D.C. Mun. Regs. tit. 22, r. 22-B1912

Current through Register Vol. 71, No. 50, December 13, 2024

Rule 22-B1912 - LABELING OF DISPENSED DRUGS

1912.1

The labeling requirements of this section shall apply to all pharmacies, unless otherwise exempted by this chapter or the Director.

1912.2

A container in which a prescription drug or device is sold or dispensed must bear a label containing the following information:

(a) The name, address, and telephone number of the pharmacy;

(b) The name of the patient, or if the ultimate user is an animal, the name of the owner, the first name of the animal, and the species of the animal;

(c) The name of the prescribing practitioner;

(d) The date of filling;

(e) The generic, chemical, or brand name of the drug unless omission is specifically requested by the prescriber in writing pursuant to the District of Columbia Prescription Drug Price Information Act, (D.C. Law 1-81, D.C. Code §§ 48-801 et al);

(f) The strength, dosage, and quantity of the drug dispensed;

(g) The directions for use and cautionary statements, if any, contained in the prescription or required by law;

(h) The serial number of the prescription or prescription number; and

(i) The expiration date of the product according to the manufacturer or one (1) year from the date the drug or medical device is dispensed, whichever comes first, subject to the discretion of the pharmacist to select an earlier date on which the life of a compounded drug product may expire.

1912.3

If a prescription order is for a controlled substance, the label shall also include a clear, concise warning that it is a crime to transfer the drug to any person other than the patient.

1912.4

A pharmacy shall be responsible for labeling each prepackaged or repackaged container with the following information:

(a) The name of the drug;

(b) The name of the manufacturer if the drug is generic;

(c) The drug strength and quantity;

(d) The manufacturer or distributor's control or lot number; and

(e) The expiration date of the product according to the manufacturer or on one (1) year from the date the drug or medical device is prepackaged, whichever comes first, subject to the discretion of the pharmacist to select an earlier date on which the life of a compounded drug product may expire.

1912.5

When the size of the label required pursuant to this section requires a reduction in type, the reduction shall not be made to a size smaller than is necessary and under no circumstances shall the size be less than six (6) point type.

1912.6

Once opened, a multi-dose container shall be labeled with the expiration date of the product according to the manufacturer or on one (1) year from the date the drug or medical device is prepackaged, whichever comes first, subject to the discretion of the pharmacist to select an earlier date on which the life of a compounded drug product may expire.

D.C. Mun. Regs. tit. 22, r. 22-B1912

Final Rulemaking published at 38 DCR 6734, 6744 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008)