Section 333.8303 - Records; notification; prohibited acts; destruction of marihuana determined not pharmaceutical-grade cannabis; standards; manner of irradiation(1) A pharmaceutical-grade cannabis licensed facility shall maintain on the premises a record of the name, address, and date of birth of each officer, director, partner, member, manager, or employee of that licensed facility. The licensed facility shall obtain the individual's identification and have a criminal history check conducted to determine if that individual is qualified to work at or be associated with the licensed facility under this article.(2) A pharmaceutical-grade cannabis licensed facility shall notify the department in writing within 10 days after an officer, director, partner, member, manager, or employee ceases to work at or otherwise be associated with the licensed facility.(3) A pharmaceutical-grade cannabis licensed facility shall not acquire, possess, cultivate, deliver, transfer, transport, supply, sell, or dispense pharmaceutical-grade cannabis for any purpose except as provided in this article.(4) A pharmaceutical-grade cannabis licensed facility shall not possess more than the amount of pharmaceutical-grade cannabis plants or dried pharmaceutical-grade cannabis allowed in its inventory as prescribed in rules promulgated under this article.(5) A pharmaceutical-grade cannabis licensed facility shall destroy all marihuana that it cultivates or that is otherwise in its possession that is determined not to be pharmaceutical-grade cannabis. A licensed facility shall keep records of its activities under this subsection in order to verify its compliance to the department.(6) Pharmaceutical-grade cannabis shall meet the following standards: Microbiological |
Microbiological Analysis | FPL Specifications |
Total coliforms | < 3 MPN/g |
Std. plate count aerobic | < 100 CFU/g |
Std. plate count anaerobic | < 100 CFU/g |
Escherichia coli | Absent |
Salmonella | Absent |
Staphylococcus aureus | < 100 CFU/g |
Yeast and molds | < 100 CFU/g |
Mycotoxins |
Test | Specification |
Aflatoxin B1 | < 20 µg/kg of substance |
Aflatoxin B2 | < 20 µg/kg of substance |
Aflatoxin O1 | < 20 µg/kg of substance |
Aflatoxin O2 | < 20 µg/kg of substance |
Ochratoxin A | < 20 µg/kg of substance |
Heavy Metals |
Metal | NHP Acceptable Limits |
µg/kg bw/day |
Arsenic | < 0.14 |
Cadmium | < 0.09 |
Lead | < 0.29 |
Mercury | < 0.29 |
(7) A licensed facility shall irradiate all pharmaceutical-grade cannabis in the manner determined by the department before delivering that pharmaceutical-grade cannabis to another person.Added by 2013, Act 268,s 25, eff. 12/30/2013.