New Mexico Administrative Code
Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING
Chapter 19 - PHARMACISTS
Part 17 - DANGEROUS DRUGS AND DANGEROUS DRUG RESEARCH
Section 16.19.17.8 - RESEARCH LICENSING REQUIREMENTS

Universal Citation: 16 NM Admin Code 16.19.17.8

Current through Register Vol. 35, No. 18, September 24, 2024

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.

Disclaimer: These regulations may not be the most recent version. New Mexico may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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