26-1-9. Addition of poisonous or deleterious substances; color additives.
A. The board may adopt regulations authorizing color additives.
B. Any added poisonous or deleterious substance or any color additive, shall with respect to any particular use or intended use be deemed unsafe for the purpose of application of Section 10 A [26-1-10 NMSA 1978] of the New Mexico Drug [, Device] and Cosmetic Act with respect to any drug or device or Section 25 A [26-1-25 NMSA 1978] of the New Mexico Drug [, Device] and Cosmetic Act with respect to any cosmetic unless there is in effect a regulation pursuant to Subsection C of this section limiting the quantity of such substance, and the use or intended use of such substance conform [conforms] to the terms prescribed by such regulation. While such regulation relating to such substance is in effect, drug or cosmetic shall not, by reason of bearing or containing such substance in accordance with the regulation be considered adulterated within the meaning of Section 10 or Section 25 of the New Mexico Drug [, Device] and Cosmetic Act.
C. The board, whenever public health or other considerations in the state so require, is authorized to adopt, amend or repeal regulations whether or not in accordance with regulations promulgated under the federal act, prescribing the conditions under which a color additive may be safely used and exemptions where such color additive is to be used solely for investigational or experimental purposes, upon its own motion or upon the petition of any interested party requesting that such a regulation be established, and it shall be incumbent upon the petitioner to establish by data submitted to the board of pharmacy that a necessity exists for such regulation, and that its effect will not be detrimental to public health. If the data furnished by the petitioner is not sufficient to allow the board to determine whether such regulation should be promulgated, the board may require additional data to be submitted and failure to comply with the request shall be sufficient grounds to deny the request. In adopting, amending or repealing regulations relating to such substances, the board shall consider among other relevant factors, the following which the petitioner, if any, shall furnish:
(1) the name and all pertinent information concerning such substance including where available, its chemical identity and composition, a statement of conditions of the proposed use, including directions, recommendations and suggestions and including specimens of proposed labeling, all relevant data bearing on the physical or other technical effect and the quantity required to produce such effect;
(2) the probable composition of, or the relevant exposure from the article and of any substance formed in or on a drug or cosmetic resulting from the use of such substance;
(3) safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of such substances for the use or uses for which they are proposed to be used, are generally recognized as appropriate for the use of animal experimentation data;
(4) the availability of any needed practicable methods of analysis for determining the identity and quantity of:
(a) such substance in or on an article;
(b) any substance formed in or on such article because of the use of such substance; and
(c) the pure substance and all intermediates and impurities; and
(5) facts supporting a contention that the proposed use of such substance will serve a useful purpose.
26-1-9. Addition of poisonous or deleterious substances; color additives.
A. The board may adopt regulations authorizing color additives.
B. Any added poisonous or deleterious substance or any color additive, shall with respect to any particular use or intended use be deemed unsafe for the purpose of application of Section 10 A [26-1-10 NMSA 1978] of the New Mexico Drug [, Device] and Cosmetic Act with respect to any drug or device or Section 25 A [26-1-25 NMSA 1978] of the New Mexico Drug [, Device] and Cosmetic Act with respect to any cosmetic unless there is in effect a regulation pursuant to Subsection C of this section limiting the quantity of such substance, and the use or intended use of such substance conform [conforms] to the terms prescribed by such regulation. While such regulation relating to such substance is in effect, drug or cosmetic shall not, by reason of bearing or containing such substance in accordance with the regulation be considered adulterated within the meaning of Section 10 or Section 25 of the New Mexico Drug [, Device] and Cosmetic Act.
