La. Admin. Code tit. 46 § LIII-2517

Current through Register Vol. 50, No. 9, September 20, 2024

Section LIII-2517 - Prescription Dispensing; Equivalent Drug Product Interchange; Drug Returns; Drug Disposal

A. Prescription dispensing means the issuance, by a licensed pharmacist, of one or more doses of medication in a suitable container, properly labeled for subsequent administration, and shall consist of the following procedures or practices:

1. receiving and interpretation of the prescription order;

2. assembling the drug products and an appropriate container;

3. preparing the prescription by compounding, mixing, counting, or pouring;

4. affixing the proper label to the final container;

5. patient counseling as required; and

6. transfer of possession.

B. Equivalent Drug Product Interchange

1. The pharmacist shall not select an equivalent drug product when the prescriber prohibits interchange by any one of the following methods.

a. On a prescription generated in written form, the prescriber shall handwrite a mark in a check box labeled "Dispense as Written", or the abbreviation "DAW", or both, and shall manually sign the prescription form.

i. For prescriptions reimbursable by the state Medicaid program, the prescriber shall handwrite the words "Brand Necessary" or "Brand Medically Necessary" on the prescription form or on a sheet of paper attached to the prescription form.

b. On a prescription generated in oral or verbal form, the prescriber (or the prescribers agent) shall indicate a specific brand name drug or product is ordered by the practitioner, and the pharmacist shall note such information on the file copy of the prescription.

c. On a prescription generated in electronic form, the prescriber shall indicate "Dispense as Written", "DAW", or "Brand Medically Necessary."

2. Where the prescriber has indicated that an equivalent drug product interchange is prohibited, then a non-licensed, non-certified, or non-registered agent of the pharmacy shall not inquire as to a patients desire for an equivalent drug product interchange.

3. In the event the prescriber has not prohibited equivalent drug product interchange in the manner described above, the pharmacist may select an equivalent drug product for dispensing, provided the patient has been informed of, and has consented to, the proposed cost saving interchange.

4. When the pharmacist selects a biological product rated as interchangeable for the product ordered by the prescriber, the dispensing pharmacist (or his designee) shall communicate to the prescriber by any means, but no later than five business days following the dispensing date, the specific product dispensed to the patient, including the name of the product and the manufacturer. However, no such communication to the prescriber is required when:

a. the prescriber prohibited interchange in the manner described above;

b. there is no product rated as interchangeable or therapeutically equivalent; or

c. the product dispensed is a refill not changed from the product dispensed on the prior filling of the prescription.

C. Unless otherwise allowed by law, drugs dispensed on prescription to a patient shall not be accepted for return, exchange, or re-dispensing by any pharmacist or pharmacy after such drugs have been removed from the pharmacy premises where they were dispensed.

D. When a patient or his designee wishes to return previously dispensed prescription drugs to a pharmacy for disposal, the pharmacy shall inform the patient or his designee of the disposal mechanisms available to him. In the event the pharmacy elects to accept such previously dispensed products for disposal, the pharmacy shall comply with the following requirements:

1. From the time of receipt of such products until the time of disposal, the pharmacy shall quarantine such products to keep them separate from its active dispensing stock and shall take appropriate security measures to prevent the theft or diversion of such products.

2. The pharmacy shall comply with the provisions of 21 CFR § 1317 or its successor for the pharmacy's disposal of controlled substances and other non-hazardous waste pharmaceuticals.

3. The pharmacy shall comply with the provisions of 40 CFR § 261 or its successor for the pharmacy's disposal of hazardous waste pharmaceuticals.

La. Admin. Code tit. 46, § LIII-2517

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2104 (October 2003), effective January 1, 2004, Amended by the Department of Health, Board of Pharmacy, LR 432162 (11/1/2017), Amended LR 46793 (6/1/2020).

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.