Iowa Admin. Code r. 657-10.22

Current through Register Vol. 47, No. 11, December 11, 2024

Rule 657-10.22 - Disposal of registrant stock

A registrant shall dispose of controlled substances pursuant to the requirements of this rule. Disposal records shall be maintained by the registrant for at least two years from the date of the record.

(1)Registrant stock supply. Controlled substances shall be removed from current inventory and disposed of by one of the following procedures.

a. The registrant shall utilize the services of a DEA-registered and Iowa-licensed reverse distributor.

b. The board may authorize and instruct the registrant to dispose of the controlled substances in one of the following manners:

(1) By delivery to an agent of the board or to the board office.

(2) By destruction of the drugs in the presence of a board officer, agent, inspector, or other authorized individual.

(3) By such other means as the board may determine to ensure that drugs do not become available to unauthorized persons.

(2)Waste resulting from administration or compounding. Except as otherwise specifically provided by federal or state law or rules of the board, the unused portion of a controlled substance resulting from administration to a patient from a registrant's stock or emergency supply or resulting from drug compounding operations may be destroyed or otherwise disposed of by the registrant, a certified paramedic, or a pharmacist in witness of one other licensed health care provider or a registered pharmacy technician 18 years of age or older pursuant to this subrule. A written record of the wastage shall be made and maintained by the registrant for a minimum of two years following the wastage. The record shall include the following:

a. The controlled substance wasted.

b. The date of wastage.

c. The quantity or estimated quantity of the wasted controlled substance.

d. The source of the controlled substance, including identification of the patient to whom the substance was administered or the drug compounding process utilizing the controlled substance.

e. The reason for the waste.

f. The signatures of both individuals involved in the wastage.

Iowa Admin. Code r. 657-10.22

ARC 7636B, IAB 3/11/09, effective 4/15/09; ARC 9410B, IAB 3/9/11, effective 4/13/11; ARC 9912B, IAB 12/14/11, effective 1/18/12

Amended by IAB September 27, 2017/Volume XL, Number 7, effective 11/1/2017

Amended by IAB May 22, 2019/Volume XLI, Number 24, effective 6/26/2019