# COMAR Title 10 — Maryland Department of Health

## Subtitle 34 — Board of Pharmacy

### Chapter 01 — Disciplinary Proceedings

**Authority:** Health Occupations Article, §§12-313, 12-315, 12-6B-09 and 12-6D-11; State Government Article, §10-206; Annotated Code of Maryland

**Administrative History:** Effective date: September 1, 1971

**Administrative History:** Regulation .03A, E, G amended effective February 19, 1990 (17:3 Md. R. 298)

**Administrative History:** Regulation .03D amended effective February 13, 1984 (11:3 Md. R. 202)

**Administrative History:** Regulation .04A, G amended effective February 19, 1990 (17:3 Md. R. 298)

**Administrative History:** Regulation .04D, G amended effective October 3, 1980 (7:20 Md. R. 1879)

**Administrative History:** Regulation .06 amended effective February 19, 1990 (17:3 Md. R. 298)

**Administrative History:** Chapter revised effective January 24, 2000 (27:1 Md. R. 77)

**Administrative History:** Regulations .01 — .07 repealed and new Regulations .01 — .15 adopted effective September 1, 2003 (30:17 Md. R. 1203)

**Administrative History:** Regulation .02B amended effective January 28, 2008 (35:2 Md. R. 127); July 1, 2015 (42:7 Md. R. 569)

**Administrative History:** Regulation .05 amended effective January 28, 2008 (35:2 Md. R. 127)

**Administrative History:** Regulation .06B, C amended effective January 28, 2008 (35:2 Md. R. 127)

**Administrative History:** Regulation .12 amended effective January 28, 2008 (35:2 Md. R. 127)

**Administrative History:** Regulation .13A amended effective January 28, 2008 (35:2 Md. R. 127)

**Administrative History:** Regulation .14 amended effective January 28, 2008 (35:2 Md. R. 127)

**Administrative History:** Regulation .15 amended effective January 28, 2008 (35:2 Md. R. 127)

**Administrative History:** Annotation: COMAR 10.34.01.03G(1) cited in Eichberg v. Board of Pharmacy, 50 Md. App. 189 (1981)

#### Regulation .01 Scope.

*COMAR 10.34.01.01*

This chapter governs procedures for disciplinary matters and hearings before the Board.

#### Regulation .02 Definitions.

*COMAR 10.34.01.02*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Administrative law judge” means the hearing officer assigned to preside over a hearing in a case that the Board has delegated to the Office of Administrative Hearings under State Government Article, §10-205, Annotated Code of Maryland.

  (2) “Administrative Procedure Act” means State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, which governs contested cases arising from charges issued by the Board.

  (3) “Board” means the State Board of Pharmacy.

  (4) “Case resolution conference” means a voluntary, informal, and confidential meeting between the parties to a contested case and the Board's case resolution conference committee to discuss possible settlement of a disciplinary matter pending before the Board.

  (5) “Case resolution conference committee” means a committee comprised of one or more members of the Board who make recommendations to the Board regarding settlement of disciplinary matters.

  (6) “Cease and desist letter” means a public letter issued by the Board ordering:

    (a) A registrant or licensee to cease doing a specified activity; or

    (b) An unlicensed person to cease the unauthorized practice of pharmacy or the unauthorized operation of a pharmacy.

  (7) “Charges” means a nonpublic record issued by the Board which:

    (a) Alleges conduct by a registrant or licensee that the Board believes constitutes a violation under the Maryland Pharmacy Act;

    (b) Sets forth sections of the Maryland Pharmacy Act that the Board believes were violated; and

    (c) Provides notice to the registrant or licensee of disciplinary proceedings before the Board.

  (8) “Complaint” means an allegation received by the Board that a registrant or licensee may have violated the Maryland Pharmacy Act, and which may be grounds for an investigation or disciplinary action by the Board.

  (9) “Consent order” means a final order issued by the Board that has been negotiated and agreed to by both the registrant or licensee and the Board to resolve a formal disciplinary action.

  (10) “Contested case” means a proceeding conducted under the Administrative Procedure Act.

