Maine Revised Statutes Title 32 Sec. 13781 – Generic and therapeutically equivalent substitution
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Terms Used In Maine Revised Statutes Title 32 Sec. 13781
- Board: means the Maine Board of Pharmacy. See Maine Revised Statutes Title 32 Sec. 13702-A
- Department: means the Department of Professional and Financial Regulation. See Maine Revised Statutes Title 32 Sec. 13702-A
- dispensing: means the preparation and delivery of a prescription drug in a suitable container appropriately labeled for subsequent administration to or use by a patient or other individual entitled to receive the prescription drug pursuant to a lawful order of a practitioner. See Maine Revised Statutes Title 32 Sec. 13702-A
- Drug: means :
A. See Maine Revised Statutes Title 32 Sec. 13702-AElectronic transmission: means transmission of information in electronic form or the transmission of the exact visual image of a document by way of electronic equipment. See Maine Revised Statutes Title 32 Sec. 13702-A Interchangeable biological product: means a biological product that the federal Food and Drug Administration has:
A. See Maine Revised Statutes Title 32 Sec. 13702-AManufacturer: means a person engaged in the manufacture of prescription drugs. See Maine Revised Statutes Title 32 Sec. 13702-A Person: means an individual, corporation, partnership, association or any other legal entity. See Maine Revised Statutes Title 32 Sec. 13702-A Pharmacist: means an individual provider of health care services licensed by this State to engage in the practice of pharmacy. See Maine Revised Statutes Title 32 Sec. 13702-A Pharmacy: means :
A. See Maine Revised Statutes Title 32 Sec. 13702-APractitioner: means an individual who is licensed, registered or otherwise authorized in the appropriate jurisdiction to prescribe and administer drugs in the course of professional practice. See Maine Revised Statutes Title 32 Sec. 13702-A therapeutically equivalent drug: means any drug that has identical amounts of the same active ingredients in the same dosage form and in the same concentration that, when administered in the same amounts, will produce or can be expected to have the same therapeutic effect as the drug prescribed. See Maine Revised Statutes Title 32 Sec. 13702-A United States: includes territories and the District of Columbia. See Maine Revised Statutes Title 1 Sec. 72
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 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.” [PL 2019, c. 34, §4 (AMD).]
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 § 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. [PL 2019, c. 34, §4 (AMD).]
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, 21 United States Code § 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. [PL 2019, c. 34, §4 (AMD).]
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 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. [PL 2019, c. 34, §4 (AMD).]
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. [PL 1987, c. 710, §5 (NEW).]
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. [PL 2019, c. 34, §4 (NEW).]
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. [PL 2019, c. 34, §4 (NEW).]
For the purposes of this section, “drug” does not include biological products. [PL 2019, c. 34, §4 (NEW).]
SECTION HISTORY
PL 1987, c. 710, §5 (NEW). PL 1997, c. 245, §§13,14 (AMD). PL 2003, c. 384, §1 (AMD). PL 2003, c. 689, §B6 (REV). PL 2007, c. 85, §§1, 2 (AMD). PL 2019, c. 34, §4 (AMD).