LB1181 LB1181
2024 2024
LEGISLATURE OF NEBRASKA
ONE HUNDRED EIGHTH LEGISLATURE
SECOND SESSION
LEGISLATIVE BILL 1181
Introduced by Ballard, 21.
Read first time January 12, 2024
Committee: Health and Human Services
1 A BILL FOR AN ACT relating to drugs; to amend sections 38-2854, 38-2890,
2 and 38-28,104, Reissue Revised Statutes of Nebraska, sections
3 28-410, 28-414, 71-2454, and 71-2478, Revised Statutes Cumulative
4 Supplement, 2022, and sections 38-2801 and 71-2479, Revised Statutes
5 Supplement, 2023; to change inventory requirements for registrants
6 manufacturing, distributing, storing, or dispensing controlled
7 substances; to allow a pharmacist to make certain changes to a
8 prescription for a Schedule II controlled substance after
9 consultation with the prescriber; to provide requirements for self-
10 inspection of pharmacies and hospital pharmacies; to change
11 qualifications for pharmacist interns; to change a registration
12 requirement for pharmacy technicians; to change prescription drug
13 labeling requirements; to eliminate obsolete provisions; to
14 harmonize provisions; and to repeal the original sections.
15 Be it enacted by the people of the State of Nebraska,
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1 Section 1. Section 28-410, Revised Statutes Cumulative Supplement,
2 2022, is amended to read:
3 28-410 (1) Each registrant manufacturing, distributing, or
4 dispensing controlled substances in Schedule I, II, III, IV, or V of
5 section 28-405 shall keep and maintain a complete and accurate record of
6 all stocks of such controlled substances on hand. Such records shall be
7 maintained for five years.
8 (2) Each registrant manufacturing, distributing, storing, or
9 dispensing such controlled substances shall prepare a biennial an annual
10 inventory of each controlled substance in the registrant's his or her
11 possession in accordance with 21 C.F.R. 1304.11, as such regulation
12 existed on January 1, 2024. Such inventory shall (a) be taken within two
13 years one year after the previous annual inventory date, (b) contain such
14 information as shall be required by the Board of Pharmacy, (c) be copied
15 and such copy forwarded to the department within thirty days after
16 completion, (d) be maintained at the location listed on the registration
17 for a period of five years, (e) contain the name, address, and Drug
18 Enforcement Administration number of the registrant, the date and time of
19 day the inventory was completed, and the signature of the person
20 responsible for taking the inventory, (f) list the exact count or measure
21 of all controlled substances listed in Schedules I, II, III, IV, and V of
22 section 28-405, and (g) be maintained in permanent, read-only format
23 separating the inventory for controlled substances listed in Schedules I
24 and II of section 28-405 from the inventory for controlled substances
25 listed in Schedules III, IV, and V of section 28-405. A registrant whose
26 inventory fails to comply with this subsection shall be guilty of a Class
27 IV misdemeanor.
28 (3) This section shall not apply to practitioners who prescribe or
29 administer, as a part of their practice, controlled substances listed in
30 Schedule II, III, IV, or V of section 28-405 unless such practitioner
31 regularly engages in dispensing any such drug or drugs to his or her
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1 patients.
2 (4) Controlled substances shall be stored in accordance with the
3 following:
4 (a) All controlled substances listed in Schedule I of section 28-405
5 must be stored in a locked cabinet; and
6 (b) All controlled substances listed in Schedule II, III, IV, or V
7 of section 28-405 must be stored in a locked cabinet or distributed
8 throughout the inventory of noncontrolled substances in a manner which
9 will obstruct theft or diversion of the controlled substances or both.
10 (5) Each pharmacy which is registered with the administration and in
11 which controlled substances are stored or dispensed shall complete a
12 controlled-substances inventory when there is a change in the pharmacist-
13 in-charge. The inventory shall contain the information required in the
14 annual inventory, and the original copy shall be maintained in the
15 pharmacy for five years after the date it is completed.
16 Sec. 2. Section 28-414, Revised Statutes Cumulative Supplement,
17 2022, is amended to read:
18 28-414 (1) Except as otherwise provided in this section or section
19 28-412 or when administered directly by a practitioner to an ultimate
20 user, a controlled substance listed in Schedule II of section 28-405
21 shall not be dispensed without a prescription from a practitioner
22 authorized to prescribe. All Beginning January 1, 2022, all such
23 prescriptions shall be subject to section 38-1,146, except that all such
24 prescriptions issued by a practitioner who is a dentist shall be subject
25 to section 38-1,146 beginning January 1, 2024. No prescription for a
26 controlled substance listed in Schedule II of section 28-405 shall be
27 filled more than six months from the date of issuance. A prescription for
28 a controlled substance listed in Schedule II of section 28-405 shall not
29 be refilled.
