N.D. Admin. Code 61-06-01-05

Current through Supplement No. 394, October, 2024

Section 61-06-01-05 - Drug distribution and control

1.General. A drug distribution system is the entirety of that mechanism by which a physician's prescription is executed, from the time the drug is ordered and received in the pharmacy, to the time the prescribed drug is dispensed to the patient.

2.Purchasing. All drugs and pharmaceutical products purchased and dispensed by a pharmacy providing home health care pharmacy services must meet national standards of quality (USP-NF standards) and must be clearly and accurately labeled by the manufacturer or distributor as to contents.

3.Procedure manual. A policy and procedure manual must be prepared in accordance with section 61-02-01-18 home health care pharmacy services.

4.Prescription. The pharmacist or pharmacy intern acting under the immediate supervision of a pharmacist must receive a written or verbal prescription from a physician before dispensing any compounded, sterile parenteral product. Prescriptions must be filed as required by law or rules of the board.

5.Profile. A pharmacy generated profile must be maintained for each patient as required by North Dakota Century Code section 43-15-31.1, and must also include:

a. Age.

b. Weight.

c. Sex.

d. Patient directions.

e. Other drugs patient is receiving.

f. Drug sensitivities and allergies to drugs and foods.

g. Primary diagnosis.

h. Documentation of patient training and continued competency.

i. Documentation of patient visits.

6.Labeling. Each compounded, sterile parenteral product dispensed to outpatients must be labeled with a permanent label with the following information:

a. Name, address, and telephone number of the pharmacy providing home health care pharmacy services.

b. Date and identifying prescription number.

c. Patient's full name.

d. Name of each drug, strength, and amount.

e. Directions for use to the patient, including infusion rate.

f. Physician's full name.

g. Required precautionary information.

h. Date and time of compounding.

i. Expiration date and time.

j. Identity of pharmacist compounding and dispensing.

7.Records and reports. The pharmacist managing the section of the pharmacy providing home health care pharmacy services shall maintain access to and submit, as appropriate, such records and reports as are required to ensure patient's health, safety, and welfare. Such records must be readily available, maintained for five years, and subject to inspections by the board of pharmacy or its agents. These must include, as a minimum, the following:

a. Policy and procedures manual.

b. Training manuals.

c. Policies and procedures for cytotoxic waste, if applicable.

d. Such other records and reports as may be required by law and rules of the board of pharmacy.

8.Delivery service. The pharmacist managing the section of the pharmacy providing home health care pharmacy services is responsible for the environment control of all products shipped. Therefore, any compounded, sterile parenteral product that is frozen, or requires refrigeration, must be shipped or delivered to a patient in appropriate coolers and stored appropriately in the patient's home.

N.D. Admin Code 61-06-01-05

Effective April 1, 1988. .

Amended by Administrative Rules Supplement 2014-354, October 2014, effective 10/1/2014. .

General Authority: NDCC 28-32-02

Law Implemented: NDCC 43-15-10(9), 43-15-10(12), 43-15-10(14), 43-15-31, 43-15-31.1