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HF 712

1st Engrossment - 90th Legislature (2017 - 2018) Posted on 02/20/2018 12:32pm

KEY: stricken = removed, old language.
underscored = added, new language.
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A bill for an act
relating to health; modifying and adding definitions; establishing standards for the
substitution of biological products; amending Minnesota Statutes 2016, sections
151.01, subdivision 5, by adding subdivisions; 151.21.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

Minnesota Statutes 2016, section 151.01, subdivision 5, is amended to read:


Subd. 5.

Drug.

"Drug" means all medicinal substances and preparations recognized by
the United States Pharmacopoeia and National Formulary, or any revision thereofdeleted text begin, vaccines
and biologicals, and
deleted text endnew text begin; biological products, other than blood or blood components;new text end all
substances and preparations intended for external and internal use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in humans or other animalsdeleted text begin,deleted text endnew text begin;new text end and all substances
and preparations, other than food, intended to affect the structure or any function of the
bodies of humans or other animals. The term drug shall also mean any compound, substance,
or derivative that is not approved for human consumption by the United States Food and
Drug Administration or specifically permitted for human consumption under Minnesota
law, and, when introduced into the body, induces an effect similar to that of a Schedule I
or Schedule II controlled substance listed in section 152.02, subdivisions 2 and 3, or
Minnesota Rules, parts 6800.4210 and 6800.4220, regardless of whether the substance is
marketed for the purpose of human consumption.

Sec. 2.

Minnesota Statutes 2016, section 151.01, is amended by adding a subdivision to
read:


new text begin Subd. 40. new text end

new text begin Biological product. new text end

new text begin "Biological product" has the meaning provided in United
States Code, title 42, section 262.
new text end

Sec. 3.

Minnesota Statutes 2016, section 151.01, is amended by adding a subdivision to
read:


new text begin Subd. 41. new text end

new text begin Interchangeable biological product. new text end

new text begin "Interchangeable biological product"
means a biological product that the U.S. Food and Drug Administration has:
new text end

new text begin (1) licensed, and determined to meet the standards for "interchangeability" under United
States Code, title 42, section 262(k)(4); or
new text end

new text begin (2) determined to be therapeutically equivalent, as set forth in the most recent edition
or supplement of the U.S. Food and Drug Administration publication titled "Approved Drug
Products with Therapeutic Equivalence Evaluations."
new text end

Sec. 4.

Minnesota Statutes 2016, section 151.21, is amended to read:


151.21 SUBSTITUTION.

Subdivision 1.

Generally.

Except as provided in this section, it shall be unlawful for
any pharmacist or pharmacist intern who dispenses prescriptions, drugs, and medicines to
substitute an article different from the one ordered, or deviate in any manner from the
requirements of deleted text beginan order ordeleted text end new text begina new text endprescriptionnew text begin drug ordernew text end without the approval of the prescriber.

Subd. 2.

deleted text beginBrand name specifieddeleted text endnew text begin Dispense as written prescription drug ordersnew text end.

When
a pharmacist receives a paper or hard copy prescriptionnew text begin drug ordernew text end on which the prescriber
has personally written in handwriting "dispense as written" or "D.A.W.," a prescription sent
by electronic transmission on which the prescriber has expressly indicated in a manner
consistent with the standards for electronic prescribing under Code of Federal Regulations,
title 42, section 423, that the prescription is to be dispensed as transmitted and which bears
the prescriber's electronic signature, or an oral prescription deleted text beginindeleted text endnew text begin fornew text end which the prescriber has
expressly indicated that the prescription is to be dispensed as communicated, the pharmacist
shall dispense the deleted text beginbrand name legenddeleted text end drug as prescribed.

Subd. 3.

deleted text beginBrand name not specifieddeleted text endnew text begin Other prescription drug ordersnew text end.

When a pharmacist
receives a paper or hard copy prescription on which the prescriber has not personally written
in handwriting "dispense as written" or "D.A.W.," a prescription sent by electronic
transmission on which the prescriber has not expressly indicated in a manner consistent
with the standards for electronic prescribing under Code of Federal Regulations, title 42,
section 423, that the prescription is to be dispensed as transmitted and which bears the
prescriber's electronic signature, or an oral prescription in which the prescriber has not
expressly indicated that the prescription is to be dispensed as communicated, and there is
available in the pharmacist's stock a less expensive generically equivalent drug new text beginor, if a
biological product is prescribed, a less expensive interchangeable biological product
new text enddeleted text beginthat,
in the pharmacist's professional judgment, is safely interchangeable with the prescribed
drug
deleted text end, then the pharmacist shall, after disclosing the substitution to the purchaser, dispense
the deleted text begingenericdeleted text endnew text begin generically equivalentnew text end drugnew text begin or the interchangeable biological productnew text end, unless
the purchaser objects. A pharmacist may also substitute pursuant to the oral instructions of
the prescriber. A pharmacist may not substitute a generically equivalent drug deleted text beginproductdeleted text end unless,
in the pharmacist's professional judgment, the substituted drug is therapeutically equivalent
and interchangeable to the prescribed drug.new text begin A pharmacist may not substitute a biological
product unless the U.S. Food and Drug Administration has determined the substituted
biological product to be interchangeable with the prescribed biological product.
new text end A pharmacist
shall notify the purchaser if the pharmacist is dispensing a drugnew text begin or biological productnew text end other
than the deleted text beginbrand namedeleted text endnew text begin specificnew text end drug new text beginor biological product new text endprescribed.