30 (2)(a) Except as provided in subdivision (2)(b) of this section, a
31 (2) A prescription for controlled substances listed in Schedule II of
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1 section 28-405 must contain the following information prior to being
2 filled by a pharmacist or dispensing practitioner: (i) (a) Patient's name
3 and address, (ii) (b) name of the drug, device, or biological, (iii) (c)
4 strength of the drug or biological, if applicable, (iv) (d) dosage form
5 of the drug or biological, (v) (e) quantity of the drug, device, or
6 biological prescribed, (vi) (f) directions for use, (vii) (g) date of
7 issuance, (viii) (h) prescribing practitioner's name and address, and
8 (ix) (i) Drug Enforcement Administration number of the prescribing
9 practitioner.
10 (b) After consultation with the prescribing practitioner, a
11 pharmacist may add or change the dosage form, drug strength, drug
12 quantity, directions for use, and issue date for a prescription for a
13 controlled substance listed in Schedule II of section 28-405.
14 (c) If the prescription is a written paper prescription, the paper
15 prescription must contain the prescribing practitioner's manual
16 signature. If the prescription is an electronic prescription, the
17 electronic prescription must contain all of the elements in subdivision
18 (2)(a) of this section subdivisions (a) through (i) of this subsection,
19 must be digitally signed, and must be transmitted to and received by the
20 pharmacy electronically to meet all of the requirements of the Controlled
21 Substances Act, 21 U.S.C. 801 et seq., as it existed on January 1, 2014,
22 pertaining to electronic prescribing of controlled substances.
23 (3)(a) In emergency situations, a controlled substance listed in
24 Schedule II of section 28-405 may be dispensed pursuant to an oral
25 prescription reduced to writing in accordance with subsection (2) of this
26 section, except for the prescribing practitioner's signature, and bearing
27 the word "emergency".
28 (b) For purposes of this section, emergency situation means a
29 situation in which a prescribing practitioner determines that (i)
30 immediate administration of the controlled substance is necessary for
31 proper treatment of the patient, (ii) no appropriate alternative
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1 treatment is available, including administration of a drug which is not a
2 controlled substance listed in Schedule II of section 28-405, and (iii)
3 it is not reasonably possible for the prescribing practitioner to provide
4 a signed, written or electronic prescription to be presented to the
5 person dispensing the controlled substance prior to dispensing.
6 (4)(a) In nonemergency situations:
7 (i) A controlled substance listed in Schedule II of section 28-405
8 may be dispensed pursuant to a facsimile of a written, signed paper
9 prescription if the original written, signed paper prescription is
10 presented to the pharmacist for review before the controlled substance is
11 dispensed, except as provided in subdivision (a)(ii) or (iii) of this
12 subsection;
13 (ii) A narcotic drug listed in Schedule II of section 28-405 may be
14 dispensed pursuant to a facsimile of a written, signed paper prescription
15 (A) to be compounded for direct parenteral administration to a patient
16 for the purpose of home infusion therapy or (B) for administration to a
17 patient enrolled in a hospice care program and bearing the words "hospice
18 patient"; and
19 (iii) A controlled substance listed in Schedule II of section 28-405
20 may be dispensed pursuant to a facsimile of a written, signed paper
21 prescription for administration to a resident of a long-term care
22 facility.
23 (b) For purposes of subdivisions (a)(ii) and (iii) of this
24 subsection, a facsimile of a written, signed paper prescription shall
25 serve as the original written prescription and shall be maintained in
26 accordance with subsection (1) of section 28-414.03.
27 (5)(a) A prescription for a controlled substance listed in Schedule
28 II of section 28-405 may be partially filled if the pharmacist does not
29 supply the full quantity prescribed and he or she makes a notation of the
30 quantity supplied on the face of the prescription or in the electronic
31 record. The remaining portion of the prescription may be filled no later
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1 than thirty days after the date on which the prescription is written. The
2 pharmacist shall notify the prescribing practitioner if the remaining
3 portion of the prescription is not or cannot be filled within such
4 period. No further quantity may be supplied after such period without a
5 new written, signed paper prescription or electronic prescription.
