Plain Text Law

Regulation .07 Record-Keeping Requirements.

Regulation .07 Record-Keeping Requirements.Copy Citation

A.
Patient Prescription Records.
(1)
The pharmacy shall maintain records of patient prescriptions.
(2)
Patient prescription records shall contain:
(a)
Available medical information consistent with prevailing pharmacy standards; and
(b)
The complete record of the formulations of the solutions that were compounded.
(3)
The pharmacy shall keep completed patient prescription records in a retrievable manner for at least 5 years, either:
(a)
At the inspection site; or
(b)
So as to be immediately retrievable by computer or other electronic means.
B.
Compounded Sterile Preparations Records.
(1)
For a pharmacy preparing compounded sterile preparations, the following records shall be maintained for at least 5 years:
(a)
The training and competency evaluation of employees in sterile preparation procedures;
(b)
Refrigerator and freezer temperatures;
(c)
Certification of the sterile compounding environment, including ISO 5 workstations and the clean and anterooms;
(d)
Other facility quality control logs specific to the pharmacy's policies and procedures, for example, cleaning logs for facilities and equipment;
(e)
Records documenting inspection for expired or recalled pharmaceutical preparations or raw ingredients;
(f)
Preparation records including compounding work sheets, and records of the registered pharmacy technicians' checking/sign-off process; and
(g)
Preparation records including compounding work sheets and records of the pharmacists' checking/sign-off process.
(2)
In addition to the records requirement in §B(1) of this regulation, for batch compounded sterile preparations, a pharmacy compounding sterile batch preparations for future use shall have records indicating the:
(a)
Drug and ingredient names;
(b)
Lot numbers;
(c)
Expiration dates;
(d)
Drug/diluent amounts; and
(e)
Date on which the compounded sterile batch preparations were prepared.
(3)
A pharmacy shall maintain records of media fill verification results for 5 years.