Relating to
Scheduling suvorexant as a schedule IV controlled substance.
Rule Type
Permanent.
1. Finding/Nature of Emergency (Emergency Rule Only)
N/A
2. Detailed Description of the Objective of the Proposed Rule
The objective of the proposed rule is to schedule suvorexant as a Schedule IV controlled substance.
3. Description of the Existing Policies Relevant to the Rule, New Policies Proposed to be Included in the Rule, and an Analysis of Policy Alternatives
On August 28, 2014, the United States Food and Drug Administration, Drug Enforcement Administration published its final rule in the Federal Register placing suvorexant into Schedule IV of the federal Controlled Substances Act. The scheduling action was effective September 29, 2014. The Controlled Substances Board did not receive an objection to similarly treat suvorexant as a schedule IV under ch.
961, Stats., within 30 days of the date of publication in the federal register of the final order designating tramadol as a controlled substance.
Pursuant to s.
961.11 (4), Stats., the Controlled Substances Board took affirmative action to similarly treat suvorexant under ch.
961, Stats., by creating the following:
CSB 2.38 Addition of suvorexant to schedule IV. Section
961.20 (2) (mr), Stats., is created to read:
961.20 (2) (mr) Suvorexant
The Affirmative Action order, dated October 8, 2014, will take effect on November 1, 2014 to allow for publication in the Administrative Register and expires upon promulgation of a final rule.
4. Detailed Explanation of Statutory Authority for the Rule (Including the Statutory Citation and Language)
961.11 (2) After considering the factors enumerated in sub. (1m), the controlled substances board shall make findings with respect to them and promulgate a rule controlling the substance upon finding that the substance has a potential for abuse.
961.11 (4) If a substance is designated, rescheduled or deleted as a controlled substance under federal law and notice thereof is given to the controlled substances board, the board by affirmative action shall similarly treat the substance under this chapter after the expiration of 30 days from the date of publication in the federal register of a final order designating the substance as a controlled substance or rescheduling or deleting the substance or from the date of issuance of an order of temporary scheduling under
21 USC 811 (h), unless within that 30-day period, the board or an interested party objects to the treatment of the substance. If no objection is made, the board shall promulgate, without making the determinations or findings required by subs. (1), (1m), (1r) and (2) or s.
961.13,
961.15,
961.17,
961.19 or
961.21, a final rule, for which notice of proposed rulemaking is omitted, designating, rescheduling, temporarily scheduling or deleting the substance. If an objection is made the board shall publish notice of receipt of the objection and the reasons for objection and afford all interested parties an opportunity to be heard. At the conclusion of the hearing, the board shall make a determination with respect to the treatment of the substance as provided in subs. (1), (1m), (1r) and (2) and shall publish its decision, which shall be final unless altered by statute. Upon publication of an objection to the treatment by the board, action by the board under this chapter is stayed until the board promulgates a rule under sub. (2).
5. Estimate of Amount of Time that State Employees Will Spend Developing the Rule and of Other Resources Necessary to Develop the Rule
25 hours
6. List with Description of all Entities that may be Affected by the Proposed Rule
Pharmacists, prescribers, courts, police, and the Controlled Substances Board.
7. Summary and Preliminary Comparison with any Existing or Proposed Federal Regulation that is Intended to Address The Activities to be Regulated by the Proposed Rule
On July 2, 2014, the United States Food and Drug Administration, Drug Enforcement Administration published its final rule in the Federal Register placing suvorexant into Schedule IV of the federal Controlled Substances Act. The scheduling action was effective September 29, 2014.
8. Anticipated Economic Impact of Implementing the Rule (Note if the Rule is Likely to Have a Significant Economic Impact on Small Businesses)
None to minimal. It is not likely to have a significant economic impact on small businesses.
Contact Person
Sharon Henes, Administrative Rules Coordinator, (608) 261-2377
Controlled Substances Board
This statement of scope was approved by the governor on November 12, 2014.
