§ 21-221. Label requirements for prescription drugs; exemption from provisions on misbranded drugs

   (a) Label requirements. -- A drug that is dispensed under a prescription shall bear a label that states:

   (1) The name and address of the dispenser;

   (2) The serial number of the prescription;

   (3) The date of the prescription or the date that the prescription was filled;

   (4) The name of the prescriber; and

   (5) If stated in the prescription:

      (i) The name of the patient;

      (ii) Any directions for use; and

      (iii) Any cautionary statements.

(b) Scope of exemptions. -- If a drug dispensed under a prescription meets the label requirements of this section, it is exempt from the provisions of:

   (1) Section 21-217(b)(3) through (7) of this subtitle; and

   (2) Section 21-218(b)(1) through (4), (7), (8), (13), and (14) of this subtitle.

(c) Exceptions to exemptions. -- The exemptions under this section do not apply to any drug that is dispensed in the course of the conduct of a business of dispensing drugs on the basis of diagnosis made through the mail.

HISTORY: An. Code 1957, art. 43, § 189C; 1982, ch. 240, § 2; 1987, ch. 306, § 2, 15; 1988, ch. 6, § 11.