N.M. Admin. Code § 16.19.36.15

Current through Register Vol. 35, No. 23, December 10, 2024

Section 16.19.36.15 - QUALITY ASSURANCE OF COMPOUNDED STERILE PREPARATIONS

A. There shall be a documented, ongoing performance improvement control program that monitors personnel performance, equipment, and facilities:

(1) all aspects of sterile product preparation, storage, and distribution, including details such as the choice of cleaning materials and disinfectants and monitoring of equipment accuracy shall be addressed in policy and procedures;

(2) if non-sterile to sterile bulk compounding of more than 25 units of compounded sterile preparations is performed using non-sterile chemicals, containers, or devices, and the results of appropriate end product testing must be documented prior to the release of the product from quarantine; the test must include appropriate tests for particulate matter and pyrogens;

(3) there shall be documentation of quality assurance audits at regular, planned intervals, including infection control and sterile technique audits; a plan for corrective action of problems identified by quality assurance audits shall be developed which includes procedures for documentation of identified problems and action taken; a periodic evaluation as stated in the policy and procedures of the effectiveness of the quality assurance activities shall be completed and documented;

(4) the batch label of each sterile compounded product shall contain:

(a) drug product name(s), diluent names(s), and amount(s) of each;

(b) assigned internal identification number (e.g., barcode, prescription, order, or lot number);

(c) final concentration(s), and volume when appropriate, solution ingredient names and amounts;

(d) beyond use date, and time when applicable;

(e) dosage form

(f) route of administration when applicable;

(g) date of preparation;

(h) name or initials of person preparing the product and, if prepared by supportive personnel, the name or identifying initials and the name or initials of the pharmacist that completed the final check;

(i) when appropriate, ancillary instructions such as storage instructions or cautionary systems, including hazardous material warning labels and containment bags;

(j) device instructions when needed;

(k) if it is a single-dose container, a statement stating such;

(l) if it is a multiple-dose container, a statement stating such; and

(m) compounding facility name and contact information if the CSP is to be sent outside of the facility or healthcare system in which it was compounded.

(5) the patient specific label of a CSP shall contain:

(a) patient name;

(b) solution, ingredient names, amounts;

(c) beyond use date, and time when applicable;

(d) dosage form;

(e) route of administration;

(f) directions for use, including infusion rates, specific times scheduled, when appropriate and applicable;

(g) identifier of person preparing the product and, if prepared by supportive personnel (i.e., pharmacist intern or pharmacy technician), the identifier of the pharmacist that completed the final check;

(h) when appropriate, ancillary instructions such as storage instructions or cautionary systems, including hazardous material warning labels and containment bags;

(i) device instructions when needed;

(j) assigned internal identification number (e.g., barcode, prescription, order, or lot number);

(k) if it is a single-dose container, a statement stating such;

(l) if it is a multiple-dose container, a statement stating such; and

(m) if dispensed for other than inpatient use, the label shall include all other required information.

B. There shall be a mechanism for tracking and retrieving products which have been recalled. The following records must be maintained for CSPs.

(1) A master formulation record (MFR) shall be created for all CSPs prepared from nonsterile ingredients(s) and CSP batch preparations and shall include the following:

(a) name, strength, dosage form, and final volume of the compounded preparation;

(b) all ingredients and their quantities; if applicable, relevant characteristics of components (e.g., particle size, salt form, purity grade, solubility)

(c) complete instructions for preparing the CSP, including equipment, supplies, a description of the compounding steps, and any special precautions;

(d) other information as needed to describe the compounding process and ensure repeatability (e.g., adjusting pH and tonicity; sterilization method, such as steam, dry heat, irradiation, or filter);

(e) beyond use dating and storage requirements;

(f) information needed for proper labeling (e.g. sample label);

(g) type and size of container closure system(s);

(h) physical description of the final CSP;

(i) quality control (QC) procedures (e.g., pH testing, filter integrity testing); and

(j) reference source to support the stability of the CSP.

(2) A compounding record (CR) must be created for all Category one, Category two, and Category three CSPs. A CR must also be created for immediate-use CSPs prepared for more than one patient. The CR must include at least the following information:

(a) reference to the MFR for the CSP (if applicable);

(b) name, strength, weight or volume, manufacturer, manufacturer's lot number, and expiration date for each component;

(c) name, strength, dosage form, and volume of the finished CSP;

(d) reconciliation of actual yield with anticipated yield, and total number of CSP units produced;

(e) identifier of person preparing the product and, if prepared by a pharmacist intern or pharmacy technician, the identifier of the pharmacist that completed the final check;

(f) date and time of preparation;

(g) assigned internal identification number (e.g. prescription, order, or lot number);

(h) assigned beyond use date, and time when appropriate and storage requirements;

(i) results of applicable quality control procedures; and

(j) calculations made to determine and verify quantities and/or concentrations of components, if applicable.

N.M. Admin. Code § 16.19.36.15

Amended, New Mexico Register, Volume XXV, Issue 16, August 29, 2014, eff. 9/7/2014, Amended by New Mexico Register, Volume XXVI, Issue 05, March 16, 2015, eff. 3/22/2015, Amended by New Mexico Register, Volume XXXV, Issue 15, August 13, 2024, eff. 8/13/2024