Maine Regluations

Maine State Regulatory Update April 2019

LB659 - An Act Regarding the Use of Interchangeable Biological Products

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. 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. 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.

What does this mean for pharmacists practicing in the state of Maine?

  • Pharmacists can now provide information to patients about potential interchangeable biological products. This will result in more positive health outcomes and improved adherence to prescribed therapy. If an interchange is made, then the pharmacist must provide notification to the prescriber. Ensure that proper documentation of the interchange occurs in the pharmacy system and that SOPs include this notification.

Maine State Regulatory Summary- 2018

The following laws, summarized below, were enacted by the Maine legislature during the 2018 session. All take effect August 1, 2018, unless otherwise noted.

LD 565 Public Law Chapter 364 Prescribing and Dispensing of Naloxone Hydrochloride by Pharmacists

LD 1892 Public Law Chapter 417 Emergency Prescribing and Dispensing of Naloxone Hydrochloride by Pharmacists

Chapter 40 Authorization Training and Procedures for Prescribing and Dispensing Naloxone Hydrochloride (Effective May 23, 2018)

Taken from the Maine Board of Pharmacy.

What do these new regulations mean for pharmacists practicing within the state of Maine?

  • Pharmacists can now prescribe, as well as dispense, naloxone for use to patients. Naloxone can be provided to a patient of any age, or to an immediate family member, friend, or any person in position to assist that individual in the event of an opioid related drug overdose.
  • Proper treatment and prescribing protocols must be established if the pharmacist is dispensing without a standing order or collaborative practice agreement under another qualified healthcare professional.
  • All prescribing activities must be within the guidelines outlined in Title 32, section 13815 of the Maine Regulatory code.

For full regulatory language, refer to the Maine Division of Professional Licensing.

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