The Florida Senate

893.035  Control of new substances; findings of fact; delegation of authority to Attorney General to control substances by rule.--

(1)(a)  New substances are being created which are not controlled under the provisions of this chapter but which have a potential for abuse similar to or greater than that for substances controlled under this chapter. These new substances are sometimes called "designer drugs" because they can be designed to produce a desired pharmacological effect and to evade the controlling statutory provisions. Designer drugs are being manufactured, distributed, possessed, and used as substitutes for controlled substances.

(b)  The hazards attributable to the traffic in and use of these designer drugs are increased because their unregulated manufacture produces variations in purity and concentration.

(c)  Many such new substances are untested, and it cannot be immediately determined whether they have useful medical or chemical purposes.

(d)  The uncontrolled importation, manufacture, distribution, possession, or use of these designer drugs has a substantial and detrimental impact on the health and safety of the people of Florida.

(e)  These designer drugs can be created more rapidly than they can be identified and controlled by action of the Legislature. There is a need for a speedy and expert administrative determination of their proper classification under this chapter. It is therefore necessary to delegate to an administrative agency restricted authority to identify and classify new substances that have a potential for abuse, so that they can be controlled in the same manner as other substances currently controlled under this chapter.

(2)  The Attorney General shall apply the provisions of this section to any substance not currently controlled under the provisions of s. 893.03 The Attorney General may by rule:

(a)  Add a substance to a schedule established by s. 893.03, or transfer a substance between schedules, if he or she finds that it has a potential for abuse and he or she makes with respect to it the other findings appropriate for classification in the particular schedule under s. 893.03 in which it is to be placed.

(b)  Remove a substance previously added to a schedule if he or she finds the substance does not meet the requirements for inclusion in that schedule.

Rules adopted under this section shall be made pursuant to the rulemaking procedures prescribed by chapter 120.

(3)(a)  The term "potential for abuse" in this section means that a substance has properties as a central nervous system stimulant or depressant or a hallucinogen that create a substantial likelihood of its being:

1.  Used in amounts that create a hazard to the user's health or the safety of the community;

2.  Diverted from legal channels and distributed through illegal channels; or

3.  Taken on the user's own initiative rather than on the basis of professional medical advice.

Proof of potential for abuse can be based upon a showing that these activities are already taking place, or upon a showing that the nature and properties of the substance make it reasonable to assume that there is a substantial likelihood that such activities will take place, in other than isolated or occasional instances.

(b)  The terms "immediate precursor" and "narcotic drug" shall be given the same meanings as provided by s. 102 of the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C. s. 802, as amended and in effect on April 1, 1985.

(4)  In making any findings under this section, the Attorney General shall consider the following factors with respect to each substance proposed to be controlled or removed from control:

(a)  Its actual or relative potential for abuse.

(b)  Scientific evidence of its pharmacological effect, if known.

(c)  The state of current scientific knowledge regarding the drug or other substance.

(d)  Its history and current pattern of abuse.

(e)  The scope, duration, and significance of abuse.

(f)  What, if any, risk there is to the public health.

(g)  Its psychic or physiological dependence liability.

(h)  Whether the substance is an immediate precursor of a substance already controlled under this chapter.

The findings and conclusions of the United States Attorney General or his or her delegee, as set forth in the Federal Register, with respect to any substance pursuant to s. 201 of the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C. s. 811, as amended and in effect on April 1, 1985, shall be admissible as evidence in any rulemaking proceeding under this section, including an emergency rulemaking proceeding under subsection (7).

