Section 21-221 - Label requirements for prescription drugs; exemption from provisions on misbranded drugs. - Maryland Statutes

§ 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. 
 

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