STATE OF WISCONSIN
CONTROLLED SUBSTANCES BOARD
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IN THE MATTER OF RULE-MAKING : ORDER OF THE
PROCEEDINGS BEFORE THE : CONTROLLED SUBSTANCES BOARD
CONTROLLED SUBSTANCES BOARD : ADOPTING RULES
: (CLEARINGHOUSE RULE 19-157)
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ORDER
An order of the Controlled Substances Board to renumber and amend CSB 3.04 (7); to amend CSB 3.02 (4), 3.03 (2), 3.04 (1) (a) and (note), (b), (c), and (d), (3) (intro) and (b), (4) (a) (intro.) and (5) (a) (intro.); and to create CSB 3.03 (2m), 3.042, and 3.08 (1) (f) and (g) relating to special use authorizations.
Analysis prepared by the Department of Safety and Professional Services.
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ANALYSIS
Statutes interpreted: s. 961.335, Stats. Explanation of agency authority:
The controlled substances board may promulgate rules relating to the granting of special use permits including, but not limited to, requirements for the keeping and disclosure of records, filing of applications and suspension or revocation of permits. [s. 961.335 (8), Stats.] Related statute or rule: s. 961.335, Stats. Plain language analysis:
Section 1 updates the rule to reflect current drafting standards by removing the phrase “but are not limited to.”
Sections 2 and 3 separates the current CSB 3.03 (2) into two separate subsections to create clarity. Special use authorizations are issued to individuals only. If a permit is issued to an individual who is designated by a college or university, or research unit, the students, laboratory technicians, research specialists or chemical analysts under the individual’s supervision do not need to obtain a special use authorization.
Section 4 updates language and creates clarity. This section removes “checklists” from the application and updates the note to reflect the current address. The reference to s. 961.335 is removed because the statute does not state the fee is $25; rather it says up to $25. The current rule creates difficulty in applying for a special use authorization because it requires proof an application is submitted to the federal Drug Enforcement Administration and the Drug Enforcement Administration will not accept an application without proof the individual has a special use authorization. To resolve this situation, the proposed rule requires an affidavit that the individual intends to file an application with the Drug Enforcement Administration. Lastly this section removes proof of compliance with the requirements for security and instead requires a plan for security. Section 5 clarifies that individuals providing euthanasia at humane shelters shall provide the documentation in the application including their completion of a board-approved euthanasia by injection course. In addition, for dog trainers and animal control applicants, it removes the phrase “unless other documentation is required by the board” to clarify that the letter is the requirement.
Section 6 moves the board’s discretion to request an appearance to the general application requirements to create clarity.
Section 7 creates the storage requirements. Controlled substances shall be stored in a safe or steel cabinet. The safe or cabinet must be bolted or cemented to the floor if it is less than 750 pounds so that it can’t be readily removed. It must meet requirements for forced entry and housed in a room which is locked during non-use hours. Other secure storage areas may be approved by the Controlled Substances Board if the storage will protect the controlled substances from theft and unauthorized use. The controlled substances must be locked up unless in use by the authorized user.
Sections 8, 9, 10 and 11 amends language to reflect the acronym “SUA” and defined term “SUA permit” for consistency throughout the rule.
Section 12 clarifies that it is a violation to not obtain a drug enforcement administration registration or if there is a violation of a state or federal law relating to controlled substances.
Summary of, and comparison with, existing or proposed federal regulation:
The federal government requires security controls for non-practitioners storing controlled substances. The drugs are to be stored in a safe or steel cabinet with the following specifications: 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against lock manipulation, and 20 man-hours against radiological techniques. If the safe or steel cabinet weighs less than 750 pounds, it must be bolted or cemented to the floor or wall in a way that it can’t be readily removed. The room must limit access during working hours and provide security after working hours.
Comparison with rules in adjacent states:
Illinois: In Illinois, every person who, or proposes to, manufacture, distribute, or dispense any controlled substances; engages in chemical analysis, research, or instructional activities which utilize controlled substances; purchases, stores, or administers euthanasia drugs, provides canine odor detection services; must obtain a registration issued by the Department of Financial and Professional Regulation. Registered persons may possess, manufacture, distribute, or dispense controlled substances, or administer euthanasia drugs to the extent authorized by their registration. Registration is site-specific, so persons operating at more than one site must have a separate registration for each. A registration to manufacture, distribute, or dispense a controlled substance or purchase, store, or administer euthanasia drugs may be denied, refused renewal, suspended or revoked if a person does any of the following: provided false or fraudulent material information in any application; has been convicted of a felony related to any controlled substance; has had their federal DEA registration suspended or revoked; has been convicted of bribery, perjury or other infamous crime; violated any provision of the controlled substances act; or failed to provide effective controls against the diversion of controlled substances in other than legitimate medical, scientific or industrial channels. [Ill. Admin. Code 77 § 3100]
Iowa:
In Iowa, researchers, analytical laboratories, animal shelters, dog training facilities, and teaching institutions are required to apply for a controlled substances registration permit with the Pharmacy Board. Registration applies to one site only, so persons operating at more than one site must have separate registrations for each. Registered persons may possess, manufacture, distribute, dispense, or conduct research using controlled substances to the extent authorized by their registration only and in conformity with the other provisions of Iowa’s controlled substances registration law. A registration to manufacture, distribute, dispense, prescribe, import or export, conduct research or instructional activities or conduct chemical analysis with controlled substances may be denied if the board determines that the issuance of the registration would be inconsistent with the public interest. In determining the public interest, the board shall consider the following factors: maintenance of effective controls against diversion of controlled substances into other than legitimate medical, scientific or industrial channels; compliance with applicable state and local law; any convictions related to any controlled substance; past experience in the manufacture or distribution of controlled substances, and the existence in the applicant’s establishment of effective controls against diversion; furnishing false or fraudulent material in any application for registration; suspension or revocation of the federal DEA registration; and any other factors relevant to and consistent with the public health and safety. [Iowa Admin. Code r. 657-10]
Michigan:
In Michigan, an individual in charge of a licensed dog pound or animal shelter, must obtain both a Drug Enforcement Agency (DEA) controlled substance registration and a Michigan controlled substance license for the limited purpose of buying, possessing, or administering a commercially prepared, premixed solution of sodium pentobarbital to practice euthanasia on animals. Michigan officers or state employees are exempted from licensure if that person is engaged in the enforcement of a state or local law relating to controlled substances and who is duly authorized to possess controlled substances in the course of that person's duties. Licensed researchers and manufacturers of a controlled substance may conduct research with those substances, perform chemical analysis, manufacture the substance, distribute the substance to other persons who are licensed or authorized, and conduct instructional activities with the substances. Certain activities involving schedule 1 controlled substances may require a separate license. The license shall be granted unless the issuance of the license would be inconsistent with the public interest. In determining the public interest, the following shall be considered: maintenance of effective controls against diversion to other than legitimate and professionally recognized therapeutic, scientific, or industrial channels; compliance with applicable state and local law; conviction relating to a controlled substance; past experience in the manufacture or distribution of controlled substances and the existence in the applicant’s establishment of effective controls against diversion; furnishing false or fraudulent material in an application for a controlled substance license; suspension or revocation of the federal DEA registration; and any other factor relevant to and consistent with the public health and safety. [Mich. Admin. Code r. 338]