(5)  Before initiating proceedings under subsection (2), the Attorney General shall request from the Department of Health and the Department of Law Enforcement a medical and scientific evaluation of the substance under consideration and a recommendation as to the appropriate classification, if any, of such substance as a controlled substance. In responding to this request, the Department of Health and the Department of Law Enforcement shall consider the factors listed in subsection (4). The Department of Health and the Department of Law Enforcement shall respond to this request promptly and in writing; however, their response is not subject to chapter 120. If both the Department of Health and the Department of Law Enforcement recommend that a substance not be controlled, the Attorney General shall not control that substance. If the Attorney General determines, based on the evaluations and recommendations of the Department of Health and the Department of Law Enforcement and all other available evidence, that there is substantial evidence of potential for abuse, he or she shall initiate proceedings under paragraph (2)(a) with respect to that substance.

(6)(a)  The Attorney General shall by rule exempt any nonnarcotic substance controlled by rule under this section from the application of this section if such substance may, under the Federal Food, Drug, and Cosmetic Act, be lawfully sold over the counter without a prescription.

(b)  The Attorney General may by rule exempt any compound, mixture, or preparation containing a substance controlled by rule under this section from the application of this section if he or she finds that such compound, mixture, or preparation meets the requirements of either of the following subcategories:

1.  A mixture or preparation containing a nonnarcotic substance controlled by rule, which mixture or preparation is approved for prescription use and which contains one or more other active ingredients which are not listed in any schedule and which are included therein in such combinations, quantity, proportion, or concentration as to vitiate the potential for abuse.

2.  A compound, mixture, or preparation which contains any substance controlled by rule, which is not for administration to a human being or animal, and which is packaged in such form or concentration, or with adulterants or denaturants, so that as packaged it does not present any significant potential for abuse.

(7)(a)  If the Attorney General finds that the scheduling of a substance in Schedule I of s. 893.03 on a temporary basis is necessary to avoid an imminent hazard to the public safety, he or she may by rule and without regard to the requirements of subsection (5) relating to the Department of Health and the Department of Law Enforcement schedule such substance in Schedule I if the substance is not listed in any other schedule of s. 893.03 The Attorney General shall be required to consider, with respect to his or her finding of imminent hazard to the public safety, only those factors set forth in paragraphs (3)(a) and (4)(d), (e), and (f), including actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution.

(b)  The Attorney General may use emergency rulemaking provisions under s. 120.54(4) in scheduling substances under this subsection. Notwithstanding the provisions of s. 120.54(4)(c), any rule adopted under this subsection shall not expire except as provided in subsection (9).

(8)(a)  Upon the effective date of a rule adopted pursuant to this section adding or transferring a substance to a schedule under s. 893.03, such substance shall be deemed included in that schedule, and all provisions of this chapter applicable to substances in that schedule shall be deemed applicable to such substance.

(b)  A rule adopted pursuant to this section shall continue in effect until it is repealed; until it is declared invalid in proceedings under s. 120.56 or in proceedings before a court of competent jurisdiction; or until it expires under the provisions of subsection (9).

(9)  The Attorney General shall report to the Legislature by March 1 of each year concerning the rules adopted under this section during the previous year. Each rule so reported shall expire on the following June 30 unless the Legislature adopts the provisions thereof as an amendment to this chapter.

(10)  The repeal, expiration, or determination of invalidity of any rule shall not operate to create any claim or cause of action against any law enforcement officer or other enforcing authority for actions taken in good faith in reliance on the validity of the rule.

(11)  In construing this section, due consideration and great weight should be given to interpretations of the United States Attorney General and the federal courts relating to s. 201 of the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C. s. 811, as amended and in effect on April 1, 1985. All substantive rules adopted under this part shall not be inconsistent with the rules of the United States Attorney General and the decisions of the federal courts interpreting the provisions of s. 201 of the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C. s. 811, as amended and in effect on April 1, 1985.

(12)  The adoption of a rule transferring a substance from one schedule to another or removing a substance from a schedule pursuant to this section shall not affect prosecution or punishment for any crime previously committed with respect to that substance.

History.--s. 3, ch. 85-242; s. 72, ch. 87-226; s. 255, ch. 94-218; s. 318, ch. 96-410; s. 1826, ch. 97-102; s. 16, ch. 99-186.