HB550 (2017) Detail

Establishing a controlled drug scientific review board.


HB 550-FN - AS INTRODUCED

 

 

2017 SESSION

17-0124

01/10

 

HOUSE BILL 550-FN

 

AN ACT establishing a controlled drug scientific review board.

 

SPONSORS: Rep. Ammon, Hills. 40; Rep. Fraser, Belk. 1; Rep. Avellani, Carr. 5

 

COMMITTEE: Health, Human Services and Elderly Affairs

 

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ANALYSIS

 

This bill establishes the controlled drug scientific review board whose duty shall be to ensure that all provisions of RSA 318-B are enforced.  The board is granted rulemaking authority for the purposes of the bill.

 

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Explanation: Matter added to current law appears in bold italics.

Matter removed from current law appears [in brackets and struckthrough.]

Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.

17-0124

01/10

 

STATE OF NEW HAMPSHIRE

 

In the Year of Our Lord Two Thousand Seventeen

 

AN ACT establishing a controlled drug scientific review board.

 

Be it Enacted by the Senate and House of Representatives in General Court convened:

 

1  New Paragraph; Controlled Drug Act; Definition Added.  Amend RSA 318-B:1 by inserting after paragraph III the following new paragraph:

III-a.  “Board” means the controlled drug scientific review board established under RSA 318-B:1-d.

2  New Section; Controlled Drug Act; Controlled Drug Scientific Review Board.  Amend RSA 318-B by inserting after section 1-c the following new section:

318-B:1-d  Controlled Drug Scientific Review Board; Composition; Compensation.

I.  There is hereby established a controlled drug scientific review board.  The board shall consist of 7 members, including one psychiatrist actively engaged in the treatment of substance use disorders, one addiction medicine physician, one pharmacist experienced in the use of controlled substances, one clinical researcher active in medical applications of controlled substances, one psychologist or qualified therapist engaged in counseling for substance use disorder recovery, one member of state, county, or municipal law enforcement, and one public member, each to be appointed by the governor, with the approval of the council.  Terms of board members shall be 3 years, except the initial appointments shall be staggered so that no more than 1/3 of the members’ terms shall expire in the same year.  No member shall be appointed to more than 2 consecutive terms and no member shall serve for more than 6 consecutive years.  Only board members provided for in this section shall have the authority to vote in board determinations.  Scientific members of the board shall have been practicing in their fields for at least 3 years and shall have practiced in this state for at least 2 years.  The public member of the board shall be a person who is not, and never was, a psychiatrist, physician, pharmacist, clinical researcher, psychologist, therapist, member of law enforcement, or the spouse of any such person, and does not have, and never has had, a material financial interest in either the sale of controlled substances or an activity directly related to controlled substances, including the representation of the board or members’ professions for a fee at any time during the 5 years preceding appointment.

II.  The members of the board shall be paid $100 per day and necessary expenses while engaged in the performance of their duties.

III.  The board shall have a president, vice-president, secretary, and a treasurer who shall be elected from among their number upon creation and then annually in the month of September.  The president shall serve as chief executive officer of the board and shall preside at all meetings and hearings of the board and shall appoint any subcommittees from among the members as deemed necessary.  In the absence of the president, the vice-president shall perform the duties of the president.

IV.  Notwithstanding RSA 21-G:9, the board shall adopt rules, pursuant to RSA 541-A, relative to:

(a)  Adding, deleting or rescheduling controlled substances to the schedule under this chapter.

(b)  The annual recertification and publication of the schedule under this chapter.

(c)  Exempting preparations pursuant to RSA 318-B:11.

(d)  The approval of investigational trials of scheduled substances by qualified practitioners and institutions.  All investigators, patients, and institutions for such studies shall be residents of or incorporated in the state.

(e)  Governing the shipping of such substances to the state, as required by the studies under subparagraph (d).

(f)  Communicating with federal rulemaking agencies and bodies regarding discrepancies between the state schedule and the federal schedule.

(g)  Investigations and hearings on controlled drugs under RSA 318-B:1, VI.

V.  It shall be the duty of the board, through officials and employees appointed by it or under its supervision for that purpose, and of all peace officers within the state, and of all county attorneys, to enforce all the provisions of RSA 318-B:1-a, RSA 318-B:1-b, and this section.  When so requested, the department and its officials and employees shall cooperate with the board in collecting and analyzing samples of controlled substances used in violation of this chapter.  The members of the board, its inspectors and investigators shall have free access during business hours to all places where controlled substances are held, stored, or offered for sale and to all records of sale and disposition of drugs.

