ML19260B997
| ML19260B997 | |
| Person / Time | |
|---|---|
| Issue date: | 11/09/1979 |
| From: | Kimberly Green NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | NRC OFFICE OF STATE PROGRAMS (OSP) |
| References | |
| NUDOCS 7912180104 | |
| Download: ML19260B997 (2) | |
Text
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UNITED STATES NUCLEAR REGULATORY COMMISSION t
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WASHING TON, D. C. 20555
(
NOV D 1979
+....
MEMORANDUM FOR: Files FROM:
Kenneth Green
SUBJECT:
PROGRESS ON PROVIDING P0TASSIUM I0DIDE FOR A LARGE SCALE RADIOLOGICAL ACC'. CENT AT A NUCLEAR POWER UNIT At the present time there is progress on several of the following tracks:
Track One: Approval of the New Drug Application of the Carter-Wallace Incorporated Canberry, New Jersey.
The Food and Drug Administration's New Drug Evaluation unit will' finish its review of the Carter-Wallace application sometime next week.
I discussed the need for KI with Dr.
Marion Finkel, who is Associate Director in charge of New Drug Evalua-tion, and she says that her approval is last step before Carter-Wallace can produce and distribute the drug. At the moment there are two approval letters on Dr. Finkel's desk: One dealing with KI tablets (uncoated) and the other dealing with a solution.
Track Two: The letter from Chairman Hendrie to Patricia Harris requesting policy guidance on KI. The letter is now being approved by the NRC Commis-sioners. Hendrie and Bradford have approved it as of Thursday. Miss Schultz, who works for the Commissioners, is obtaining the necessary ap-provals before the letter can be signed by Hendrie and forwarded to HEW Secretary Harris.
Track Three: The readiness of Carter-Wallace to produce KI useful for thyroid blocking in the event of a radiological accident.
These labs, after Finkel's approval, will be in a position to produce KI with the following characteristics:
Tablets - 130 mg scored for half doses not coated each bottle contains 14 tablets or one (1) tablet a day labels are for a shelf life of two (2) years (may be revised to a greater length after testing) labels say to use 'for ten (10) days unless advised differently no serious side-effects expected for this small dosage Solution - the 30 cc or one ounce bottle calibrated dropper integral part of bottle for institutional use six (6) drops for adults per day three (3) drops for less than one (1) year old infants 1613 238 n1213o fou e
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- Fhles In general the Carter-Wallace labs shall not stockpile these tablets or solu-tions.
They shall produce on "special order".
order a dosage equal to the needs of the City's population during a busines day.
The tablets and solutions have been produced in the form that is at the lowest cost compatible with the requirements of a radiological emergency.
example, the higher cost of producing tablets in tin foil and solutions in For smaller bottles were avoided.
In the event of an emergency the Carter-Wallace Labs have set up a telephone number:
- days and nights 609/655-6000 night backup 609/799-1167 The tablets will be available for emergency use and there are no plans to mar-ket them through pharmacies.
The name of the drug that is on the label is " Thyro-Block".
r
/
nneth Green Emergency Preparedness Office of State Programs 1613 239