  (11) “Final order” means a public record issued by the Board resolving a formal disciplinary action by consent or after an adjudication, which:

    (a) Denies a registration or license;

    (b) Sanctions by:

      (i) Reprimand;

      (ii) Probation;

      (iii) Fine; or

      (iv) Suspension or revocation of a registration or license;

    (c) Summarily suspends a registration or license;

    (d) Dismisses charges;

    (e) Surrenders a registration or license;

    (f) Resolves the contested case by consent of the parties; or

    (g) Takes any other action that the Board may take by law.

  (12) “Formal disciplinary action” means action taken by the Board that:

    (a) Is initiated by:

      (i) Charges; or

      (ii) A notice of initial denial;

    (b) Is resolved by a consent order;

    (c) Results in a summary suspension; or

    (d) Results in a letter of surrender.

  (13) “Informal action” means that the Board closes a case, without formal disciplinary action or issuing a final order, by sending a:

    (a) Letter of education;

    (b) Letter of admonishment; or

    (c) Letter of agreement.

  (14) “Letter of admonishment” means an informal action taken by the Board consisting of a nonpublic letter closing the case if the Board believes a registrant or licensee engaged in conduct that violated the Maryland Pharmacy Act and may include a letter of agreement in which a registrant or licensee agrees to satisfy certain conditions instead of the Board issuing charges.

  (15) Letter of Education.

    (a) “Letter of education” means an informal action consisting of a nonpublic letter:

      (i) Issued by the Board, closing the case if the Board does not believe that the registrant's or licensee's conduct rose to the level of a violation of the Maryland Pharmacy Act; and

      (ii) In which the Board educates the registrant or licensee regarding the laws and standards of the practice of pharmacy or operating a pharmacy.

    (b) “Letter of education” may include a letter of agreement in which a registrant or licensee agrees to satisfy certain conditions.

  (16) Letter of Surrender.

    (a) “Letter of surrender” means a public record accepted by the Board in which:

      (i) The licensee agrees to surrender the licensee's license or permit; or

      (ii) The registrant agrees to surrender the registrant's registration.

    (b) “Letter of surrender” may include conditions for the Board's acceptance of the surrender as a resolution of the case.

  (17) “Licensee” means the holder of a license or permit issued by the Board.

  (18) “Maryland Pharmacy Act” means Health Occupations Article, Title 12, Annotated Code of Maryland.

  (19) “Notice of initial denial” means a nonpublic record issued by the Board by which an applicant, registrant, or licensee is notified that the Board intends to:

    (a) Change a registration or licensure status;

    (b) Deny a registration, license, or permit; or

    (c) Deny some other benefit sought by the registrant or licensee.

  (20) “Party” means the:

    (a) Respondent or person named or admitted as a party, or properly seeking and entitled as a right to be a party in a formal disciplinary proceeding; or

    (b) Administrative prosecutor from the Office of the Attorney General presenting a case on behalf of the Board.

  (21) “Postdeprivation hearing” means a show cause or an evidentiary hearing scheduled by the Board after the Board has issued an order for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland, in which the registrant or licensee may challenge the Board's basis for issuing the order of summary suspension.

  (22) “Predeprivation hearing” means a show cause hearing in which the registrant or licensee has an opportunity to demonstrate to the Board why the Board should not:

    (a) Issue an order for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland; or

    (b) Take some other action that the Board may take.

  (23) “Presiding officer” means the president of the Board or, in the president's absence, a Board member designated by the president, who:

    (a) Conducts hearings before the Board; and

    (b) Issues prehearing orders.

  (24) “Probation” means a sanction imposed by the Board in a public final order under which the registrant or licensee is:

    (a) Monitored by the Board for a period of time; and

    (b) Required to comply with certain conditions in order to avoid further disciplinary action.

  (25) “Public record” means a document that the Board is permitted or required to disclose to the public under State Government Article, Title 10, Subtitle 6, Annotated Code of Maryland.

  (26) “Recommended decision” means a nonpublic record issued to the Board by an administrative law judge which sets out proposed findings of fact, proposed conclusions of law, a proposed sanction, or any combination of these actions.

