NAC585.220. License required to manufacture, prepare or compound drug; qualifications for license.

     1. No natural person, partnership, association, corporation or other business organization may manufacture, prepare or compound amygdalin (laetrile) or procaine hydrochloride with preservatives and stabilizers without a license from the State Board of Health.

     2. The State Board of Health will not grant a license to manufacture amygdalin or procaine hydrochloride unless the applicant has satisfied the Commissioner that the applicant:

     (a) Is a person of good character, honesty and integrity;

     (b) Is a person whose background, reputation and associations will not result in adverse publicity for the State of Nevada and its drug manufacturing industry; and

     (c) Has adequate business competence and experience for the role or position for which application is made.

     3. The State Board of Health will not grant a license to manufacture amygdalin or procaine hydrochloride unless the applicant has satisfied the Commissioner that the proposed financing of the entire operation will be adequate for the nature of the operation and will be obtained from a suitable source. The Commissioner will determine the suitability of the source in accordance with the standards enumerated in subsection 2.

     4. No natural person, partnership, association, corporation or other business organization may manufacture, prepare or compound any drug other than amygdalin or procaine hydrochloride without a license from the Commissioner.

     5. The Commissioner will not issue a license to manufacture a drug other than amygdalin or procaine hydrochloride unless the applicant has satisfied the Commissioner that the applicant:

     (a) Will construct or has constructed a plant in accordance with a set of plans approved by the Commissioner;

     (b) Has the competence to manufacture the drug; and

     (c) Has the business competence and adequate experience for performing in the role or position for which the application is made.

     [Comm’r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 7.1-7.2.2, eff. 5-15-78]—(NAC A 9-17-82)