6 (b) A prescription for a controlled substance listed in Schedule II
7 of section 28-405 written for a patient in a long-term care facility or
8 for a patient with a medical diagnosis documenting a terminal illness may
9 be partially filled. Such prescription shall bear the words "terminally
10 ill" or "long-term care facility patient" on its face or in the
11 electronic record. If there is any question whether a patient may be
12 classified as having a terminal illness, the pharmacist shall contact the
13 prescribing practitioner prior to partially filling the prescription.
14 Both the pharmacist and the prescribing practitioner have a corresponding
15 responsibility to assure that the controlled substance is for a
16 terminally ill patient. For each partial filling, the dispensing
17 pharmacist shall record on the back of the prescription or on another
18 appropriate record, uniformly maintained and readily retrievable, the
19 date of the partial filling, quantity dispensed, remaining quantity
20 authorized to be dispensed, and the identification of the dispensing
21 pharmacist. The total quantity of controlled substances listed in
22 Schedule II which is dispensed in all partial fillings shall not exceed
23 the total quantity prescribed. A prescription for a Schedule II
24 controlled substance for a patient in a long-term care facility or a
25 patient with a medical diagnosis documenting a terminal illness is valid
26 for sixty days from the date of issuance or until discontinuance of the
27 prescription, whichever occurs first.
28 Sec. 3. Section 38-2801, Revised Statutes Supplement, 2023, is
29 amended to read:
30 38-2801 Sections 38-2801 to 38-28,107 and section 4 of this act and
31 the Nebraska Drug Product Selection Act shall be known and may be cited
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1 as the Pharmacy Practice Act.
2 Sec. 4. Effective January 1, 2025, any self-inspection of a
3 pharmacy or a hospital pharmacy shall be made using a form authorized by
4 the board. The board shall authorize the form for use beginning January
5 1, 2025, on or before November 1, 2024, and such form shall remain in
6 effect for a period of at least one year. Any updates to the form for
7 subsequent years shall be authorized on or before November 1 of that
8 year. If the board fails to authorize the form on or before November 1 of
9 any year, any inspection of a pharmacy or hospital pharmacy for the
10 following calendar year shall be conducted by the board or department, as
11 applicable.
12 Sec. 5. Section 38-2854, Reissue Revised Statutes of Nebraska, is
13 amended to read:
14 38-2854 (1) A pharmacist intern shall be (a) at least seventeen
15 years of age and (b)(i) (a) a student currently enrolled in an accredited
16 pharmacy program, (ii) (b) a graduate of an accredited pharmacy program
17 serving his or her internship, or (iii) (c) a graduate of a pharmacy
18 program located outside the United States which is not accredited and who
19 has successfully passed equivalency examinations approved by the board.
20 Intern registration based on enrollment in or graduation from an
21 accredited pharmacy program shall expire not later than fifteen months
22 after the date of graduation or at the time of professional licensure,
23 whichever comes first. Intern registration based on graduation from a
24 pharmacy program located outside of the United States which is not
25 accredited shall expire not later than fifteen months after the date of
26 issuance of the registration or at the time of professional licensure,
27 whichever comes first.
28 (2) A pharmacist intern may compound and dispense drugs or devices
29 and fill prescriptions only in the presence of and under the immediate
30 personal supervision of a licensed pharmacist. Such licensed pharmacist
31 shall either be (a) the person to whom the pharmacy license is issued or
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1 a person in the actual employ of the pharmacy licensee or (b) the
2 delegating pharmacist designated in a delegated dispensing agreement by a
3 hospital with a delegated dispensing permit.
4 (3) Performance as a pharmacist intern under the supervision of a
5 licensed pharmacist shall be predominantly related to the practice of
6 pharmacy and shall include the keeping of records and the making of
7 reports required under state and federal statutes. The department, with
8 the recommendation of the board, shall adopt and promulgate rules and
9 regulations as may be required to establish standards for internship.
10 Sec. 6. Section 38-2890, Reissue Revised Statutes of Nebraska, is
11 amended to read:
12 38-2890 (1) All pharmacy technicians employed by a health care
13 facility licensed under the Health Care Facility Licensure Act shall be
14 registered with the Pharmacy Technician Registry created in section
15 38-2893. In order to be employed as a pharmacy technician in su