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10.19.03.00.htm 10.19.03.00. Title 10 MARYLAND DEPARTMENT OF HEALTH Subtitle 19 DANGEROUS DEVICES AND SUBSTANCES Chapter 03 Controlled Dangerous Substances Authority: Criminal Law Article, Title 5; Health-General Article, §21-220; Annotated Code of Maryland
10.19.03.01.htm 10.19.03.01. 01 Scope and Purpose.. A. The Secretary of Health recognizes that the public interest requires control over the use of controlled dangerous substances in the legitimate manufacture, distribution, and dispensing of controlled dangerous substances. The Secretary is adopting some sections of the Code of Federal Regulations, and these sections are identified by the federal citation in parentheses after the heading.B. This chapter applies to every registrant who ma
10.19.03.02.htm 10.19.03.02. 02 Definitions.. A. As used in this chapter, unless otherwise provided, those definitions appearing in Criminal Law Article, §5-101, Annotated Code of Maryland, shall apply.B. In this chapter, the following terms have the meanings indicated.. C. Terms Defined.. 1) "Act" means the Maryland Controlled Dangerous Substances Act, Criminal Law Article, §5-101―5-1101, Annotated Code of Maryland.2) Commercial Container.. a) "Commercial container" means any bottle, jar, t
10.19.03.03.htm 10.19.03.03. 03 Registration; Registration Certificate.. A. Requirement. A person shall register with the Department and obtain and maintain a registration certificate before the person:1) Manufactures, distributes, or dispenses controlled dangerous substances;. 2) Conducts research or instructional activities with controlled dangerous substances listed in Schedules II through V of Criminal Law Article, §5-403―5-406, Annotated Code of Maryland;3) Conducts research or instructional activities w
10.19.03.04.htm 10.19.03.04. 04 Labeling and Packaging Requirements for Controlled Dangerous Substances. (Title 21, Code of Federal Regulations 1302.01)A. Requirements governing the labeling and packaging of controlled dangerous substances pursuant to Criminal Law Article, §5-202 and 5-604, Annotated Code of Maryland, are set forth generally by those sections and specifically by the sections of this regulation.B. Symbol Required―Exceptions (21 CFR §1302.03). 1) Each commercial container of a controlled dange
10.19.03.05.htm 10.19.03.05. 05 Records and Reports Required of Registrants.. A. Records and reports required of applicants, pursuant to Criminal Law Article, §5-306, Annotated Code of Maryland, shall be the same as required in 21 CFR 1304, as amended.B. Inventories developed under the Federal Act under the date of May 1, 1971, and subsequent biennial inventory dates are acceptable for purposes of the Maryland Act. After the initial inventory is taken, the registrant shall take a new inventory of
10.19.03.06.htm 10.19.03.06. 06 Order Forms.. The Maryland Act directs that Controlled Dangerous Substances in Schedule I and II shall be distributed by a registrant, pursuant to an order form, and that compliance with the provisions of the federal law respecting order forms for these schedules is compliance with the Maryland Act. For administrative interpretations, the regulations effective pertaining to the federal law respecting order forms are hereby incorporated into these regulations i
10.19.03.07.htm 10.19.03.07. 07 Prescriptions.. A. Provisions governing the issuance, filling, and filing of prescriptions pursuant to Criminal Law Article, §5-501―5-505, Annotated Code of Maryland, are set forth generally in those sections and specifically by the sections of this regulation.B. Persons Entitled to Issue Prescriptions (21 CFR §1306.03). 1) A prescription for a controlled dangerous substance may be issued only by an individual practitioner who is:a) Authorized to prescribe controlled dangerous su
10.19.03.08.htm 10.19.03.08. 08 Controlled Substances Listed in Schedule II.. A. Requirement of Prescription―Schedule II (21 CFR §1306.11). 1) A pharmacist may dispense directly a controlled dangerous substance listed in Schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, only pursuant to a written prescription signed by the prescribing individual practitioner, except as provided in §A(4) of this regulation. Except as noted in §A(5)7) of this regulation, a pr
10.19.03.09.htm 10.19.03.09. 09 Controlled Substances Listed in Schedules III, IV, and V.. A. Requirement of Prescriptions Listed in Schedules III, IV, and V (21 CFR §1306.21). 1) A pharmacist may dispense directly a controlled dangerous substance listed in Schedules III, IV, or V, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, or State Law, only pursuant to either a written prescription signed by a prescribing individual practitioner or a facsimile rece
10.19.03.10.htm 10.19.03.10. 10 Miscellaneous (21 CFR §1307). A. Distribution by Dispenser to Another Practitioner (21 CFR §1307.11). 1) A practitioner who is registered to dispense a controlled dangerous substance may distribute (without being registered to distribute) a quantity of the substance to another practitioner for the purpose of general dispensing by the practitioner to the practitioner's patients, if:a) The practitioner to whom the controlled dangerous substance is to be distributed is registered un
10.19.03.11.htm 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 Departm
10.19.03.12.htm 10.19.03.12. 12 Physical Security Controls for Registrants.. A. General.. 1) All applicants and registrants shall provide effective controls and procedures to guard against theft and unlawful diversion of controlled substances. In order to determine whether a registrant or applicant has provided protective controls against theft and unlawful diversion, the Department shall use the security requirements set forth in §B of this regulation and 21 CFR §1307.71―1301.77 as standards for physical secu
10.19.03.13.htm 10.19.03.13. 13 Additional Controlled Dangerous Substances ― Schedule I.. The following substances, also known as "bath salts" are added to the Maryland Controlled Dangerous Substances Act, Schedule I of the Criminal Law Article, §5-402, Annotated Code of Maryland:A. 3,4-Methylenedioxypyrovalerone (MDPV). B. 4-Methylmethcathinone (Mephedrone, 4-MMC). C. 3,4-Methylenedioxymethcathinone (Methylone, MDMC). D. 4-Fluoromethcathinone (Flephedrone, 4-FMC). E. 3-Fluoromethcathinone (3-FMC) and.
10.19.03.9999.htm 10.19.03.9999. Administrative History Effective date: January 19, 1977 (4:2 Md. R. 87). 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 .07E and J amended effective August 17, 1992 (19:16 Md. R. 1474). Regulation .07H amended effective July 12, 1998 (25:14 Md. R. 1132). Regulations .07N, R and .10B amended effective February 10, 1978 (5:3 Md. R. 138).
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