Bill Text: MI HB5598 | 2013-2014 | 97th Legislature | Introduced

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Bill Title: Health; pharmaceuticals; FDA-designated biosimilar drug products; allow substitution for brand-name drugs by pharmacists. Amends secs. 17702, 17704 & 17755 of 1978 PA 368 (MCL 333.17702 et seq.).

Spectrum: Partisan Bill (Republican 2-0)

Status: (Introduced - Dead) 2014-05-28 - Printed Bill Filed 05/28/2014 [HB5598 Detail]

Download: Michigan-2013-HB5598-Introduced.html

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HOUSE BILL No. 5598

May 27, 2014, Introduced by Reps. Yonker and Muxlow and referred to the Committee on Health Policy.

 

     A bill to amend 1978 PA 368, entitled

 

"Public health code,"

 

by amending sections 17702, 17704, and 17755 (MCL 333.17702,

 

333.17704, and 333.17755), section 17702 as amended by 2012 PA 209.

 

THE PEOPLE OF THE STATE OF MICHIGAN ENACT:

 

     Sec. 17702. (1) "Agent" means an individual designated by a

 

prescriber to act on behalf of or at the discretion of that

 

prescriber as provided in section 17744.

 

     (2) "Biosimilar drug product" means a biological product that

 

the FDA has determined to be biosimilar to a reference product and

 

to be interchangeable with that reference product for the indicated

 

use as prescribed. As used in this subsection, "biological

 

product", "biosimilar", "interchangeable", and "reference product"

 

mean those terms as defined in 41 USC 262.

 

     (3) (2) "Brand name" means the registered trademark name given

 

to a drug product by its manufacturer.

 

     (4) (3) "Current selling price" means the retail price for a

 

prescription drug that is available for sale from a pharmacy.

 

     Sec. 17704. (1) "FDA" means the United States food and drug

 

administration.

 

     (2) (1) "Federal act" means the federal food, drug, and

 

cosmetic act, of 1938, 21 U.S.C. USC 301 to 392.399f.

 

     (3) (2) "Generic name" means the established or official name

 

of a drug or drug product.

 

     (4) (3) "Harmful drug" means a drug intended for use by human

 

beings which that is harmful because of its toxicity, habit-forming

 

nature, or other potential adverse effect, the method of its use,

 

or the collateral measures necessary to its safe and effective use,

 

and which that is designated as harmful by the department, in

 

consultation with a board, according to rule.

 

     (5) (4) "Internship" means an educational program of

 

professional and practical experience for an intern.

 

     Sec. 17755. (1) When Except as otherwise provided in this

 

section, a pharmacist who receives a prescription for a brand name

 

drug product , the pharmacist may, or when a purchaser requests a

 

lower cost generically equivalent drug product, the pharmacist

 

shall may dispense a lower cost but not higher cost generically

 

equivalent drug product or lower cost biosimilar drug product if

 

available in the pharmacy. , except as provided in subsection (3).

 

If Except as otherwise provided in this section, upon the request

 

of the purchaser, a pharmacist who receives a prescription for a

 

brand name drug product shall dispense a lower cost generically

 

equivalent drug product or lower cost biosimilar drug product if

 

available in the pharmacy. The pharmacist shall notify the

 

purchaser if a drug is dispensed which that is not the prescribed

 

brand , the purchaser shall be notified and the prescription label

 

name drug product. Except as otherwise provided in section 17756,

 

the pharmacist shall indicate both the name of the brand name of

 

the drug product prescribed and the generic name or biosimilar name

 

of the brand drug product dispensed and designate each respectively

 

on the prescription label. If Except as otherwise provided in

 

section 17756, if the dispensed drug does not have a brand name,

 

the prescription label pharmacist shall indicate the generic name

 

or biosimilar name of the drug product dispensed , except as

 

otherwise provided in section 17756.on the prescription label.

 

     (2) If a pharmacist dispenses a generically equivalent drug

 

product or biosimilar drug product under subsection (1), the

 

pharmacist shall pass on the savings in cost to the purchaser or to

 

the third party payment source if the prescription purchase is

 

covered by a third party pay contract. The savings in cost is the

 

difference between the wholesale cost to the pharmacist of the 2

 

drug products.

 

     (3) If a pharmacist dispenses a biosimilar drug product under

 

subsection (1), the pharmacist shall indicate the biosimilar name

 

and the full name of the manufacturer and distributor, if

 

available, of the biosimilar drug product dispensed on the file

 

copy of the prescription.

 

     (4) (3) The pharmacist shall not dispense a generically

 

equivalent drug product or biosimilar drug product under subsection

 

(1) if any of the following applies:

 

     (a) The prescriber, in the case of a prescription in writing

 

signed by the prescriber, writes in his or her own handwriting

 

"dispense as written" or "d.a.w." on the prescription.

 

     (b) The prescriber, having preprinted on his or her

 

prescription blanks the statement "another brand of a generically

 

equivalent drug product or biosimilar drug product, identical in

 

dosage, form, and content of active ingredients, may be dispensed

 

unless initialed d.a.w.", writes in his or her own handwriting, the

 

initials "d.a.w." in a space, box, or square adjacent to the

 

statement.

 

     (c) The prescriber, in the case of a prescription other than

 

one 1 in writing signed by the prescriber, expressly indicates the

 

prescription is to be dispensed as communicated.

 

     (5) (4) A pharmacist may shall not dispense a drug product

 

with a total charge that exceeds the total charge of the drug

 

product originally prescribed, unless agreed to by the purchaser.