SB350 (2018) Detail

Relative to biological products dispensed by pharmacists.


SB 350 - AS AMENDED BY THE SENATE

 

03/22/2018   1096s

03/22/2018   1125s

 

2018 SESSION

18-2758

03/05

 

SENATE BILL 350

 

AN ACT relative to biological products dispensed by pharmacists.

 

SPONSORS: Sen. Innis, Dist 24; Sen. Avard, Dist 12; Sen. Fuller Clark, Dist 21; Sen. Hennessey, Dist 5; Rep. T. Wolf, Hills. 7; Rep. L. Ober, Hills. 37; Rep. Weber, Ches. 1

 

COMMITTEE: Health and Human Services

 

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ANALYSIS

 

This bill establishes requirements for dispensing and substituting biological products by pharmacists.

 

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Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.

03/22/2018   1096s

03/22/2018   1125s 18-2758

03/05

 

STATE OF NEW HAMPSHIRE

 

In the Year of Our Lord Two Thousand Eighteen

 

AN ACT relative to biological products dispensed by pharmacists.

 

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

 

1  Prescription Labels.  Amend RSA 318:47-a to read as follows:

318:47-a  Prescription Labels.  Whenever a pharmacist dispenses a noncontrolled drug pursuant to a prescription, he or she shall affix to the container in which such drug is dispensed a label showing at least the name and address of the pharmacy and the name or initials of the dispensing pharmacist or pharmacist-in-charge; the prescription identification number assigned by the pharmacy; the date dispensed; any directions as may be stated on the prescription; the name of the prescribing practitioner; the name of the patient; all pertinent auxiliary labels; and, unless otherwise indicated by the prescribing physician, dentist, veterinarian, or advanced practice registered nurse, the name, strength, and quantity of the drug dispensed.  All drugs dispensed to a patient that have been filled using a centralized prescription processing system shall bear a label containing an identifiable code that provides a complete audit trail of the dispensing of the drug and pharmaceutical care activities.  A biological product, as defined in RSA 318:47-dd, I, shall also be labeled as provided in RSA 318:47-dd, VII.  No person shall alter, deface, or remove any label so affixed.  A compounded drug product shall also be labeled as provided in RSA 318:14-a, II.  The compound drug product shall bear the label of the pharmacy responsible for compounding and dispensing the product directly to the patient for administration, and the prescription shall be filed at that pharmacy.  Compounded prescription labels shall include the phrase "compounded per subscriber request'' or a similar statement on the prescription label or through the use of an auxiliary label attached to the prescription container.

2  Substituting Generic Drugs.  Amend RSA 318:47-d to read as follows:

318:47-d  Pharmacies; Substituting Generic Drugs.  Pharmacies, including mail-order pharmacies, may substitute generically equivalent drug products for all legend and non-legend prescriptions unless the prescribing practitioner handwrites "medically necessary'' on each paper prescription, or uses electronic indications when transmitted electronically, or gives instructions when transmitted orally that the brand name drug product is medically necessary.  In this section, "drug product" does not include a biological product.

3  New Section; Substituting Biological Products.  Amend RSA 318 by inserting after section 47-d the following new section:

318:47-dd  Pharmacies; Substituting Biological Products.

I.  In this section:

(a)  "Biological product" means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.

(b)  "Proper name" means the nonproprietary name for a biological product designated by the federal Food and Drug Administration license for use upon each package of the product.

(c)  "Interchangeable biological product" means a biological product that the federal Food and Drug Administration:

(1)  Has licensed and determined meets the standards for interchangeability pursuant to 42 U.S.C. section 262(k)(4); or

(2)  Has determined is therapeutically equivalent as set forth in the latest edition of or supplement to the federal Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations.

II.  The board shall maintain a link on its website to the federal Food and Drug Administration's Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.

III.  A pharmacist shall substitute a biological product pursuant to this section only if it has been licensed by the federal Food and Drug Administration as an interchangeable biological product for the prescribed biological product.

