CHAPTER 306
                                          HB 1466 - FINAL VERSION
10Mar2022... 0406h
04/28/2022 1696s
26May2022... 2039CofC
                                                2022 SESSION
                                                                                                   22-2514
                                                                                                   05/08
HOUSE BILL               1466
AN ACT              relative to the off-label use of prescription drugs and relative to pharmacy
                    prescriptions.
SPONSORS:           Rep. Cross, Merr. 3; Rep. Yakubovich, Merr. 24; Rep. Aron, Sull. 7; Rep. Blasek, Hills.
                    21; Rep. Potucek, Rock. 6; Rep. Layon, Rock. 6
COMMITTEE:          Health, Human Services and Elderly Affairs
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                                            AMENDED ANALYSIS
    This bill clarifies circumstances under which a physician, physician assistant, and advanced practice
registered nurse may prescribe a drug for an off-label indication. The bill also prohibits disciplinary action
against a pharmacist for filling a valid prescription for off-label use.
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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                   Matter which is either (a) all new or (b) repealed and reenacted appears in regular type.
                                                     CHAPTER 306
                                                HB 1466 - FINAL VERSION
     10Mar2022... 0406h
     04/28/2022 1696s
     26May2022... 2039CofC                                                                           22-2514
                                                                                                     05/08
                                               STATE OF NEW HAMPSHIRE
                                    In the Year of Our Lord Two Thousand Twenty Two
     AN ACT                 relative to the off-label use of prescription drugs and relative to pharmacy
                            prescriptions.
               Be it Enacted by the Senate and House of Representatives in General Court convened:
1        306:1 New Paragraph; Physicians and Surgeons; Disciplinary Action; Off-Label Use of Prescription
2    Drug. Amend RSA 329:17 by inserting after paragraph VI-a the following new paragraph:
3            VI-b.      The state of New Hampshire confirms its strong support for shared decision making
4    between healthcare professionals and their patients. A licensee may lawfully prescribe an FDA approved
5    drug product for an off-label indication and be held to the same standard of care as when prescribing for
6    on-label indication when:
7                    (a) Off-label use of the drug product for this indication has longstanding common use;
8                    (b) There is medical evidence to support this use and no known evidence contraindicating
9    such use, including but not limited to peer reviewed studies and practice guidelines from relevant medical
10   societies; or
11                   (c) The licensee has provided and the patient, or if the patient is a minor, the patient’s parent
12   or guardian, has signed an informed consent form that includes the known potential benefits, known
13   potential risks, alternative treatment options, expected prognosis without treatment, and a disclosure that
14   a prescription is for an off-label indication. The signed informed consent form shall remain part of the
15   patient’s medical record.
16       306:2 New Paragraph; Nurse Practice Act; Advanced Practice Registered Nurse; Disciplinary Action;
17   Off-label Use of Prescription Drug. Amend RSA 326-B:37 by inserting after paragraph III the following
18   new paragraph:
19           III-a.     The state of New Hampshire confirms its strong support for shared decision making
20   between healthcare professionals and their patients. A licensee may lawfully prescribe an FDA approved
21   drug product for an off-label indication and be held to the same standard of care as when prescribing for
22   on-label indication when:
23                   (a) Off-label use of the drug product for this indication has longstanding common use;
24                   (b) There is medical evidence to support this use and no known evidence contraindicating
25   such use, including but not limited to peer reviewed studies and practice guidelines from relevant medical
26   societies; or
27                   (c) The licensee has provided and the patient, or if the patient is a minor, the patient’s parent
28   or guardian, has signed an informed consent form that includes the known potential benefits, known
29   potential risks, alternative treatment options, expected prognosis without treatment, and a disclosure that
                                                   CHAPTER 306
                                              HB 1466 - FINAL VERSION
                                                     - Page 2 -
1    a prescription is for an off-label indication. The signed informed consent form shall remain part of the
2    patient’s medical record.
3        306:3 New Section; Physician Assistant; Disciplinary Action; Off-label Use of Prescription Drug.
4    Amend RSA 328-D by inserting after section 6 the following new section:
5        328-D:6-a    Off-label Use of Prescription Drugs; When Permitted.          The state of New Hampshire
6    confirms its strong support for shared decision making between healthcare professionals and their
7    patients. A licensee may lawfully prescribe an FDA approved drug product for an off-label indication and
8    be held to the same standard of care as when prescribing for on-label indication when:
9            I. Off-label use of the drug product for this indication has longstanding common use;
10           II. There is medical evidence to support this use and no known evidence contraindicating such
11   use, including but not limited to peer reviewed studies and practice guidelines from relevant medical
12   societies; or
13           III. The licensee has provided and the patient, or if the patient is a minor, the patient’s parent or
14   guardian, has signed an informed consent form that includes the known potential benefits, known
15   potential risks, alternative treatment options, expected prognosis without treatment, and a disclosure that
16   a prescription is for an off-label indication. The signed informed consent form shall remain part of the
17   patient’s medical record.
18       306:4 New Section; Pharmacists and Pharmacies; Prescriptions. Amend RSA 318 by inserting after
19   section 13 the following new section:
20       318:13-a Filling of Prescriptions. No licensed pharmacist shall face non-disciplinary or disciplinary
21   action by the pharmacy board for filling a valid prescription for an off-label use.
22       306:5 Construction of Act. Nothing in this act shall be construed to legalize, constitute, condone,
23   authorize, or approve suicide, assisted suicide, mercy killing, or euthanasia, or permit any affirmative or
24   deliberate act or omission to end one's own life or to end the life of another other than to permit the natural
25   process of dying.
         306:6 Effective Date. The act shall take effect upon its passage.
     Approved: July 01, 2022
     Effective Date: July 01, 2022
Statutes affected: Introduced: 329:17
As Amended by the House: 329:17, 326-B:37
As Amended by the Senate: 329:17, 326-B:37
Version adopted by both bodies: 329:17, 326-B:37
CHAPTERED FINAL VERSION: 329:17, 326-B:37
latest version: 329:17