Rule No.
Relating to
Scheduling tramadol as a schedule IV controlled substance.
Rule Type
Permanent.
1. Finding/Nature of Emergency (Emergency Rule Only)
N/A
2. Detailed description of the objective of the proposed rule
The objective of the proposed rule is to schedule tramadol as a Schedule IV controlled substance.
3. Description of the Existing Policies Relevant to the Rule, New Policies Proposed to be Included in the Rule, and an Analysis of Policy Alternatives
On July 2, 2014, the United States Food and Drug Administration, Drug Enforcement Administration published its final rule in the Federal Register placing tramadol into schedule IV of the federal Controlled Substances Act. The scheduling action was effective August 18, 2014. The Controlled Substances Board did not receive an objection to similarly treat tramadol as a schedule IV under ch.
961, Stats., within 30 days of the date of publication in the federal register of the final order designating tramadol as a controlled substance.
Pursuant to s.
961.11 (4), Stats., the Controlled Substances Board took affirmative action to similarly treat tramadol under chapter 961, Stats., by creating the following:
CSB 2.36 Addition of tramadol to schedule IV. Section
961.20 (4) (e), Stats., is created to read:
961.20 (4) (e) Tramadol, including any of its isomers and salts of isomers.
The Affirmative Action order, dated August 14, 2014, took effect on September 1, 2014 to allow for publication in the Administrative Register and expires upon promulgation of a final rule.
4. Detailed Explanation of Statutory Authority for the Rule (Including the Statutory Citation and Language)
961.11 (2) After considering the factors enumerated in sub. (1m), the controlled substances board shall make findings with respect to them and promulgate a rule controlling the substance upon finding that the substance has a potential for abuse.
961.11 (4) If a substance is designated, rescheduled or deleted as a controlled substance under federal law and notice thereof is given to the controlled substances board, the board by affirmative action shall similarly treat the substance under this chapter after the expiration of 30 days from the date of publication in the federal register of a final order designating the substance as a controlled substance or rescheduling or deleting the substance or from the date of issuance of an order of temporary scheduling under
21 USC 811 (h), unless within that 30-day period, the board or an interested party objects to the treatment of the substance. If no objection is made, the board shall promulgate, without making the determinations or findings required by subs. (1), (1m), (1r) and (2) or s.
961.13,
961.15,
961.17,
961.19 or
961.21, a final rule, for which notice of proposed rulemaking is omitted, designating, rescheduling, temporarily scheduling or deleting the substance. If an objection is made the board shall publish notice of receipt of the objection and the reasons for objection and afford all interested parties an opportunity to be heard. At the conclusion of the hearing, the board shall make a determination with respect to the treatment of the substance as provided in subs. (1), (1m), (1r) and (2) and shall publish its decision, which shall be final unless altered by statute. Upon publication of an objection to the treatment by the board, action by the board under this chapter is stayed until the board promulgates a rule under sub. (2).
5. Estimate of Amount of Time that State Employees Will Spend Developing the Rule and of Other Resources Necessary to Develop the Rule
25 hours
6. List with Description of all Entities that may be Affected by the Proposed Rule
Pharmacists, prescribers, courts, police, and the Controlled Substances Board
7. Summary and Preliminary Comparison with any Existing or Proposed Federal Regulation that is Intended to Address the Activities to be Regulated by the Proposed Rule
On July 2, 2014, the United States Food and Drug Administration, Drug Enforcement Administration published its final rule in the Federal Register placing tramadol into Schedule IV of the federal Controlled Substances Act. The scheduling action was effective August 18, 2014.
8. Anticipated Economic Impact of Implementing the Rule (Note if the Rule is Likely to Have a Significant Economic Impact on Small Businesses)
None to minimal. It is not likely to have a significant economic impact on small businesses.
Contact Person
Sharon Henes, Administrative Rules Coordinator, (608) 261-2377
Controlled Substances Board
This statement of scope was approved by the governor on November 14, 2014.
