Information Notice No. 88-15:Availability of U.S. Food and Drug Administration (FDA)-Approved Potassium Iodide for Use in Emergencies Involving Radioactive Iodine
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C. 20555
April 18, 1988
Information Notice No. 88-15: AVAILABILITY OF U.S. FOOD AND DRUG
ADMINISTRATION (FDA)-APPROVED POTASSIUM
IODIDE FOR USE IN EMERGENCIES INVOLVING
RADIOACTIVE IODINE
Addressees:
Medical, Academic, and Commercial licensees who possess radioactive iodine.
Purpose:
This notice is intended to provide information on the storage and use of
potassium iodide as a thyroid blocking agent in incidents involving exposure
to radioactive iodine. It is expected that licensees will review this infor-
mation for applicability to their licensed activities and distribute this
notice to responsible radiation safety staff. However, suggestions contained
in this information notice do not constitute new NRC requirements, and no
written response is required.
Description of Circumstances:
During a nuclear pharmacy inspection, NRC and the licensee discussed the
possibility of maintaining a supply of potassium iodide at each pharmacy
location. This supply would be used as a thyroid blocking agent in case of an
iodine-131 sodium iodide spill with possible personnel contamination. The
licensee asked for a statement of NRC's policy regarding on-site storage of
potassium iodide for use in incidents involving radioactive exposures. There
is an NRC and Federal Emergency Management Agency (FEMA) policy addressing
on-site storage of FDA-approved "radiation emergency potassium iodide" as a
thyroid blocking agent for power reactor emergency workers (Federal Register,
Vol. 50, No. 142, p. 30258, July 24, 1985).
Discussion:
There is no NRC policy on non-reactor licensees using FDA-approved "radiation
emergency potassium iodide" (i.e., the generic drug nomenclature). However,
as discussed below, licensees may wish to provide for its availability in case
of an emergency.
8804120097
. IN 88-15
April 18, 1988
Page 2 of 3
The FDA has evaluated the medical and radiological risks of administering
potassium iodide for thyroid blocking under emergency conditions. The FDA has
concluded that FDA-approved "radiation emergency potassium iodide" is safe and
effective and has approved it for over-the-counter sale for this purpose
(Federal Register, Vol. 50, No. 142, p. 30258, July 24, 1985). FDA guidance
states that risks of side effects, such as allergic reactions, from the
short-term use of relatively low doses of potassium iodide for thyroid
blocking in a radiation emergency, are outweighed by the risks of radioiodine-
induced thyroid nodules or cancer, if the projected dose to the thyroid gland
is 25 rems or greater. Because FDA has authorized the non-prescription sale
of "radiation emergency potassium iodide," it is legally available to organi-
zations or individuals who, based on their own corporate or personal analysis,
choose to have the drug immediately available.
At this time, ANBEX, Inc. (Box 863, Radio City Station, New York, NY 10019)
and Carter-Wallace, Inc. (P.O. Box 1001, Cranbury, NJ 08512) are the only
companies that have received FDA new drug application (NDA) approval for their
non-prescription "radiation emergency potassium iodide" drugs. These drugs
are not stocked in pharmacies and must therefore be ordered directly from the
companies. The non-prescription "radiation emergency potassium iodide" is
manufactured at the proper adult dosage for thyroid blocking, is readily
absorbed by the body, and has a package insert providing information on the
dosage, method of action, warnings and storage. The directions in the package
insert should be followed. Other forms of potassium iodide are available by
prescription, only.
Potassium iodide is effective as a thyroid blocking agent. It reduces thyroid
gland accumulation of radioiodine that has entered the body through inhalation
or ingestion if the potassium iodide is administered before, or immediately
after, exposure to the radioiodine. If potassium iodide is administered later
than four hours after an individual has suffered an acute ingestion or in-
halation of radioiodine, its effectiveness as a thyroid blocking agent is less
than 50 percent.
If the licensee wants to implement a potassium iodide thyroid blocking
program, the potassium iodide should be on hand (because it is not readily
available), and guidelines should be developed to ensure rapid determination
of whether a radioactive iodine spill or leak warrants administration of the
potassium iodide. The guidelines should also address the more detailed
measurements, surveys, and other followup procedures needed to determine
whether continued treatment with potassium iodide is needed.
It is important to stress that the use of potassium iodide is not a substitute
for preventive measures; e.g., proper handling techniques, control measures,
and emergency procedures that protect the individual from exposure to radio-
active material.
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April 18, 1988
Page 3 of 3
Licensees are also advised that although FDA has approved "radiation emergency
potassium iodide" for non-prescription sales, licensees or individuals still
may wish to consult with a physician about any medical risks of use in an
emergency.
No specific action or written response is required by this information notice.
If you have any questions regarding this matter, please contact the person
listed below or the appropriate NRC regional office.
Richard E. Cunningham, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Technical Contact: Donna-Beth Howe, NMSS
(301) 492-0636
Attachments:
1. Federal Policy on Distribution of Potassium
Iodide Around Nuclear Power Sites for Use
as a Thyroidal Blocking Agent
2. List of Recently Issued NRC Information Notices
. Attachment 2
IN 88-15
April 18, 1988
Page 1 of 1
LIST OF RECENTLY ISSUED
NRC INFORMATION NOTICES
_____________________________________________________________________________
Information Date of
Notice No._____Subject_______________________Issuance_______Issued to________
88-14 Potential Problems with 4/18/88 All holders of OLs
Electrical Relays or CPs for nuclear
power reactors.
88-13 Water Hammer and Possible 4/18/88 All holders of OLs
Piping Damage Caused by or CPs for nuclear
Misapplication of Kerotest power reactors.
Packless Metal Diaphragm
Globe Valves
88-12 Overgreasing of Electric 4/12/88 All holders of OLs
Motor Bearings or CPs for nuclear
power reactors.
88-11 Potential Loss of Motor 4/7/88 All holders of OLs
Control Center and/or or CPs for nuclear
Switchboard Function Due power reactors.
to Faulty Tie Bolts
88-10 Materials Licensees: Lack 3/28/88 All NRC licensees
of Management Controls Over authorized to use
Licensed Programs byproduct
material.
87-44, Thimble Tube Thinning in 3/28/88 All holders of OLs
Supp. 1 Westinghouse Reactors or CPs for nuclear
power reactors
that employ a
Westinghouse NSSS.
88-09 Reduced Reliability of 3/18/88 All holders of OLs
Steam-Driven Auxiliary or CPs for nuclear
Feedwater Pumps Caused power reactors.
by Instability of Woodward
PG-PL Governors
88-08 Chemical Reactions with 3/14/88 All NRC licensees
Radioactive Waste generating or pro-
Solidification Agents cessing low level
radioactive waste.
_____________________________________________________________________________
OL = Operating License
CP = Construction Permit
Page Last Reviewed/Updated Tuesday, March 09, 2021