An Act Regarding the Use of Interchangeable Biological Products
Maine Legislature, Session 129, LD 0659
Committee: Health Coverage, Insurance and Financial Services
Sponsors: PERRY, GRATWICK, ARATA, CRAVEN, O'CONNOR, MOORE
Amends: 32 MRSA §13702-A, 32 MRSA §13781, 32 MRSA §13794

Legislative Document
No. 659
H.P. 480
House of Representatives, February 7, 2019
An Act Regarding the Use of Interchangeable Biological Products
Reference to the Committee on Health Coverage, Insurance and Financial Services 
suggested and ordered printed.
ROBERT B. HUNT
Clerk
Presented by Representative PERRY of Calais.
Cosponsored by Senator GRATWICK of Penobscot and
Representatives: ARATA of New Gloucester, CRAVEN of Lewiston, O'CONNOR of 
Berwick, Senator: MOORE of Washington.
Be it enacted by the People of the State of Maine as follows:
Sec. 1.  32 MRSA §13702-A, sub-§1-A is enacted to read:
1-A.  Biological product.  "Biological product" has the same meaning as in 42 
United States Code, Section 262.
Sec. 2.  32 MRSA §13702-A, sub-§14-A is enacted to read:
14-A.  Interchangeable biological product.  "Interchangeable biological product" 
means a biological product that the federal Food and Drug Administration has:
A.  Licensed and determined meets the standards for interchangeability pursuant to 
United States Code, Section 262(k)(4); or
B.  Determined is therapeutically equivalent as set forth in the most recent edition of 
or supplement to the federal Food and Drug Administration's "Approved Drug 
Products with Therapeutic Equivalence Evaluations" or a successor publication.
Sec. 3.  32 MRSA §13702-A, sub-§31-A is enacted to read:
31-A.  Proper name.  "Proper name," as it relates to a biological product, means the 
nonproprietary name for a biological product designated by the federal Food and Drug 
Administration for use on each package of the product.
Sec. 4.  32 MRSA §13781, as amended by PL 2007, c. 85, §§1 and 2, is further 
amended to read:
§13781.  Generic and therapeutically equivalent substitution
A written prescription issued by a practitioner in this State may contain a box in the 
lower right-hand corner of the prescription form. The following words must appear to the 
left of this box: "Any drug which that is the generic and therapeutic equivalent of the 
drug or any biological product that is an interchangeable biological product of the 
biological product specified above in this prescription must be dispensed, provided that 
no check mark ( ) has been handwritten in the box in the lower right-hand corner."
Except with regard to a patient who is paying for a drug or biological product with 
the patient's own resources, any pharmacist receiving a prescription in which no 
handwritten check mark ( ) is found in the box provided shall substitute a generic and 
therapeutically equivalent drug for the drug or an interchangeable biological product for 
the biological product specified on the prescription if the substituted drug or 
interchangeable biological product is distributed by a business entity doing business in 
the United States that is subject to suit and the service of legal process in the United 
States and the price of the substituted drug or interchangeable biological product does not 
exceed the price of the drug or biological product specified by the practitioner; except 
that, when the cost of a prescription is to be reimbursed under the MaineCare program 
pursuant to Title 22, chapter 855, the pharmacist shall substitute a generic and 
therapeutically equivalent drug or an interchangeable biological product only when the 
Department of Health and Human Services has determined that the substitute drug or 
interchangeable biological product would be a more cost-effective alternative than the 
drug or biological product prescribed by the practitioner.  Except for prescribed drugs 
listed under the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 
United States Code, Section 812, as amended, as Schedule II drugs, with regard to a 
patient who is paying for a drug or biological product with the patient's own resources, a 
pharmacist shall inquire about the patient's preference for either the brand-name drug or 
generic and therapeutically equivalent drug or for either the prescribed biological product 
or interchangeable biological product and dispense the drug or biological product that the 
patient prefers.
