H4607

	SECTION 1. Chapter 94C of the General Laws is hereby amended by inserting after section 19D1/2 the following section:-
	Section 19E. (a) For the purposes of this section, unless the context clearly requires otherwise, “epinephrine delivery system” shall mean an epinephrine autoinjector or any other device that is approved by the federal food and drug administration, that contains a premeasured dose of epinephrine, and that is used to administer epinephrine into the human body to prevent or treat a life-threatening allergic reaction. 
	(b) The department shall ensure that a statewide standing order is issued to authorize the dispensing of an epinephrine delivery system in the commonwealth by any licensed pharmacist. The statewide standing order shall include, but not be limited to, written, standardized procedures or protocols for the dispensing of an epinephrine delivery system by a licensed pharmacist. Notwithstanding any general or special law to the contrary, the commissioner, or physician designated by the commissioner who is registered to distribute or dispense a controlled substance in the course of professional practice pursuant to section 7, shall issue a statewide standing order that may be used by a licensed pharmacist to dispense an epinephrine delivery system under this section.
	(c) Notwithstanding any general or special law to the contrary, a licensed pharmacist may dispense an epinephrine delivery system in accordance with the statewide standing order issued under subsection (b). Except for an act of gross negligence or willful misconduct, a pharmacist who, acting in good faith, dispenses an epinephrine delivery system shall not be subject to any criminal or civil liability or any professional disciplinary action by the board of registration in pharmacy related to the use or administration of an epinephrine delivery system. 
	(d) Before dispensing an epinephrine delivery system authorized under this section, a pharmacist may complete an anaphylaxis training program approved by the commissioner; provided however, that the training shall include, but not be limited to, techniques on how to recognize symptoms of severe allergic reactions, including anaphylaxis, and emergency follow-up procedures.  
	(e) A pharmacist who dispenses an epinephrine delivery system under this section shall annually provide to the department the number of times such epinephrine delivery systems are dispensed. Reports made pursuant to this section shall not identify any individual patient, shall be confidential and shall not be public records as defined by clause Twenty-sixth of section 7 of chapter 4 or section 10 of chapter 66. The department shall publish an annual report that includes aggregate information about the dispensing of epinephrine delivery systems in the commonwealth.  
	(f) Except for an act of gross negligence or willful misconduct, the commissioner or a physician who issues the statewide standing order under subsection (b) and any medical practitioner who, acting in good faith, directly or through the standing order, prescribes or dispenses an epinephrine delivery system shall not be subject to any criminal or civil liability or any professional disciplinary action. 
	(g) The department, board of registration in medicine, board of registration in nursing and board of registration in pharmacy shall adopt regulations to implement this section.
	SECTION 2. Chapter 94C of the General Laws is hereby amended by inserting, after section 34A1/2, the following section:-
	Section 34B. (a) As used in this section, the following word shall have the following meaning unless the context clearly requires otherwise:
	"Epinephrine delivery system”, a device that is approved by the federal food and drug administration, that contains a premeasured dose of epinephrine, and that is used to administer epinephrine into the human body to prevent or treat a life-threatening allergic reaction.
	“First responder”, a law enforcement officer, a paid, call, reserve or volunteer firefighter, a paid, call, reserve or volunteer emergency medical technician or any other person whose usual and regular duties include rendering assistance at the scene of a crime, accident or other emergency. 
	(b) A first responder, who, in good faith, seeks medical assistance for someone experiencing an anaphylactic reaction shall not be charged or prosecuted for possession of a controlled substance under sections 34 or 35 if the evidence for the charge of possession of a controlled substance was gained as a result of the seeking of medical assistance.
	(b) A person who experiences an anaphylactic reaction and is in need of medical assistance and, in good faith, seeks such medical assistance, or is the subject of such a good faith request for medical assistance, shall not be charged or prosecuted for possession of a controlled substance under said sections 34 or 35 if the evidence for the charge of possession of a controlled substance was gained as a result of the anaphylactic reaction and the need for medical assistance.
	(c) The act of seeking medical assistance for someone who is experiencing an anaphylactic reaction may be used as a mitigating factor in a criminal prosecution under the Controlled Substance Act,1970 P.L. 91–513, 21 U.S.C. section 801, et seq.
