Section 2085.55  Reports and Recordkeeping

a)         Copies of all reports and forms required under the Mechanism and the Guidelines to be submitted to the NCI and DEA shall be submitted to the Department.

b)         Research orders filled by the hospital pharmacy shall be kept on pharmacy premises separate and apart from other pharmacy documents and shall be filed by date of filling.  Such Research Orders shall be available to Department personnel for inspection and audit.

c)         The original and one copy of the Research Order for delta-9-THC Medication shall be delivered to the hospital pharmacy.  The original Research Order Form for delta-9-THC Medication shall be retained by the hospital pharmacy and by the 15^th of the month following the month in which the Research Order Form was filled, the duplicate shall be returned to the Department.  The duplicate copy shall not contain any patient or recipient identifying information.  The pharmacy shall retain their copies of the orders for the same period as required for controlled substances pursuant to the Illinois Pharmacy Act (Ill. Rev. Stat. 1981, ch. 111, par. 4030).

d)         Any unused medication shall be returned to the distributing pharmacy upon completion of the Research Order expiration date.  Any unused amount of THC shall be recorded on the form which issued the THC to the patient. It may be redispensed to the same patient pursuant to a new Research Order. Such redistribution period shall not extend beyond the lot expiration date.