§ 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

Wyoming § 33-24-153

• Jurisdiction: Wyoming
• Title 33: Professions and Occupations
• Ch. 24: PHARMACY
• Art. 1: IN GENERAL

Text

(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(d) Repealed By Laws 2007, Ch. 211, § 2.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.