	(d) Nothing contained in this section shall prevent anyone from being charged with trafficking, distribution or possession of a controlled substance with intent to distribute.
	(e) A first responder acting in good faith may receive an epinephrine delivery system, possess an epinephrine delivery system and administer an epinephrine delivery system to an individual appearing to experience an anaphylactic reaction, and provided further that no first responder shall be liable in a civil suit for damages as a result of any acts or omissions in providing or obtaining, or attempting to provide or obtain, such assistance unless such acts or omissions constitute willful, wanton or reckless conduct.
	SECTION 3. Chapter 111 of the General Laws is hereby amended by inserting after section 4O the following section:- 
	Section 4P. (a) As used in this section, the following words shall have the following meanings unless the context clearly requires otherwise:
	"Authorized entity", any entity or organization at which allergens capable of causing anaphylaxis may be present, including, but not limited to, restaurants, recreation camps, youth sports leagues, amusement parks, colleges, universities, and sports arenas.
	"Epinephrine delivery system”, a device that is approved by the federal food and drug administration, that contains a premeasured dose of epinephrine, and that is used to administer epinephrine into the human body to prevent or treat a life-threatening allergic reaction.  
	(b) An authorized entity may acquire and maintain a supply of epinephrine delivery systems from a wholesaler approved by the department pursuant to this section. All acquired epinephrine delivery systems shall be stored in a location readily accessible in an emergency and in accordance with the epinephrine delivery system’s instructions for use. An authorized entity shall designate employees or agents who have successfully completed the training required by subsection (e) of this section to be responsible for the storage, maintenance and general oversight of epinephrine delivery systems acquired under this section.
	(c) An authorized entity that chooses to acquire and maintain a supply of epinephrine delivery systems shall maintain an operations plan on the premises. Such plan shall include, but not be limited to:
	how the training required by subsection (e) will be provided to employees or agents of an authorized entity; 
	where and how epinephrine delivery systems will be stored;
	names of the employees or agents who have successfully completed the training required by subsection (e); and,
	how and when epinephrine delivery systems will be inspected to ensure that they have not expired.  
	(d) An employee or agent of an authorized entity who has completed the training required by subsection (e) of this section may, on the premises of or in connection with the authorized entity, use epinephrine delivery systems obtained under this section to provide or administer an epinephrine delivery system to any individual who the employee or agent believes in good faith is experiencing anaphylaxis for immediate self-administration, regardless of whether the individual has a prescription for an epinephrine delivery system or has previously been diagnosed with an allergy. 
	(e) An employee, agent, or other individual described in subsection (c) of this section must successfully complete an anaphylaxis training program prior to providing or administering an epinephrine delivery system made available by an authorized entity. The training must be conducted by a nationally recognized organization experienced in training laypersons in emergency health treatment or by an entity or individual approved by the department of public health. Training may be conducted online, and at a minimum, shall cover: 
	(i) techniques on how to recognize symptoms of severe allergic reactions, including anaphylaxis;
	(ii) recommended dosages for adults and children;
	(iii) standards and procedures for the storage and administration of epinephrine delivery systems; and
	(iv) emergency follow-up procedures.
	(f) Training certification shall be valid for no more than two years, after which recertification with nationally recognized organization experienced in training laypersons in emergency health treatment or by an entity or individual approved by the department of public health is required.
	(g) The entity shall submit proof of training to the department and receive approval for the acquisition of epinephrine delivery systems. 
	(h) An authorized entity that possesses and makes available epinephrine delivery systems and its trained employees and agents shall not liable for any injuries or related damages that result from the administration or self-administration of an epinephrine delivery system, the failure to administer an epinephrine delivery system, or any other act or omission taken pursuant to this section, provided that said immunity does not apply to acts or omissions constituting gross negligence or willful or wanton misconduct. 
	(i) An authorized entity that possesses and makes available epinephrine delivery systems shall submit to the department of public health, on a form developed by the department, a report of each incident on the authorized entity's premises that involves the distribution or administration of the authorized entity's epinephrine delivery systems. The department of public health shall annually publish a report that summarizes and analyzes all reports submitted to it under this subsection.
	(j) The department shall promulgate guidance or regulations to carry out this section.