10A NCAC 13G .1003       MEDICATION LABELS

(a)  Prescription legend medications shall have a legible label with the following information:

(1)           the name of the resident for whom the medication is prescribed;

(2)           the most recent date of issuance;

(3)           the name of the prescriber;

(4)           the name and concentration of the medication, quantity dispensed, and prescription serial number;

(5)           directions for use clearly stated and not abbreviated;

(6)           a statement of generic equivalency shall be indicated if a brand other than the brand prescribed is dispensed;

(7)           the expiration date, unless dispensed in a single unit or unit dose package that already has an expiration date;

(8)           auxiliary statements as required of the medication;

(9)           the name, address, telephone number of the dispensing pharmacy; and

(10)         the name or initials of the dispensing pharmacist.

(b)  For medication systems such as med paks and multi-paks when two or more solid oral dosage forms are packaged and dispensed together, labeling shall be in accordance with Paragraph (a) of this Rule and the label or package shall also have a physical description or identification of each medication contained in the package.

(c)  The facility shall assure the container is relabeled by a pharmacist or a dispensing practitioner at the refilling of the medication when there is a change in the directions by the prescriber.  The facility shall have a procedure for identifying direction changes until the container is correctly labeled.  No person other than a pharmacist or dispensing practitioner shall alter a prescription label.

(d)  Non-prescription medications shall have the manufacturer's label with the expiration date clearly visible, unless the container has been labeled by a pharmacist or a dispensing practitioner.  Non-prescription medications in the original manufacturer's container shall be labeled with at least the resident's name and the name shall not obstruct any of the information on the container.  Facility staff may label or write the resident's name on the container.

(e)  Medications, prescription and non-prescription, shall not be transferred from one container to another except when prepared for administration to a resident.

(f)  Prescription medications leaving the facility shall be in a form packaged and labeled by a pharmacist or a dispensing practitioner.  Non-prescription medications that are not packaged or labeled by a pharmacist or dispensing practitioner must be released in the original container and directions for administration must be provided to the resident or responsible party.  The facility shall assure documentation of medications, including quantity released and returned to the facility.

Note:  Dispensing of medications is restricted to pharmacists or other health care practitioners that are approved by the North Carolina Board of Pharmacy.  Repackaging or providing more than one dose of a prescription medication, including unit dose prescription medications, for subsequent administration is an act of dispensing.

 

History Note:        Authority G.S. 131D-2; 131D-4.5; 143B-165; S.L. 1999-0334;

Temporary Adoption Eff. December 1, 1999;

Eff. July 1, 2000.