N.M. Admin. Code § 16.19.17.8

Current through Register Vol. 35, No. 21, November 5, 2024

Section 16.19.17.8 - RESEARCH LICENSING REQUIREMENTS

A. Authorized persons to be licensed: public agencies, institutions of higher education and private organizations, or individuals for the purpose of conducting research, demonstration or special projects with the use of a dangerous drug.

B. The person applying for licensure must fill out a license for dangerous drug research application prior to purchasing any dangerous drug. The applicant must provide information pertinent to the research including:

(1) name, address, and date of birth of persons who will be involved in handling of dangerous drugs, and if they have been convicted of a felony:

(2) drug protocol:

(a) formulary of dangerous drugs for research;

(b) how will the dangerous drug be utilized;

(c) how much of the dangerous drug will be used for each administered dose or experiment;

(d) how much drug will be purchased annually.

(3) policy and procedure manual including:

(a) drug security: storage area, list of individuals with access to dangerous drugs;

(b) drug procurement: invoices, receipts, and drug sources;

(c) drug usage: records or logs for accountability;

(d) drug waste/destruction: memorandum report describing accountability;

(e) drug storage area;

(f) research protocol: proprietary or trade secrets are confidential and not subject to public disclosure;

(4) qualifications of the applicant to conduct such research with dangerous drugs which may include:

(a) degrees;

(b) higher education;

(c) specialized training.

C. The board will review all applicants for licensure for consistency with the public's best interest.

N.M. Admin. Code § 16.19.17.8

16.19.17.8 NMAC - N, 09-15-06, Amended by New Mexico Register, Volume XXVIII, Issue 22, November 28, 2017, eff. 11/28/2017