GENERAL ASSEMBLY OF NORTH CAROLINA

SESSION 1989

H	1 

HOUSE BILL 1120

Short Title:  Coded Prescription Drugs.	(Public)
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Sponsors: Representative Warner.
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Referred to:  Human Resources.
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April 10, 1989

A BILL TO BE ENTITLED
AN ACT TO PROVIDE FOR CODED IMPRINTS ON PRESCRIPTION DRUGS DISPENSED IN SOLID DOSAGE FORM.
The General Assembly of North Carolina enacts:
Section 1.  Article 12 of Chapter 106 of the General Statutes is amended by adding a new section to read:
"§ 106-134.2.  Drug imprinting.
(a)	Definitions.  The following definitions apply in this section:
(1)	Code imprint.  A series of letters or numbers assigned by the manufacturer or wholesaler to a specific drug, or marks or monograms unique to the manufacturer or wholesaler, or both.  The National Drug Code may be used as a code imprint.
(2)	Practitioner.  Defined in G.S. 106-121.
(3)	Prescription.  Defined in G.S. 105-121.
(4)	Solid dosage form.  A capsule or tablet intended for oral administration.
(5)	Wholesaler.  Defined in G.S. 106-121.
(b)	Prescription Drug Imprint.  No prescription drug in solid dosage form may be manufactured or distributed for sale in this State unless there is clearly marked or imprinted on the dosage form a code imprint identifying the drug and the manufacturer or wholesaler of the drug.  The Department of Agriculture, upon application by a manufacturer or wholesaler, may exempt a particular drug product from the requirement that it be imprinted on the grounds that imprinting is not feasible because of the drug product's size, texture, or other unique characteristics.
(c)	Coding Lists.  On or before October of each year, every manufacturer and wholesaler of prescription drugs shall provide to the Department of Agriculture a list of its prescription drugs and a description of the code imprint each bears.  The Department shall provide for the distribution of this information to all poison control centers in the State.  The Department shall provide to any licensed health care provider, upon request, lists of legend drugs and code imprints provided to the Department under this section, and may charge a reasonable fee to cover copying and postage costs.  Manufacturers and wholesalers shall provide updated lists to the Department annually and as changes or revisions occur.
(d)	Violations.  A prescription drug that does not meet the above requirements shall be deemed misbranded.
A person who manufactures, distributes for sale, or otherwise provides to another person for dispensing a prescription drug in solid dosage form that is not imprinted as provided in this section shall be guilty of a Class I felony.
(e)	Exemption.  This section does not apply to drugs manufactured by or upon the order of a practitioner which are to be used solely by patient for whom prescribed."
Sec.  2.  G.S. 106-134 is amended by adding a new subdivision to read:
"(19)	If it is a prescription drug in solid dosage form that does not bear the code imprint required by G.S. 106-134.2."
Sec. 3.  This act shall become effective October 1, 1989, and applies to drugs manufactured on or after that date.  The coding lists required by G.S. 106-134.2 shall be provided to the Department of Agriculture on October 1, 1989.