10.19.03.11

.11 Administrative Functions, Practices, and Procedures.

A. Administrative Inspections.

(1) Procedures regarding administrative inspections and warrants pursuant to Criminal Law Article, §§5-305, 5-804, and 5-805, Annotated Code of Maryland, are governed generally by those sections of the Annotated Code and specifically by this regulation.

(2) Authority to Make Inspections. In carrying out the Secretary's functions under the Act, the Secretary, through the Department's inspectors, is authorized in accordance with Criminal Law Article, §§5-804—5-805, Annotated Code of Maryland, to enter controlled premises and conduct administrative inspections for the purpose of all of the following:

(a) Inspecting, copying, and verifying the correctness of records, reports, or other documents required to be kept or made under the Act and the regulations promulgated under the Act, including inventory and other records required to be kept pursuant to Regulation .05, order form records required to be kept pursuant to Regulation .06, prescription and distribution records required to be kept pursuant to Regulation .07, shipping records identifying the name of each carrier used and the date and quantity of each shipment, and storage records identifying the name of each warehouse used and the date and quantity of each storage;

(b) Making a physical inventory of all controlled substances on hand at the premises;

(c) Collecting samples of controlled dangerous substances or precursors (if samples are collected during an inspection, the inspector shall issue a receipt for these samples to the owner, operator, or agent in charge of the premises);

(d) Checking of records and information on distribution of controlled dangerous substances by the registrant as they relate to total distribution of the registrant (i.e., has the distribution in controlled dangerous substances increased markedly within the past year, and if so, why);

(e) Except as provided in Criminal Law Article, §5-805(f), Annotated Code of Maryland, all other things therein (including records, files, papers, processes, controls and facilities) appropriate for verification of the records, reports, documents referred to above or otherwise bearing on the provisions of the Act and the Regulations under it.

(3) Entry.

(a) An inspection shall be carried out by an inspector.

(b) An inspector shall have the right to enter the premises and conduct inspections at reasonable times and in a reasonable manner, upon the following conditions:

(i) Stating the inspector's purpose; and

(ii) Presenting to the owner, operator, or agent in charge of the premises to be inspected, appropriate credentials and written notice of the inspector's inspection authority under Criminal Law Article, §5-305, 5-804, or 5-805, Annotated Code of Maryland.

(4) Consent to Inspection of Financial Data; Sales Data other than Shipment Data; or Pricing Data.

(a) If inspection is desired of financing, sales, or pricing data, written consent shall first be obtained from the owner, operator, or agent in charge of the premises to be inspected.

(b) This written consent shall contain the following information:

(i) That the owner, operator, or agent in charge has the right to refuse to consent to an inspection of these items;

(ii) That anything of an incriminating nature which may be found may be seized and used against the owner, operator, or agent in charge in a criminal prosecution;

(iii) That the owner, operator, or agent in charge has been presented with a notice of inspection;

(iv) That the consent is given by the owner, operator, or agent in charge voluntarily and without threats of any kind; and

(v) That the owner, operator, or agent in charge may withdraw the owner's, operator's, or agent in charge's consent at any time during the course of inspection.

(c) The written consent shall be produced in duplicate and be distributed as follows:

(i) The original will be retained by the inspector; and

(ii) The duplicate will be given to the person inspected.

(5) Administrative Probable Cause. If the judge or magistrate is satisfied that "administrative probable cause", as defined in Criminal Law Article, §5-804(a), Annotated Code of Maryland, exists, the judge or magistrate shall issue an administrative warrant. Administrative probable cause does not mean criminal probable cause as defined by federal statute or case law.

(6) Execution of Warrants. An administrative inspection warrant shall be executed and returned as required by, and any inventory or seizure made shall comply with the requirements of Criminal Law Article, §5-804(d), Annotated Code of Maryland.

(7) Refusal to Allow Inspection with an Administrative Warrant. If a registrant or any person subject to the Act refuses to permit execution of an administrative warrant, or impedes the inspector in the execution of that warrant, the registrant or person shall be advised that this refusal or action constitutes a violation of Criminal Law Article, §5-902(a)(3), Annotated Code of Maryland.

B. Enforcement Proceedings.

(1) Authority for Enforcement Proceeding. A hearing may be ordered or granted by the Secretary, at the Secretary's discretion, to permit any person against whom criminal or civil action is contemplated under the Controlled Dangerous Substances Act an opportunity to present the individual's views and the individual's proposals for bringing the individual's alleged violations into compliance with the law. The hearing will also permit the individual to show cause why prosecution should not be instituted, or to present the individual's views on the contemplated proceeding.

(2) The rules of procedure for hearings before the Secretary of Health and shall be governed by COMAR 10.01.03 and State Government Article, §§10-201—10-226, Annotated Code of Maryland.

C. Administrative Hearings. Procedures for administrative hearings shall be governed by the rules set forth in Criminal Law Article, §5-308, Annotated Code of Maryland, if applicable; Health-General Article, §2-207, and State Government Article, §§10-201—10-226, Annotated Code of Maryland; and COMAR 10.01.03.