Iowa Admin. Code r. 657-20.23 - [Rescinded effective 7/16/2025] Records
(1)
Retention. All records required by this chapter shall be
retained as original records of the pharmacy or outsourcing facility and shall
be readily available for inspection and photocopying by agents of the board or
other authorized authorities for at least two years following the date of the
record.
(2)
Required
elements. Records shall allow for the identification of the following:
a. All ingredients used in compounding,
including manufacturer or National Drug Code (NDC), lot number, and expiration
date.
b. The compounding steps
involved in the preparation.
c. All
personnel involved in compounding.
d. All personnel involved in reviewing
compounded preparations.
(3)
Batch disbursements. The
pharmacy or outsourcing facility shall maintain records documenting the
disbursements from each batch of a compounded preparation.
Notes
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(1) Retention. All records required by this chapter shall be retained as original records of the pharmacy or outsourcing facility and shall be readily available for inspection and photocopying by agents of the board or other authorized authorities for at least two years following the date of the record.
(2) Required elements. Records shall allow for the identification of the following:
a. All ingredients used in compounding , including manufacturer or National Drug Code (NDC), lot number, and expiration date.
b. The compounding steps involved in the preparation.
c. All personnel involved in compounding .
d. All personnel involved in reviewing compounded preparations.
(3) Batch disbursements. The pharmacy or outsourcing facility shall maintain records documenting the disbursements from each batch of a compounded preparation.