TITLE I: COMPOUNDING PHARMACIES
1. For the purposes of this title:
A.
chronically ill patient means a patient whose physician has diagnosed the patient as having a long-term disease or condition that if left untreated may cause major irreversible morbidity and who might benefit from individualized or specialized medication that is not commercially available.
B.
compounding pharmacy means a pharmacy that is classified as a 503a pharmacy by the Atlasian Food and Drug Administration (FDA).
C.
monographs means quality standards for prescription medicines and dietary supplements that articulate the quality expectations for a medicine or dietary supplement, including its identity, strength, purity and performance.
D.
terminally ill patient means a patient whose physician has diagnosed the patient with a disease that, taking into account the patient’s medical circumstances, will cause the patient’s death in a reasonably foreseeable time.
2. Chronically-ill patients and terminally ill patients in the Southern Region have the right to determine, with the assistance and guidance of their health care providers, individual courses of treatment through the use of medications and treatments obtained from a compounding pharmacy.
3. Compounding pharmacies that are licensed in the Southern Region shall have access to Active Pharmaceutical Ingredients for use in compounding that meet Atlasia Pharmacopeia Monographs, if the Active Pharmaceutical Ingredient is:
A. prepared for use by an FDA-registered Active Pharmaceutical Ingredient manufacturer or packager; and
B. shipped into this Region in compliance with Regional and State law and arrives with a certificate of analysis detailing quality specifications, including any medications, dietary supplements and amino acids that are already in use by compounding pharmacies in the Region and State, in order to provide chronically ill patients and terminally ill patients with the prescribed individual course of treatment.
4. Section (3) of this Title does not apply if the Active Pharmaceutical Ingredient is deemed unsafe for compounding by the FDA or is placed on the Interim 503a Category II Bulk Drug Substance List. Compounding pharmacies may use substances placed on the Interim 503a Category III Bulk Drug Substance List only if the substance meets the requirements of this act.
5. This act does not allow any treatment or use of medication that is intended to cause the death of the patient.
TITLE II: DRUG DONATIONS
1. For the purposes of this title:
A.
Donate means to give without requiring anything or significant monetary value from the recipient. The term shall include giving by a nonprofit organization to another nonprofit organization where the donor organization has charged a nominal fee to the donee organization, and distribution by a nonprofit organization to an ultimate recipient who has been required to pay a nominal fee to the nonprofit organization.
B.
Drug means:
i. any article recognized in the official Atlasian Pharmacopoeia, or the official National Formulary, or any supplement to them; or
ii. any article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans; or
iii. any article other than food intended to affect the structure or any function of the human body; but does not mean medical supply as defined in this title.
C.
Gross negligence means conduct by a person with knowledge, at the time of the conduct, that the conduct is harmful to the health or well-being of another person.
D.
Intentional misconduct means conduct by a person with knowledge, at the time of the conduct, that the conduct is harmful to the health or well-being of another person.
E.
Medical supply means any instrument, apparatus, implement, contrivance, implant, in vitro reagent, or other similar or related article including any component, part, or accessory, which is:
i. recognized in the official National Formulary, or the official Atlasian Pharmacopoeia, or any supplement to them; or
ii. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in humans; or
iii. intended to affect the structure of any function of the human body, and which does not achieve any of its principal intended purposes through chemical action within or on the human body and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.
F.
Nonprofit organization means an incorporated or unincorporated entity that:
i. is operating for religious, charitable, or educational purposes; and
ii. does not provide net earnings to, or operate in any other manner that insures to the benefit of, any office employee, or shareholder of the entity. As used in this paragraph, earning shall not include employee compensation.
G.
Person means an individual, corporation, partnership, organization, association, or governmental entity including but not limited to a drug manufacturer, medical supply manufacturer, retail pharmacy, hospital pharmacy, wholesaler, clinic, physician, nurse, hospital, dentist, outpatient health facility nursing home, home health care entity, or nonprofit drug or medical supply distributor. In the case of a corporation, partnership, organization, association or government entity, the term includes as officer, director, partner, deacon, elder, priest, pastor, rabbi, imam, trustee, council member, or other elected or appointed individual responsible for the governance of the entity. In the case of an individual, the term includes heirs, executors, and administrators of an estate who donate unused drugs or medical supplies belonging to a deceased person.
