Bill Text: NJ A5104 | 2018-2019 | Regular Session | Introduced
Bill Title: Requires pharmacies to maintain minimum stock of opioid antidote.
Spectrum: Partisan Bill (Democrat 6-0)
Status: (Introduced - Dead) 2019-03-05 - Introduced, Referred to Assembly Health and Senior Services Committee [A5104 Detail]
Download: New_Jersey-2018-A5104-Introduced.html
Sponsored by:
Assemblywoman VALERIE VAINIERI HUTTLE
District 37 (Bergen)
Assemblywoman PAMELA R. LAMPITT
District 6 (Burlington and Camden)
Assemblywoman YVONNE LOPEZ
District 19 (Middlesex)
SYNOPSIS
Requires pharmacies to maintain minimum stock of opioid antidote.
CURRENT VERSION OF TEXT
As introduced.
An Act concerning pharmacies and amending P.L.2017, c.88.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. Section 1 of P.L.2017, c.88 (C.45:14-67.2) is amended to read as follows:
1. a. Notwithstanding any other law or regulation to the contrary, a pharmacist may dispense an opioid antidote to any patient, regardless of whether the patient holds an individual prescription for the opioid antidote, pursuant to a standing order issued by a prescriber or pursuant to the standing order issued pursuant to subsection b. of this section. A pharmacist who dispenses an opioid antidote pursuant to this section shall comply with the provisions of the "Overdose Prevention Act," P.L.2013, c.46 (C.24:6J-1 et al.).
b. The Commissioner of Health, or, if the commissioner is not a duly licensed physician, the Deputy Commissioner for Public Health Services, shall issue, upon request by a pharmacist licensed to practice in this State, a standing order authorizing the pharmacist to dispense an opioid antidote to any patient, regardless of whether the patient holds an individual prescription for the opioid antidote, provided the pharmacist complies with the requirements of the "Overdose Prevention Act," P.L.2013, c.46 (C.24:6J-1 et al.).
c. As used in this section:
"Opioid antidote" means naloxone hydrochloride, or any other similarly acting drug approved by the United States Food and Drug Administration for self-administration for the treatment of an opioid overdose.
"Patient" means the same as that term is defined in section 3 of P.L.2013, c.46 (C.24:6J-3).
"Prescriber" means the same as that term is defined in section 3 of P.L.2013, c.46 (C.24:6J-3).
"Retail pharmacy" means any place in this State where drugs are dispensed or patient care services are provided by a licensed pharmacist, but shall not include any pharmacy that limits the provision of pharmaceutical care services to a defined and exclusive group of patients and is not open for dispensing to the general patient population.
"Retail unit of an opioid antidote" means a package containing one unit of an opioid antidote, which package is intended for individual sale or dispensation directly to a patient.
d. (1) Each retail pharmacy shall stock a minimum of one retail unit of an opioid antidote at all times.
(2) A retail pharmacy that fails to stock at least one retail unit of an opioid antidote shall receive a written warning from the board following a first offense, and shall be subject to a civil penalty of $250 for a second or subsequent offense. Following receipt of a written warning for a first offense, each day during which a violation continues shall constitute a separate offense. The civil penalty may be sued for and collected by the board in a summary proceeding pursuant to the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.), and the rules of court governing actions for the collection of civil penalties in the municipal or Special Civil Part of the Law Division of the Superior Court where the offense occurred. It shall be an affirmative defense to a violation of this subsection if the pharmacy demonstrates that:
(a) fewer than three days elapsed between the date of the violation and the date on which the pharmacy was last in compliance with the requirements of paragraph (1) of this subsection;
(b) fewer than seven days elapsed between the date of the violation and the date on which the pharmacy was last in compliance with the requirements of paragraph (1) of this subsection, and the pharmacy had ordered an adequate replacement stock prior to the date of the violation; or
(c) the pharmacy was unable to comply with the requirements of paragraph (1) of this subsection because of a wholesaler shortage of retail units of opioid antidotes.
(cf: P.L.2017, c.88, s.1)
2. The Board of Pharmacy, in consultation with the Department of Health, shall promulgate rules and regulations, pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.), as may be necessary to effectuate the provisions of this act.
3. This act shall take effect 30 days after the date of enactment.
STATEMENT
This bill requires retail pharmacies to stock at least one retail unit of an opioid antidote, such as naloxone hydrochloride or any other federally-approved drug intended for self-administration for the treatment of an opioid overdose, at all times. The bill defines "retail unit of an opioid antidote" to mean a package containing one unit of an opioid antidote that is intended for individual sale or dispensation directly to a patient. "Retail pharmacy" is defined as any place where drugs are dispensed and pharmaceutical services are provided by a licensed pharmacist, but does not include any pharmacy that limits pharmaceutical care services to a defined and exclusive group of patients and that is not open for dispensing to the general patient population.
A pharmacy that fails to maintain at least one retail unit of an opioid antidote will be issued a written warning by the Board of Pharmacy for a first offense, and will be subject to a civil penalty of $250 for a second or subsequent offense. Following receipt of a written warning from the board for a first offense, each day during which a violation continues will constitute a separate offense. However, it will constitute an affirmative defense to a violation of the requirements of the bill if the pharmacy demonstrates that: fewer than three days elapsed between the date of the violation and the date on which the pharmacy was last in compliance with the requirements of the bill; fewer than seven days elapsed between the date of the violation and the date on which the pharmacy was last in compliance, and the pharmacy had ordered an adequate replacement stock prior to the date of the violation; or the pharmacy was unable to comply because of a wholesaler shortage of retail units of opioid antidotes.