  (27) “Recusal” means the disqualification of a member of the Board to participate in a proceeding because of interest, bias, or some other reason that may interfere with the Board member's participation in the case.

  (28) “Registrant” means the holder of a:

    (a) Pharmacy technician registration issued by the Board; or

    (b) Pharmacy intern registration issued by the Board.

  (29) “Respondent” means a registrant or licensee subject to the jurisdiction of the Board, who has been:

    (a) Given formal notice of allegations concerning violations of the Maryland Pharmacy Act; and

    (b) Notified as to the possible imposition of sanctions or a summary suspension.

  (30) “Revocation” means the removal of a registrant's registration or licensee's license or permit.

  (31) “Sanction” means an action by the Board which:

    (a) Reprimands;

    (b) Places on probation;

    (c) Fines; or

    (d) Suspends or revokes a registration, license, or permit.

  (32) “Show cause hearing” means a nonevidentiary hearing in which the registrant or licensee may demonstrate to the Board why the Board should not issue a proposed order or continue to take an action that the Board may take.

  (33) “Summary suspension” means the indefinite suspension of a registration or license under State Government Article, §10-226(c)(2), Annotated Code of Maryland, issued if the Board believes emergency action is necessary to protect the public health, safety, or welfare.

  (34) “Suspension” means the temporary denial of the right to use a registration, license, or permit and is usually defined by:

    (a) A specified period of time;

    (b) Specific dates; or

    (c) Specific conditions.

#### Regulation .03 Confidentiality of Proceedings.

*COMAR 10.34.01.03*

A. Except as otherwise provided by law, the proceedings of the Board are confidential and that confidentiality may not be waived by the parties.

B. The Office of Administrative Hearings' proceedings involving the adjudication of a Board formal disciplinary action and the administrative law judge's recommended decision are confidential.

C. The respondent may not waive the confidentiality of the:

  (1) Proceedings; or

  (2) Patients whose medical records or care are reflected in the record of the proceedings.

D. To the extent possible, even after the close of a formal disciplinary action, the parties shall refrain from revealing:

  (1) Legal documents;

  (2) Oral statements; or

  (3) Information that would reveal the identity of patients involved in the matter.

#### Regulation .04 Representation by Counsel.

*COMAR 10.34.01.04*

A. A respondent may be represented by counsel at any stage of a formal disciplinary action.

B. If a hearing is held on a matter, the respondent shall be represented:

  (1) In proper person; or

  (2) By an attorney who has been:

    (a) Admitted to the Maryland Bar; or

    (b) Specially admitted to practice law under Maryland Rules, Rules Governing Admission to the Bar of Maryland, Rule 14, Annotated Code of Maryland.

C. The Board may request the Office of the Attorney General to participate in a hearing to present the case on behalf of the State.

D. The member of the Office of the Attorney General presenting the case on behalf of the State has the same rights as any party with regard to:

  (1) Submission of evidence, examination, and cross-examination of witnesses; and

  (2) The filing of objections, exceptions, and motions.

E. The Board may request a member of the Office of the Attorney General to act as legal advisor to the Board on questions of:

  (1) Procedure;

  (2) Evidence; and

  (3) Law.

#### Regulation .05 Disposition of Complaints.

*COMAR 10.34.01.05*

A. For each complaint, after reviewing any completed investigative information or reports, the Board shall:

  (1) Dismiss the complaint;

  (2) Close the case with informal action;

  (3) Issue a cease and desist order;

  (4) Refer the matter for further investigation;

  (5) Refer the matter to an administrative prosecutor; or

  (6) Vote to:

    (a) Charge a registrant or licensee with a violation of the Maryland Pharmacy Act;

    (b) Consider the matter as a basis for a summary suspension;

    (c) Initially deny a registration, license, or permit or reinstatement of a registration, license, or permit; or

    (d) Accept the surrender of a registration, license, or permit subject to conditions acceptable to the Board.

B. The Board may refer a complaint or other disciplinary matter to the administrative prosecutor at any time, whether or not the Board has voted to charge a registrant or licensee with violations of the Maryland Pharmacy Act.

