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Diabetes in Pets

CP Pharma

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Hypurin Bovine Protamine Zinc insulin.

The natural bovine and porcine insulins of CP Pharma[1],now known as Wockhardt UK (originally a UK company, now owned by Indian pharmaceutical major Wockhardt Ltd.)[2] have been available for the last 25 years but did not really come to attention in North America until the 1990's when both Novo Nordisk and Eli Lilly stopped producing their 100% porcine and bovine insulin formulations.

With the scheduled 2007 discontinuations of Novo Nordisk's Pork Actrapid, Pork Insulatard and Pork Mixtard 30, CP Pharma/Wockhardt UK's Hypurin Porcine line will serve as comparable insulins for each[3].


ImportingEdit

At first, there was no red tape involved in importing these insulins to the US. Now it is necessary to fill out forms, obtain a doctor's letter, and to apply for a USDA import permit. Those currently importing or wishing to import insulin from CP Pharma/Wockhardt UK to the US need to send the following to CP Pharma/Wockhardt UK with each order: A copy of the doctor's letter stating the need for the importation of insulin AND a letter from the patient or caregiver stating that the insulin is being imported for personal use only.

Importing is now the only way those wanting manufactured 100% bovine and porcine insulins are able to get them; the last such natural insulins available on the North American market Iletin II NPH & Iletin II R were discontinued by Eli Lilly in July 2005. (Note that compounded 100% bovine insulin and manufactured 90% bovine/10% porcine insulin are available in the US in PZI suspensions.) For the convenience of US and Canadian customers, CP Pharma/Wockhardt UK has toll-free phone numbers on its website.


CP/Wockhardt Exports to:

US bovine-needs permit
porcine-needs permit
Canada bovine-needs permit
porcine-available OTC
Australia bovine-Neutral & Isophane (NPH)available Rx[4][5]
Australia all porcine (pork), Beef (Bovine) Lente and Beef (Bovine) Protamine Zinc (PZI) needs importation[6][7]

Germany

Switzerland


Your vet may be able to obtain manufactured beef insulin from the UK for you through Health Canada's Emergency Drug Release program[8]. With it, you are able to receive up to 6 months worth of insulin; a C$ 50.00 fee for the application is required [9]. If permitted, you would then be eligible to import PZI insulins such as Hypurin Vet Protamine Zinc, or Hypurin Bovine Protamine Zinc, as well as the other insulins produced by CP Pharma. The program is similar to Health Canada's Special Access Programme [10] for importing necessary drugs for people.

CostsEdit

No More UDSA Permit FeeEdit

For those in the US, the USDA permit is good for 5 years and the $94 permit fee has now been waived for personal importation. Import permits are granted on a case-by-case basis. USDA says that it cannot remove the reference to the import fee from their website because the fee is valid for permits other than personal importation of insulin. For questions regarding this, the USDA APHIS phone number is: 301-734-3277.

If you expect to import insulin from anywhere, you must have a permit to do it. Without this paperwork, your insulin runs the risk of being confiscated; the only change in the importation rules is that there are now no more permit fees.

If you wish to import more than one species of insulin, you will need a USDA permit for each one. Permits allow you to import up to 6 months worth of insulin for your own personal needs. You can apply for a permit online at the USDA website[11].

Update (3/22/2007) - You will need a USDA import permit. As of October 2005 - and I suspect farther back than that - a USDA import permit is required if you want to import insulins form CP Pharmacueticals (now part of Wockhardt ). I have an import permit application filed with the USDA right now. The price is quoted correctly, $94 for a 5 year permit. You can then renew the permit for, I belive, $60.00 for an additional 3 years.

It appears that the USDA did waive the requirement of an import permit but the FDA apparently complained about this and it looks like the USDA was "convinced" to again require the import permit.

I am working to import bovine insulin for our diabetic cats but when I asked about needing a permit I was told that I need one and people importing the insulins for personal use also need one.

Additional Importing CostsEdit

Another cost factor besides the insulin itself is the need for a courier service to get the shipment through US Customs. The current fee for this is £100 plus a £100 administration fee for each order[12].

The courier and administration fees are a "flat" amount whether you are importing 1 vial or many. CP's courier and administration fees are exactly the same for Canada[13]. The Canadian ordering process is much the same as that in the US[14]. Knowing that all of CP's Hypurin insulins have a shelf life of 3 years[15] may help you determine if, cost-wise, importing is for you.

Available in CanadaEdit

Hypurin Pork Canada

Hypurin Porcine R/Neutral and Porcine NPH/Isophane insulins as sold in Canada.

For those in Canada, CP Pharma/Wockhardt UK's Hypurin Porcine Isophane (pork NPH)-known in Canada as Hypurin Pork Isophane or Hypurin Pork NPH and its Hypurin Porcine Neutral (pork R)-known in Canada as Hypurin Pork Regular have been approved[16][17] . They are currently available in Canada without need of importation[18][19]. Nucro-Technics[20] is the importer to contact regarding availability of these two insulins in Canada.


UK AvailabilityEdit

Best Pet Pharmacy[21]is online and UK-based, serving the UK and Northern Ireland only. As of October 31, 2005, UK law abolished all prescription-writing fees vets may charge, thus allowing one to obtain medications from non-veterinary sources. All insulins in the UK are considered POM--Prescription-Only-Medications[22][23]--so you will need a prescription to acquire insulin from that source. Best Pet Pharmacy has CP Pharma/Wockhardt UK's Hypurin Bovine Lente and Hypurin Bovine Protamine Zinc in stock.

See this link for more information on CP Pharma/Wockhardt UK products.

More Help and Information SourcesEdit

Diabetics International Foundation If you want or need to import, this group will talk you through the red tape process. They are well-versed in importing to most countries.

US-FDA FAQ's about importing beef or pork insulin.

HealthCanada's Special Access Program (SAP).

Canadian Diabetes Association has more information about importing insulins into Canada.

CP Pharma/Wockhardt UK's website has information about importing pork insulin into Australia. Click on Insulins, then Supply, then Australia. Their Supply pages for Germany and Switzerland also provide importing information for these countries.

ReferencesEdit

  1. CP Pharma/Wockhardt UK Website
  2. Wockhardt Ltd. Website
  3. Response to Withdrawal of Novo Porcine Insulins-CP/Wockhardt UK
  4. Australian Consumer Information Leaflet--Hypurin Bovine Neutral & Isophane
  5. CP Pharma/Wockardt-Australian Importing Information
  6. Australia-Availability of Hypurin Insulins
  7. CP Pharma/Wockhardt-Australian Order Form
  8. Health Canada-Veterinary: Emergency Drug Release Information
  9. Health Canada-Emergency Drug Release Form
  10. Health Canada-Special Access Programme
  11. USDA Online Permit Application
  12. CP Pharma/Wockhardt US Order Form for Beef (Bovine) Insulin
  13. Pharma/Wockhardt Canadian Order for for Beef (Bovine) Insulin
  14. CP Pharma/Wockhardt Canadian Personal Import Information
  15. EMC-Electronic Medicines Compendium-UK-Hypurin Bovine Protamine Zinc
  16. HealthCanada Hypurin Porcine Insulin Approvals
  17. Photo of Hypurin Pork R/Neutral & Pork N/Isophane Insulins sold in Canada-CP/Wockhardt
  18. Hypurin Pork Insulins--Further Information
  19. Porcine Insulin Launched in Canada--CP/Wockhardt UK
  20. Nucro-Technics Website
  21. Best Pet Pharmacy Website
  22. Current Veterinary POM Medications-UK
  23. DTI-UK-Page 3

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