Iowa Admin. Code r. 657-6.16

Current through Register Vol. 47, No. 8, October 30, 2024

Rule 657-6.16 - Records

Every record required to be kept under Iowa Code chapters 124 and 155A or rules of the board shall be kept by the pharmacy and be available for inspection and copying by the board or its representative for at least two years from the date of the record or last activity except as specifically identified by law or rule. Controlled substances records shall be maintained in a readily retrievable manner in accordance with federal requirements and 657-Chapter 10.

(1)Combined records. If controlled substances, prescription drugs, or nonprescription drug items are listed on the same record, the controlled substances shall be asterisked, red-lined, or in some other manner made readily identifiable from all other items appearing on the records.

(2)Storage of records. Original hard-copy prescriptions and other pharmacy records shall be maintained by the pharmacy for a minimum of two years from the date of the record in accordance with this subrule.

a. Records shall be maintained within the licensed pharmacy department for a minimum of 12 months, except as provided herein. Pharmacy records less than 12 months old may be stored in a secure storage area outside the licensed pharmacy department, including at a remote location, if the pharmacy has retained an electronic copy of the records in the pharmacy that is immediately available and if the original records are available within 72 hours of a request by the board or its authorized agent, unless such remote storage is prohibited under federal law.

b. Records more than 12 months old may be maintained in a secure storage area outside the licensed pharmacy department, including at a remote location, if the records are retrievable within 72 hours of a request by the board or its authorized agent, unless such remote storage is prohibited under federal law.

(3)Number imprinted. The original hard-copy prescription shall be imprinted with the prescription or control number assigned to the prescription drug order, except as provided in 657-subrule 21.5(1).

(4)Alternative data retention system. Records, except when specifically required to be maintained in original or hard-copy form, may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided:

a. The records maintained in the alternative system contain all of the information required on the manual record;

b. The data processing system is capable of producing a hard copy of the record, within two business days, upon the request of the board, its representative, or other authorized local, state, or federal law enforcement or regulatory agencies; and

c. The information maintained in the alternative system is not obscured or rendered illegible due to security features of the original record.

Iowa Admin. Code r. 657-6.16

ARC 7636B, IAB 3/11/09, effective 4/15/09; ARC 8539B, IAB 2/24/10, effective 4/1/10

Amended by IAB February 14, 2018/Volume XL, Number 17, effective 3/21/2018

Amended by IAB March 25, 2020/Volume XLII, Number 20, effective 4/29/2020