Wyo. Code R. 059-0001-1
Pharmacy, Board of
Chapter 1: Rules of Practice and Procedure
Effective Date: 01/16/2014 to 05/16/2017
Rule Type: Superceded Rules & Regulations
Reference Number: 059.0001.1.01162014
These rules are promulgated as authorized by the Act, and pursuant to the Wyoming Administrative Procedure Act, W.S. 16-3-101, et. seq.
For the purposes of these regulations, and the Wyoming Pharmacy Act the following definitions shall prevail.
(a) 'Act' means the Wyoming Pharmacy Act, W.S. 33-24-101, et. seq., and the Wyoming Pharmacy Technician Act, W.S. 33-24-301, et. seq.
(b) 'Board' means the Wyoming State Board of Pharmacy.
(c) 'Contestee' means the person, persons, firm or corporations who are licensees by law under the jurisdiction of said Board against whom a proceeding by petition, verified complaint in writing or formal notice, alleging violation directly or indirectly of any of the terms and provisions of the Act or of the lawful Rules and Regulations of the Board or any related acts and resulting lawful rules and regulations (i.e. Controlled Substances Act, 1971).
(d) 'Contested Case' means any proceeding including, but not restricted to, any licensing requirements in which legal rights, duties or privileges of a party are required by law to be determined by the Board after an opportunity for hearing.
(e) 'Dangerous Substance' means pursuant to § 33-24-127, the Board adopts the most recent edition and its supplements of section 3.1 'Prescription Drug Product List' of the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, (The Orange Book) as the official listing of Dangerous Substances for the State of Wyoming.
(f) 'Executive Director' means the Executive Director of the Board.
(g) 'License' means the whole or part of any Board permit, certificate, approval, registration charter or similar form of permission required by law, but it does not include a license required solely for revenue purposes.
(h) 'Licensing' means the Board process respecting the grant, denial, renewal, revocation, suspension, annulment, withdrawal or amendment of a license.
(i) 'Rule' or 'Regulation' means any Board statement of general applicability that implements, interprets and prescribes law or policy.
(j) 'Staff' means the personnel of the Board or Executive Director.
(k) 'State' means the State of Wyoming.
(a) Upon receipt of a completed application, the Board Office shall review the application and if it is complete and, if there are no known grounds for denial of the license requested, issue the license. If there are known grounds for denial, the Board Office shall forward the application to the Application Review Committee (ARC).
(b) The ARC shall review the application and all other information available and following the review may:
(i) Approve the application if the applicant meets all requirements; or
(ii) If there are questions as to whether denial is appropriate, forward the application and an ARC report to the Assistant Attorney General assigned to the Board for prosecution to review.
(c) If, after review, the ARC and Assistant Attorney General recommend denial of an application:
(i) A preliminary denial letter shall be sent to applicant. The letter shall:
(A) State the basis for the denial including relevant statutes and rules; and
(B) Advise the applicant of the right to request reconsideration.
(ii) If the applicant fails to request reconsideration in writing within thirty (30) days of the date of the preliminary denial letter, the preliminary denial becomes final.
(iii) If the applicant requests reconsideration within thirty (30) days, a reconsideration conference shall be held with the ARC, the Assistant Attorney General, and the applicant.
(iv) Following a reconsideration conference, the ARC shall either approve or deny the application.
(v) If denied, the applicant must submit a written request for a hearing within thirty (30) days of the date of the denial letter.
(d) Application denial hearings.
(i) An application denial hearing is a formal contested case hearing conducted pursuant to the Wyoming Administrative Procedure Act.
(ii) The applicant has the burden of proving that he/she meets all requirements for the license requested.
(e) The ARC may attend hearings, but shall not take part in the consideration of any contested case.
Section 4. Complaints.
(a) A disciplinary action is initiated against a license holder by submitting a written complaint to the Board office. A complaint concerning an alleged violation of the Act or Board Rules may be submitted by any person or entity, a Board member, or a Board staff member. The written complaint should provide as much of the following information as may be available and applicable:
(i) The name and address of the complainant;
(ii) The name, address, place of employment, and telephone number of the license holder against whom the charges are made;
(iii) The specific conduct alleged to constitute the violation;
(iv) The name and address of any other witnesses; and
(v) The signature of the complainant.
Section 5. Review of Written Complaint.
