A BILL TO BE ENTITLED
AN ACT amending the north carolina controlled substances act to establish new violations involving counterfeit controlled substances AND CONTROLLED SUBSTANCES; To Require health care practitioners and pharmacists to educate patients with prescriptions for opioid pain medications and medications to treat opioid use disorder about the potential dangers of opioids, overdose prevention, and the availability and use of opioid antagonists to prevent overdose deaths; To Expand the state's definition of opioid antagonist to include all opioid antagonists approved by the federal food and drug administration for the treatment of a drug overdose; and to allow the use of all such federal food and drug‑approved opioid antagonists in needle and hypodermic syringe exchange programs; to Protect national opioid settlement proceeds for north carolina and its units of local government by prohibiting the assertion of any released claims against any released entities pursuant to the final consent judgments resolving this litigation; and to Continue to authorize pharmacists, pharmacy interns, and pHARmacy technicians to administer vaccinations and immunizations in response to the expiring public readiness and emergency preparedness act.
The General Assembly of North Carolina enacts:

PART I. STOP COUNTERFEIT PILLS ACT
SECTION 1.(a)  G.S. 90‑108 reads as rewritten:
"§ 90‑108.  Prohibited acts; penalties.
(a)	It shall be unlawful for any person:
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(12)	To do either of the following:
a.	To possess, manufacture, distribute, export, or import any three‑neck round‑bottom flask, tableting machine, encapsulating machine, or gelatin capsule, or any equipment, chemical, product, or material which may be used to create a counterfeit controlled substance, knowing, intending, or having reasonable cause to believe that it will be used to create a counterfeit controlled substance.
b.	To make, distribute, or possess any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any drug or container or labeling thereof so as to render such drug a counterfeit controlled substance, knowing, intending, or having reasonable cause to believe that it will be used to create a counterfeit controlled substance.
(12a)	To possess, manufacture, distribute, export, or import any three‑neck round‑bottom flask, tableting machine, encapsulating machine, or gelatin capsule, or any equipment, chemical, product, or material which may be used to manufacture a controlled substance or listed chemical, knowing, intending, or having reasonable cause to believe that it will be used to manufacture a controlled substance. This subdivision shall not apply to a pharmacy, a pharmacist, a pharmacy technician, or a pharmacy intern licensed or permitted under Article 4A of Chapter 90 of the General Statutes possessing any item included in this subdivision utilized in the compounding, dispensing, delivering, or administering of a controlled substance pursuant to a prescription.
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(b)	Any person who violates this section shall be guilty of a Class 1 misdemeanor. Provided, that if the criminal pleading alleges that the violation was committed intentionally, and upon trial it is specifically found that the violation was committed intentionally, such violations shall be a Class I felony unless one of the following applies:
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(1a)	A person who violates subdivision (12a) of subsection (a) of this section shall be punished as a Class E felon.
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SECTION 1.(b)  This section becomes effective December 1, 2023, and applies to offenses committed on or after that date.

PART II. EDUCATE PATIENTS ABOUT OPIOID ANTAGONISTS
SECTION 2.(a)  Article 1 of Chapter 90 of the General Statutes is amended by adding a new section to read:
"§ 90‑12.8.  Requirement to provide opioid antagonist education.
(a)	Consistent with the federal Food and Drug Administration's labeling requirements for opioid pain medication and medication to treat opioid use disorder announced in its Drug Safety Communication dated July 23, 2020, a practitioner as defined in G.S. 90‑87(22) shall do all of the following when issuing a prescription for a Schedule II controlled substance described in G.S. 90‑90(1):
(1)	Provide information regarding all of the following to each patient receiving the prescription:
a.	The potential dangers of opioids.
b.	Overdose prevention.
c.	The availability and use of a drug approved by the federal Food and Drug Administration as an opioid antagonist for the complete or partial reversal of opioid‑induced respiratory depression.
(2)	Provide the information described in sub‑subdivisions (1)a. through (1)c. of this subsection to one or more persons if designated by the patient receiving the prescription or, for a patient who is a minor, to the minor's parent, guardian, or person standing in loco parentis.
(b)	When dispensing a Schedule II controlled substance described in G.S. 90‑90(1), a pharmacy, through a pharmacist or pharmacy personnel, shall do one of the following:
(1)	Make available the information described in sub‑subdivisions (a)(1)a. through (a)(1)c. of this section that is consistent with the federal Food and Drug Administration's labeling requirements for opioid pain medication and medication to treat opioid use disorder announced in its Drug Safety Communication dated July 23, 2020.
(2)	Post signage in a conspicuous place containing the information described in sub‑subdivisions (a)(1)a. through (a)(1)c. of this section.
(c)	Nothing in this section shall be construed to do any of the following:
(1)	Limit a practitioner's liability for negligent diagnosis or treatment of a patient, as allowed under applicable State or federal law.
(2)	Constitute negligence per se or create a private right of action against any practitioner, including a pharmacy, a pharmacist, or pharmacy personnel, who fails to follow the requirements of this section.
(d)	This section shall not apply to the following:
(1)	A practitioner providing hospice services as defined in G.S. 131E‑201(5b) to a hospice patient as defined in G.S. 131E‑201(4).
(2)	A veterinarian acting in the practice of veterinary medicine, as defined in G.S. 90‑181, at an animal health center, emergency facility, mobile facility, veterinary clinic, or veterinary hospital, as defined in G.S. 90‑181.1."
SECTION 2.(b)  This section becomes effective October 1, 2023.

