Section 12-505 - Labeling requirements for prescription medicines. - Maryland Statutes

§ 12-505. Labeling requirements for prescription medicines.
 

(a)  Label required.- Except for a drug or device dispensed to an inpatient in a hospital or related institution, each container of a drug or device dispensed shall be labeled in accordance with this section. 

(b)  Required information.- In addition to any other information required by law, the label shall include: 

(1) The date the prescription is filled; and 

(2) Unless otherwise required by the prescriber: 

(i) An expiration date of the drugs or devices which shall be the lesser of: 

1. 1 year from the date of dispensing; 

2. The month and year when the drugs or devices expire; 

3. The appropriate expiration date for repackaged drugs or devices; or 

4. A shorter period as determined by the pharmacist; 

(ii) Any appropriate special handling instructions regarding proper storage of the drugs or devices; and 

(iii) Subject to the provisions of subsection (c) of this section, the name and strength of the drugs or devices. 

(c)  Name of medication.-  

(1) Except as provided in paragraph (2) of this subsection, the label shall indicate the same name for the drug or device as that used by the authorized prescriber. 

(2) If, under § 12-504 of this subtitle, the pharmacist substitutes a drug or device product for that named by the authorized prescriber, the label shall indicate both the name of the drug or device product and the name of the manufacturer or distributor of the drug or device dispensed. 

(d)  Medication dispensed by an authorized prescriber.-  

(1) Except as provided in this subsection, if an authorized prescriber dispenses a drug or device, the prescriber shall label each container of the drug or device. 

(2) In addition to any other information required by law, the authorized prescriber shall include on the label: 

(i) The name and strength of the drug or device; 

(ii) The date the prescription is dispensed; 

(iii) An expiration date of the drug or device which shall be the lesser of: 

1. 1 year from the date of dispensing; 

2. The month and year when the drug or device expires; or 

3. A shorter period as determined by the authorized prescriber; and 

(iv) Any appropriate special handling instructions regarding proper storage of the drug or device. 

(3) The labeling requirements of this subsection do not apply if the authorized prescriber dispenses the drug or device: 

(i) To an inpatient in a hospital or related institution; 

(ii) In an emergency situation; or 

(iii) As a sample drug or device dispensed in the regular course of the authorized prescriber's practice. 

(e)  Tampering with label prohibited.- So long as any of the original contents remain in the container, a person may not alter, deface, or remove any label required by this section. 
 

[An. Code 1957, art. 43, §§ 254A, 254B; 1981, ch. 8, § 2; 1989, ch. 608; 1990, ch. 6, § 11; 1997, ch. 614; 2006, ch. 523, § 3.]