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I.EXECUTIVE ORDERS - page 157 / 359

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C.Scheduling of Additional Controlled Substances. R.S. 40:963 authorizes the secretary of the department to add additional substances to the schedules identified in Subsection B. In making the determination to add a substance, the secretary is required to make certain findings, as identified in R.S. 40:963.

1.In determining whether a drug has a "stimulant effect" on the central nervous system, the secretary shall consider, among other relevant factors, whether there is substantial evidence that the drug may produce any of the following:
a.extended wakefulness;
b.elation, exhilaration or euphoria (exaggerated sense of well-being);
c.alleviation of fatigue;
d.insomnia, irritability, or agitation;
e.apprehension or anxiety;
f.flight of ideas, loquacity, hypomania or transient delirium.
2.In determining whether a drug has a "depressant effect" on the central nervous system, the secretary shall consider, among other relevant factors, whether there is substantial evidence that the drug may produce any of the following:
a.calming effect or relief of emotional tension or anxiety;
b.drowsiness, sedation, sleep, stupor, coma, or general anesthesia;
c.increase of pain threshold;
d.mood depression or apathy;
e.disorientation, confusion or loss of mental acuity.
3.In determining whether a drug is "habit-forming," the secretary shall consider, among other relevant factors, whether there is substantial evidence that the drug may produce any of the following:
a.a psychological or physical dependence on the drug (compulsive use);
b.euphoria;
c.personality changes;
d.transient psychoses, delirium, twilight state, or hallucinations;
e.chronic brain syndrome;
f.increased tolerance or a need or desire to increase the drug dosage;
g.physical dependence or a psychic dependence evidenced by a desire to continue taking the drug for a sense of improved well-being that it engenders;
h.pharmacological activity similar or identical to that of drugs previously designated as habit-forming.
4.In determining whether a drug has a "hallucinogenic effect," the secretary shall consider, among other relevant factors, whether there is substantial evidence that the drug may produce hallucinations, illusions, delusions, or alteration of any of the following:
a.orientation with respect to time or place;
b.consciousness, as evidenced by confused states, dreamlike revivals of past traumatic events or childhood memories;
c.sensory perception, as evidenced by visual illusions, synesthesia, distortion of space and perspective;
d.motor coordination;
e.mood and affectivity, as evidenced by anxiety, euphoria, hypomania, ecstasy, autistic withdrawal;
f.ideation, as evidenced by flight of ideas, ideas of reference, impairment of concentration and intelligence;
g.personality, as evidenced by depersonalization and derealization, impairment of conscience and of acquired social and cultural customs.
5.The secretary may determine that a substance has a potential for abuse because of its depressant or stimulant effect on the central nervous system or its hallucinogenic effect if:
a.there is evidence that individuals are taking the drug or drugs containing such a substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or of the community;
b.there is significant diversion of the drug or drugs containing such a substance from legitimate drug channels;
c.individuals are taking the drug or drugs containing such a substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such drugs in the course of his professional practice; or
d.the drug or drugs containing such a substance are new drugs so related in their action to a drug or drugs already listed as having a potential for abuse to make it likely that the drug will have the same potentiality for abuse as such drugs, thus making it reasonable to assume that there may be significant diversions from legitimate channels, significant use contrary to or without medical advice, or that it has a substantial capability of creating hazards to the health of the user or to the safety of the community.

D.Combination Drugs; Exemption from Certain Requirements. Pursuant to R.S. 40:965, the list of combination drugs and preparations exempted from the application of this Chapter shall be the List of Exempted Prescription Products as identified in the current Code of Federal Regulations, specifically at 21 CFR 1308.32.

E.Excepted Drugs; Exemption from Certain Requirements. Pursuant to R.S. 40:965, the list of excepted drugs and preparations which contain any depressant or stimulant substance listed in Subsections 1, 2, 3, or 4 of Schedule III shall be the List of Exempted Prescription Products as identified in the current Code of Federal Regulations, specifically at 21 CFR 1308.32.

F.Changes in the Schedule of Controlled Substances. Pursuant to changes in the schedule of a controlled substance by either the United States Drug Enforcement Administration or the state of Louisiana, all licensees shall adhere to the more stringent requirement.

AUTHORITY NOTE:Promulgated in accordance with R.S. 40:972.

HISTORICAL NOTE:Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2128 (October 2008).

Subchapter B.Licenses

§2705.Licenses and Exemptions

A.Every person who manufactures, distributes, prescribes, or dispenses any controlled substance or who proposes to engage in the manufacture, distribution, prescribing, or dispensing of any controlled substance shall obtain a Controlled Dangerous Substance (CDS) License

Louisiana Register   Vol. 34, No. 10   October 20, 2008

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