Md. Code Regs. 10.19.03.18

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.19.03.18 - Administrative Inspections and Warrants

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 is authorized in accordance with Criminal Law Article, §§ 5-804 and 5-805, Annotated Code of Maryland, to enter controlled premises and conduct administrative inspections for the purpose of the following:

(a) Documents required to be kept or made pursuant to 21 CFR §1304, under the Act, or regulations promulgated under the Act may be:

(i) Inspected;

(ii) Copied;

(iii) Verified for correctness; and

(iv) Inventoried;

(b) Collecting samples of controlled 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);

(c) Review of records and information on the distribution of controlled substances by the authorized provider;

(d) Reviewing the authorized providers processes;

(e) Reviewing the authorized providers controls; and

(f) Inspecting the authorized providers facility operations;

(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 authorized provider inspected.

B. Administrative Warrants.

(1) Probable Cause. If the Department is satisfied that administrative probable cause exists, the Department shall issue an administrative warrant.

(2) Execution of Warrants. An administrative inspection warrant shall be executed as required by Criminal Law Article, § 5-804(d), Annotated Code of Maryland.

(3) Refusal to Allow Inspection with an Administrative Warrant. If an authorized provider 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 authorized provider 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.

Md. Code Regs. 10.19.03.18

Regulation .18 adopted effective 51:20 Md. R. 899, eff. 10/14/2024.