Nebraska Administrative Code
Topic - HEALTH AND HUMAN SERVICES SYSTEM
Title 181 - SPECIAL HEALTH PROGRAMS
Chapter 6 - CANCER DRUG REPOSITORY PROGRAM
Section 181-6-004 - DISPENSING AND DISTRIBUTION REQUIREMENTS

Universal Citation: 181 NE Admin Rules and Regs ch 6 ยง 004

Current through September 17, 2024

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

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

(A) Licensed physicians who do not charge a handling fee for the cancer drugs;

(B) Licensed physicians who charge a handling fee for the cancer drugs and who hold a valid dispensing practitioner pharmacy license; and

(C) Licensed pharmacists.

004.02 ACCEPTABLE USES OF DONATED DRUGS. Cancer drugs accepted by a participant from the donor may be:

(A) Dispensed to an ultimate user of the cancer drug; or

(B) Distributed to another participant for dispensing.

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

004.04 STORAGE REQUIREMENTS. The participant that receives donated cancer drugs for dispensing or distribution must:

(A) Provide equipment for the storage of cancer 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 cancer drugs separate from all other drug inventory of the participant; and

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

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

004.05(A) PERPETUAL LOG BOOK REQUIREMENTS. The perpetual inventory log book must contain the following information regarding all cancer drugs received, dispensed and distributed by a participant under the program:
(i) Name of the cancer drug;

(ii) Quantity of the cancer drug;

(iii) Expiration date of the cancer drug;

(iv) Lot number of the cancer drug;

(v) Name of participant;

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

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

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

(ix) Date the cancer drug was dispensed;

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

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

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

(xiii) Date of destruction of the expired cancer drug; and

(xiv) Whether a handling fee was charged and the amount of any such fee.

004.05(B) RECORDS RETENTION. Hard copies of all prescriptions dispensed must be maintained by the participant to document the receipt of a prescription for the cancer drug to be dispensed and must be kept for 5 years pursuant to Neb. Rev. Stat. § 38-2871.

004.06 HANDLING FEE. A handling fee may be charged for dispensing donated drugs.

004.06(A) DISPENSING PERMIT. A participant that receives donated cancer drugs may charge a handling fee to the ultimate user for dispensing or distribution of cancer drugs under the program, except that a physician must hold a valid dispensing practitioner pharmacy license in order to charge the handling fee.

004.06(B) FEE LIMITS. If a handling fee is charged to the ultimate user to whom the cancer drug is dispensed or to the entity to which the cancer drug was distributed, the handling fee must not exceed the Medicaid provider dispensing fee that is applicable at the time the dispensing or distribution occurs.

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