PART III. EXPAND DEFINITION OF OPIOID ANTAGONIST
SECTION 3.(a)  G.S. 90‑12.7(a) reads as rewritten:
"(a)	As used in this section, "opioid antagonist" means an opioid antagonist that is approved by the federal Food and Drug Administration for the treatment of a drug overdose."
SECTION 3.(b)  G.S. 90‑113.27 reads as rewritten:
"§ 90‑113.27.  Needle and hypodermic syringe exchange programs authorized; limited immunity.
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(b)	Programs established pursuant to this section shall offer all of the following:
(1)	Disposal of used needles and hypodermic syringes.
(2)	Needles, hypodermic syringes, and other injection supplies at no cost and in quantities sufficient to ensure that needles, hypodermic syringes, and other injection supplies are not shared or reused.
(3)	Reasonable and adequate security of program sites, equipment, and personnel. Written plans for security shall be provided to the police and sheriff's offices with jurisdiction in the program location and shall be updated annually.
(4)	Educational materials on all of the following:
a.	Overdose prevention.
b.	The prevention of HIV, AIDS, and viral hepatitis transmission.
c.	Drug abuse prevention.
d.	Treatment for mental illness, including treatment referrals.
e.	Treatment for substance abuse, including referrals for medication assisted treatment.
(5)	Access to opioid antagonist kits that contain an opioid antagonist that is approved by the federal Food and Drug Administration for the treatment of a drug overdose, or referrals to programs that provide access to an opioid antagonist that is approved by the federal Food and Drug Administration for the treatment of a drug overdose.
(6)	For each individual requesting services, personal consultations from a program employee or volunteer concerning mental health or addiction treatment as appropriate.
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(e)	Not later than one year after commencing operations of a program established pursuant to this section, and every 12 months thereafter, each organization operating such a program shall report the following information to the North Carolina Department of Health and Human Services, Division of Public Health:
(1)	The number of individuals served by the program.
(2)	The number of needles, hypodermic syringes, and needle injection supplies dispensed by the program and returned to the program.
(3)	The number of opioid antagonist kits distributed by the program.
(4)	The number and type of treatment referrals provided to individuals served by the program, including a separate report of the number of individuals referred to programs that provide access to an opioid antagonist that is approved by the federal Food and Drug Administration for the treatment of a drug overdose."
SECTION 3.(c)  This section is effective when it becomes law.

