Md. Code Regs. 10.19.03.04

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

Section 10.19.03.04 - Registration: Requirements and Qualifications

A. Except for military and federal employees working within the scope of federal employment, a person shall register with the Department and obtain a registration certificate before the person:

(1) Manufactures, distributes, dispenses, stores, and orders controlled substances;

(2) Conducts research or instructional activities with controlled 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 with a controlled substance listed in Schedule I of Criminal Law Article, § 5-402, Annotated Code of Maryland, with prior registration from the DEA;

(4) Conducts a chemical analysis with controlled substances listed in any schedule;

(5) Installs and maintains an automated dispensing machine containing controlled substances; or

(6) Manufactures peyote for, or distributes peyote to, the Native American Church for bona fide religious ceremonies of the Native American Church.

B. An authorized provider shall:

(1) Apply for a registration certificate on a form made available by the Department to:

(a) Obtain one registration for all locations that a provider prescribes only and no controlled substances are stored; or

(b) Obtain a single registration for each separate location where the provider prescribes, dispenses, orders, and stores controlled substances;

(2) Have a professional license in good standing;

(3) Be of good moral character;

(4) Have no convictions for crimes of moral turpitude;

(5) Be 18 years of age or older;

(6) Be registered with the Prescription Drug Monitoring Program if the authorized provider is also a prescriber as defined under HealthGeneral Article, §21-2A-04.1, Annotated Code of Maryland; and

(7) Except for researchers, have completed 2 continuing education credit hours:

(a) Prior to applying for an initial controlled substance registration occurring on or after October 1, 2018; or

(b) Prior to the first renewal of a controlled substance registration occurring on or after October 1, 2018.

C. Continuing Education.

(1) The continuing education shall:

(a) Be accredited by the Accreditation Council for Continuing Medical Education; or

(b) Meet the requirements for approval by the authorized providers professional board.

(2) The continuing education shall pertain to the prescribing or dispensing of controlled substances.

(3) Authorized providers shall meet the requirements of §§B and C of this regulation upon the completion of the 2 credit hours of continuing education.

(4) Recent graduates meet the requirements of §§B and C of this regulation upon initial application if two academic course credits were issued relating to controlled substances.

D. An establishment shall:

(1) Apply for a registration certificate on a form made available by the Department;

(2) Obtain one registration for each separate place of business, professional practice, or location where controlled substances are:

(a) Ordered;

(b) Purchased;

(c) Administered;

(d) Delivered to the ultimate user;

(e) Stored;

(f) Manufactured; or

(g) Distributed; and

(3) Have a professional or occupational license in good standing to perform any of the following functions related to controlled substances:

(a) Manufacture;

(b) Distribute;

(c) Deliver to the ultimate user;

(d) Administer;

(e) Store;

(f) Order;

(g) Prescribe;

(h) Package;

(i) Label; or

(j) Compound.

Md. Code Regs. 10.19.03.04

Regulation .04 adopted effective 51:20 Md. R. 899, eff. 10/14/2024.