181 Neb. Admin. Code, ch. 7, § 004

Current through September 17, 2024

Section 181-7-004 - DISPENSING AND DISTRIBUTION OF IMMUNOSUPPRESSANT DRUGS

Only those licensees who are authorized to dispense as set out in Neb. Rev. Stat. § 38-2850 may dispense immunosuppressant drugs.

004.01DISPENSING AND DISTRIBUTION REQUIREMENTS. Participants must meet the requirements set out in Neb. Rev. Stat. § 71-2441 and these regulations.

004.01(A) AUTHORIZED TO DISPENSE. The following persons are authorized pursuant to Neb. Rev. Stat. § 38-2850 to dispense drugs:

(i) Licensed physicians who do not charge for the drugs;

(ii) Licensed physicians who hold a valid dispensing practitioner pharmacy license; and

(iii) Licensed pharmacists.

004.01(B)ACCEPTABLE USES OF DONATED DRUGS. Immunosuppressant drugs accepted by a participant from the donor may be:

(i) Dispensed to an ultimate user of the immunosuppressant drug; or

(ii) Distributed to another participant for dispensing.

004.01(C)PATIENT NOTIFICATION. Patients for whom immunosuppressant drugs are dispensed under the program must be notified by the prescribing practitioner that the immunosuppressant drugs they receive were originally dispensed to another patient and were returned for re-dispensing through the program.

004.02STORAGE REQUIREMENTS. The participant that receives donated immunosuppressant drugs for dispensing or distribution must:

(A) Provide equipment for the storage of immunosuppressant drugs donated to the program at controlled room temperature that must be stored between 59 and 86 degrees Fahrenheit;

(B) Maintain the inventory of donated immunosuppressant drugs separate from all other drug inventory of the participant; and

(C) Establish a secure location for the storage of the donated immunosuppressant drugs.

004.03RECORD KEEPING REQUIREMENTS. A perpetual inventory log book of all immunosuppressant drugs received, dispensed and distributed by a participant under the program must be maintained.

004.03(A)PERPETUAL INVENTORY LOG BOOK REQUIREMENTS. The perpetual inventory log book must contain the following information regarding all immunosuppressant drugs received, dispensed and distributed by a participant under the program:

(i) Name of the immunosuppressant drug;

(ii) Quantity of the immunosuppressant drug;

(iii) Expiration date of the immunosuppressant drug;

(iv) Lot number of the immunosuppressant drug;

(v) Name of participant;

(vi) Name of person who donated the immunosuppressant drug;

(vii) Name of person to whom the immunosuppressant drug was originally prescribed;

(viii) Name of person to whom the immunosuppressant drug was dispensed;

(ix) Date the immunosuppressant drug was dispensed;

(x) Name of the prescribing practitioner who wrote the prescription for the immunosuppressant drug to be dispensed under the program;

(xi) Name of the participant to which the immunosuppressant drug was distributed;

(xii) Date the immunosuppressant drug was distributed to another participant; and

(xiii) Date of destruction of the expired immunosuppressant drug.

004.03(B)RECORDS RETENTION. Hard copies of all prescriptions dispensed must be maintained by the participant to document the receipt of a prescription for the immunosuppressant drug to be dispensed and must be kept for five years pursuant to Neb. Rev. Stat. § 38-2871.

181 Neb. Admin. Code, ch. 7, § 004

Amended effective 12/23/2020