1308.1 The pharmacist filling a written or emergency oral prescription for a controlled substance listed in Schedule II shall affix to the package a label meeting the requirements set forth in § 1912.2 of this title.

1308.2 The label of a drug listed in Schedules II, III, IV, and V shall, when dispensed to or for a patient, contain a clear, concise warning that it is a crime to transfer the drug to any person other than the patient. When the size of the label space requires a reduction in type, the reduction shall be made to a size no smaller than necessary and in no event to a size smaller than necessary and in no event to a size smaller than six (6) point type.

1308.3 The requirements of § 1308.1 do not apply when a controlled substance listed in Schedule II is prescribed for administration to an ultimate user who is institutionalized, if the following limitations are observed:

(a) Not more than a seven (7) day supply of the controlled substance listed in Schedule II is dispensed at one time;

(b) The controlled substance listed in Schedule II is not listed in the possession of the ultimate user before the administration;

(c) The institution maintains appropriate safeguards and records regarding the proper administration, control dispensing, and storage of the controlled substance listed in Schedule II; and

(d) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product, and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.

1308.4 When dispensed to or for a patient, the label of a drug listed in Schedules II, III, IV, or V shall contain a clear and concise warning that it is a crime to transfer the drug to any person other than the patient.

SOURCE: Final Rulemaking published at 33 DCR 1046, 1070 (February 21, 1986); as amended by Final Rulemaking published at 56 DCR 4742 (June 19, 2009).