#### Regulation .06 Notice of Charges or Notice of Initial Denial.

*COMAR 10.34.01.06*

A. If the Board issues charges or a notice of initial denial, the document shall be:

  (1) Served on the respondent by certified mail at the address the respondent is required to maintain with the Board; or

  (2) Hand delivered in person.

B. Charges or notice of initial denial shall:

  (1) Inform the respondent of the statutory basis for the charges or denial of a registration, license, or permit;

  (2) Allege sufficient facts that the Board believes constitute a basis for:

    (a) Violation of the Maryland Pharmacy Act; or

    (b) Denial of a registration, license, or permit; and

  (3) Include the notice of hearing.

C. If the Board issues a notice of initial denial to an applicant for a registration or license, the applicant may not withdraw the application without approval from the Board.

#### Regulation .07 Notice of Hearing.

*COMAR 10.34.01.07*

A. Except for a show cause hearing, written notice of hearings shall be sent by the Executive Director or an officer of the Board to the parties at least 20 days before the hearing.

B. The Board shall serve the notice of hearing by:

  (1) Certified mail at the address the respondent is required to maintain with the Board; or

  (2) Hand delivery in person.

C. The notice of hearing shall state, if applicable:

  (1) The date, time, place, and nature of the hearing;

  (2) The right to:

    (a) Representation;

    (b) Call witnesses;

    (c) Submit documents or other relevant evidence;

    (d) Request subpoenas for witnesses and evidence and the costs associated with such a request;

  (3) That a failure to appear for the scheduled hearing may result in an adverse action against the party; and

  (4) That the parties may agree to the evidence and waive their right to appear at the hearing.

D. The notice of hearing may include:

  (1) Deadlines for:

    (a) Discovery; and

    (b) Motions; and

  (2) Dates for the:

    (a) Prehearing conference; and

    (b) Case resolution conference.

#### Regulation .08 Prehearing Conferences and Case Resolution Conferences.

*COMAR 10.34.01.08*

A. The Board may set a prehearing conference or a case resolution conference, or both.

B. The prehearing conference may be used to prepare for the hearing by:

  (1) Delineating the issues;

  (2) Stipulating to:

    (a) Facts;

    (b) Laws; and

    (c) Other matters;

  (3) Arranging a schedule for the:

    (a) Exchange of documents and witness information; and

    (b) Submission of motions and responses to motions; or

  (4) Addressing other matters that will promote the orderly and efficient conduct of the hearing.

C. Prehearing Orders.

  (1) If a prehearing conference has been held, a prehearing order may be issued by the presiding officer.

  (2) The prehearing order shall set forth the actions taken or to be taken with regard to any matter addressed at the prehearing conference.

  (3) If a prehearing conference is not held, the presiding officer may issue a prehearing order to regulate the conduct of the proceedings.

  (4) Absent an exception from the presiding officer, the prehearing order shall be binding on the parties.

D. The Case Resolution Conference.

  (1) Matters admitted, revealed, negotiated, or otherwise discussed are without prejudice and may not be used by the respondent, administrative prosecutor, or the Board in subsequent proceedings, unless the information is otherwise discoverable or available through another source.

  (2) The Board is not bound by the recommendations of the case resolution conference committee and may:

    (a) Modify the proposed settlement;

    (b) Require additional conditions; or

    (c) Reject the recommendation and require the respondent to proceed to a hearing.

  (3) If the respondent disagrees with the recommendation of the case resolution conference committee, the respondent may elect to proceed to a hearing on the matter, regardless of whether the Board has ratified the recommendation of the case resolution conference committee.

  (4) Participation in a case resolution conference is not a basis for recusal of a Board member, Board counsel, or Board prosecutor from further proceedings.

E. Motions.

  (1) Unless otherwise set forth in a prehearing order or notice of hearing, motions shall be:

    (a) Accompanied by a memorandum of points and authorities; and

    (b) Filed with the Board at least 15 working days before the hearing.

  (2) A copy of a motion filed with the Board shall be served on the opposing party by the party filing the motion.

  (3) A response shall be filed with the Board at least 10 working days before the hearing and a copy served on the opposing party.

