21 NCAC 46 .1418             HEALTH CARE FACILITY PHARMACY TECHNICIANS

(a)  For the purposes of this Rule, a "Validating Technician" shall be a pharmacy technician who:

(1)           is registered with the Board and trained as specified in G.S. 90-85.15A;

(2)           is a certified technician;

(3)           is employed by a Health Care Facility pharmacy; and

(4)           either:

(A)          holds an associate's degree in pharmacy technology conferred by one of the following: (i) an institution within the North Carolina Community College System or University System; (ii) an institution accredited by one of the regional accrediting agencies recognized by the United States Department of Education; or (iii) a program accredited by the American Society of Health System Pharmacists; or

(B)          holds a current Advanced Certified Pharmacy Technician (CPhT-Adv) credential from the Pharmacy Technician Certification Board (PTCB), and also holds a current Technician Product Verification Certificate either as part of or in addition to the CPhT-Adv credential. The Subparagraphs in this Rule may require other specific certifications for functions described in those Subparagraphs.

(b)  A Health Care Facility may utilize Validating Technicians to validate the following functions for a Health Care Facility pharmacy:

(1)           stocking of patient care unit medication inventories;

(2)           stocking of ancillary drug cabinet inventories;

(3)           stocking of automated dispensing or drug supply devices;

(4)           stocking of emergency kits;

(5)           prepackaging of prescription drugs within the Health Care Facility pharmacy;

(6)           selection of the correct dose by an automated medication system that has been stocked and restocked in compliance with 21 NCAC 46 .3404, only in the following circumstances:

(A)          If a pharmacist has performed a Drug Regimen Review to ensure that dispensing the order is safe and effective for the patient, and that the requirements of 21 NCAC 46. 1414 have been met; and

(B)          If the order has not changed following the Drug Regimen Review and review for compliance with 21 NCAC 46 .1414;

(7)           preparation of a product by an automated compounding device, only in the following circumstances:

(A)          If the technician qualifies as a Validating Technician by virtue of holding the certifications set out in Part (a)(4)(B) of this Rule, in addition to those qualifications, the Validating Technician must hold a current Certified Compounded Sterile Preparation Technician credential from the PTCB. If the technician qualifies as a Validating Technician by virtue of the educational requirements set out in Part (a)(4)(A) of this Rule, the technician is not required to hold this credential;

(B)          A Health Care Facility pharmacist must prepare the automated compounding device to compound the appropriate compounded product; and

(C)          The automated compounding device must automatically measure and compound the components for the compounded product, and must keep and maintain records of all steps in the compounding process; or

(8)           validating the preparation and repackaging by other registered pharmacy technicians of non-sterile low-risk products that are compounded in multi-patient volume and whose composition does not vary by patient. If the technician qualifies as a Validating Technician by virtue of holding the certifications set out in Part (a)(4)(B) of this Rule, in addition to those qualifications, the Validating Technician must hold a current Nonsterile Compounding Certificate from the PTCB, either as part of or in addition to the CPhT-Adv credential. If the technician qualifies as a Validating Technician by virtue of the educational requirements set out in Part (a)(4)(A) of this Rule, the technician is not required to hold this credential.

(c)  If the Health Care Facility elects to utilize Validating Technicians for functions described in this Rule, the pharmacist-manager shall develop written policies and procedures that:

(1)           establish the parameters for pharmacist supervision of pharmacy technician validation functions;

(2)           establish facility-specific training for pharmacy technician validation functions;

(3)           establish an ongoing evaluation and assessment program to ensure that pharmacy technician validation functions are performed safely and accurately; and

(4)           establish a recordkeeping system that shall permit the identification of the Validating Technician who performs activities authorized by this Rule. Readily retrievable records generated by this system shall be maintained for the period of time specified in 21 NCAC 46 .1414(j)(1) and (2).

(d)  A Health Care Facility's pharmacist-manager is responsible for the oversight of all validation functions, and that responsibility may not be delegated pursuant to 21 NCAC 46 .1411. This Rule does not permit a pharmacy technician to perform any act requiring the exercise of professional judgment by a pharmacist.

(e)  Pursuant to G.S. 90-85.15A(c), the Board approves a pharmacist's supervision of more than two pharmacy technicians where the additional technicians are Validating Technicians. This Rule does not relieve the pharmacist-manager of the obligation to request and receive written Board approval for a pharmacist's supervision of more than two pharmacy technicians where the additional technicians are certified pharmacy technicians but are not Validating Technicians.

History Note:        Authority G.S. 90-85.6; 90-85.15A; 90-85.21; 90-85.26; 90-85.32; 90-85.33; 90-85.34;

Eff. June 18, 2011;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. October 3, 2017;

Amended Eff. May 1, 2026.