90-85.28. Selection by pharmacists permissible; prescriber may permit or prohibit selection; price limit on selected drugs; communication of dispensed biological products under specified circumstances.
(a) A pharmacist dispensing a prescription for a drug product prescribed by its brand name may select any equivalent drug or interchangeable biological product which meets all of 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) 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.
(5) The manufacturer shall have adequate provisions for return of outdated drugs, through the distributor or otherwise.
(b) The pharmacist shall not select an equivalent drug or interchangeable biological 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 instructions to the pharmacist by signing the appropriate line.
(2) In the event the preprinted or stamped prescription form specified in subdivision (1) of subsection (b) of this section 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.
(b1) A prescription for a narrow therapeutic index drug shall be refilled using only the same drug product by the same manufacturer that the pharmacist last dispensed under the prescription, unless the prescriber is notified by the pharmacist prior to the dispensing of another manufacturer's product, and the prescriber and the patient give documented consent to the dispensing of the other manufacturer's product. For purposes of this subsection, the term "refilled" shall include a new prescription written at the expiration of a prescription which continues the patient's therapy on a narrow therapeutic index drug.
(b2) Expired.
(b3) The Board of Pharmacy shall maintain a link on its Internet Web site to the current list of biological products determined by the United States Food and Drug Administration to be interchangeable with a specific biological product.
(b4) Expired.
(c) The pharmacist shall not select an equivalent drug or interchangeable biological product unless its price to the purchaser is less than the price of the prescribed drug product. (1979, c. 1017, s. 1; 1981 (Reg. Sess., 1982), c. 1188, s. 3; 1997-76, s. 2; 2015-27, s. 2.)
Structure North Carolina General Statutes
North Carolina General Statutes
Chapter 90 - Medicine and Allied Occupations
Article 4A - North Carolina Pharmacy Practice Act.
§ 90-85.2 - Legislative findings.
§ 90-85.3A - Practice of pharmacy.
§ 90-85.4 - North Carolina Pharmaceutical Association.
§ 90-85.5 - Objective of Pharmaceutical Association.
§ 90-85.6 - Board of Pharmacy; creation; membership; qualification of members.
§ 90-85.7 - Board of Pharmacy; selection; vacancies; commission; term; per diem; removal.
§ 90-85.10 - Employees; Executive Director.
§ 90-85.11 - Compensation of employees.
§ 90-85.11A - Acquisition of real property; equipment; liability insurance.
§ 90-85.12 - Executive Director to make investigations and prosecute.
§ 90-85.13 - Approval of schools and colleges of pharmacy.
§ 90-85.14 - Practical experience program.
§ 90-85.15A - Pharmacy technicians.
§ 90-85.15B - Immunizing pharmacists.
§ 90-85.18 - Approval of continuing education programs.
§ 90-85.20 - Licensure without examination.
§ 90-85.21A - Applicability to out-of-state operations.
§ 90-85.21B - Unlawful practice of pharmacy.
§ 90-85.21C - Pharmacy permit exemption for dispensing and delivery of home renal products.
§ 90-85.22 - Device and medical equipment permits; exemptions.
§ 90-85.23 - License and permit to be displayed.
§ 90-85.24 - Fees collectible by Board.
§ 90-85.25 - Disasters and emergencies.
§ 90-85.26A - Clinical pharmacist practitioners subcommittee.
§ 90-85.29 - Prescription label.
§ 90-85.30 - Prescription record.
§ 90-85.31 - Prescriber and pharmacist liability not extended.
§ 90-85.33 - Unit dose medication systems.
§ 90-85.34 - Unique pharmacy practice.
§ 90-85.34A - Public health pharmacy practice.
§ 90-85.35 - Availability of patient records.
§ 90-85.36 - Availability of pharmacy records.
§ 90-85.38 - Disciplinary authority.
§ 90-85.39 - Injunctive authority.
§ 90-85.44 - Drug, Supplies, and Medical Device Repository Program established.