  (4) The Board may refuse to consider a motion or response that is not timely filed.

#### Regulation .09 Discovery.

*COMAR 10.34.01.09*

A. Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, as appropriate, a party may require another party to produce, within 15 days, the following:

  (1) A list of witnesses to be called;

  (2) Copies of documents intended to be produced at the hearing; or

  (3) Both §A(1) and (2) of this regulation.

B. Mandatory Discovery.

  (1) Each party shall provide to the other party not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier:

    (a) The name and curriculum vitae of any expert witness who will testify at the hearing; and

    (b) A detailed written report summarizing the expert's testimony, which includes the:

      (i) Opinion offered;

      (ii) Factual basis for the opinion; and

      (iii) Reasons underlying the opinion.

  (2) If the Board or the Office of Administrative Hearings, as appropriate, finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of §B(1) of this regulation, the Board or the Office of Administrative Hearings, as appropriate, shall exclude from the hearing the testimony of the expert and any report of the expert.

  (3) The Board or the Office of Administrative Hearings, as appropriate, shall consider and decide arguments regarding the sufficiency of the report:

    (a) At the prehearing conference, if scheduled; or

    (b) Immediately before the scheduled hearing.

  (4) If an expert adopts a sufficiently specific charging document as the expert's report, that adoption satisfies the requirements set forth in §B(1) of this regulation.

C. Parties are not entitled to discovery of items other than as listed in §§A and B of this regulation.

D. Both parties have a continuing duty to supplement their disclosure of witnesses and documents.

E. Absent unforeseen circumstances that would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list:

  (1) After the prehearing conference, if scheduled; or

  (2) Later than 15 days before the hearing, if no prehearing conference is scheduled.

F. The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes.

G. Construction.

  (1) In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this regulation shall, whenever possible, be construed as supplementing and in harmony with COMAR 28.02.01.

  (2) In the event of a conflict between this regulation and COMAR 28.02.01, this regulation applies.

#### Regulation .10 Evidentiary Hearings.

*COMAR 10.34.01.10*

A. Hearings shall be conducted under the Administrative Procedure Act.

B. The Board may delegate its authority to conduct hearings to the Office of Administrative Hearings.

C. Hearings are not open to the public.

D. Records, including the recommended decision, shall be treated as confidential and sealed.

E. Records.

  (1) The Board shall prepare an official record of hearings that shall include all:

    (a) Pleadings;

    (b) Testimony;

    (c) Exhibits; and

    (d) Other memoranda or material filed in the proceeding.

  (2) Unless waived by all parties, a stenographic record of the proceedings shall be made at the expense of the Board.

  (3) The stenographic record may not be transcribed, unless requested by a party or by the Board.

  (4) The cost of transcribing all or part of a proceeding, shall be paid by the party requesting the typewritten transcript.

F. Quorum.

  (1) A majority of the members serving on the Board is a quorum of the Board.

  (2) Hearings shall be held before a quorum of the Board.

G. Presiding Officer.

  (1) The presiding officer shall:

    (a) Conduct a full, fair, and impartial hearing;

    (b) Take action to avoid unnecessary delay in the disposition of the proceedings;

    (c) Maintain order; and

    (d) Adjourn or recess the hearing from time to time.

  (2) The presiding officer may regulate the course of the hearing and the conduct of the parties, including the authority to:

    (a) Permit the examination of witnesses;

    (b) Rule on offers of proof and admit relevant and material evidence;

    (c) Consider and rule on motions;

    (d) Grant a continuance or postponement;

    (e) Determine the order in which the parties shall present their cases;

    (f) Limit unduly repetitious testimony;

    (g) Reasonably limit the time for presentation; and

    (h) Issue orders necessary to:

      (i) Secure procedural simplicity and administrative fairness; and

      (ii) Eliminate unjustifiable expense and delay.

H. Examination of Witnesses and Introduction of Evidence.

  (1) The rules of evidence in State Government Article, §10-213, Annotated Code of Maryland apply to hearings before the Board.

