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3397-C - Antonio G. Olivieri controlled substances therapeutic research program established; participation.

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§3397-c.AntonioG.Oliviericontrolledsubstancestherapeuticresearch program established; participation.1. The Antonio G. Oliviericontrolled substances therapeutic research program is hereby establishedin the department of health. The commissioner shall promulgate rules andregulations necessary for the proper administrationofthecontrolledsubstances therapeutic research act.Insuchpromulgation,thecommissioner shall take into considerationthosepertinentrulesandregulations promulgated by the drug enforcement administration, food anddrug administration and the national institute on drug abuse.2.ParticipationintheAntonioG. Olivieri controlled substancestherapeutic researchprogramshallbelimitedtocancerpatients,glaucomapatientsandpatientsafflicted with other diseases as suchdiseases areapprovedbythecommissioner.Suchpatientshallbecertifiedbyaphysiciantoand approved by a patient qualificationreview board or committeeinthemannerprovidedbythisarticle.Physician certification and board or committee approval shall be limitedto such patients who are involvedinalife-threateningorsense-threatening situation.Patientsseekingparticipationinsuchprogrammayseektheadviceandshall be entitled to be advised byappropriatemedicalpersonnelconcerningthemedicalefficacy oftreatment with conventional controlled substances.3.Thecommissioner, on behalf of the department, shall apply to thefood and drug administration foraninvestigationalnewdrugpermitwithin ninety days after the effective date of this section.
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  • § 3397-c. Antonio G. Olivieri controlled substances therapeutic research program established; participation. 1. The Antonio G. Olivieri controlled substances therapeutic research program is hereby established in the department of health. The commissioner shall promulgate rules and regulations necessary for the proper administration of the controlled substances therapeutic research act. In such promulgation, the commissioner shall take into consideration those pertinent rules and regulations promulgated by the drug enforcement administration, food and drug administration and the national institute on drug abuse. 2. Participation in the Antonio G. Olivieri controlled substances therapeutic research program shall be limited to cancer patients, glaucoma patients and patients afflicted with other diseases as such diseases are approved by the commissioner. Such patient shall be certified by a physician to and approved by a patient qualification review board or committee in the manner provided by this article. Physician certification and board or committee approval shall be limited to such patients who are involved in a life-threatening or sense-threatening situation. Patients seeking participation in such program may seek the advice and shall be entitled to be advised by appropriate medical personnel concerning the medical efficacy of treatment with conventional controlled substances. 3. The commissioner, on behalf of the department, shall apply to the food and drug administration for an investigational new drug permit within ninety days after the effective date of this section.

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