NORTH CAROLINA GENERAL ASSEMBLY
1979 SESSION

CHAPTER 1017
HOUSE BILL 818

AN ACT TO PROVIDE FOR DRUG PRODUCT SELECTION BY PHARMACISTS.

The General Assembly of North Carolina enacts:

Section 1.  G.S. 90-76 is repealed. Part 1A is added to Article 4 of Chapter 90 of the General Statutes, as follows:
"Part 1A.
"Drug Product Selection.
"§ 90-76.1.  Definitions. — As used in this Part:
(1)	'established name' has the meaning given in Section 502(e)(3) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 352(e)(3);
(2)	'equivalent drug product' means a drug product which has the same established name, active ingredient, strength, quantity, and dosage form, and which is therapeutically equivalent to the drug product identified in the prescription;
(3)	'good manufacturing practice' has the meaning given it in Part 211 of Chapter 1 of Title 21 of the Code of Federal Regulations;
(4)	'manufacturer' means the actual manufacturer of the finished dosage form of the drug;
(5)	'prescribed' means anyone authorized to prescribe drugs pursuant to the laws of this State.
"§ 90-76.2.  Selection by pharmacists permissible; prescriber may permit or prohibit selection; price limit on selected drugs. — (a) A pharmacist dispensing a prescription for a drug product prescribed by its brand name may select any equivalent drug product which meets the following standards:
(1)	the manufacturer's name and the distributor's name, if different from the manufacturer's name, shall appear on the label of the stock package;
(2)	it shall be manufactured in accordance with current good manufacturing practices;
(3)	effective January 1, 1982, all oral solid dosage forms shall have a logo, or other identification mark, or the product name to identify the manufacturer or distributor;
(4)	the manufacturer shall have adequate provisions for drug recall; and
(5)	the manufacturer shall have adequate provisions for return of outdated drugs, through his distributor or otherwise.
(b)	The pharmacist shall not select an equivalent drug product if the prescriber instructs otherwise by one of the following methods:
(1)	A prescription form shall be preprinted or stamped with two signature lines at the bottom of the form which read:
'_________________________		_______________________
Product Selection Permitted		Dispense as Written'
On this form, the prescriber shall communicate his instructions to the pharmacist by signing the appropriate line.
(2)	In the event the preprinted or stamped prescription form specified in (b)(1) is not readily available, the prescriber may handwrite 'Dispense as Written' or words or abbreviations of the same meaning on a prescription form.
(3)	When ordering a prescription orally, the prescriber shall specify either that the prescribed drug product be dispensed as written or that product selection is permitted. The pharmacist shall note the instructions on the file copy of the prescription and retain the prescription form for the period prescribed by law.
(c)	The pharmacist shall not select an equivalent drug product unless its price to the purchaser is less than the price of the prescribed drug product.
"§ 90-76.3.  Prescription label. — The prescription label of every drug product dispensed shall contain the brand name of any drug product dispensed, or in the absence of a brand name, the established name.
"§ 90-76.4.  Prescription record. — The pharmacy file copy of every prescription shall include the brand or trade name, if any, or the established name and the manufacturer of the drug product dispensed.
"§ 90-76.5.  Prescriber and pharmacist liability not extended. — The selection of an equivalent drug product pursuant to this Part shall impose no greater liability upon the pharmacist for selecting the dispensed drug product or upon the prescriber of the same than would be incurred by either for dispensing the drug product specified in the prescription.
"§ 90-76.6.  Violation a misdemeanor. — Violation of this Part is a misdemeanor and shall be punishable by a fine or imprisonment, or both, at the discretion of the court."
Sec. 2.  This act shall become effective January 1, 1980, and shall apply only to prescriptions written or ordered orally after January 1, 1980.
In the General Assembly read three times and ratified, this the 8th day of June, 1979.