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.
Notes
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; ARC 3638C, IAB 2/14/18, effective
3/21/18; ARC 5007C, IAB 3/25/20,
effective 4/29/20
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
Rescinded by
IAB
June 11, 2025/Volume XLVII, Number 25, effective
7/16/2025