3  Controlled Drug Act; Scheduling by the Commissioner; Schedule Tests.  Amend RSA 318-B:1-a and RSA 318-B:1-b to read as follows:

318-B:1-a  Scheduling by the Commissioner.

I.  The board may add, delete, or reschedule all substances, by rule, pursuant to RSA 541-A, after hearing and after consulting with the pharmacy board.  In making a determination regarding a substance, the [commissioner] board shall consider the following:

(a)  Actual or relative potential for abuse;

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

(c)  State of current scientific knowledge regarding the substance;

(d)  History and current pattern of abuse;

(e)  Scope, duration, and significance of abuse;

(f)  Risk to the public health;

(g)  Potential of the substance to produce psychic or physical dependence liability; and

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

II.  After considering the factors in paragraph I, the [commissioner] board shall make findings relative to the substance and adopt a rule [controlling] incorporating the findings of the board regarding the substance [if he finds the substance has a potential for abuse] by a 3/5 vote of the board.  In the case of a simple majority vote of the board to adopt a rule, the rule shall be adopted only upon approval of the rule by the commissioner.

III.  In addition to the provisions of RSA 541-A, the [commissioner] board shall give due notice of the time, place and purpose of all hearings required under this chapter to podiatrists, osteopaths, hospitals, pharmacists, physicians, dentists, veterinarians, advanced registered nurse practitioners, optometrists, laboratories, registered manufacturers, suppliers and to the general public by such means as he shall deem adequate.  From and after the hearing date, the sale or dispensation (except by prescription) of a drug or chemical containing any quantity of such substance as is the subject matter of the hearing shall be suspended pending a determination as to whether such substance is to be designated as a controlled drug.  Designation as a controlled drug shall result in the continued suspension of the sale or dispensation (except by prescription) of any drug or chemical containing any quantity of such substance until the effective date of the designation.  The substance shall thereafter be a controlled drug subject to this chapter.  If any substance is so designated, the commissioner shall publish the designation in a newspaper of general circulation in the state once each week for 3 successive weeks.

IV.  Substances which are precursors of the controlled precursor shall not be subject to control solely because they are precursors of the controlled precursor.

V.  If any substance is designated, rescheduled, or deleted as a controlled substance under federal law and notice thereof is given to the commissioner, the commissioner shall direct the board to similarly control the substance under this chapter after the expiration of 30 days from publication in the Federal Register of a final order designating a substance as a controlled substance or rescheduling or deleting a substance, unless, within that 30 day period, the [commissioner] board objects to inclusion, rescheduling, or deletion.  In that case, the [commissioner] board shall publish the reasons for objection and afford all interested persons an opportunity to be heard.  At the conclusion of the hearing, the [commissioner] board shall publish [his] its decision, and the commissioner shall adopt the decision as a rule using the procedure under paragraph II, which shall be final unless altered by law.  Upon publication of objection to inclusion, rescheduling, or deletion under this chapter by the [commissioner] board, control under this chapter shall be stayed until the [commissioner] board publishes [his] its decision.

VI.  Authority to control under this section shall not extend to distilled spirits, wine, malt beverages, or tobacco.

VII.  Controlled drugs shall be scheduled by whatever official, common, usual, chemical or trade name designated.

VIII.  The [commissioner] board shall revise and republish the schedules in RSA 318-B:1-b semi-annually for 2 years from the effective date of this section, and thereafter annually.  The schedule shall be complete and include the findings of the board for each drug on the schedule.

318-B:1-b  Schedule Tests.

I.  Schedule I Tests.  The [commissioner] the board shall place a substance in schedule I if [he finds] it is found that the substance:

(a)  Has high potential for abuse; and

(b)  Has no accepted medical use in treatment in the [United States] scientific community or lacks [accepted] acceptable peer reviewed safety protocols for use in treatment under medical supervision.

II.  Schedule II Tests.  The [commissioner] board shall place a substance in schedule II if [he finds] it is found that:

(a)  The substance has high potential for abuse;

(b)  The substance has currently accepted medical use in treatment in the [United States] scientific community, or currently accepted medical use with severe restrictions; and

(c)  The abuse of the substance may lead to severe psychic or physical dependence.

III.  Schedule III Tests.  The [commissioner] the board shall place a substance in schedule III if [he finds] it is found that:

(a)  The substance has a potential for abuse less than the substances listed in schedules I and II of the state schedule or current [chapter] Title 21, Code of Federal Regulations;

(b)  The substance has currently accepted medical use in treatment in the [United States] scientific community; and

(c)  Abuse of the substance may lead to moderate or low physical dependence or high psychological dependence.

