N.J. Admin. Code § 13:39-11.16

Current through Register Vol. 56, No. 11, June 3, 2024

Section 13:39-11.16 - Training and evaluation requirements

(a) The pharmacist-in-charge and all pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs involved in compounding sterile preparations shall have didactic and practical training in sterile preparation compounding, including proper personnel cleansing and garbing, and cleaning and disinfecting the sterile compounding areas, cleanroom technology, laminar flow technology, isolator technology, if applicable, and quality assurance techniques. Such training shall be documented for each person before that individual begins to compound sterile preparations and annually thereafter for all pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs who compound sterile preparations. That documentation shall be maintained by the permitholder for five years and made available to the Board upon request.

(b) The pharmacist-in-charge shall be responsible for ensuring that, prior to compounding sterile preparations and annually thereafter, all pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs shall have passed a written test that demonstrates competency in all areas set forth in (a) above, and in the pharmacy's standard operating procedures with regard to compounding sterile preparations as set forth in the policy and procedure manual required to be maintained pursuant to 13:39-11.23.

(c) The pharmacist-in-charge shall be responsible for testing of the aseptic technique of all pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs involved in compounding sterile preparations, consistent with the methods set forth in USP 797 concerning "Aseptic Manipulation Competency Evaluation," incorporated herein by reference, as amended and supplemented, and which is available for purchase at the United States Pharmacopeia website, http://www.usp.org, prior to compounding sterile preparations. Aseptic technique retesting shall be conducted annually for all personnel engaged in compounding low- and medium-risk level preparations and semi-annually for all personnel engaged in compounding high-risk level preparations.

(d) All pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs engaging in the compounding of sterile preparations shall successfully complete an initial gloved fingertip/thumb sampling procedure prior to compounding sterile preparations. Gloved fingertip/thumb sampling shall be conducted annually for all personnel engaged in compounding low- and medium-risk level preparations and semi-annually for all personnel engaged in compounding high-risk level preparations. All initial and subsequent gloved fingertip/thumb sampling procedures shall be consistent with the standards established in USP 797, which is incorporated herein by reference, as amended and supplemented, and which is available for purchase at the United States Pharmacopeia website, www.usp.org.

(e) Individuals who fail the written test and/or the test of aseptic technique shall be prohibited from compounding sterile preparations until passing both tests.

(f) All test results shall be maintained by the permit holder for five years and shall be made available to the Board for inspection upon request.

N.J. Admin. Code § 13:39-11.16

Amended by 49 N.J.R. 3761(a), effective 12/4/2017