10.19.03.04

.04 Labeling and Packaging Requirements for Controlled Dangerous Substances. (Title 21, Code of Federal Regulations 1302.01).

A. Requirements governing the labeling and packaging of controlled dangerous substances pursuant to Criminal Law Article, §§5-202 and 5-604, Annotated Code of Maryland, are set forth generally by those sections and specifically by the sections of this regulation.

B. Symbol Required—Exceptions (21 CFR §1302.03).

(1) Each commercial container of a controlled dangerous substance (except for a controlled dangerous substance excepted by the Administrator pursuant to Title 21, Code of Federal Regulations, §1308.31, shall have printed on the label the symbol designating the schedule in which this controlled dangerous substance is listed. Each commercial container, if it has no label, shall bear a label complying with the requirement of this part.

(2) Each manufacturer shall print upon the labeling of each controlled dangerous substance distributed by the manufacturer the symbol designating the schedule in which this controlled dangerous substance is listed.

(3) Schedules.

(a) The following symbols shall designate the schedule corresponding to it:

Schedule Symbol
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

(b) The word "schedule" need not be used. A distinction need not be made between narcotic and non-narcotic substances.

(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 this carton or wrapper.

(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) The symbol is not required on a commercial container containing, or on the labeling of, a controlled dangerous substance being used in clinical research involving blind and double blind studies.

C. Location and Size of Symbol on Label (21 CFR §1302.04).

(1) The symbol shall be prominently located on:

(a) The label or the labeling of the commercial container;

(b) The panel of the commercial container normally displayed to dispensers of any controlled substance; or

(c) Both.

(2) In all cases the symbol shall be clear and large enough to afford easy identification of the schedule of the controlled dangerous substance upon inspection, without removal from the dispenser's shelf.

(3) The symbol shall be prominently located on all labeling other than labels covered by this section. In all cases the symbol shall be clear and large enough to afford prompt identification of the controlled dangerous substance upon inspection of the labeling.

D. Effective Dates of Labeling Requirements (21 CFR §1302.05).

(1) All labels on commercial containers of, and all labeling of, a controlled substance which either is transferred to another schedule or is added to any schedule, shall comply with the requirements of §B of this regulation, on or before the effective date established in the final order for the transfer or addition.

(2) In the case of any controlled dangerous substance, the Secretary may require compliance with the requirements of §B within a period of time shorter than required by this regulation if the Secretary finds that public health or safety necessitates an earlier effective date.

(3) Until compliance is required under this regulation, the label on commercial containers containing, and the labeling of, any controlled dangerous substance, shall comply with any requirements under federal law as to labels of these substances existing before the effective date prescribed in this regulation.

E. Sealing of Controlled Dangerous Substances (21 CFR §1302.06). On each bottle, multiple dose vial, or other commercial container of any controlled dangerous substance, there shall be securely affixed to the stopper, cap, lid, covering, or wrapper of that container a seal to disclose upon inspection any tampering or opening of the container.

F. Labeling and Packaging Requirements for Imported and Exported Substances (21 CFR §1302.07).

(1) The symbol requirements of §§B—D of this regulation apply to every commercial container containing, and to all labeling of, controlled substances imported into the jurisdiction of or the customs territory of the United States.

(2) The symbol requirements of §§B—D of this regulation do not apply to any commercial containers containing, or any labeling of, a controlled dangerous substance intended to export from the jurisdiction of the United States.

(3) The sealing requirements of §E of this regulation apply to every bottle, multiple dose vial, or other commercial container of any controlled substance listed in Schedule I or II, or any narcotic controlled substance listed in Schedule III or IV, imported into, exported from, or intended for export from, the jurisdiction of or the customs territory of the United States.