IV.  Schedule IV Tests.  The [commissioner] the board shall place a substance in schedule IV if [he finds] it is found that:

(a)  The substance has a low potential for abuse relative to substances listed in the state schedule or schedule III of the current [chapter] Title 21, Code of Federal Regulations;

(b)  The substance has currently accepted medical use in treatment in the [United States] scientific community; and

(c)  Abuse of the substance may lead to limited physical dependence or psychological dependence relative to the substances in schedule III of the state schedule or current [chapter] Title 21, Code of Federal Regulations.

V.  Schedule V Tests.  The [commissioner] board shall place a substance in schedule V if [he finds] it is found that:

(a)  The substance has a low potential for abuse relative to substances listed in schedule IV of the state schedule or current [chapter] Title 21, Code of Federal Regulations;

(b)  The substance has currently accepted medical use in treatment in the [United States] scientific community; and

(c)  The substance has limited physical dependence liability or psychological dependence liability relative to the substances in schedule IV of the state schedule or current [chapter] Title 21, Code of Federal Regulations.

4  Repeal.  RSA 318-B:24, I(a), relative to investigations and hearings on controlled drugs, is repealed.

5  Effective Date.  This act shall take effect January 1, 2018.

 

LBAO

17-0124

1/12/17

 

HB 550-FN- FISCAL NOTE

as introduced

 

AN ACT establishing a controlled drug scientific review board.

 

FISCAL IMPACT:      [ X ] State              [    ] County               [    ] Local              [    ] None

 

 

 

Estimated Increase / (Decrease)

STATE:

FY 2018

FY 2019

FY 2020

FY 2021

   Appropriation

$0

$0

$0

$0

   Revenue

$0

$0

$0

$0

   Expenditures

Indeterminable Increase

Indeterminable Increase

Indeterminable Increase

Indeterminable Increase

Funding Source:

  [ X ] General            [    ] Education            [    ] Highway           [    ] Other

 

METHODOLOGY:

This bill establishes a seven-member controlled drug review board to ensure the provisions of RSA 318:B are enforced and adopt rules related to scheduling controlled substances, investigative trials of scheduled substances, shipping of such substances in-state, investigations and hearings, and communications with federal regulatory authorities.  The Department of Health and Human Services assumes the board would meet one day per month as well as require a Program Specialist I (1 FTE) and a Pharmacy Board Compliance Inspector (1 FTE) position to fulfill statutory duties.  Based on the effective date of the bill,  estimated costs are as follows:

Expenditure Type

FY 2018

FY 2019

FY 2020

FY 2021

Program Specialist I

   Salary

$19,000

$39,000

$41,000

$43,000

   Benefits

$12,000

$26,000

$28,000

$29,000

   Position Total

$31,000

$65,000

$69,000

$72,000

Pharmacy Compliance Inspector*

   Salary

$27,000

$55,000

$57,000

$60,000

   Benefits

$14,000

$29,000

$31,000

$33,000

   Position Total

$42,000

$84,000

$88,000

$93,000

Board Member Per Diem (excludes mileage)

$4,200

$8,400

$8,400

$8,400

Other

$11,000

$700

$700

$700

TOTAL

$88,200

$158,100

$166,100

$174,000

*Pharmacists employed by the State receive a 30 percent salary enhancement through June 30, 2017 in accordance with a March 26, 2015 decision of the Department of Administrative Services and RSA 99:8. The salary enhancement is not included for the Pharmacy Board Compliance Inspector position.

 

The Department notes components of the proposed legislation potentially duplicate existing duties of the Board of Pharmacy established under RSA 318:2-5-a.

 

AGENCIES CONTACTED:

Department of Health and Human Services

 

 

Links

HB550 at GenCourtMobile

Action Dates

Date Body Type
Jan. 31, 2017 House Hearing
Feb. 7, 2017 House Exec Session
Feb. 15, 2017 House Floor Vote

Bill Text Revisions

HB550 Revision: 289 Date: Jan. 25, 2017, 3:58 p.m.

Docket

Date Status
Jan. 5, 2017 Introduced 01/05/2017 and referred to Health, Human Services and Elderly Affairs HJ 3 P. 18
Jan. 31, 2017 Public Hearing: 01/31/2017 11:00 AM LOB 205
Feb. 7, 2017 Executive Session: 02/07/2017 LOB 205
Feb. 15, 2017 Committee Report: Inexpedient to Legislate for 02/15/2017 (Vote 19-1; CC)
Feb. 15, 2017 Inexpedient to Legislate: MA VV 02/15/2017 HJ 7 P. 16