Current through Register Vol. 54, No. 45, November 9, 2024
Section 1211a.29a - Research initiative(a) An ACRC, in coordination with its contracted clinical registrant, may conduct a research initiative on the antimicrobial effects of applying solvent-based extraction methods and processes to microbial contamination of immature medical marijuana plants, medical marijuana plants, medical marijuana or medical marijuana products.(b) An ACRC shall submit to the Department for approval a completed written research protocol of the planned research initiative. The Department shall grant approval or denial of the protocol within 15 days of its submission. The following apply: (1) The research initiative shall commence no later than 30 days from the date the Department issues approval and shall be completed no later than 6 months from the start date of the research initiative.(2) Research initiative findings shall be provided to the Department by the ACRC within 15 days of the research initiative's conclusion.(3) An ACRC and its contracted clinical registrant shall present research initiative findings to the Medical Marijuana Advisory Board (Board) and the Board's research subcommittee for the Board's review and consideration under sections 1201 and 1202 of the act (35 P.S. §§ 10231.1201 and 10231.1202). The Board shall issue a written report, with recommendations and findings regarding the use of solvent-based extraction methods and processes on microbial contamination by a clinical registrant or grower/processor. The secretary may approve the Board's recommendation in accordance with section 1202.(4) Prior to implementing a recommendation of the Board under paragraph (3), as approved by the secretary, a clinical registrant or grower/processor shall seek approval from the Department for a change in its grower/ processor extraction process. The Department shall inspect the site and facility equipment. Upon approval, the Department shall issue a notice of final approval to implement the process.Adopted by Pennsylvania Bulletin, Vol 53, No. 09. March 4, 2023, effective 3/4/2023