Right of Access to Establishments and Information Relating to Manufacturing; Sampling and Analysis.

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11-17-207. Right of access to establishments and information relating to manufacturing; sampling and analysis.

(a) The director or his agent shall have access during normal business hours to any establishment or facility in which an animal remedy is manufactured, transported or held for distribution and to information relating to the manufacture, transportation and distribution of the animal remedy for purposes of sampling and inspection.

(b) Any method of sampling and analysis shall be as approved by the director from current established methods. In any case not covered by an approved method, or in any case where methods are available in which improved applicability has been demonstrated, the director may approve the appropriate methods from other sources. The director, in determining whether an animal remedy is deficient in any component, shall be guided solely by the official sample analyzed in accordance with approved methods. For purposes of this article, the results of official analysis shall be final, unless it is determined by the director that a resample is warranted. If a distributor or registrant requests a resample of an animal remedy based upon the director's findings of a deficiency, all costs associated with the resampling and analysis shall be borne by the distributor or registrant. If the results of the resampling establish the result of the first analysis was invalid, the department shall bear the costs associated with the resampling. Any requests for a resample to the director shall be made in writing.

(c) The director shall make or cause to be made under his direction, analysis and examinations of samples of animal remedies furnished to him by the director to determine whether the animal remedy sampled conforms with this article and shall certify the results of the examinations to the director.

(d) When the inspection and analysis of an official sample indicates an animal remedy has been adulterated or misbranded, the results of analysis shall be forwarded by the director to the distributor and the purchaser.

(e) Any animal remedy that is manufactured and distributed under registration from and under the supervision of the United States department of agriculture, and in compliance with the regulations of that department shall not be considered adulterated or misbranded.

(f) An animal remedy shall be deemed to be misbranded under the following circumstances:

(i) It is not properly labeled;

(ii) It is not labeled as required in W.S. 11-17-205 and in regulations promulgated under this article;

(iii) If the label is false or misleading;

(iv) If the information required on the label is not conspicuous and clear and if any word, statement or other information required to appear on the label is not prominently placed conspicuously on the label, as compared with other words, statements, designs or devices in the labeling and in such terms, as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

(v) It is distributed under the name of another animal remedy;

(vi) If the recommended dosage is dangerous to the health of animals when used in the dosage or with the frequency or duration prescribed, recommended or suggested in the labeling of the animal remedy.

(g) An animal remedy shall be deemed to be adulterated if:

(i) It consists in whole or in part of any filthy, putrid or decomposed substance;

(ii) It bears or contains any poisonous or deleterious substance which may render it injurious to health under customary or usual use;

(iii) Its container is composed of any injurious or deleterious substance which may render the animal remedy injurious to health;

(iv) It was prepared, packed or held under unsanitary conditions where the animal remedy may have become contaminated with filth or where the animal remedy may have been rendered injurious to animal health;

(v) Its composition, purity, strength or quality falls below or differs from that which it is purported or is represented to possess by its labeling. The director shall allow a reasonable tolerance from such representation as is in accordance with good manufacturing practices.

(h) No person shall forge, counterfeit, simulate or falsely represent or without proper authority use, any mark, stamp, tag, label or other identification device required by W.S. 11-17-205.

(j) No person shall alter, mutilate, destroy, obliterate or remove any part of the labeling of any animal remedy if the act results in the animal remedy being misbranded, or do any other act, while the animal remedy is being held for sale, which results in the misbranding of the animal remedy.

(k) All provisions for enforcement of animal remedies found to be short weight shall be administered by the department under W.S. 40-10-117 through 40-10-136 of the Wyoming weights and measures law.


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