Except with regard to a patient who is paying for a drug or biological product with 
the patient's own resources, if a written prescription issued by a practitioner in this State 
does not contain the box described in this section, a pharmacist shall substitute a generic 
and therapeutically equivalent drug for the drug or an interchangeable biological product 
for the biological product specified on the prescription if the substituted drug or 
interchangeable biological product is distributed by a business entity doing business in 
the United States that is subject to suit and the service of legal process in the United 
States and the price of the substituted drug or interchangeable biological product does not 
exceed the price of the drug or biological product specified by the practitioner, unless a 
practitioner has handwritten on the prescription form, along with the practitioner's 
signature, "dispense as written," "DAW," "brand," "brand necessary" or "brand medically 
necessary"; except that, when the cost of a prescription is to be reimbursed under the 
MaineCare program pursuant to Title 22, chapter 855, the pharmacist shall substitute a 
generic and therapeutically equivalent drug or an interchangeable biological product only 
when the Department of Health and Human Services has determined that the substitute 
drug or interchangeable biological product would be a more cost-effective alternative 
than the drug or biological product prescribed by the practitioner.  Except for prescribed 
drugs listed under the Comprehensive Drug Abuse Prevention and Control Act of 1970, 
United States Code, Section 812, as amended, as Schedule II drugs, with regard to a 
patient who is paying for a drug or biological product with the patient's own resources, a 
pharmacist shall inquire about the patient's preference for either the brand-name drug or 
generic and therapeutically equivalent drug or for either the prescribed biological product 
or interchangeable biological product and dispense the drug or biological product that the 
patient prefers.
Any pharmacist who substitutes a generic and therapeutically equivalent drug or an 
interchangeable biological product under this section shall inform the person to whom the 
drug or interchangeable biological product is dispensed of the substitution.  When any 
substitution is made under this section, the pharmacist shall cause all information as 
required by section 13794, the name of the generic and therapeutically equivalent drug, 
and the name or abbreviation of the drug manufacturer or distributor of that substitute 
drug and all other information as required by section 13794 or, in the case of an 
interchangeable biological product, the proper name and the name of the manufacturer of 
the interchangeable biological product, to appear on the container label of the drug or 
interchangeable biological product dispensed.
This section does not apply to prescriptions ordered by practitioners for patients in 
hospitals when those prescriptions are filled by a hospital pharmacy or in any institution 
where a formulary system is established.
Within 5 business days after a pharmacist dispenses a biological product, the 
dispensing pharmacist or the pharmacist's designee shall enter in an electronic records 
system that is electronically accessible to the practitioner who prescribed the biological 
product the specific biological product dispensed, including the name of the biological 
product and the manufacturer.  For purposes of this paragraph, "electronic records 
system" means an interoperable electronic medical records system, an electronic 
prescribing technology, a pharmacist benefit management system or an electronic 
pharmacy record.  Entry into an electronic records system as described in this paragraph 
is presumed to provide notice to the practitioner.  If a pharmacist cannot make an entry in 
an electronic records system, the pharmacist shall notify the practitioner of the specific 
biological product dispensed by facsimile, telephone, electronic transmission or other 
similar means.  Notice to a practitioner under this paragraph is not required if the federal 
Food and Drug Administration has not approved an interchangeable biological product 
for the product prescribed or a refill prescription is not changed from the biological 
product dispensed on the prior filling of the prescription.
The board shall maintain a link on the board's publicly accessible website to the 
current list of all biological products determined by the federal Food and Drug 
Administration to be an interchangeable biological product.
For the purposes of this section, "drug" does not include biological products.
Sec. 5.  32 MRSA §13794, first ¶, as amended by PL 1999, c. 130, §14, is further 
amended to read:
Every drug dispensed pursuant to prescription, whether for a legend drug or not, must 
carry on the label the following information:  the prescription number; the date of filling; 
the patient's name; directions for use; the name and strength of the drug and the amount 
dispensed, including either the brand name of the drug or, if a generic and therapeutically 
equivalent drug or interchangeable biological product is dispensed it the label must be in 
accordance with section 13781; the beyond use date of the drug; the name of the 
practitioner prescribing the drug; and the name, address and telephone number of the 
pharmacy where the prescription was compounded and dispensed.  For purposes of this 
section, "beyond use date" means a date beyond which the contents of the prescription are 
not recommended to be used.
SUMMARY
This bill provides for pharmacist substitution of interchangeable biological products 
for prescribed biological products in a manner similar to the current regulation of generic 
drug substitution.  The bill defines "biological product" and "interchangeable biological 
product."