Current through Register Vol. XLI, No. 25, June 21, 2024
Section 15-2-6 - Labeling And Packaging RequirementsForControlled Substances6.1 Symbol required; exceptions. 6.1.1. A commercial container of a controlled substance shall have printed on the label the symbol designating the schedule in which the controlled substance is listed. A commercial container, if it otherwise has no label, shall bear a label complying with the requirement of this section.6.1.2. A manufacturer shall print upon the labeling of a controlled substance distributed the symbol designating the schedule in which the controlled substance is listed.6.1.3. The following symbols shall designate the schedule corresponding thereto: Schedule I ........... CI or C-I.
Schedule II .........CII or C-II.
Schedule III.......... CIII or C-III.
Schedule IV.......... CIV or C-IV.
Schedule V ..........CV or C-V.
The word "Schedule" does not need to be used. There is no distinction made between narcotic and nonnarcotic substances.
6.1.4. The symbol is not required on a carton or wrapper in which a commercial container is held if the symbol is easily legible through the carton or wrapper.6.1.5. The symbol is not required on a commercial container too small or otherwise unable to accommodate a label, if the symbol is printed on the box or package from which the commercial container is removed upon dispensing to an ultimate user.6.1.6. The symbol is not required on a commercial container containing, or on the labeling of, a controlled substance being utilized in clinical research involving blind and double blind studies.6.1.7. The symbol is not required on a commercial container containing, or on the labeling, of a controlled substance intended for export from the United States.6.2. Location and size of symbol on label. 6.2.1. The symbol shall be prominently located on the right upper corner of the principal panel of the label of the commercial container and/or the panel of the commercial container normally displayed to dispensers of any controlled substance listed in Schedule I through V. The symbol shall be at least two times as large as the largest type otherwise printed on the label.6.2.2. In lieu of locating the symbol in the corner of the label, as prescribed in subsection 6.2.1. of this rule, the symbol may be overprinted on the label, in which case the symbol shall be printed at least one half the height of the label and in a contrasting color providing clear visibility against the background color of the label.6.2.3. The symbol shall be clear and large enough to afford easy identification of the schedule of the controlled substance upon inspection without removal from the dispenser's shelf.6.3. Sealing of controlled substances.6.3.1. On a bottle, multiple dose vial, or other commercial container of a controlled substance, there shall be securely affixed to the stopper, cap, lid, covering or wrapper or other container, a seal to disclose upon inspection any tampering or opening of the container.