Md. Code Regs. 10.34.19.07

Current through Register Vol. 51, No. 24, December 2, 2024

Section 10.34.19.07 - Record-Keeping Requirements

A. Patient Prescription Records.

(1) The sterile compounding facility shall maintain records of patient prescriptions.

(2) Patient prescription records shall contain:

(a) Available medical information consistent with prevailing sterile compounding 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 sterile compounding facility 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 sterile compounding facility'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 health care practitioners' checking/sign-off process.

(2) In addition to the records requirement in §B(1) of this regulation, for batch compounded sterile preparations, a sterile compounding facility 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 sterile compounding facility shall maintain records of media fill verification results for 5 years.

Md. Code Regs. 10.34.19.07

Regulations .07 adopted effective September 10, 2007 (34:18 Md. R. 1580)
Regulation .07 amended effective 41:13 Md. R. 752, eff.1/1/2015; amended effective 43:2 Md. R. 127, eff.2/1/2016