IV.  When a pharmacist dispenses an interchangeable biological product for the prescribed biological product, the pharmacist or his or her designee shall inform the patient.

V.  A pharmacist shall not substitute an interchangeable biological product pursuant to this section if the prescriber indicates that substitution is not authorized by specifying on the prescription "medically necessary" on a paper prescription, or uses electronic indications when transmitted electronically, or gives instructions when transmitted orally that the biological product prescribed is medically necessary.

VI.(a)  Within 5 business days following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall make an entry of the specific product provided to the patient, including the name of the product and the manufacturer.  The communication shall be conveyed by making an entry that is electronically accessible to the prescriber through:

(1)  An interoperable electronic medical records system;

(2)  An electronic prescribing technology; or

(3)  A pharmacy benefit management system; or

(4)  A pharmacy record.

(b)  Entry into an electronic records system as described in this paragraph is presumed to provide notice to the prescriber.  Otherwise, the pharmacist shall communicate the biological product dispensed to the prescriber using facsimile, telephone, electronic transmission, or other prevailing means, provided that the communication shall not be required where:

(1)  There is no federal Food and Drug Administration-approved interchangeable biological product for the biological product prescribed; or

(2)  A refill prescription is not changed from product dispensed on the prior filling of the prescription.

VII.  The label of all biological products dispensed by a pharmacist shall include the proper name and the name of the manufacturer of the product.

4  Effective Date.  This act shall take effect January 1, 2019.

Links

SB350 at GenCourtMobile

Action Dates

Date Body Type
March 13, 2018 Senate Hearing
March 22, 2018 Senate Floor Vote
March 21, 2018 Senate Floor Vote
March 21, 2018 Senate Floor Vote
March 22, 2018 Senate Floor Vote
April 11, 2018 House Hearing
April 17, 2018 House Exec Session

Bill Text Revisions

SB350 Revision: 3335 Date: March 23, 2018, 11:43 a.m.
SB350 Revision: 2687 Date: Dec. 14, 2017, 12:40 p.m.

Docket

Date Status
Jan. 3, 2018 To Be Introduced 01/03/2018 and Referred to Health and Human Services; SJ 1
March 13, 2018 Hearing: 03/13/2018, Room 101, LOB, 01:00 pm; SC 11
March 22, 2018 Committee Report: Ought to Pass with Amendment # 2018-1096s, 03/22/2018; Vote 5-0; CC; SC 13
March 21, 2018 Committee Report: Ought to Pass with Amendment # 2018-1096s, 03/21/2018; Vote 5-0; CC; SC 13
March 21, 2018 Sen. Bradley Moved to Remove SB 350 from the Consent Calendar; 03/21/2018; SJ 9
March 22, 2018 Special Order to 03/22/2018, Without Objection, MA; 03/21/2018 SJ 9
March 22, 2018 Committee Report: Ought to Pass with Amendment # 2018-1096s, 03/22/2018;
March 22, 2018 Committee Amendment # 2018-1096s, AA, VV; 03/22/2018; SJ 10
March 22, 2018 Sen. Bradley Floor Amendment # 2018-1125s, AA, VV; 03/22/2018; SJ 10
March 22, 2018 Ought to Pass with Amendments 2018-1096s and 2018-1125s, MA, VV; OT3rdg; 03/22/2018; SJ 10
March 22, 2018 Introduced 03/22/2018 and referred to Health, Human Services and Elderly Affairs HJ 10 P. 52
April 11, 2018 ==ROOM CHANGE== Public Hearing: 04/11/2018 10:00 AM LOB 206
April 17, 2018 Executive Session: 04/17/2018 10:00 AM LOB 205
Majority Committee Report: Refer for Interim Study (Vote 16-7; RC)
April 26, 2018 Majority Committee Report: Refer for Interim Study for 04/26/2018 (Vote 16-7; RC) HC 16 P. 13
Minority Committee Report: Ought to Pass with Amendment # 2018-1523h
April 26, 2018 Refer for Interim Study: MA VV 04/26/2018