1. 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.

2. 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. (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. (2) drug protocol:

      1. (a) formulary of dangerous drugs for research;
      2. (b) how will the dangerous drug be utilized;
      3. (c) how much of the dangerous drug will be used for each administered dose or experiment;
      4. (d) how much drug will be purchased annually.

   3. (3) policy and procedure manual including:

      1. (a) drug security: storage area, list of individuals with access to dangerous drugs;
      2. (b) drug procurement: invoices, receipts, and drug sources;
      3. (c) drug usage: records or logs for accountability;
      4. (d) drug waste/destruction: memorandum report describing accountability;
      5. (e) drug storage area;
      6. (f) research protocol: proprietary or trade secrets are confidential and not subject to public disclosure;

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

      1. (a) degrees;
      2. (b) higher education;
      3. (c) specialized training.

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

   HISTORY OF 16.19.17 NMAC:

   Pre-NMAC History: The material in this part was derived from that previously filed with the state records center and archives:

   Regulation No. 17, Dangerous Drugs, filed 3-19-92.

   History of Repealed Material: [RESERVED]

   Other History:

   Regulation No. 17, Dangerous Drugs (filed 3-19-92) renumbered, reformatted and replaced by 16 NMAC 19.17, Pharmacists - Dangerous Drugs, effective 02-15-96.

   16 NMAC 19.17, Pharmacists - Dangerous Drugs (filed 02-02-96) renumbered and replaced by 16.19.17 NMAC, Dangerous Drugs, effective 03-30-2002.

[16.19.17.8 NMAC - N, 09-15-06; A, 11-28-17]