PART IV. PROTECT NC OPIOID SETTLEMENT PAYMENTS
SECTION 4.(a)  Chapter 122C of the General Statutes is amended by adding a new Article to read:
"Article 7.
"Legislative Release to Protect National Opioid Settlement Payments.
"§ 122C‑470.2.  Definitions.
Definitions. – The following definitions apply in this Article:
(1)	Initial Opioid Consent Judgments. – The final consent judgments, including all exhibits, resolving the following cases in the General Court of Justice, Superior Court Division, Wake County:
a.	State of North Carolina, ex rel. Joshua H. Stein, Attorney General v. McKesson Corporation; Cardinal Health, Inc.; and AmerisourceBergen Corporation, No. 22CV4020.
b.	State of North Carolina, ex rel. Joshua H. Stein, Attorney General v. Johnson & Johnson; Janssen Pharmaceuticals, Inc.; Ortho‑McNeil‑Janssen Pharmaceuticals, Inc.; and Janssen Pharmaceutica, Inc., No. 22CV4244.
(2)	Initial Released Claim. – Any claim defined as Released Claims in the Initial Opioid Consent Judgments.
(3)	Initial Released Entity. – Any entity defined as Released Entities in the Initial Opioid Consent Judgments, including Johnson & Johnson, Janssen Pharmaceuticals, Inc., Ortho‑McNeil‑Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica, Inc., McKesson Corporation, Cardinal Health, Inc., and AmerisourceBergen Corporation.
(4)	Initial Settling Opioid Defendants. – Johnson & Johnson, Janssen Pharmaceuticals, Inc., Ortho‑McNeil‑Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica, Inc., McKesson Corporation, Cardinal Health, Inc., and AmerisourceBergen Corporation.
(5)	State. – The State of North Carolina and includes every public office, public officer or official (elected or appointed), institution, board, commission, bureau, council, department, or authority or other unit of government of the State.
(6)	Subsequent Opioid Settlement Agreements. – The national opioid settlement agreement announced in November and December 2022, with the Subsequent Settling Opioid Defendants.
(7)	Subsequent Released Claim. – Any claim defined as Released Claims in the Subsequent Opioid Settlement Agreements.
(8)	Subsequent Released Entity. – Any entity defined as Released Entities in the Subsequent Opioid Settlement Agreements, including Walmart, Inc., Teva Pharmaceutical Industries Ltd., Allergan Finance, LLC, Allergan Limited, CVS Health Corporation, CVS Pharmacy, Inc., and Walgreen Co.
(9)	Subsequent Settling Opioid Defendants. – Walmart, Inc., Teva Pharmaceutical Industries Ltd., Allergan Finance, LLC, Allergan Limited, CVS Health Corporation, CVS Pharmacy, Inc., and Walgreen Co.
(10)	Unit of Local Government. – Every public office, public officer or official (elected or appointed), institution, board, commission, bureau, council, department, or authority or other unit of government of any county, unit, special district, or other political subdivision of government, including, but not limited to, a county; city; consolidated city‑county; local school administrative unit; community college; area mental health, developmental disabilities, and substance abuse authority; nonprofit corporation or association operating or leasing a public hospital; public health authority; water or sewer authority; metropolitan sewerage district; sanitary district; county water and sewer district; metropolitan water district; metropolitan water and sewerage district; airport authority; airport board or commission; regional natural gas district; regional transportation authority; regional public transportation authority; ferry transportation authority; a special district created under Article 43 of Chapter 105 of the General Statutes; or any other local or regional authority, district, board, commission, or administrative unit.
"§ 122C‑470.4.  Legislative findings.
The General Assembly makes the following findings:
(1)	The opioid epidemic has taken the lives of more than 32,000 North Carolinians, caused immeasurable suffering and harm, and imposed substantial costs on the State, counties, municipalities, healthcare and social service providers, residents, and others.
(2)	The epidemic was fueled by misconduct on the part of the Initial Settling Opioid Defendants and other companies engaged in the manufacture, marketing, promotion, distribution, or dispensing of prescription opioid medications.
(3)	The State, through its Attorney General, engaged in investigations, litigation, and settlement discussions involving the Initial Settling Opioid Defendants, Subsequent Settling Opioid Defendants, and 76 counties and eight municipalities, through their counsel, filed lawsuits against at least one of the Initial Settling Opioid Defendants or Subsequent Settling Opioid Defendants seeking to hold them accountable for the damage caused by their misconduct.
(4)	On July 21, 2021, a national coalition of states and political subdivisions announced agreements with the Initial Settling Opioid Defendants to resolve legal claims against those companies stemming from actions that fueled the opioid epidemic.
(5)	The State, all 100 counties, and 47 municipalities in North Carolina have formally joined the agreements with the Initial Settling Opioid Defendants. On March 11, 2022, all of North Carolina's litigating counties and municipalities dismissed their lawsuits against the Initial Settling Opioid Defendants. On April 6 and April 26, 2022, the General Court of Justice, Superior Court Division, Wake County, entered the Initial Opioid Consent Judgments making the agreements with the Initial Settling Opioid Defendants effective in North Carolina.