  (2) A party may:

    (a) Submit evidence;

    (b) Examine and cross-examine witnesses; and

    (c) File objections, exceptions, and motions.

  (3) If a party is represented by counsel, submission of evidence, examination and cross-examination of witnesses, and filing of objections, exceptions, and motions shall be done and presented solely by the counsel.

  (4) The presiding officer, or a person designated by the presiding officer for that purpose, may examine a witness called by a party.

  (5) The presiding officer may call as a witness a person necessary to ensure a full and complete record.

  (6) Any Board member may examine any witness.

I. Briefs.

  (1) A party may submit a brief on the issues of fact and law involved in the hearing.

  (2) The presiding officer may designate:

    (a) The form of the brief;

    (b) The number of copies to be submitted; and

    (c) The date and time of submission.

  (3) The Board may refuse to consider a brief that is not timely filed or fails to conform to requirements imposed by the presiding officer.

J. If a party who is the respondent in the proceedings fails to appear at a hearing after due notice, the Board may:

  (1) Reschedule the hearing; or

  (2) In the Board's discretion, proceed upon the investigation, report, documents, witnesses, and records before it.

K. The Board shall take testimony under oath.

L. Decision and Order.

  (1) A decision and order rendered by the Board shall:

    (a) Be in writing; and

    (b) Include the findings of fact and conclusions of law.

  (2) A copy of the decision and order and accompanying findings and conclusions shall be delivered or mailed promptly to each party or the party's attorney of record.

  (3) The findings of fact, conclusions of law, and order referred to in §L of this regulation shall be retained as a permanent record by the Board.

M. A party aggrieved by a final decision of the Board under Health Occupations Article, §12-313, Annotated Code of Maryland, may seek judicial review of the Board's decision.

N. The review referenced in §M shall be in accordance with State Government Article, §§10-222 — 10-223, Annotated Code of Maryland.

O. Rehearings.

  (1) Within 10 days after service on a party of the decision of the Board, the party may apply to the Board for rehearing.

  (2) The application shall state the grounds for rehearing.

  (3) The Board shall grant or deny the application within 20 days of submission to the Board.

  (4) Unless otherwise ordered, neither the rehearing nor the application for rehearing shall:

    (a) Stay the enforcement of the order; or

    (b) Excuse the persons affected by the order for failure to comply with the terms of the order.

  (5) At a rehearing, the Board shall only consider facts not presented in the original proceeding, including facts arising after the date of the original proceeding.

  (6) By new order, the Board may abrogate, change, or modify its original order.

#### Regulation .11 Exceptions Hearings.

*COMAR 10.34.01.11*

A. If a case has been delegated to the Office of Administrative Hearings under State Government Article, §10-205, Annotated Code of Maryland, for proposed findings of fact, conclusions of law, and disposition, a party may file exceptions with the Board within 30 days of receipt of the recommended decision.

B. The opposing party to the exceptions shall respond within 15 days of receipt of the exceptions.

C. If a party files exceptions, the Board shall schedule a hearing to be held before a quorum of the Board.

D. The exceptions hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the exceptions to the recommended decision.

E. The Board shall:

  (1) Consider:

    (a) The exceptions;

    (b) Responses to exceptions; and

    (c) The record in the case; and

  (2) Issue an order containing accepted findings of fact, conclusions of law, and disposition.

F. The presiding officer:

  (1) Shall determine procedural issues governed by this regulation; and

  (2) May:

    (a) Impose reasonable time limitations; and

    (b) Make rulings reasonably necessary to facilitate the effective and efficient operation of the exceptions hearing.

G. If the parties do not file timely exceptions, a quorum of the Board shall:

  (1) Consider the recommended decision from the Office of Administrative Hearings; and

  (2) Issue an order based on the:

    (a) Board's accepted findings of fact and conclusions of law; and

    (b) The record of the case.

#### Regulation .12 Summary Suspensions.

*COMAR 10.34.01.12*

A. The Board shall order the summary suspension of a registration, license, or permit if the Board determines that there is a substantial likelihood that a registrant or licensee poses a risk of harm to the public health, safety, or welfare.

