Utah Admin. Code R380-60-7 - Record Keeping

(1) Records regarding the inventory (lot number, expiration date, etc.), distribution, dispensing and administration (patient data collection) of a vaccine, antiviral, antibiotic, or other prescription medication that is not a controlled substance shall be consistent with the terms of any Emergency Use Authorization or specific Strategic National Stockpile instructions.

(2) The Department, local health department or receiving facility described in Section R380-60-3 that dispenses or administers a vaccine, antiviral, antibiotic or other prescription medication under the authorization of this Rule shall comply with the conditions of any Emergency Use Authorization and shall keep an inventory record describing the drug and the name and contact information for each individual that received the drug.

(3) If the circumstances of the emergency make it impossible to keep these inventory records, the Executive Director of the Department may grant an exception to this requirement limiting the record keeping requirement to such records as are appropriate and possible in the circumstances of the emergency.

(4) If no exception is made by the Executive Director of the Department as described in R380-60-7(3), all record keeping shall be in effect as required by Utah Administrative Rule R156-37-602.

Notes

Utah Admin. Code R380-60-7

Adopted by Utah State Bulletin Number 2016-4, effective 1/20/2016