Rule No.
Relating to
Rescheduling hydrocodone combination products as schedule II controlled substances.
Rule Type
Permanent.
1. Finding/Nature of Emergency (Emergency Rule Only)
N/A
2. Detailed Description of the Objective of the Proposed Rule
The objective of the proposed rule is reschedule hydrocodone combination products from schedule III to schedule II controlled substance.
3. Description of the Existing Policies Relevant to the Rule, New Policies Proposed to be Included in the Rule, and an Analysis of Policy Alternatives
On August 22, 2014, the United States Food and Drug Administration, Drug Enforcement Administration published its final rule in the Federal Register rescheduling hydrocodone combination products from schedule III to schedule II of the federal Controlled Substances Act. The scheduling action was effective October 6, 2014. The Controlled Substances Board did not receive an objection to similarly treat hydrocodone combination products as a Schedule II under ch.
961, Stats., within 30 days of the date of publication in the federal register of the final order designating hydrocodone combination products as a controlled substance.
Pursuant to s.
961.11 (4), Stats., the Controlled Substances Board took affirmative action to similarly treat hydrocodone combination products under ch.
961, Stats., by creating the following:
CSB 2.37 Rescheduling of hydrocodone combination products. Sections 961.18 (5) (c) and (d), Stats., are repealed.
The Affirmative Action order, dated October 7, 2014, will take effect on November 1, 2014, to allow for publication in the Administrative Register and expires upon promulgation of a final rule.
4. Detailed Explanation of Statutory Authority for The Rule (Including the Statutory Citation and Language)
961.11 (2) After considering the factors enumerated in sub. (1m), the controlled substances board shall make findings with respect to them and promulgate a rule controlling the substance upon finding that the substance has a potential for abuse.
961.11 (4) If a substance is designated, rescheduled or deleted as a controlled substance under federal law and notice thereof is given to the controlled substances board, the board by affirmative action shall similarly treat the substance under this chapter after the expiration of 30 days from the date of publication in the federal register of a final order designating the substance as a controlled substance or rescheduling or deleting the substance or from the date of issuance of an order of temporary scheduling under
21 USC 811 (h), unless within that 30-day period, the board or an interested party objects to the treatment of the substance. If no objection is made, the board shall promulgate, without making the determinations or findings required by subs. (1), (1m), (1r) and (2) or s.
961.13,
961.15,
961.17,
961.19 or
961.21, a final rule, for which notice of proposed rulemaking is omitted, designating, rescheduling, temporarily scheduling or deleting the substance. If an objection is made the board shall publish notice of receipt of the objection and the reasons for objection and afford all interested parties an opportunity to be heard. At the conclusion of the hearing, the board shall make a determination with respect to the treatment of the substance as provided in subs. (1), (1m), (1r) and (2) and shall publish its decision, which shall be final unless altered by statute. Upon publication of an objection to the treatment by the board, action by the board under this chapter is stayed until the board promulgates a rule under sub. (2).
5. Estimate of Amount of Time that State Employees Will Spend Developing the Rule and of Other Resources Necessary to Develop the Rule
25 hours
6. List with Description of all Entities that may be Affected by the Proposed Rule
Pharmacists, prescribers, courts, police, and the Controlled Substances Board.
7. Summary and Preliminary Comparison with any Existing or Proposed Federal Regulation that is Intended to Address the Activities to be Regulated by the Proposed Rule
On August 22, 2014, the United States Food and Drug Administration, Drug Enforcement Administration published its final rule in the Federal Register rescheduling hydrocodone combination products from schedule III to schedule II of the federal Controlled Substances Act. The scheduling action was effective October 6, 2014.
8. Anticipated Economic Impact of Implementing the Rule (Note if the Rule is Likely to Have a Significant Economic Impact on Small Businesses)
None to minimal. It is not likely to have a significant economic impact on small businesses.
