Bill Text - SB581 (2018)

(Second New Title) relative to compounding of drugs and establishing a committee to study rulemaking authority for reconstituted drugs.


Revision: May 2, 2018, 1:24 p.m.

SB 581-FN - AS AMENDED BY THE HOUSE

 

03/14/2018   0976s

2May2018... 1718h

2018 SESSION

18-2755

01/03

 

SENATE BILL 581-FN

 

AN ACT relative to compounding of drugs and establishing a committee to study rulemaking authority for reconstituted drugs.

 

SPONSORS: Sen. Sanborn, Dist 9

 

COMMITTEE: Health and Human Services

 

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AMENDED ANALYSIS

 

This bill amends the definition of compounding for the purposes of the law regulating pharmacists and pharmacies.  This bill also establishes a study committee to study rulemaking authority for reconstituted drugs.

 

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Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.

03/14/2018   0976s

2May2018... 1718h 18-2755

01/03

 

STATE OF NEW HAMPSHIRE

 

In the Year of Our Lord Two Thousand Eighteen

 

AN ACT relative to compounding of drugs and establishing a committee to study rulemaking authority for reconstituted drugs.

 

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

 

1  Pharmacists and Pharmacies; Definitions.  Amend RSA 318:1, III-a to read as follows:

III-a.  "Compounding'' means the preparation, mixing, assembling, packaging or labeling of a drug or device as a result of a practitioner's prescription drug order or initiative based on the pharmacist-patient-prescriber relationship in the course of professional practice or, for the purpose of, or as an incident, to research, teaching, or chemical analysis, but not selling or dispensing.  "Compounding'' also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.  "Compounding'' shall not include the reconstitution of powdered formulations before dispensing or the addition of flavoring.  "Compounding" shall not include the simple addition of flavoring, nor shall it include the preparation of a single dose of a non-hazardous commercially available drug or licensed biologic for administration within 2 hours of preparation to an individual patient when done in accordance with the manufacturer's approved labeling or instructions consistent with that labeling.

2  Committee Established.  There is established a committee to study rulemaking authority for reconstituted drugs.

3  Membership and Compensation.

I.  The members of the committee shall be as follows:

(a)  Three members of the house of representatives, at least 2 of whom shall be from the house executive departments and administration committee, appointed by the speaker of the house of representatives.

(b)  One member of the senate, appointed by the president of the senate.

II.  Members of the committee shall receive mileage at the legislative rate when attending to the duties of the committee.

4  Duties.  The committee shall study rulemaking authority for reconstituted drugs.  The committee shall solicit information and testimony from any individual or entity the committee deems relevant to its study.

5  Chairperson; Quorum.  The members of the study committee shall elect a chairperson from among the members.  The first meeting of the committee shall be called by the first-named house member.  The first meeting of the committee shall be held within 45 days of the effective date of this section.  Three members of the committee shall constitute a quorum.

6  Report.  The committee shall report its findings and any recommendations for proposed legislation to the speaker of the house of representatives, the president of the senate, the house clerk, the senate clerk, the governor, and the state library on or before November 1, 2018.

7  Effective Date.  This act shall take effect upon its passage.

 

LBAO

18-2755

1/16/18

 

SB 581-FN- FISCAL NOTE

AS INTRODUCED

 

AN ACT relative to pharmacy benefit managers under the managed care law.

 

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

 

 

 

Estimated Increase / (Decrease)

STATE:

FY 2019

FY 2020

FY 2021

FY 2022

   Appropriation

$0

$0

$0

$0

   Revenue

Indeterminable

Indeterminable

Indeterminable

Indeterminable

   Expenditures

Indeterminable

Indeterminable

Indeterminable

Indeterminable

Funding Source:

  [ X ] General            [    ] Education            [    ] Highway           [ X ] Other - Federal matching Medicaid Funds

 

 

 

 

 

COUNTY:

 

 

 

 

   Revenue

$0

$0

$0

$0

   Expenditures

Indeterminable

Indeterminable

Indeterminable

Indeterminable

 

 

 

 

 

LOCAL:

 

 

 

 

   Revenue

$0

$0

$0

$0

   Expenditures

Indeterminable

Indeterminable

Indeterminable

Indeterminable

 

METHODOLOGY:

This bill prohibits a health carrier or pharmacy benefit manager from requiring accreditation, credentialing, or licensing of a provider by a nongovernmental body, or from preventing a provider from dispensing a new drug product for which the provider meets dispensing guidelines, or from otherwise discriminating against a provider.  The Insurance Department is unable to predict what impact, if any, the bill will have on health insurance premiums, and so the impact on insurance premium tax revenue is indeterminable.  The Department of Health and Human Services states that although it is not directly subject to the bill, it is possible its provisions could affect the price and cost of prescription medications for Medicaid enrollees.  The Department is unable to determine the extent, if any, of these impacts.

 

This bill contains penalties that may have an impact on the New Hampshire judicial system.  There is no method to determine how many charges would be brought as a result of the changes contained in this bill to determine the fiscal impact on expenditures.  However, the Judicial Branch has provided the potential costs associated with these penalties below.

 

 

FY 2019

FY 2020

Complex Civil Case

$737

$745

Complex Equity Case

$740

$746

Appeals

Varies

Varies

 

AGENCIES CONTACTED:

Department of Health and Human Services, Insurance Department, and Judicial Branch