B. Based on information gathered in an investigation or otherwise provided to the Board, the Board may vote to issue:

  (1) A notice of an intent to summarily suspend a registration, license, or permit; or

  (2) An order of summary suspension.

C. If the Board votes to issue a notice of intent to summarily suspend a registration, license, or permit or an order of summary suspension, the Board shall refer the matter to an administrative prosecutor for prosecution.

D. Service of the notice of intent to summarily suspend a registration, license, or permit shall be made by:

  (1) Hand delivery in person;

  (2) Certified mail to the address the respondent is required to maintain with the Board; or

  (3) Other reasonable means to effect service.

E. Notice of Intent to Summarily Suspend.

  (1) A notice of intent to summarily suspend a registration, license, or permit shall include:

    (a) A proposed order of summary suspension which is unexecuted by the Board and which includes:

      (i) The statutory authority on which the action has been taken;

      (ii) Allegations of fact which the Board believes demonstrate a substantial likelihood that the registrant or licensee poses a risk of harm to the public health, safety, or welfare; and

      (iii) Notice to the respondent of the right to request an evidentiary hearing of the summary suspension if the Board executes the proposed order of summary suspension; and

    (b) An order or summons to appear before the Board:

      (i) To show cause why the Board should not execute the order of summary suspension; and

      (ii) Which notifies the respondent of the consequences of failing to appear.

  (2) Predeprivation Hearing.

    (a) If the Board issues a notice of intent to summarily suspend a registration, license, or permit, the Board shall offer the respondent the opportunity to appear before the Board to show cause why the respondent's registration, license, or permit should not be summarily suspended.

    (b) The show cause hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the proposed summary suspension.

    (c) The presiding officer:

      (i) Shall determine procedural issues;

      (ii) May impose reasonable time limits on each party's oral argument; and

      (iii) Shall make rulings reasonably necessary to facilitate the effective and efficient operation of the show cause hearing.

F. Order of Summary Suspension.

  (1) The Board may order the summary suspension of a registration, license, or permit without first issuing a notice of intent to summarily suspend or providing a respondent with a predeprivation hearing if the Board determines that the threat to public health, safety, and welfare requires the immediate suspension of the registration, license, or permit.

  (2) Postdeprivation Hearing.

    (a) The respondent shall be provided with a show cause hearing within a reasonable time after the effective date of the order of summary suspension.

    (b) The show cause hearing under §F(2)(a) of this regulation shall:

      (i) Be conducted before the Board as provided in §E(2) of this regulation; and

      (ii) Provide the respondent with an opportunity to show cause why the Board should lift the summary suspension.

  (3) After the show cause hearing, if the Board votes to continue the summary suspension, the respondent may request an evidentiary hearing before the Board.

  (4) An evidentiary hearing:

    (a) May be consolidated with a hearing on charges issued by the Board that include the facts that form the basis for the summary suspension; and

    (b) Shall be conducted under the Administrative Procedure Act.

G. Disposition.

  (1) If the Board issues a notice of intent to summarily suspend a registration, license, or permit, the Board may, after the show cause hearing, vote to:

    (a) Order a summary suspension;

    (b) Deny the summary suspension;

    (c) Enter into a consent order; or

    (d) Enter into any interim order warranted by the circumstances of the case, including one providing for the stay of the summary suspension subject to certain conditions.

  (2) If the Board orders a summary suspension before a show cause hearing, the Board may, at the conclusion of the show cause hearing, vote to:

    (a) Affirm the order of summary suspension;

    (b) Rescind the order of summary suspension;

    (c) Enter into a consent order; or

    (d) Enter into an interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions.

  (3) An order for summary suspension or any other order of the Board issued after the initiation of summary suspension proceedings is a:

    (a) Final order of the Board; and

    (b) Public record.

#### Regulation .13 Surrender of a Registration, License, or Permit.

*COMAR 10.34.01.13*

A. The Board may:

  (1) Accept the surrender of a registration, license, or permit;

  (2) Require conditions for surrender of a registration, license, or permit, including:

    (a) The admission of a violation of the Maryland Pharmacy Act;

    (b) The admission of facts;

    (c) A statement of the circumstances under which the surrender was offered or accepted;

    (d) Restrictions on future registration, licensing, or permit;

    (e) Conditions for reinstatement of the registration, license, or permit; or

    (f) An agreement that the respondent may not again apply for a registration, license, or permit.