2. A person shall not be subject to any civil or criminal liability arising from the nature, age, packaging, or condition of drugs or medical supplies that the person donates in good faith to a nonprofit organization for ultimate distribution to needy individuals, except that this paragraph shall not apply to an injury to or death or an ultimate user or recipient of the drug or medical supply that results from an act or omission of the donor constituting gross negligence or intentional misconduct.
3. If some or all of the donated drugs or medical supplies do not meet all quality and labeling standards imposed by federal, Regional, State, and local laws and regulations, the person who donates the drug or medical supply shall not be subject to civil or criminal liability in accordance with this title if the donor:
A. is informed by the doctor of the distressed or defective condition of the donated drug or medical supply; and
B. agrees to take necessary measures to comply with all relevant quality standards imposed by federal, Regional, State, and local laws and regulations prior to distribution of the donated drug or medical supply; and
C. is made knowledgeable as to the quality standards applicable to the donated drug or medical supply under federal, Regional, State, and local laws and regulations.
4. This title shall not be construed to create any liability.
5. The Southern Chamber of Delegates memorializes the federal government to work with the Region, States, and localities in establishing recycling and redistribution programs for narcotics in health care facilities and other established state drug repositories.
TITLE III: OVERDOSE PREVENTION
1. For the purposes of this title:
A.
Opioid antagonist means a drug, such as naloxone, that satisfies all of the following:
i.The drug binds to the opioid receptors and competes with or displaces opioid agonists at the opioid receptor site but does not activate the receptors, effectively blocking the receptor and preventing or reversing the effect of an opioid agonist; and
ii.The drug is not a controlled substance.
B.
Standing order means an order transmitted electronically or in writing by a practitioner for a drug or device for multiple patients or for one or more groups of patients.
2. The Southern Region shall permit all emergency medical technicians or service providers, certified first responders, law enforcement officers, fire fighters, and physicians, physician assistants, advanced practice nurses, or pharmacists to administer naloxone or another opioid antagonist to individuals who are undergoing or who are believed to be undergoing an opioid-related drug overdose.
3. Any emergency medical technicians or service providers, certified first responders, law enforcement officers, fire fighters, and physicians, physician assistants, advanced practice nurses, or pharmacists shall undergo any training necessary to safely and properly administer naloxone or another opioid antagonist.
4. Every ambulance service provider shall do all of the following:
A. Ensure that every emergency medical technicians or service providers and certified first responders under the ambulance service provider’s supervision who has obtained the training necessary to safely and properly administer naloxone or another opioid antagonist has a supply of naloxone or the other opioid antagonist available for administration when he or she is performing his or her duties as an emergency medical technician, to the extent that naloxone or the other opioid antagonist is available to the ambulance service provider.
B. Require each emergency medical technicians or service providers and certified first responders under the supervision of the ambulance service provider to keep a record of each instance in which naloxone or another opioid antagonist is administered to an individual who is undergoing or who is believed to be undergoing an opioid-related drug overdose.
C. Submit such records to the State in which the administration occurs annually.
5. A law enforcement agency or fire department may enter into a written agreement to affiliate with an ambulance service provider or a physician for all of the following purposes:
A. Obtaining a supply of naloxone or another opioid antagonist; and
B. Allowing law enforcement officers and fire fighters to obtain the training necessary to safely and properly administer naloxone or another opioid antagonist to individuals who are undergoing or who are believed to be undergoing an opioid-related drug overdose.
6. An emergency medical technician or service provider, certified first responder, law enforcement officer, fire fighter, physician, physician assistant, advanced practice nurse, or pharmacist who, reasonably believing another person to be undergoing an opioid-related drug overdose, administers naloxone or another opioid antagonist to that person shall be immune from civil or criminal liability for any outcomes resulting from the administration of the opioid antagonist to that person, if the person so administering is acting pursuant to any training required by this title.
