201 KAR 2:061. Procedures followed by the Kentucky Board of Pharmacy in the investigation and hearing of complaints.

      RELATES TO: KRS 315.131, 315.191(4)

      STATUTORY AUTHORITY: KRS 315.191(1), (4)

      NECESSITY, FUNCTION, AND CONFORMITY: This administrative regulation establishes board procedure for investigations and the administrative hearings process.

      Section 1. Complaints against licensees may be oral or written, from such sources as consumers, competitors, health professionals, government and provider agencies, or other interested parties.

      Section 2. Upon receipt of a complaint, the board shall instruct its staff to:

      (1) Conduct an investigation; and

      (2) Report the conclusions and recommendations of the investigation to the:

      (a) Executive director; and

      (b) Board member assigned by the board to review conclusions and recommendations relating to an investigation.

      Section 3. (1) A panel consisting of the assigned board member, the executive director, and the pharmacy drug inspector shall review the conclusions and recommendation relating to an investigation.

      (2) The panel shall recommend one (1) of the following options to the board:

      (a) A reprimand restricting the licensee, permit or certificate holder;

      (b) The issuance of a formal complaint, order, and notice of hearing.

      (3) Documentation of a board reprimand shall be maintained in the appropriate board files.

      Section 4. (1) With the approval of the board, the executive director shall notify the licensee, permittee, or certificate holder, in writing, that he may request an administrative conference before the executive director and the pharmacy drug inspector to be held prior to the hearing.

      (2) The licensee, permit or certificate holder shall be notified that he may appear with counsel.

      (3) An administrative conference shall be held to determine whether an agreement may be reached to resolve the complaint that is acceptable to all parties.

      (4) If an agreement is reached, it shall be submitted to the board for approval and board order.

      Section 5. (1) A settlement conference may be requested by the attorney for a licensee, permit or certificate holder.

      (2) If the board approves the request, a settlement conference shall be held by the attorney for the licensee, permit or certificate holder, and the board attorney.

      (3) If the parties to a settlement conference agree on stipulations, proposed terms, and conditions for an agreed order to resolve the complaint, they shall forward the agreed order to the board for approval.

      (4) If the proposed agreed order is approved by the board the complaint shall be considered resolved and a hearing shall not be held.

      Section 6. Hearings. (1) The president of the board or the duly appointed hearing officer shall:

      (a) Preside over all administrative hearings; and

      (b) Have the authority to:

      1. Rule on all motions;

      2. Control the procedure of the hearing; and

      3. Admit or exclude testimony or other evidence.

      (2) Evidence in support of the complaint shall be presented by the counsel for the board.

      (3)(a) Evidence may be admitted if it is of the type commonly relied upon by reasonably prudent men and women in the conduct of their affairs.

      (b) Irrelevant, immaterial or unduly repetitious evidence shall be excluded.

      (c) Hearsay evidence, including affidavits, may be admitted for the purpose of supplementing competent evidence in the discretion of the president of the board or the hearing officer appointed to conduct the hearing.

      (4) All hearings before the board shall proceed in the following order, wherever practical:

      (a) Opening statements in the following order:

      1. Board counsel;

      2. Licensee's counsel or licensee;

      (b) Witnesses and evidence in support of the complaint;

      (c) Witnesses and evidence on behalf of licensee;

      (d) Closing statements in the following order:

      1. Licensee's counsel or licensee;

      2. Board counsel.

      (5)(a) Testimony to be considered by the board may be taken by deposition.

      (b) A party or witness may be allowed to testify by deposition, rather than attend the hearing, upon:

      1. A showing of inability to attend; and

      2. That the other party will have an opportunity to cross-examine at the deposition.

      Section 7. Posthearing Proceedings. (1) The board shall deliberate on all cases in closed session.

      (2) Board counsel shall not attend, or be involved in any manner, the closed session.

      (3) The specific findings of the board shall be made in open session following the board's deliberation. (18 Ky.R. 2449; Am. 2773; eff. 3-4-92.)