B. A letter of surrender is a final order of the Board and is a public record.

#### Regulation .14 Probation and Violation of Probation.

*COMAR 10.34.01.14*

A. If the Board imposes a period of probation as a sanction, the Board may impose conditions of probation that the Board considers appropriate, including:

  (1) Re-education or completion of approved courses;

  (2) Payment of a fine;

  (3) Practicing pharmacy or operating a pharmacy under supervision;

  (4) Monitoring by the Board or by an individual or entity approved by the Board with periodic reporting to the Board;

  (5) Periodic review of a licensee's practice or operations;

  (6) Periodic audits of a licensee's billing practice;

  (7) An examination by a physician or other appropriate health care provider;

  (8) Limitation of the licensee's practice or operations;

  (9) Limitation of the pharmacy technician's scope of duties;

  (10) Drug screenings;

  (11) Individual or group counseling or therapy;

  (12) Obtaining a passing score on an appropriate examination; or

  (13) Any other condition the Board considers appropriate for the rehabilitation or retraining of a registrant or a licensee.

B. A term of probation may be defined by a specific period of time or the successful completion of certain conditions or acts by the registrant or licensee.

C. A registrant or licensee seeking release from probation shall do so by petitioning the Board to terminate the probation when the:

  (1) Specific period of time has passed; or

  (2) Registrant or licensee has successfully completed the conditions or acts required for release.

D. If, at any time, the Board has reason to believe that the registrant or licensee is not in compliance with the conditions of probation, the Board shall:

  (1) Charge the registrant or licensee with a violation of probation;

  (2) Take an action provided for in the final order in the event of a violation of probation, including suspension of the registration, license, or permit;

  (3) Consider a summary suspension of the registration, license, or permit; or

  (4) Take any other action the Board considers appropriate and which the Board may take by law.

E. If the Board determines that the respondent has violated probation, the Board shall:

  (1) Take an action provided for in the final order in the event of a violation of probation;

  (2) Impose additional conditions or probation; or

  (3) Impose a sanction or take any other action that the Board considers appropriate and may take by law.

#### Regulation .15 Reinstatement.

*COMAR 10.34.01.15*

A. A registrant or licensee shall petition the Board for a lifting of the suspension of a registration, license, or permit or a reinstatement following revocation or surrender of a registration, license, or permit.

B. The Board may reinstate a registration, license, or permit in accordance with:

  (1) The terms and conditions of the order of revocation or suspension;

  (2) A letter of surrender;

  (3) An order of reinstatement issued by the Board; or

  (4) A final judgment in any proceeding for judicial review.

C. If not otherwise specified in a document under §B of this regulation, the licensee shall meet the requirements of COMAR 10.34.13 to reinstate a license or permit.

C-1. If not otherwise specified in a document under §B of this regulation, the registrant shall meet the requirements of COMAR 10.34.34 to reinstate a registration.

D. If a time period is not specified in the Board's final order, a petition for reinstatement may not be considered by the Board before the expiration of 1 year after the date of the order.

E. The form of a reinstated registration, license, or permit shall:

  (1) Be similar in every respect to an original registration, license, or permit; and

  (2) Bear the new date of issue.

F. If the Board grants reinstatement of a registration, license, or permit, it may impose any restrictions or conditions on the registration, license, or the licensee's practice that it considers appropriate.

G. The Board may reinstate the license of an individual whose license has been revoked under Criminal Law Article, §5-702, Annotated Code of Maryland, if:

  (1) The individual has petitioned the Board for reinstatement;

  (2) The petition for reinstatement is made to the Board after the expiration of 5 years after the revocation;

  (3) The individual has met the requirements of COMAR 10.34.13 to reinstate a license; and

  (4) The individual has made restitution to aggrieved persons that may have resulted from a violation and conviction of Criminal Law Article, §5-702, Annotated Code of Maryland.
