Certificate of Medical Necessity

You must have a new doctor's letter every time you order along with the added sentence below
(one of 4 FDA required documents)

      USDA Permits Still Required!

_______________________________
Date

RE: ____________________________________________________________

(Patient’s Name)

To Whom It May Concern:

The above named patient has a history of Type __1 __2 diabetes mellitus and s/he has had significant __ hypoglycemia without adequate early warnings, __ allergy, __ glucose control, __ other ___________________________ problems when s/he uses any of the insulins available in the US, synthetic human or other synthetic insulin. Therefore, the use of the insulins still available and the US is contraindicated in this patient. The patient manifests the daily need for at least _____ units of insulin per day and requires at least ____ 1,000 Unit/10cc bottles of these insulins every six months.  The patient requires natural  bovine and or porcine insulin.

Projecting a patient’s precise insulin needs is not possible. At this time, patient would need to use approximately ____ bottles of natural Neutral (R) every six months, and _____ bottles of natural Isophane (N) every 6 months, and ____ bottles of natural Lente (L)  every six months,  and ___ bottles of Protamine Zinc (nearest comparable for UL or PZI) every six months. If s/he does not use the specificied medications, the risk of significant and potentially life-threatening problems is markedly increased and other complications can occur.  New sentence below: Furthermore, I will report any adverse reactions in connection with these insulins to Wockhardt UK Limited/CP Pharmaceuticals Limited located at: Ash Road North Wrexham Industrial Estate Wrexham LL139UF United Kingdom

If there are any questions, please do not hesitate to contact this office.

Sincerely,

_______________________________________________

Doctor's Signature                                                       Title

USDA Import Permit, Doctor’s Certificate of Medical Necessity, and Personal Certificate of personal use and 6 month supply