Labeling Requirements

Section 2085 Section 2085.40  Labeling Requirements a)         Medication for Outpatient Use The hospital pharmacy shall affix to the package or container of delta-9-THC Medication a label showing date of filling, the hospital pharmacy name, address and telephone number, the pharmacy DEA number, the serial number of the research order, the name of the patient, the name of the prescribing physician, the directions for use, the period covered by the research order, the name, strength and quantity of medication, the pharmacist's initials, and the following cautionary statements:  The medication is non-refillable, the patient is to return unused portions of the medication, and Federal and State law prohibits the transfer or use of the medication by any person other than the person for whom it is prescribed.  A sample label is attached as Exhibit D. b)         Medication for Inpatient Use Delta-9-THC Medication prescribed and dispensed for a patient who is institutionalized may be exempt from the provisions of subparagraph 1 above in accordance with 21 CFR 1306.14(b).