Md. Code Regs. 10.19.03.03

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

Section 10.19.03.03 - Definitions

A. Applicability to Chapter. In this chapter, the terms defined in §B of this regulation have the meanings indicated. In addition, and unless otherwise provided in this chapter, the definitions appearing in Criminal Law Article, § 5-101, Annotated Code of Maryland, shall also apply to this chapter.

B. Terms Defined.

(1) "Act" means the Maryland Controlled Dangerous Substances Act, Criminal Law Article, §§5-101-5-1101, Annotated Code of Maryland.

(2) "Administrative probable cause" means a valid public interest, sufficient to justify an administrative warrant, allowing the inspection of the area, premises, or building to enforce this chapter.

(3) "Agent" means a person who acts on behalf of the Department.

(4) "Authorized provider" or "provider" means a:

(a) Person licensed, registered, or otherwise allowed to dispense, order, and store controlled substances;

(b) Pharmacy, laboratory, hospital, or other institution licensed, registered, or otherwise allowed to manufacture, distribute, dispense, store, and order controlled substances; or

(c) Person licensed, registered, or otherwise allowed to conduct research on a controlled substance in the State in the course of professional practice or research.

(5) "Board" means the Maryland Boards of Physicians, Podiatry, Dental Examiners, Nursing, and Veterinary Medicine.

(6) "Chemical analysis" means the act of decomposing a substance into its constituent elements.

(7) "Civil fine" means a fine assessed by the Department against an authorized provider, including establishments.

(8) Commercial Container.

(a) "Commercial container" means any bottle, jar, tube, ampule, or other receptacle in which a substance is held for distribution or dispensing to an ultimate user.

(b) "Commercial container" includes any box or package in which a receptacle is held for distribution or dispensing to an ultimate user.

(c) "Commercial container" does not include any package liner, package insert, or other material kept with or within a commercial container, or any carton, crate, drum, or other package in which commercial containers are stored or are used for shipment of controlled substances.

(9) Controlled Premises.

(a) "Controlled premises" means places where original or other records or documents required under the Act are kept or required to be kept.

(b) "Controlled premises" includes factories, warehouses, other establishments, and conveyances, where persons registered under the Act or exempt from registration under the Act may lawfully hold, manufacture, distribute, dispense, administer, or otherwise dispose of controlled substances.

(10) "Department" means the Maryland Department of Health.

(11) "Disciplinary action" includes but is not limited to a penalty, reprimand, restriction, suspension, or revocation of a license.

(12) "Federal Act" means the Controlled Substance Act (84 Stat. 1242; 21 U.S.C. 801) or the Controlled Substance Import and Export Act (84 Stat. 1285; 21 U.S.C. 951).

(13) "Fee exempt" means an authorized provider that is required to register with the Department but is not required to pay the registration fee.

(14) "In good standing" means having a professional license that is not subject to any form of sanction by the Board or Criminal Law.

(15) "Inspector" means an officer or employee of the Department authorized by the Secretary to make inspections under the Act.

(16) "Labeling" means all labels and other written, printed, or graphic matter on any controlled substance or any of its commercial containers or wrappers accompanying controlled substances.

(17) "License" has the same meaning as State Government Article, § 10-226, Annotated Code of Maryland.

(18) Manufacture.

(a) "Manufacture" means:

(i) Producing, preparation, propagation, compounding, or processing of a drug or other substance;

(ii) Packaging or repackaging of the substance; or

(iii) Labeling or re-labeling of the commercial container of the substance.

(b) "Manufacture" does not include the activities of a provider who, as an incident to the provider's administration or dispensing the substance in the course of the provider's professional practice, prepares, compounds, packages, or labels the substance.

(19) "Manufacturer" means a person who manufactures a drug or other substance under:

(a) A registration as a manufacturer; or

(b) Authority of registration as a researcher or chemical analyst.

(20) "Office of Controlled Substances Administration (OCSA)" refers to the division within the Maryland Department of Health responsible for administering the enforcement of Criminal Law Article, Title 5, Annotated Code of Maryland.

(21) "Penalty" means monetary penalty, including but not limited to a fine.

(22) "Person" means:

(a) An authorized provider;

(b) The responsible party listed on the application licensed by the DEA; or

(c) The responsible party listed on the application for an establishment not licensed by the DEA.

(23) "Peyote" means the controlled substance in Schedule I under Criminal Law Article, § 5-402, Annotated Code of Maryland. This schedule I listing does not apply to the nondrug use of peyote in bona fide religious ceremonies of the Native American Church, and members of the Native American Church using peyote in this manner are exempt from registration.

(24) "Pharmacist" means:

(a) A pharmacist licensed in the State or otherwise authorized to dispense controlled substances; or

(b) An individual, for example, a pharmacist intern, authorized by a state to dispense controlled substances under the supervision of a pharmacist licensed by that state.

(25) Prescription.

(a) "Prescription" means an order for medication that is dispensed to or for an ultimate user.

(b) "Prescription" does not include an order for medication which is dispensed for immediate administration to the ultimate user, such as an order to dispense a drug to a bed patient for immediate administration in a hospital.

(26) "Registration" means initial registration or subsequent re-registration with OCSA.

(27) "Secretary" means the Secretary of the Maryland Department of Health.

(28) "Sufficient application" means an application that is completed in full and has provided all of the information required by the Department.

Md. Code Regs. 10.19.03.03

Regulation .03A amended effective December 17, 1984 (11:25 Md. R. 2134); February 17, 1992 (19:3 Md. R. 304); December 24, 2001 (28:25 Md. R. 2190)
Regulation .03 repealed and new Regulation .03 adopted effective April 24, 2006 (33:8 Md. R. 732)
Regulation .03 amended effective 42:22 Md. R. 1377, eff.1/1/2016; adopted effective 51:20 Md. R. 899, eff. 10/14/2024.