Personal Import of Wockhardt UK Ltd bovine and porcine insulins into the United States
The FDA may permit you to import beef or pork insulin into the United States for your personal use if your diabetes can not be treated with human insulin or analogues.
This guide has been written to help you if you have not been able to find a suitable replacement for porcine or bovine insulin in the United States and wish to obtain these insulins from Wockhardt UK Ltd.
Although Wockhardt’s bovine and porcine insulins have been approved and used in the United Kingdom and other countries for the last 25 years, they are not approved for use in the United States. Therefore, Wockhardt UK Ltd cannot supply insulin to you as a U.S. resident until you have received permission from the relevant U.S. authorities to bring the insulin into the United States
This is what to do:
1. Contact the U.S. Department of Agriculture (USDA)
Because Wockhardt UK Ltd insulins are derived from cows or pigs you need permission from the United States Department of Agriculture to bring Wockhardt UK Ltd insulins into the country. An "Application for Permit to Import Controlled Material or Transport Organisms or Vectors is required and a simplified form is currently available by request from our Export Dept. (Phone +44 1978 669201, +44 1978 669275, Fax +44 1978 661262 or Email export@wockhardt.co.uk). Fill in the blank spaces marked with stars, and send it along with your application fee of $94.00 for a 5 year permit to: (renewals fee = $61.00/5 years) Note these charges may vary according to the USDA requirements.
U.S. Department of Agriculture
Animal and Plant Health Inspection Service
Veterinary Services
National Center for Import-Export Products Program
Riverdale MD 20737 1231
Tel (301) 734-3277
The USDA will send you an official import permit.
2. Contact Wockhardt UK
Personal importation of small amounts of unapproved medicines under specific circumstances may be allowed at the discretion of the U.S. Food and Drugs Administration (FDA). You need to send some documents to Wockhardt UK Ltd when you order your insulin so that FDA officials can release your insulin when it arrives in the US. Wockhardt UK Ltd will enclose a copy of these documents with your shipment of insulin for the FDA officials to look at when it arrives in the U.S.
These are the documents you should send to Wockhardt UK:
1. A copy of the USDA import permit (see section 1 above)
2.
A completed order form for beef insulin(pdf), and/or a completed order form for pork insulin (pdf). Alternatively this form is available upon request from our Export Department.
3. A letter from your U.S. licensed practitioner saying that your diabetes can not be treated with human insulin or analogues and that the insulins available in the U.S. do not effectively control your diabetes and are therefore unacceptable.
4.
A ‘Compassionate Use/ Named Patient Supply: Drug Safety (Pharmacovigilance) Agreement for Hypurin Insulin’ (PDF) completed by the licensed practitioner responsible for the treatment of your diabetes.
Note: Communication regarding technical or medical aspects of Hypurin insulin or its use.
The Company must ensure that the patient communicates directly with and obtains all advice on his or her diabetes treatment from the physician responsible for treatment of his or her diabetes.
· The Company can not communicate directly with the patient regarding technical or medical aspects of Hypurin insulin or its use.
· The patient must direct all enquiries of this nature to the physician responsible for treatment of his/her diabetes.
· Contact with the Company on matters of this nature must be made by the physician responsible for treatment of the patient’s diabetes.
· Communication received by the Company directly from the patient, will be forwarded within two working days of receipt, to the physician responsible for treatment of the patient’s diabetes.
5. A statement, signed by you, saying that the insulin is for your own personal use and that the number of vials being ordered is no more than six months supply. (Include your name, address, telephone and fax number if you have one, on this statement.)
Please send the above (fax or post) to:
Export Department
Wockhardt UK Ltd
Ash Road North
Wrexham Industrial Estate
Wrexham, LL13 9UF
United Kingdom
Telephone Number: + 44 1978 669201 or + 44 1978 669275
Fax Number: + 44 1978 661262
Email: export@wockhardt.co.uk
Please note that Wockhardt UK Ltd cannot supply you with insulin without these five documents.
It is also important to note that once we have despatched your insulin, release of this product to you is entirely at the discretion of the U.S. authorities; Wockhardt UK Ltd cannot guarantee that the authorities will allow all shipments through. Wockhardt UK Ltd can take no responsibility for delay, loss, damage or improper storage of your insulin in transit. However, we will do our best to ensure you get the insulin you need.
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