N.M. Admin. Code § 16.19.36.13 - REQUIREMENTS FOR TRAINING

All personnel, including pharmacists, pharmacists who supervise compounding personnel (including designated persons), pharmacists interns and pharmacy technicians, shall have completed didactic and experiential training with competency evaluation through demonstration and testing (written or practical) as required by USP/NF <797> (USP General Chapters: <797> Pharmaceutical Compounding-Sterile Preparations) and as outlined by the pharmacist-in-charge and described in the site policy and procedures or training manual, prior to compounding sterile preparations.

A. Instructional topics shall include:

(1) aseptic technique;

(2) achieving and/or maintaining sterility (and apyrogenicity if compounding with nonsterile components);

(3) principles of high-efficiency particulate air (HEPA)-filtered unidirectional airflow within the ISO Class five area

(4) environmental monitoring;

(5) proper use of PECs;

(6) equipment and supplies;

(7) sterile pharmaceutical calculations, measuring, mixing, and terminology;

(8) documentation of the compounding process (MFR and CR);

(9) quality assurance procedures;

(10) hand hygiene

(11) proper gowning and gloving technique;

(12) the handling of cytotoxic and hazardous drugs (if applicable);

(13) principles of movement of materials and personnel within the compounding area; and

(14) cleaning and disinfection.

B. Training shall be obtained through completion of a site-specific, structured on-the-job didactic and experiential training program (not transferable to another practice site).

C. Pharmacy technicians shall complete 100 hours of documented experiential training in compounded sterile preparations in accordance with Section 61-11-11.1 of the Pharmacy Act NMSA 1978 prior to compounding sterile preparations. Documentation of experiential training as defined in Subsection A of this section is transferrable to another practice site.

D. Experiential training shall include those areas of training as outlined in USP <797> (USP General Chapters: <797> Pharmaceutical Compounding-Sterile Preparations) with appropriate observational assessment and testing of performance as outlined in USP <797> (USP General Chapters: <797> Pharmaceutical Compounding-Sterile Preparations) including garbing competency and aseptic manipulation competency evaluations.

E. All personnel, including pharmacists compounding sterile hazardous drugs, pharmacists supervising compounding personnel, pharmacy interns compounding sterile hazardous drugs, and pharmacy technicians compounding sterile hazardous drugs, shall have completed didactic and experiential training with competency evaluation through demonstration and written or practical testing as required by USP/NF <800> (USP General Chapters: <800> Hazardous Drugs - Handling in Healthcare Settings) in addition to training in sterile non-hazardous preparations as listed above. Training will be conducted as outlined by the pharmacist-in-charge and described in the site policy and procedures or training manual and shall be completed prior to compounding sterile hazardous preparations.

F. Frequency of training and assessment shall be conducted as required by USP <797> (USP General Chapters: <797> Pharmaceutical Compounding-Sterile Preparations) to assure continuing competency and include:

(1) initial training before compounding sterile preparations;

(2) annual refresher training and assessment in didactic topics;

(3) garbing competency and aseptic manipulation competency evaluations every six months for personnel compounding Category one and Category two CSPs;

(4) garbing competency and aseptic manipulation competency evaluations every three months for personnel compounding Category three CSPs.

(5) Personnel who have direct oversight of compounding personnel (including designated persons) must complete garbing competency and aseptic manipulation competency evaluations annually (unless a more frequent requirement applies).

G. Documentation of training: Written documentation of initial and in-service training, the results of written or practical testing, and process validation of compounding, personnel shall be retained for three years and contain the following information:

(1) name of person receiving the training or completing the testing or process validation;

(2) date(s) of the training, testing, or process validation;

(3) general description of the topics covered in the training or testing or of the process validated;

(4) name of person supervising the training, testing, or process validation;

(5) signature of the person receiving the training or completing the testing or process validation and the designated person or other pharmacist employed by the pharmacy and designated by the pharmacist-in-charge as responsible for training, testing, or process validation of personnel.

Notes

N.M. Admin. Code § 16.19.36.13

16.19.36.13 NMAC - N, 06-28-14, 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