Subd. 3a.

Prescriptions by electronic transmission.

Nothing in this section permits a
prescriber to maintain "dispense as written" or "D.A.W." as a default on all prescriptions.
Prescribers must add the "dispense as written" or "D.A.W." designation to electronic
prescriptions individually, as appropriate.

Subd. 4.

Pricing.

A pharmacist dispensing a drug under the provisions of subdivision
3 shall not dispense a drug of a higher retail price than that of the deleted text beginbrand namedeleted text end drug prescribed.
If more than one safely interchangeable deleted text begingenericdeleted text end drug is available in a pharmacist's stock,
then the pharmacist shall dispense the least expensive alternative. deleted text beginAny difference between
acquisition cost to the pharmacist of the drug dispensed and the brand name drug prescribed
shall be passed on to the purchaser.
deleted text end

Subd. 4a.

Sign.

A pharmacy must post a sign in a conspicuous location and in a typeface
easily seen at the counter where prescriptions are dispensed stating: "In order to save you
money, this pharmacy will substitute whenever possible an FDA-approved, less expensive,
generic drug product, which is therapeutically equivalent to and safely interchangeable with
the one prescribed by your doctor, unless you object to this substitution."

Subd. 5.

Reimbursement.

Nothing in this section requires a pharmacist to substitute a
deleted text begin genericdeleted text end drug if the substitution will make the transaction ineligible for third-party
reimbursement.

Subd. 6.

Disclosure.

When a pharmacist dispenses a brand name legend drug and, at
that time, a less expensive generically equivalent drugnew text begin or interchangeable biological productnew text end
is also available in the pharmacist's stock, the pharmacist shall disclose to the purchaser
that a deleted text begingenericdeleted text endnew text begin generically equivalentnew text end drugnew text begin or interchangeable biological productnew text end is available.

Subd. 7.

Drug formulary.

This section does not apply when a pharmacist is dispensing
a prescribed drug to persons covered under a managed health care plan that maintains a
mandatory or closed drug formulary.

Subd. 8.

List of excluded products.

The Drug Formulary Committee established under
section 256B.0625, subdivision 13, shall establish a list of drug products that are to be
excluded from this section. This list shall be updated on an annual basis and shall be provided
to the board for dissemination to pharmacists licensed in the state.

Subd. 9.

Extended supply.

(a) After a patient has obtained an initial 30-day supply of
a prescription drug, and the patient returns to the pharmacy to obtain a refill, a pharmacist
may dispense up to a 90-day supply of that prescription drug to the patient when the following
requirements are met:

(1) the total quantity of dosage units dispensed by the pharmacist does not exceed the
total quantity of dosage units of the remaining refills authorized by the prescriber; and

(2) the pharmacist is exercising the pharmacist's professional judgment.

(b) The initial 30-day supply requirement in paragraph (a) is not required if the
prescription has previously been filled with a 90-day supply.

(c) Notwithstanding paragraph (a), a pharmacist may not exceed the number of dosage
units authorized by a prescriber for an initial prescription or subsequent refills if:

(1) the prescriber has specified on the prescription that, due to medical necessity, the
pharmacist may not exceed the number of dosage units identified on the prescription; or

(2) the prescription drug is a controlled substance, as defined in section 152.01,
subdivision 4.

new text begin Subd. 10. new text end

new text begin Electronic entry. new text end

new text begin (a) Within five business days following the dispensing of
a biological product, the dispensing pharmacist or the pharmacist's designee shall
communicate to the prescriber the name and manufacturer of the biological product
dispensed.
new text end

new text begin (b) The communication shall be conveyed by making an entry that is electronically
accessible to the prescriber through:
new text end

new text begin (1) an interoperable electronic medical records system;
new text end

new text begin (2) an electronic prescribing technology;
new text end

new text begin (3) a pharmacy benefit management system; or
new text end

new text begin (4) a pharmacy record.
new text end

new text begin (c) Entry into an electronic records system as described in paragraph (b) is presumed to
provide notice to the prescriber.
new text end

new text begin (d) When electronic communication as specified in paragraph (b) is not possible, the
pharmacist or the pharmacist's designee shall communicate to the prescriber the name and
manufacturer of the biological product dispensed by using mail, facsimile, telephone, or
other secure means of electronic transmission.
new text end

new text begin (e) Communication of the name and manufacturer of the biological product dispensed
shall not be required if:
new text end

new text begin (1) there is no U.S. Food and Drug Administration-approved interchangeable biological
product for the product prescribed; or
new text end

new text begin (2) a prescription is being refilled and the biological product being dispensed is the same
product dispensed on the prior filling of the prescription.
new text end