D.C. Mun. Regs. tit. 17, r. 17-10399

Current through Register Vol. 71, No. 50, December 13, 2024
Rule 17-10399 - DEFINITIONS
10399.1

The following terms shall have the meanings ascribed:

Act - the Prescription Drug Monitoring Program Act of 2013, effective February 22, 2014 (D.C. Law 20-66; D.C. Official Code §§ 48-853.01 et seq.).

Administer - the direct application of a controlled substance, whether by injection, inhalation, ingestion, or any other means, to the body of a patient or research subject by:

(a) A practitioner (or, in the practitioner's presence, by the practitioner's authorized agent); or
(b) The patient or research subject at the direction of and in the presence of the practitioner.

Controlled substance - a drug, substance, or immediate precursor, as set forth in Schedules I through V of Subchapter 2 of the District of Columbia Uniform Controlled Substances Act of 1981, effective August 5, 1981(D.C. Law 4-29; D.C. Official Code §§ 48-901 et seq.)

Covered substance - all controlled substances included in Schedules II, III, IV, and V as set forth in Subchapter 2 of the District of Columbia Uniform Controlled Substances Act of 1981, effective August 5, 1981 (D.C. Law 4-29; D.C. Official Code §§ 48-901 et seq.), Schedules II through V of the Federal Controlled Substances Act ( 21 U.S.C. § 812) , and any other drug as specified by rulemaking, that is required to be reported to the Program pursuant to the Act.

DEA - the United States Drug Enforcement Administration.

Department - the District of Columbia Department of Health.

Director - the Director of the District of Columbia Department of Health.

Dispense - to distribute a drug to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing, administering, packaging, labeling, or compounding necessary to prepare the substance for that delivery.

Dispenser - a practitioner who dispenses a covered substance to the ultimate user, or his or her agent, but shall not include:

(a) A licensed hospital or institutional facility pharmacy that distributes covered substances for the purpose of inpatient hospital care or the dispensing of prescriptions for controlled substances at the time of discharge from such a facility;
(b) A practitioner or other authorized person who administers a covered substance;
(c) A wholesale distributor of a covered substance; or
(d) A clinical researcher providing a covered substance to research subjects as part of a research study approved by a hospital-based institutional review board or an institutional review board accredited by the association for the accreditation of human research protections programs.

District - the District of Columbia.

Drug -

(a) Any substance recognized as a drug, medicine, or medicinal chemical in the official United States Pharmacopoeia, official National Formulary, official Homeopathic Pharmacopoeia, or official Veterinary Medicine Compendium or other official drug compendium or any supplement to any of them;
(b) Any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animal;
(c) Any chemical substance, other than food, intended to affect the structure or any function of the body of man or other animal; and
(d) Any substance intended for use as a component of any items specified in subparagraph (a), (b), or (c) of this paragraph, but does not include medical devices or their components, parts, or accessories.

Drugs of concern - a drug that is not a controlled substance, but which is nevertheless identified by the Director or the PDMP Advisory Committee as a drug with the potential for abuse.

Health occupations board - a board that, pursuant to Section 408 of the District of Columbia Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code § 3-1204.08) , licenses and regulates health professionals with the authority to prescribe or dispense covered substances.

Interoperability - with respect to a District of Columbia or state prescription drug monitoring program, the ability of that program to share electronically reported prescription information with another state, district, or territory of the United States' prescription drug monitoring program or a third party, approved by the Director, which operates interstate prescription drug monitoring exchanges.

Patient - the person or animal who is the ultimate user of a controlled substance or other drug required to be submitted under the Act for whom a lawful prescription is issued or for whom a controlled substance or such other drug is lawfully dispensed.

Practitioner -

(a) A physician, dentist, advanced practice registered nurse, veterinarian, scientific investigator, or other person who is licensed, registered, or otherwise permitted to distribute, dispense, conduct research with respect to, or to administer a controlled substance in the course of professional practice or research in the District of Columbia; or
(b) A pharmacy, hospital, or other institution licensed, registered, or otherwise permitted to distribute, dispense, conduct research with respect to, or administer a controlled substance in the course of its professional practice or research in the District of Columbia.

Prescriber - a practitioner or other authorized person who prescribes a controlled substance or other covered substance in the course of his or her professional practice.

Prescription drug monitoring program - a program that collects, manages, analyzes, and provides information regarding covered substances or other drugs required under the Act or a program established by a similar act in another state, district or territory of the United States.

PDMP Advisory Committee - the multi-discipline committee established pursuant to Section 3 of the Act, which functions under the Department to advise the Director on the implementation and evaluation of the District's prescription drug monitoring program.

PDMP Instruction Manual - the manual maintained by the Director that provides detailed instructions for registering with, reporting to, and requesting information from the Program.

Program or PDMP - the prescription drug monitoring program established by the Act.

Reporting period - the twenty-four (24) hour time period immediately following the dispensing of a covered substance.

Stakeholder - a person, group, or organization that could be affected by the Program's actions, objectives, and policies.

Ultimate user - a person who lawfully possesses a controlled substance for that person's own use or for the use of a member of that person's household or for administering to an animal owned by him or her or by a member of that person's household.

Zero report - an electronic data submission reflecting no dispensing activity for a given period.

D.C. Mun. Regs. tit. 17, r. 17-10399

Final Rulemaking published at 62 DCR 15828 (12/11/2015)