and non-food species
5. Name of drug
6. Drug family or class
7. Name and address of drug supplier
8. Legal status of the drug in the foreign country
9. Amount of drug to be imported, must be small, non-commercial
quantities. Please be sure to specify # of mg as well as # of
bottles (each bottle contains 100 capsules)
10. Disease condition to be treated
11. Reason why an approved human or animal drug will not treat the
disease condition
12. A statement that:
- you will notify the animal owner that the drug is not approved
- that the drug will not be used in any food animal
- and that you agree to notify the FDA if there are any adverse reactions?
13. Please inlude your email address.
ALL REQUESTS MUST BE SIGNED BY THE VETERINARIAN AND BE ON LETTERHEAD
Please allow 3-4 weeks for processing.
Revised February 1, 2007
[Go to version formatted as letter]
FDA and CVM Q/A
Q - What is MNVD (or MNVP)?
A - MNVD stands for Medically Necessary Veterinary Drug
CVM Policy Guide 1240-4170 outlines the policy for MNVD Product Shortage Management.
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
"Medically Necessary Veterinary Product (MNVP): A product is considered to be an MNVP if it is used to treat or prevent a serious disease or condition, or needed to assurethe availability of safe food products of animal origin and there is no other available source of that product of alternative drug that is judged by CVM's veterinary staff to be an adequate substitute. Inconvenience and non-therapeutic uses are insufficient basis to classify a product as an MNVP."
"It is Agency policy to attempt to prevent or alleviate shortages of MNVPs. An MNVP shortage may involve an actual or potential shortage of a drug product."
The document goes on to outline Responsibilities and Procedures.
Q - What is the MNVD form?
A - There is currently a shortage of the legal generic pergolide tablets in the United States. There is a rapidly dimishing supply of bulk pergolide available for compounding, which is actually not legal under current policies. In order to ensure that an equine patient's medication (pergolide) continues uninterrupted, it may be necessary to import generic pergolide tablets from non-US sources.
This is not actually a "form" but
a) a fax cover sheet referring to "Request to Import Drug" and
b) a second sheet, "Medically Necessary Personal Veterinary Imports", listing the 13 questions that must be answered by the attending veterinarian on letterhead with the veterinarian's signature. A separate request must be made for each equine.
In separate articles you will find:
- The list of questions
- "Standard" answers to the 13 questions
- A list of non-US suppliers of generic pergolide tablets (for question #7)
These are also available in PDF either at the Equine Cushings List files
http://pets.groups.yahoo.com/group/EquineCushings/files
or by requesting copies by entering a comment at the end of this article.
A - MNVD stands for Medically Necessary Veterinary Drug
CVM Policy Guide 1240-4170 outlines the policy for MNVD Product Shortage Management.
http://www.fda.gov/cvm/Policy_Procedures/4170.pdf
"Medically Necessary Veterinary Product (MNVP): A product is considered to be an MNVP if it is used to treat or prevent a serious disease or condition, or needed to assurethe availability of safe food products of animal origin and there is no other available source of that product of alternative drug that is judged by CVM's veterinary staff to be an adequate substitute. Inconvenience and non-therapeutic uses are insufficient basis to classify a product as an MNVP."
"It is Agency policy to attempt to prevent or alleviate shortages of MNVPs. An MNVP shortage may involve an actual or potential shortage of a drug product."
The document goes on to outline Responsibilities and Procedures.
Q - What is the MNVD form?
A - There is currently a shortage of the legal generic pergolide tablets in the United States. There is a rapidly dimishing supply of bulk pergolide available for compounding, which is actually not legal under current policies. In order to ensure that an equine patient's medication (pergolide) continues uninterrupted, it may be necessary to import generic pergolide tablets from non-US sources.
This is not actually a "form" but
a) a fax cover sheet referring to "Request to Import Drug" and
b) a second sheet, "Medically Necessary Personal Veterinary Imports", listing the 13 questions that must be answered by the attending veterinarian on letterhead with the veterinarian's signature. A separate request must be made for each equine.
In separate articles you will find:
- The list of questions
- "Standard" answers to the 13 questions
- A list of non-US suppliers of generic pergolide tablets (for question #7)
These are also available in PDF either at the Equine Cushings List files
http://pets.groups.yahoo.com/group/EquineCushings/files
or by requesting copies by entering a comment at the end of this article.
Monday, April 30, 2007
Pharmacy claiming to have no problem getting Pergolide?
Posted to EC List 4/30.2007 Msg # 90916
Re: Urgent! Pharmacy claiming to have no problem getting Pergolide!!!
> She refered to the withdrawn Pergolide as the "human" version, and
> compounded pergolide as the "animal version". She said that they
> get pergolide in a raw state from a chemical company, not a
> manufacturer. This company they get it from is in the US.
>
> They then compound it and are selling it to vets. She said the
> company they are getting it from is having no problem w/ obtaining
> it and therefore neither are they because it is the "animal" version.
She's wrong.
These little companies haven't tried to reorder any yet.
Facts:
- Unless they have some really shady black market source (not good),
the pharmacies order "raw" (bulk) from drug wholesalers. Drug
wholesalers order from foreign chemical manufacturers (there actually
are some in the US too - for $2 to $3 PER MG - so you know it's not
coming from there!).