(6)	The Initial Opioid Consent Judgments provide for payments of up to twenty‑six billion dollars ($26,000,000,000) over 18 years, with more than twenty‑three billion nine hundred million dollars ($23,900,000,000) available to fund state and local efforts to address the opioid epidemic nationwide.
(7)	Pursuant to the Initial Opioid Consent Judgments, North Carolina's share of the payments is up to approximately seven hundred fifty million dollars ($750,000,000) over 18 years. North Carolina's share of the payments will be distributed among the State and its Units of Local Government pursuant to a Memorandum of Agreement, to which the State and more than 140 Units of Local Government have agreed. The Memorandum of Agreement was approved through the Initial Opioid Consent Judgments and establishes the means by which payments will be distributed in North Carolina.
(8)	In November and December 2022, a national coalition of states and political subdivisions announced agreements with the Subsequent Settling Opioid Defendants to resolve legal claims against those companies stemming from actions that fueled the opioid epidemic.
(9)	The settlements with the Subsequent Settling Opioid Defendants are contingent on the participation of a critical mass of states and political subdivisions. The State has formally notified all Subsequent Settling Opioid Defendants of its intent to join the Subsequent Opioid Settlement Agreements. Units of Local Government have an opportunity to formally join the Subsequent Opioid Settlement Agreements in early 2023.
(10)	The Subsequent Opioid Settlement Agreements provide for payments of up to twenty billion four hundred million dollars ($20,400,000,000) over 15 years. North Carolina's share of the payments is up to approximately six hundred million dollars ($600,000,000). It is expected that North Carolina's share of the payments will be distributed among the State and its Units of Local Government pursuant to a supplemental agreement for additional funds, to which the State has agreed, and which Units of Local Government have the opportunity to approve in early 2023. This money is available to fund State and local efforts to address the opioid epidemic nationwide.
(11)	North Carolina and its Units of Local Government can secure the full one billion three hundred fifty million dollars ($1,350,000,000) available under the Initial Opioid Consent Judgments and Subsequent Opioid Settlement Agreements only if opioid litigation in North Carolina asserting Initial Released Claims against Initial Released Entities and Subsequent Released Claims against Subsequent Released Entities comes to an end with no new claims. Newly filed Initial Released Claims against Initial Released Entities, or newly filed Subsequent Released Claims against Subsequent Released Entities, would frustrate the purposes of the agreements, would put North Carolina's share of the payments at risk, and would harm the people of North Carolina, all Units of Local Government, and the State.
"§ 122C‑470.6.  Legislative intent.
It is the intent of this Article to prevent the assertion of Initial Released Claims and Subsequent Released Claims against Initial Released Entities and Subsequent Released Entities by the State and its Units of Local Government, and thereby to help secure, on behalf of North Carolina's Units of Local Government, the State, and the people of North Carolina, the full share to which the State, its Units of Local Government, and its people are otherwise entitled under the Initial Opioid Consent Judgments and the Subsequent Opioid Settlement Agreements.
"§ 122C‑470.8.  Prohibition on assertion of Released Claims against Released Entities.
Neither a Unit of Local Government nor the State may assert any Initial Released Claims against Initial Released Entities, or any Subsequent Released Claims against Subsequent Released Entities. Notwithstanding this section, the State, as expressly contemplated in the Subsequent Opioid Settlement Agreements, may initiate civil actions asserting Subsequent Released Claims against Subsequent Released Entities for the purpose of obtaining consent judgments that effectuate the Subsequent Opioid Settlement Agreements, including the release of such claims.
"§ 122C‑470.10.  Preservation of remedies.
This Article preserves all remedies the State or any Unit of Local Government may have under the Initial Opioid Consent Judgments and Subsequent Opioid Settlement Agreements. Nothing in this Article shall be construed to limit or otherwise affect such remedies."
SECTION 4.(b)  G.S. 122C‑470.8 applies to all Initial Released Claims, as defined in G.S. 122C‑470.2, whether originally asserted before or after the effective date of this act.
SECTION 4.(c)  G.S. 122C‑470.8 applies to all Subsequent Released Claims, as defined in G.S. 122C‑470.2, whether originally asserted before or after the effective date of this act, except that G.S. 122C‑470.8 does not apply to Subsequent Released Claims against Subsequent Released Entities that were included in any lawsuits filed by a Unit of Local Government prior to November 1, 2022. If the Subsequent Opioid Settlement Agreements with respect to all of the Subsequent Settling Opioid Defendants are not entered as consent judgments by the Superior Court of Wake County by December 31, 2023, then, beginning on January 1, 2024, G.S. 122C‑470.8 shall only apply to Subsequent Released Claims against Subsequent Released Entities covered by a consent judgment approved by a North Carolina court of competent jurisdiction.
SECTION 4.(d)  This section is effective when it becomes law.