(a) Written complaints shall be referred to the Board staff Compliance Officer/Investigator or to an Investigative Board Member (IBM) selected by Board staff from a rotating schedule. License holders against whom charges are made will be advised of the investigation and the nature of the complaint.
(i) The IBM shall not take part in the consideration of any contested case.
(ii) The IBM shall not, by this rule, be barred from attending any disciplinary hearing.
Section 6. Investigations and Board Action.
Board staff shall investigate those written complaints received which merit further investigation.
(a) Upon completion of the investigation the Executive Director shall:
(i) Dismiss the complaint if no evidence of violation of the Act or Board rules is found; or
(ii) Prepare an investigative report which shall include:
(A) The findings;
(B) A list of statutes and/or Board rules believed to have been violated;
and
(C) Any relevant additional information.
(b) The Executive Director shall forward the report and his/her recommendations to the Assistant Attorney General assigned to the Board for prosecution, and consult with the Assistant Attorney General.
(c) Following consultation with the Assistant Attorney General, the Executive Director may:
(i) Send the notice required by Section 5;
(ii) Prepare and file a formal petition and notice of hearing setting the matter for a contested case hearing before the Board;
(iii) Recommend the Board accept an offer of conditional terms for settlement, which may include educational courses;
(iv) Recommend the Board dismiss the complaint.
(d) The Board may resolve a complaint at any time by:
(i) Accepting a voluntary surrender of a license;
(ii) Accepting conditional terms for settlement;
(iii) Dismissal.
Prior to commencement of a formal hearing, the Executive Director shall give notice by mail to the license holder of the facts or conduct which warrant his/her intended action. The notice shall give the license holder an opportunity to show compliance with all lawful requirements for retention of the license within twenty (20) days of the mailing of the notice. Such notice shall be sent to the license holder's last known address by certified mail.
(a) Formal proceedings for a hearing before the Board regarding action against a license holder shall be commenced by petition and notice of hearing, served in person, or by certified mail sent to the address last known by the Board at least thirty (30) days prior to the date set for the hearing. The petition and notice shall contain at least:
(i) The name and address of the license holder;
(ii) A statement, in ordinary and concise language, of the nature of the complaint filed with the Board, the facts upon which the complaint is based, as well as the specific statute(s) or Board rules and regulations alleged to have been violated;
(iii) The time, place, and nature of the hearing;
(iv) That the hearing is being held pursuant to the authority provided by W.S. § 33-24-101 through 33-24-301.
(v) The license holder shall file an Answer or Notice of Appearance, which must be received by the Board at least ten (10) working days prior to the date set for hearing, or the license holder will be in default.
The Board may enter an order based on the allegations in a petition in any case where the applicant or license holder has not answered or appeared in writing ten (10) working days before the hearing, or in any case in which the applicant or license holder or his/her representative has not appeared at a scheduled hearing for which they had notice.
(a) The Office of Administrative Hearings shall act as the hearing officer and shall preside over the formal contested case hearing which shall be conducted pursuant to the Wyoming Administrative Procedure Act and the Office of Administrative Hearings' rules concerning contested case proceedings.
(b) At the Board's discretion, contested case hearings shall either be conducted in the presence of a quorum of Board Members or a committee of one (1) or more Board Members.
(c) During the formal contested case hearing, Board Members may ask questions of the witnesses and/or the parties including their attorneys.
(d) A court reporter shall be present during the hearing and report the entire proceeding.
(i) At the discretion and direction of the hearing officer, the parties may file proposed findings of fact, conclusions of law, and order after the hearing and before the deadline announced in the hearing's closing announcements.
(ii) At the discretion and direction of the Board, the hearing officer or the Assistant Attorney General assigned to advise the Board shall prepare proposed findings of fact, conclusions of law, and order following deliberations by the Board or its committee.
(b) Final Decisions. Proposed decisions will be given consideration but are not binding upon the Board. All final decisions will be issued by the Board and shall be based exclusively upon the evidence in the record and matters officially noticed. All final decisions issued by the Board shall be served to all parties by first class mail sent to their last known address.
A Petition for Judicial Review of the Board decision may be filed in the district court in accordance with the Wyoming Rules of Appellate Procedure.
If a Petition for Judicial Review is filed in the district court, the petitioner shall either arrange the preparation and pay for the transcript of the testimony, or reimburse the Board for the cost of the transcript if previously prepared at Board expense.