33-24-153. Manufacturer or wholesaler registration; requirements for registration; bonds or other security; fees; renewal; denial, revocation or suspension; record keeping; summary orders; administrative penalties; definitions.
(a) Every wholesale distributor who engages in the distribution of prescription drugs in this state shall obtain from the board a drug distributor's license for each distribution location. In addition, every nonresident wholesale distributor who ships prescription drugs into this state shall be licensed by the licensing authority in the state in which the distributor resides. For manufacturers engaged in wholesale distribution of prescription drugs in this state, the provisions of this section that are more stringent than those required by the United States food and drug administration shall not apply. This section shall not apply to resident pharmacies registered under W.S. 33-24-113, nonresident pharmacies registered under W.S. 33-24-152 or to individuals practicing medicine as defined by W.S. 33-26-102(a)(xi)(B) and (E).
(b) Applications for a drug distributor's license under this section shall be made on a form furnished by the board. Applicants for licensure under this section shall provide the board with fingerprints, necessary fees and other information required to perform a criminal history record background check as provided for by W.S. 7-19-201 for the designated representative for each wholesale drug distributor site.
(c) The fee for a drug distributor's license shall be the fee specified in W.S. 33-24-112(a)(iii).
(d) Repealed By Laws 2007, Ch. 211, § 2.
(e) Every drug distributor's license shall be renewed annually on or before the first day of July.
(f) Any administrative penalty assessed under this section shall be paid to the board who shall remit the monies to the county treasurer to the credit of the public school fund of the county in which the violation occurred.
(g) By January 1, 2009, the board shall require every drug distributor license holder and applicant to submit a bond in the amount of one hundred thousand dollars ($100,000.00), or other security acceptable to the board such as an irrevocable letter of credit or deposit in a trust account or financial institution, payable to a fund established by the board pursuant to paragraph (h) of this section. The purpose of the bond or other security shall be to secure payment of any fines or penalties imposed by the board and any fees and costs incurred by the board regarding the drug distributor's license which are authorized under state law and which remain unpaid thirty (30) days after liability for the payment is final. The board shall release the bond or security one (1) year after the distributor's license ceases to be valid. The bond or security shall cover all facilities operated by the applicant and licensed by the board. The board may waive the requirement of a bond or other security if:
(i) The drug distributor has previously obtained a comparable bond or other security for the purpose of licensure in another state where the wholesaler possesses a valid license in good standing; or
(ii) The drug distributor is a publicly held company.
(h) The board shall establish a fund, separate from its other accounts, for the deposit of amounts submitted in lieu of a bond pursuant to subsection (g) of this section.
(j) The board shall require each person engaged in wholesale distribution of prescription drugs to establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of the drugs.
(k) The board shall issue an order to cease distribution of a prescription drug if the board finds that there is probable cause that:
(i) A drug distributor has:
(A) Violated a provision of this section; or
(B) Sold, distributed, transferred, manufactured, repackaged, handled or held a counterfeit prescription drug intended for human or animal use.
(ii) The prescription drug at issue as a result of a violation in paragraph (k)(i)(B) of this section could cause serious adverse health consequences or death; and
(iii) Other procedures would result in unreasonable delay in responding to the dangers posed by the prescription drug at issue.
(m) An order issued by the board pursuant to subsection (k) of this section shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than ten (10) working days after the date of the issuance of the order, on the actions required by the order. If, after providing an opportunity for a hearing, the board determines that inadequate grounds exist to support the actions required by the order, the board shall vacate the order.
(n) The board may deny, suspend, revoke or refuse to renew a license issued under this section, may issue a letter of admonition and may assess an administrative penalty not to exceed those penalties established in paragraph (o) of this section for any of the following acts:
(i) Failure to obtain a license in accordance with this section or operating without a valid license when a license is required;
(ii) The sale, distribution or transfer of a prescription drug to a person who is not authorized to receive the prescription drug under the law of the jurisdiction in which the person receives the prescription drug;
(iii) Repealed by Laws 2017, ch. 169, § 2.
(iv) Providing the board with false or fraudulent records or making false or fraudulent statements regarding the provisions of this section or board rules;
(v) Obtaining or attempting to obtain a prescription drug by fraud, deceit or misrepresentation, or engaging in fraud or misrepresentation in the distribution of a prescription drug;
(vi) Except for the wholesale distribution by manufacturers of a prescription drug that has been delivered into commerce pursuant to an application approved by the United States food and drug administration, the adulteration, misbranding or counterfeiting of any prescription drug;
(vii) The receipt of any prescription drug that is adulterated, misbranded, stolen, obtained by fraud or deceit, counterfeit or suspected of being counterfeit, or the delivery or proffered delivery of such drug whether for pay or otherwise; and
(viii) The adulteration, mutilation, destruction, obliteration or removal of all or any part of the labeling of a prescription drug or the commission of any other act with respect to a prescription drug that results in the prescription drug being misbranded.
(o) The board may assess an administrative penalty for a violation of subsection (n) of this section as follows:
(i) If a person unknowingly engages in the wholesale distribution of prescription drugs and acts in violation of subsection (n) of this section, the person may be assessed an administrative penalty not to exceed fifty thousand dollars ($50,000.00);
(ii) If a person knowingly engages in wholesale distribution of prescription drugs in violation of subsection (n) of this section, the person may be assessed an administrative penalty not to exceed five hundred thousand dollars ($500,000.00).
(p) The board is authorized to contract with a private person or entity to inspect and accredit drug distributors. Any proprietary information obtained during the accreditation process shall remain confidential and privileged. The board shall provide by rule and regulation for the administrative review of any decision denying accreditation.
(q) The board may license by reciprocity a drug distributor that is licensed in another state if:
(i) The requirements of the distributor's domiciliary state are determined by the board to be substantially equivalent to the requirements of this state for licensing of drug distributors; or
(ii) The applicant is accredited by a third party approved by the board.
(r) For purposes of this section:
(i) "Designated representative" means an individual designated by a wholesale drug distributor and who is actively involved in and aware of the actual daily operation of the wholesale drug distributor at the wholesaler's licensed location;
(ii) Repealed by Laws 2017, ch. 169, § 2.