PART V. PREP ACT/PHARMACISTS
SECTION 5.(a)  G.S. 90‑85.15B reads as rewritten:
"§ 90‑85.15B.  Immunizing pharmacists.
(a)	Except as provided in subsections (b), (b1), and (c) of this section, an immunizing pharmacist may only administer vaccinations or immunizations to persons at least 18 years of age pursuant to a specific prescription order.
(a1)	An immunizing pharmacist may administer to persons at least 18 years of age the vaccines or immunizations recommended by the Advisory Committee on Immunization Practices if the vaccinations or immunizations are administered under written protocols as defined in 21 NCAC 46 .2507(b)(12) and 21 NCAC 32U .0101(b)(12) and in accordance with the supervising physician's responsibilities as defined in 21 NCAC 46 .2507(e) and 21 NCAC 32 .0101(e), and the physician is licensed in and has a practice physically located in North Carolina. When supervised by an immunizing pharmacist, pharmacy interns and pharmacy technicians meeting the requirements of subsection (f) may administer the vaccinations or immunizations recommended by the Advisory Committee on Immunization Practices to persons at least 18 years of age in accordance with this subsection.

	

	

(b1)	When a person chooses, or a parent or legal guardian provides written consent for a person under 18 years of age in accordance with subsection (g), an immunizing pharmacist may administer (i) an influenza vaccine, (ii) a COVID‑19 vaccine recommended by the Advisory Committee on Immunization Practices (iii) a COVID‑19 vaccine authorized under an emergency use authorization by the United States Food and Drug Administration and recommended by the Advisory Committee on Immunization Practices, or (iv) a combination of COVID‑19 and influenza vaccine recommended by the Advisory Committee on Immunization Practices to persons at least 7 years of age pursuant to 21 NCAC 46 .2507 and 21 NCAC 32U .0101. When supervised by an immunizing pharmacist, pharmacy interns and pharmacy technicians meeting the requirements of subsection (f) may administer (i) an influenza vaccine, (ii) a COVID‑19 vaccine recommended by the Advisory Committee on Immunization Practices, (iii) a COVID‑19 vaccine authorized under an emergency use authorization by the United States Food and Drug Administration, or (iv) a combination of a COVID‑19 and influenza vaccine recommended by the Advisory Committee on Immunization Practices to persons at least 7 years of age in accordance with this subsection.
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(f)	Prior to administering a vaccine or immunization pursuant to subsection (a1) or (b1), a pharmacy technician or pharmacy intern shall meet the following requirements:
(1)	Complete a practical training program that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands‑on injection technique and the recognition and treatment of emergency reactions to vaccines.
(2)	The pharmacy technician or pharmacy intern shall have a current certificate in basic cardiopulmonary resuscitation.
(3)	The pharmacy technician shall annually complete a minimum of two hours of ACPE approved, immunization‑related continuing pharmacy education.
(g)	Prior to the administration of a vaccine or immunization administered to a person under 18 years of age pursuant to this section, an immunizing pharmacist shall obtain written parental consent from the parent or legal guardian of the patient. An immunizing pharmacist, a pharmacy technician, or pharmacy intern shall, if the person is under 18 years of age, inform the patient or legal guardian accompanying the person of the importance of a well‑child visit with a pediatrician, family physician, or other licensed primary‑care provider."
SECTION 5.(b)  The North Carolina Medical Board and the North Carolina Board of Pharmacy joint subcommittee shall adopt rules to govern the administration of vaccines by pharmacy technicians as authorized in this act. Until these rules are adopted by the North Carolina Medical Board and the North Carolina Board of Pharmacy and are entered into the North Carolina Administrative Code, pharmacy technicians may administer vaccines and immunizations pursuant to subsections (a1) and (b1) in accordance with the recommendations of the Advisory Committee on Immunization Practices and the requirements of the federal COVID‑19 Public Readiness and Emergency Preparedness Act even upon the expiration of the federal COVID‑19 Public Readiness and Emergency Preparedness Act.
SECTION 5.(c)  For any new vaccination or immunization recommended by the Advisory Committee on Immunization Practices after the effective date of this act, the North Carolina Medical Board and the North Carolina Board of Pharmacy joint subcommittee shall review and update written protocols as defined in 21 NCAC 46 .2507(b)(12) and 21 NCAC 32U .0101(b)(12) as needed. Until these rules are adopted by the North Carolina Medical Board and the North Carolina Board of Pharmacy and are entered into the North Carolina Administrative Code, immunizing pharmacists, pharmacy technicians, and pharmacy interns may administer a new vaccination or immunization pursuant to subsections (a1) and (b1) and in accordance with the recommendations of the Advisory Committee on Immunization Practices.
SECTION 5.(d)  This section is effective when it becomes law.

PART VI. EFFECTIVE DATE
SECTION 6.  Except as otherwise provided, this act is effective when it becomes law.