(a) Definitions

Section 102 of the Controlled Substances Act (21 U.S.C. 802) is amended by adding at the end the following:

(61)

The term accepted medical use means the use of a drug or other substance—

(A)

in accordance with an approval under the Federal Food, Drug, and Cosmetic Act or licensure under section 351 of the Public Health Service Act;

(B)

to conduct scientific research to advance the understanding of human biology, develop new therapies, or research animal or human models of disease, syndrome, or disorder; or

(C)

in accordance with a recognized legitimate medical use if—

(i)

a jurisdiction has authorized the drug or substance for medical use;

(ii)

the drug or substance is widely used in such jurisdiction by health care practitioners; and

(iii)

such legitimate medical use is recognized by the entities that regulate the practice of medicine in such jurisdiction through evidence-based scientific evaluation that employs rigorous and generally accepted methodologies.

(62)

The term dependence liability means, with respect to a drug or other substance that could contribute to a substance use disorder, the actual propensity for physical dependence or psychological dependence to the drug or substance.

(63)

The term physical dependence means, with respect to a drug or other substance, a state that develops as a result of physiological adaptation in response to repeated, chronic use of the drug or substance, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of the drug or substance.

(64)

The term psychological dependence means, with respect to a drug or other substance, a state in which an individual’s use of the drug or substance is compromised by—

(A)

the rewarding effects of the drug or substance, thus increasing the likelihood of chronic use; or

(B)

psychological distress (including craving) that occurs in the absence of the drug or substance and contributes to compulsive drug seeking, regardless of whether such use is indicative of abuse or misuse of the drug or substance.

(65)

The term lack of accepted safety for use of the drug or other substance under medical supervision means, with respect to a drug or other substance, that based on the accepted medical use of the drug or substance, a reasonable health care practitioner would determine that the potential risk of death or significant and irreversible harm to the user would clearly outweigh any medical benefit to the user.

(66)

The term abuse means, with respect to a drug or other substance, the intentional use of the drug or substance in a manner that will lead to a substance use disorder.

(67)

The term potential for abuse means, with respect to a drug or other substance, the relative likelihood that use of the drug or substance will result in abuse of the drug or substance.

(68)

The term misuse means—

(A)

the use by an individual of a drug or other substance that is not intended for human consumption (determined in the same manner as such a determination would be made under section 203); or

(B)

the use by an individual of a drug or other substance in a way—

(i)

that was not directed by the individual’s health care practitioner; or

(ii)

that is not in accordance with the instructions for use on the labeling of such drug or substance.

(69)

The term potential benefits to society means, with respect to a drug or other substance, any medical, scientific, or other use of the drug or substance that may improve public health or quality of life.

(b) Clarification of roles in scheduling

Section 201(a) of the Controlled Substances Act (21 U.S.C. 811(a)) is amended by inserting before Rules of the Attorney General the following: In carrying out paragraph (1), the Attorney General shall (1) defer to the Secretary’s scientific and medical evaluation of a drug or other substance, and (2) add or transfer a drug or other substance to a schedule only if such schedule best corresponds to controls reasonably tailored to protect public health and safety (including the potential for abuse and dependence liability of the drug or substance) while preserving access for accepted medical uses, and recognizing the potential benefits to society, of the drug or substance..