C. The board, whenever public health or other considerations in the state so require, is authorized to adopt, amend or repeal regulations whether or not in accordance with regulations promulgated under the federal act, prescribing the conditions under which a color additive may be safely used and exemptions where such color additive is to be used solely for investigational or experimental purposes, upon its own motion or upon the petition of any interested party requesting that such a regulation be established, and it shall be incumbent upon the petitioner to establish by data submitted to the board of pharmacy that a necessity exists for such regulation, and that its effect will not be detrimental to public health. If the data furnished by the petitioner is not sufficient to allow the board to determine whether such regulation should be promulgated, the board may require additional data to be submitted and failure to comply with the request shall be sufficient grounds to deny the request. In adopting, amending or repealing regulations relating to such substances, the board shall consider among other relevant factors, the following which the petitioner, if any, shall furnish:
(1) the name and all pertinent information concerning such substance including where available, its chemical identity and composition, a statement of conditions of the proposed use, including directions, recommendations and suggestions and including specimens of proposed labeling, all relevant data bearing on the physical or other technical effect and the quantity required to produce such effect;
(2) the probable composition of, or the relevant exposure from the article and of any substance formed in or on a drug or cosmetic resulting from the use of such substance;
(3) safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of such substances for the use or uses for which they are proposed to be used, are generally recognized as appropriate for the use of animal experimentation data;
(4) the availability of any needed practicable methods of analysis for determining the identity and quantity of:
(a) such substance in or on an article;
(b) any substance formed in or on such article because of the use of such substance; and
(c) the pure substance and all intermediates and impurities; and
(5) facts supporting a contention that the proposed use of such substance will serve a useful purpose.
26-1-9. Addition of poisonous or deleterious substances; color additives.
A. The board may adopt regulations authorizing color additives.
B. Any added poisonous or deleterious substance or any color additive, shall with respect to any particular use or intended use be deemed unsafe for the purpose of application of Section 10 A [26-1-10 NMSA 1978] of the New Mexico Drug [, Device] and Cosmetic Act with respect to any drug or device or Section 25 A [26-1-25 NMSA 1978] of the New Mexico Drug [, Device] and Cosmetic Act with respect to any cosmetic unless there is in effect a regulation pursuant to Subsection C of this section limiting the quantity of such substance, and the use or intended use of such substance conform [conforms] to the terms prescribed by such regulation. While such regulation relating to such substance is in effect, drug or cosmetic shall not, by reason of bearing or containing such substance in accordance with the regulation be considered adulterated within the meaning of Section 10 or Section 25 of the New Mexico Drug [, Device] and Cosmetic Act.
C. The board, whenever public health or other considerations in the state so require, is authorized to adopt, amend or repeal regulations whether or not in accordance with regulations promulgated under the federal act, prescribing the conditions under which a color additive may be safely used and exemptions where such color additive is to be used solely for investigational or experimental purposes, upon its own motion or upon the petition of any interested party requesting that such a regulation be established, and it shall be incumbent upon the petitioner to establish by data submitted to the board of pharmacy that a necessity exists for such regulation, and that its effect will not be detrimental to public health. If the data furnished by the petitioner is not sufficient to allow the board to determine whether such regulation should be promulgated, the board may require additional data to be submitted and failure to comply with the request shall be sufficient grounds to deny the request. In adopting, amending or repealing regulations relating to such substances, the board shall consider among other relevant factors, the following which the petitioner, if any, shall furnish:
(1) the name and all pertinent information concerning such substance including where available, its chemical identity and composition, a statement of conditions of the proposed use, including directions, recommendations and suggestions and including specimens of proposed labeling, all relevant data bearing on the physical or other technical effect and the quantity required to produce such effect;
(2) the probable composition of, or the relevant exposure from the article and of any substance formed in or on a drug or cosmetic resulting from the use of such substance;
(3) safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of such substances for the use or uses for which they are proposed to be used, are generally recognized as appropriate for the use of animal experimentation data;
(4) the availability of any needed practicable methods of analysis for determining the identity and quantity of:
(a) such substance in or on an article;
(b) any substance formed in or on such article because of the use of such substance; and
(c) the pure substance and all intermediates and impurities; and
(5) facts supporting a contention that the proposed use of such substance will serve a useful purpose.