7. A pharmacist authorized to issue prescription orders may do any of the following:
A. Prescribe an opioid antagonist to a person in a position to assist an individual at risk of undergoing an opioid-related drug overdose and may deliver the opioid antagonist to that person. A prescription order under this subdivision need not specify the name and address of the individual to whom the opioid antagonist will be administered, but shall instead specify the name of the person to whom the opioid antagonist is prescribed.
B. Issue a standing order to one (1) or more persons authorizing the dispensing of an opioid antagonist.
8. A physician, physician assistant, or advanced practice nurse who prescribes or delivers an opioid antagonist shall ensure that the person to whom the opioid antagonist is prescribed has or has the capacity to provide the knowledge and training necessary to safely administer the opioid antagonist to an individual undergoing an opioid-related overdose and that the person demonstrates the capacity to ensure that any individual to whom the person further delivers the opioid antagonist has or receives that knowledge and training.
9. A physician, physician assistant, or advanced practice nurse who, acting in good faith, prescribes or delivers an opioid antagonist in accordance with this title or who, acting in good faith, otherwise lawfully prescribes or dispenses an opioid antagonist, shall be immune from criminal or civil liability and may not be subject to professional discipline for any outcomes resulting from prescribing, delivering, or dispensing the opioid antagonist.
10. A pharmacist may, upon and in accordance with the prescription order of a physician, physician assistant, or advanced practice nurse authorized to issue prescription orders that complies with law, deliver an opioid antagonist to a person specified in the prescription order and may, upon and in accordance with the standing order of a physician, physician assistant, or advanced practice nurse that complies with the law, deliver an opioid antagonist to an individual in accordance with the order. The pharmacist shall provide a consultation in accordance with law.
12. A pharmacist who, acting in good faith, delivers an opioid antagonist in accordance with this title, or who, acting in good faith, otherwise lawfully dispenses an opioid antagonist, shall be immune from criminal or civil liability and may not be subject to professional discipline under for any outcomes resulting from delivering or dispensing the opioid antagonist.
13. Any person may possess an opioid antagonist. Any person may deliver or dispense an opioid antagonist. Subject to law, any person who, acting in good faith, delivers or dispenses an opioid antagonist to another person, or who, reasonably believing another person to be undergoing an opioid-related drug overdose, administers an opioid antagonist to that person shall be immune from civil or criminal liability for any outcomes resulting from delivering, dispensing, or administering the opioid antagonist.
14. A program is hereby created for the purpose of funding grants to the following groups to purchase opioid antagonists and offer training in the use and administration of opioid antagonists:
A. Public Hospitals and free healthcare clinics;
B. Public and Private ambulance service providers;
C. Public and Private fire departments;
D. Police Departments and Sheriff offices;
E. Homeless Shelters; and
F. Other non-profit organizations that provide emergency medical services.
15. As a condition of accepting funds under this progran, all recipients must record the number of times opioid antagonists are administered and shall submit such records to the Southern Region annually.
16. Funding for the program shall come from the Addiction Services Trust Fund whuch shall receive dedicated revenue from a tax imposed on wholesale opioid distributors and mail-order pharmacies at a rate of 5 cents ($0.05) per dose manufactured or imported into the Southern Region.
17. The Opiate Overdose Prevention Act id hereby repealed.
TITLE IV: RIGHT TO TRY
1. Neither the Southern Region nor any State or locality therein shall take any action to prohibit or restrict:
A. The production, manufacture, distribution, prescribing, or dispensing of an experimental drug, biological drug product, or medical device that is intended to treat a patient who has been diagnosed with a terminal illness; and is authorized by, and in accordance with, Regional law; and
B. The possession or use of an experimental drug biological product, or device: that is described herein and (ii) of and/or which the patient has received a certification from a physician, who is in good standing with the physician's certifying organization or board, that the patient has exhausted, or otherwise does not meet qualifying criteria to receive, any other available treatment options.
TITLE V: ENACTMENT
1. This act shall take effect thirty (30) days after passage.
