NAC585.240. Application for license to manufacture amygdalin or procaine hydrochloride: Action by Commissioner and applicant.

     1. The Commissioner will give a notice of hearing by letter to each applicant desiring to manufacture amygdalin (laetrile) or procaine hydrochloride with preservatives and stabilizers, stating the time and place for consideration of the application. The applicant must appear at the hearing. The Commissioner will notify the applicant in writing of the disposition of his or her application.

     2. An applicant must submit the formula, including all components, for review and approval to ensure compliance with the formula contained in the license issued by the Board. An applicant must also submit the procedures to be used in processing the drug for review and approval to ensure that the formula contained in the license issued by the Board is not altered thereby.

     3. An applicant shall cooperate fully in any background, financial or other investigation made to ensure the accuracy and truthfulness of the information supplied to the Commissioner. The investigation will be conducted before the issuance of any license.

     4. An applicant is required to satisfy the Commissioner of its ability to meet the requirements of NAC 585.010 to 585.640, inclusive, before the issuance of any license.

     [Comm’r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 7.3.5-7.3.8, eff. 5-15-78]