- THERE IS NO DRUG AVAILABLE FROM THE LEGITIMATE WHOLESALERS. NADA, NONE, ZILCH - IT'S GONE.
- There is no such thing as the "animal version" of a bulk drug. Both
the compounded versions and the human pills were being made from the
same "raw"/bulk drug.
Even the big compounders that were initially saying they had large
supplies and didn't expect any problems with getting the bulk drug
are panicing now.
For your own (or rather, your horse's) safety, if you run into a
pharmacy that says "no problem", ask them who their supplier is. If
they won't tell you, run.
Eleanor
Re: Urgent! Pharmacy claiming to have no problem getting Pergolide!!!
> She refered to the withdrawn Pergolide as the "human" version, and
> compounded pergolide as the "animal version". She said that they
> get pergolide in a raw state from a chemical company, not a
> manufacturer. This company they get it from is in the US.
>
> They then compound it and are selling it to vets. She said the
> company they are getting it from is having no problem w/ obtaining
> it and therefore neither are they because it is the "animal" version.
She's wrong.
These little companies haven't tried to reorder any yet.
Facts:
- Unless they have some really shady black market source (not good),
the pharmacies order "raw" (bulk) from drug wholesalers. Drug
wholesalers order from foreign chemical manufacturers (there actually
are some in the US too - for $2 to $3 PER MG - so you know it's not
coming from there!).
- THERE IS NO DRUG AVAILABLE FROM THE LEGITIMATE WHOLESALERS. NADA, NONE, ZILCH - IT'S GONE.
- There is no such thing as the "animal version" of a bulk drug. Both
the compounded versions and the human pills were being made from the
same "raw"/bulk drug.
Even the big compounders that were initially saying they had large
supplies and didn't expect any problems with getting the bulk drug
are panicing now.
For your own (or rather, your horse's) safety, if you run into a
pharmacy that says "no problem", ask them who their supplier is. If
they won't tell you, run.
Eleanor
Can I Bring Pergolide into the US from Another Country?
Posted on EC List 4/29/2007 Msg #90865
> Can a person physically go to another country and
> bring pergolide into the USA?
No, because to be eligible for importation (even if you go yourself
and get it, it's still importation) it has to be an approved drug
that is identical in every way, including product labelling and
language, to the US form of the drug and has to be manufactured
according to US standards. Because there is no longer an "approved"
form of pergolide, you can't bring it into the country without a
permit.
What's interesting though is that all the importation rules apply to
**HUMAN** use. Not a peep about drugs for veterinary use. When
omissions in legislation and guidance documents like this occur, the
FDA will typically make a statement either way depending on what they
favor, rather than any legal basis. For example, the DSHEA (Dietary
Supplements Health and Education Act) protected human access to
things like glucosamine, but because it didn't specifically mention
animals there was a push a few years back to ban these things for
animals. In the case of the drug importation laws, odds are they
would declare the opposite - that they really did mean to include
animal drugs in all the importation restrictions.
By not specifically including animals, any action they might take to
stop your husband bringing it in would be subject to legal
questioning in court - but who has the time or money for that! It
might be an interesting test of the system for him to try it though.
Take your vet's prescription with you, marked clearly "for equine
use", buy just a very small amount and see what happens at customs.
Eleanor
> Can a person physically go to another country and
> bring pergolide into the USA?
No, because to be eligible for importation (even if you go yourself
and get it, it's still importation) it has to be an approved drug
that is identical in every way, including product labelling and
language, to the US form of the drug and has to be manufactured
according to US standards. Because there is no longer an "approved"
form of pergolide, you can't bring it into the country without a
permit.
What's interesting though is that all the importation rules apply to
**HUMAN** use. Not a peep about drugs for veterinary use. When
omissions in legislation and guidance documents like this occur, the
FDA will typically make a statement either way depending on what they
favor, rather than any legal basis. For example, the DSHEA (Dietary
Supplements Health and Education Act) protected human access to
things like glucosamine, but because it didn't specifically mention
animals there was a push a few years back to ban these things for
animals. In the case of the drug importation laws, odds are they
would declare the opposite - that they really did mean to include
animal drugs in all the importation restrictions.
By not specifically including animals, any action they might take to
stop your husband bringing it in would be subject to legal
questioning in court - but who has the time or money for that! It
might be an interesting test of the system for him to try it though.
Take your vet's prescription with you, marked clearly "for equine
use", buy just a very small amount and see what happens at customs.
Eleanor
Who Still Has Supplies?
Posted to EC List 4/29/2007 Msg #90861
>Do you know if any of the sources are still selling the compounded
>mix? I cannot even stomach being without it.
Danielle,
Most of the compounders still have a few weeks or months worth left but
it's not going to last long. Do a Google search for the terms
veterinary, compounding and pergolide.
Eleanor
>Do you know if any of the sources are still selling the compounded
>mix? I cannot even stomach being without it.
Danielle,
Most of the compounders still have a few weeks or months worth left but
it's not going to last long. Do a Google search for the terms
veterinary, compounding and pergolide.
Eleanor
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